Sunday, December 6, 2015

Riassunto Takeda presenta i dati dello studio clinico di fase 3 TOURMALINE-MM1 per NINLARO® (ixazomib), il primo e unico inibitore orale del proteasoma a somministrazione monosettimanale per il trattamento del mieloma multiplo

. Buy Home Accessories online Buy Insulin without prescription Buy Mysoline (Primidone) ORLANDO, Fla.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502) ha oggi presentato i risultati dello studio clinico TOURMALINE-MM1 alla 57a conferenza e fiera annuale organizzata dall American Society of Hematology (ASH), che dimostrano l efficacia del trattamento a base di capsule di NINLARO® (ixazomib) nell estensione della sopravvivenza libera da progressione (PFS) con profilo di tollerabilit`a gestibile nei pazienti affetti da mieloma multiplo recidivo e/o refrattario. Il testo originale del presente annuncio, redatto nella lingua di partenza, `e la versione ufficiale che fa fede. http://future-pharmaceuticals.blogspot.com Buy Cartia Xt (Diltiazem Hcl) without Rx Nimotop (Nimodipine) without Rx About Keflex (Cephalexin) with no prescription Le traduzioni sono offerte unicamente per comodit`a del lettore e devono rinviare al testo in lingua originale, che `e l unico giuridicamente valido.

Saturday, October 10, 2015

Feld Entertainment und Primary Children’s Hospital k"undigen Finanzierung neuer Krebsforschung an

ELLENTON, Florida--(BUSINESS WIRE)--Die Familie Feld, Eigent"umer von Feld Entertainment Inc., der Muttergesellschaft von Ringling Bros. Cialis Soft (Tadalafil) with free prescription and Barnum & Bailey® und des Ringling Bros. Tadalis Sx (Tadalafil) with no prescription Center for Elephant Conservation®, hat heute eine neue Finanzierungszusammenarbeit mit dem Intermountain Primary Children’s Hospital (PCH) und Dr. Buy Strattera (Atomoxetine) with no Rx Joshua Schiffman, Onkologe an der p"adiatrischen Abteilung der University of Utah und Forscher am Huntsman Cancer Institute, angek"undigt. Geroxalen without prescription Diese Fundraising-Aktion wird durchgef"uhrt, unmittelbar nachdem Dr. About Estrace (Estradiol) with no prescription Schiffman im Journal of the American Medical Association (JAMA) neue Krebsforschungsergebnisse ver"offentlicht hat. Dr. Buy Ester C online Schiffman und das Team des Primary Children’s Hospital, der p"adiatrischen Abteilung und des Huntsman Cancer Institute – alle in Salt Lake City, Utah – untersuchen, weshalb es bei Elefanten so wenige F"alle von Krebs gibt, warum diese Krebsresistenz bei Elefanten, nicht aber bei Menschen zu beobachten ist und wie das mit neuen Behandlungsm"oglichkeiten f"ur Kinderkrebs in Zusammenhang gebracht werden k"onnte. "Uber 16.000 Kinder und Teenager erhalten jedes Jahr in den USA eine Krebsdiagnose. http://doctor-consult.blogspot.com Elefanten erkranken dagegen im Laufe ihres Lebens fast nie an Krebs. Dr. Schiffman; Dr. Dennis Schmitt, Vorstand Veterin"arleistungen und Forschungsleiter bei Ringling Bros. and Barnum & Bailey, und Dr. Wendy Kiso, Expertin f"ur Forschung und Naturschutz am Ringling Bros. Center for Elephant Conservation, sowie weitere wissenschaftliche Mitarbeiter in ihrem Team haben k"urzlich best"atigt, dass Elefanten kaum jemals Krebs bekommen und die Sterberate bei ihnen bei weniger als f"unf Prozent liegt – im Vergleich zu bis zu 25 Prozent bei Menschen. Im Hinblick auf das Elefanten-Genom schilderten sie, dass das Tumorsuppressorgen TP53 bei Elefanten vierzigmal vorkommt – im Vergleich zu nur zweimal bei Menschen. In Zusammenarbeit mit dem Hogle Zoo in Utah und dem Ringling Bros. Center for Elephant Conservation studierten Dr. Schiffman und Kollegen die Reaktion von Elefantenblut auf DNA-sch"adigende Wirkstoffe und entdeckten, dass Elefantenzellen den Zelltod im Vergleich zu menschlichen Zellen schneller durchgehen. Dr. Schiffman glaubt, dass dies der Grund daf"ur sein k"onnte, dass Elefanten weniger oft Krebs bekommen als Menschen. Die vollst"andigen Ergebnisse der Studie wurden in der neuen Ausgabe des Journal of the American Medical Association publiziert. „Im Rahmen dieser Partnerschaft zwischen Ringling Bros. und dem Primary Children’s Hospital untersuchen wir jetzt, wie wir diese Entdeckungen bei Kindern und Familien anwenden k"onnen, bei denen das Krebsrisiko besonders hoch ist”, sagte Dr. Schiffman. „Wir wollen diese Erkenntnisse aus der Natur nutzen, um in der Humanmedizin Pr"aventivmassnahmen zu ergreifen, Werkzeuge f"ur die Fr"uherkennung zu entwickeln und Krebs zu behandeln.” Die Anwendung der Translationsforschung zu Krebs – Ergebnisse der Grundlagenwissenschaft, die die menschliche Gesundheit und das menschliche Wohlbefinden durch die Verbesserung von Heil- und Pflegemethoden und die Schaffung bedeutsamer Ergebnisse f"ur die Gesundheit f"ordern – k"onnte den Weg f"ur ganz neue Schritte in der Krebsforschung und -behandlung ebnen – vom Labortisch bis zum Klinikbett. „Wir haben das Ringling Bros. Center for Elephant Conservation vor zwanzig Jahren gegr"undet, um den bedrohten Indischen Elefanten f"ur zuk"unftige Generationen zu sch"utzen. Damals konnten wir nicht ahnen, dass bei ihm der Schl"ussel f"ur die Krebsbehandlung liegen k"onnte. Wir sind hocherfreut, dass wir diesen Beitrag leisten k"onnen”, sagte Kenneth Feld, Chairman und CEO von Feld Entertainment. Die Familie Feld gr"undet den Ringling Bros. Children’s Fund™ als Bestandteil ihrer laufenden wohlt"atigen T"atigkeit "uber die Feld Family Foundation, mit der Kinderhilfsorganisationen unterst"utzt werden. Im Rahmen der Partnerschaft mit dem Primary Children’s Hospital, der p"adiatrischen Abteilung und Dr. Schiffman werden der Ringling Bros. Children’s Fund und Ringling Bros. and Barnum & Bailey "uber eine Million US-Dollar zur Unterst"utzung der Krebsforschung und der Behandlung von Kindern stiften. In den n"achsten 50 St"adten, die Ringling Bros. and Barnum & Bailey besucht, wird Ringling Bros. jeweils 10.000 US-Dollar an eine lokale Kinderklinik oder ein Behandlungszentrum f"ur Kinder spenden, und der Ringling Bros. Children’s Fund wird jede Spende um weitere 10.000 US-Dollar an die Primary Children’s Hospital Foundation erg"anzen, mit denen das Pediatric Cancer Research Program des PCH unterst"utzt wird. Der Schwerpunkt dieses Programms, das zur Unterst"utzung der Elefantenforschung beigetragen hat, lag auf neuartigen Ans"atzen zur Pr"avention und Diagnose und zur Verbesserung der Qualit"at der Krebsbehandlung. „Bei Ringling Bros. geht es uns darum, Familien zu unterhalten und den Gemeinwesen, in denen wir jede Woche auftreten, etwas zur"uckzugeben. Zus"atzlich zu den finanziellen Beitr"agen durch Feld Entertainment und den Ringling Bros. Children’s Fund werden wir unsere K"unstler direkt in die Kliniken schicken. Dort werden sie Familien unterhalten, die nicht zur Show kommen k"onnen”, sagte Alana Feld, Executive Vice President von Feld Entertainment und Produzentin von Ringling Bros. und Barnum & Bailey. „Dank dieser laufenden Partnerschaft mit Ringling Bros. bei der Aufbringung von Forschungsgeldern k"onnen wir Unterst"utzung f"ur neue Krebsbehandlungsprotokolle bereitstellen, die einen innovativeren und integrativeren Ansatz f"ur die Krebsbehandlung erm"oglichen. Wir k"onnen ferner langfristig bessere Ergebnisse schaffen und Familien durch langfristige Pflege unterst"utzen”, sagt Dr. Dr. med. Richard Lemons, medizinischer Leiter und Leiter p"adiatrische H"amatologie/Onkologie am Primary Children’ Hospital. Dr. Lemons leitet das Pediatric Cancer Research Program des PCH . „So viele Familien im ganzen Land sind von Krebs betroffen, und leider verbreitet sich das immer mehr, vor allem bei Kindern. Wir hegen die Hoffnung, dass durch unsere Forschung neue Aussichten f"ur verbesserte Behandlungen von Kinderkrebs entstehen”, sagt Katy Welkie, CEO des Primary Children’s Hospital. Weitere Informationen "uber Ringling Bros. and Barnum & Bailey und das Ringling Bros. Center for Elephant Conservation und "uber die Partnerschaft sowie Informationen dar"uber, wie Familien f"ur die Forschung spenden k"onnen, finden Sie online unter .ringling.com und .ringlingelephantcenter.com. "Uber Feld Entertainment Feld Entertainment ist der weltweite Marktf"uhrer im Bereich der Produktion und Pr"asentation von Tourneen mit Live-Familienunterhaltung, die f"ur gute Laune und unvergessliche Momente sorgen. Die Shows des Unternehmens werden jedes Jahr von 30 Millionen Menschen besucht. Die Produktionen von Feld Entertainment wurden bisher in "uber 75 L"andern auf sechs Kontinenten gezeigt. Dazu z"ahlen Shows von Ringling Bros. and Barnum & Bailey®, Monster Jam®, Monster Energy Supercross, AMSOIL Arenacross, Disney On Ice Presented by Stonyfield YoKids Organic Yogurt, Disney Live! Presented by Stonyfield YoKids Organic Yogurt und Marvel Universe LIVE! Weitere Informationen "uber Feld Entertainment finden Sie online unter .feldentertainment.com. Weitere Informationen "uber das Ringling Bros. Center for Elephant Conservation finden Sie unter .ringlingelephantcenter.com. "Uber das Primary Children’s Hospital (PCH) Das Primary Children’s Hospital ist die einzige Kinderklinik der Maximalversorgung f"ur Utah, Idaho, Wyoming, Nevada und Montana. Hier werden Kinder mit den kompliziertesten Verletzungen und Erkrankungen behandelt, u. a. Kinder, die Herz-, Leber-, Nieren- und Knochenmarkstransplantate brauchen. Das Primary Children’s ist das einzige p"adiatrische Traumazentrum der Stufe 1 im Intermountain West. Es geh"ort zu Intermountain Healthcare, einem gemeinn"utzigen Gesundheitssystem, und ist an die University of Utah School of Medicine angegliedert. Hier kommen Forschung, Ausbildung und ausgezeichnete Versorgung zusammen, um die beste Gesundheitsversorgung f"ur Kinder zu erm"oglichen. Spenden werden von der Primary Children’s Hospital Foundation, einem separaten, eingetragenen gemeinn"utzigen Verein nach IRS Code 501(c)(3), verwaltet. Die Stiftung unterst"utzt den Auftrag der Klinik, p"adiatrische Behandlung auf h"ochstem Niveau in einer Atmosph"are von Liebe und Geborgenheit zu bieten. "Uber die p"adiatrische Abteilung der University of Utah Die p"adiatrische Abteilung ist die zweitgr"osste Abteilung an der University of Utah School of Medicine und landesweit eine der gr"ossten p"adiatrischen Abteilungen. An der Abteilung unterrichten 270 Hochschullehrkr"afte, wobei das Verh"altnis von M"annern und Frauen recht ausgewogen ist. Innerhalb der School of Medicine haben wir die meisten fest angestellten weiblichen Hochschullehrkr"afte. Die Abteilung besteht aus 22 medizinischen Abteilungen und Programmen, die in Verbindung mit vier Hauptbereichen arbeiten: Bildung, Forschung, Klinik und Wissenschaft. Die Abteilungen bieten ein komplettes Spektrum p"adiatrischer Spezial- und Unterspezialdienste f"ur Kinder im gesamten Intermountain West. "Uber das Huntsman Cancer Institute und die University of Utah Das Huntsman Cancer Institute (HCI) ist weltweit eines der f"uhrenden Zentren f"ur akademische Forschung und Krebsbehandlung. Das HCI verwaltet die Datenbank Utah Population Database – mit "uber 16 Millionen Eintr"agen zu Genealogie, Krankenakten und Bev"olkerungsstatistiken die gr"osste Genetik-Datenbank der Welt. Mit Hilfe dieser Daten konnten Forscher des HCI mehrere krebserregende Gene ermitteln, die unter anderem f"ur Melanome, Darm- und Brustkrebs und Paragangliome verantwortlich sind. Das HCI ist Mitglied des National Comprehensive Cancer Network (eines aus 26 Mitgliedern bestehenden Zusammenschlusses der f"uhrenden Krebszentren der Welt) und ist vom National Cancer Institute als Comprehensive Cancer Center ausgewiesen. Durch das HCI werden Patienten mit allen Formen von Krebs behandelt. Das Zentrum betreibt mehrere Kliniken f"ur Erkrankungen mit hohen Risiken; die Schwerpunkte liegen dabei auf Melanomen und Brust-, Darm- und Bauchspeicheldr"usenkrebs. Das HCI Cancer Learning Center f"ur Patientenbildung und "offentliche Bildung beherbergt eine der landesweit gr"ossten Sammlungen von Publikationen zu Krebs. Das Institut ist nach Jon M. Huntsman benannt, einem Philanthropen, Industriellen und Krebs"uberlebenden aus Utah. Die Ausgangssprache, in der der Originaltext ver"offentlicht wird, ist die offizielle und autorisierte Version. "Ubersetzungen werden zur besseren Verst"andigung mitgeliefert. Nur die Sprachversion, die im Original ver"offentlicht wurde, ist rechtsg"ultig. Gleichen Sie deshalb "Ubersetzungen mit der originalen Sprachversion der Ver"offentlichung ab.

Monday, October 5, 2015

John Legend to Perform at Multiple Myeloma Research Foundation (MMRF) Annual Fall Gala to Benefit Cancer Research

NORWALK, Conn.--(BUSINESS WIRE)--Oscar- and Grammy-Award Winning Singer and Songwriter, John Legend will perform at the Multiple Myeloma Research Foundation (MMRF) Annual Fall Gala on Saturday, October 24, 2015 in Old Greenwich, Connecticut. The evening’s Courage and Commitment honoree is Professor Elie Wiesel, Nobel Laureate, and the Wiesel Family. Buy Aventyl (Nortriptyline) with free Rx Mr. Viagra Oral Jelly (Sildenafil Citrate) with free Rx Wiesel is a renowned author and the President of The Elie Wiesel Foundation for Humanity. Brand Temovate (Clobetasol) with free Rx He has been awarded more than 100 honorary degrees, and is the recipient of the esteemed Presidential Medal of Freedom and the Nobel Prize for Peace. Buy Fovas with free prescription Acceptance remarks will be delivered by Mr. Buy Glucotrol Xl (Glipizide) without prescription Wiesel’s son, Elisha Wiesel. Karen E. Buy DHA online Andrews, MMRF Co-Founder and a current member of the MMRF Board of Directors, will be honored with the Spirit of Hope Award. http://webmd-magazine.blogspot.com Ms. Andrews has been a steadfast champion of accelerating cancer research and has helped the MMRF to become one of the leading research foundations in the nation, if not the world. A Greenwich, CT resident, Ms. Andrews also serves as the Senior Vice President and General Counsel for the March of Dimes. Both awards are the highest accolade presented by the Foundation in recognition of extraordinary contributions by the honorees to inspire hope through his or her life’s work. The evening’s Mistress of Ceremonies is Bonnie Hunt, Actress, Director, Producer and Writer and MMRF Honorary Board of Directors. Presenting sponsors include: Takeda Oncology and Janssen Biotech, Inc. Funds raised through this premier event will benefit the groundbreaking cancer research models of the MMRF, which are aimed at accelerating the development of new treatments to extend the lives of myeloma patients and find a cure for multiple myeloma, the second most prevalent blood cancer. The MMRF Fall Gala is the largest charity event in Fairfield County, CT and is attended by over 1,200 of the nation’s most prominent celebrities, business executives and health care professionals. For more information about the MMRF Annual Fall Gala, please visit: .themmrf.org/FallGalaTickets. To reserve a table or inquire about sponsorship opportunities, please email mmrf@benefitoffice.org or call 888-584-5463. About Multiple Myeloma Multiple myeloma is a cancer of the plasma cell. It is the second most common blood cancer. An estimated 26,850 adults (14,090 men and 12,760 women) in the United States will be diagnosed with multiple myeloma in 2015 and an estimated 11,240 people are predicted to die from the disease. About the Multiple Myeloma Research Foundation (MMRF) The Multiple Myeloma Research Foundation (MMRF) was established in 1998 as a 501(c)(3) non-profit organization by twin sisters Karen Andrews and Kathy Giusti, soon after Kathy’s diagnosis with multiple myeloma. The mission of the MMRF is to relentlessly pursue innovative means that accelerate the development of next-generation multiple myeloma treatments to extend the lives of patients and lead to a cure. As the world’s number-one private funder of multiple myeloma research, the MMRF has raised $300 million since its inception and directs nearly 90% of total budget to research and related programming.

Saturday, September 26, 2015

Exelixis Announces Positive Results from METEOR Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma Presented at European Cancer Congress 2015

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Exelixis, Inc. About Adalat Cc (Nifedipine) with no prescription (NASDAQ:EXEL) today announced positive results from METEOR, the phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI). About Ziagen (Abacavir) without Rx In July 2015, Exelixis disclosed that the trial met its primary endpoint, demonstrating a statistically significant increase in progression-free survival for patients in the cabozantinib arm. Women Pack-20 () with no Rx Principal investigator Toni K. Buy Fluox without Rx Choueiri, M.D. Buy Jelly Pack-15 () without prescription will present detailed data from the late-breaking METEOR abstract (#4-LBA) on Saturday, September 26, during the Presidential Session I at the European Cancer Congress (ECC) 2015, which is being held September 25-29 in Vienna. Buy Colon online The METEOR data and an accompanying editorial were also published today in The New England Journal of Medicine. As announced in July, the METEOR trial met its primary endpoint of demonstrating a statistically significant increase in progression-free survival (PFS) for cabozantinib as compared to everolimus, as determined by an independent radiology committee. http://webmd-help.blogspot.com Per the trial protocol, the primary analysis was conducted among the first 375 patients randomized to ensure sufficient follow up and a PFS profile that would not be primarily weighted toward early events. The median PFS was 7.4 months for the cabozantinib arm versus 3.8 months for the everolimus arm, corresponding to a 42% reduction in the rate of disease progression or death for cabozantinib as compared to the everolimus arm (hazard ratio [HR]=0.58, 95% confidence interval [CI] 0.45-0.75, p<0.001). Cabozantinib effects were favorable across patient stratification subgroups including the number of prior VEGF receptor TKI therapies and commonly applied RCC risk criteria developed by Motzer et al. In a post-hoc subset analysis of patients who had received sunitinib, the most commonly used first-line therapy, as their only prior VEGF receptor TKI, the median PFS for cabozantinib-treated patients (n=76) was 9.1 months versus 3.7 months for everolimus-treated patients (n=77). This corresponds to a 59% reduction in the rate of disease progression or death for patients treated with cabozantinib (HR=0.41, 95% CI 0.28-0.61). “In the METEOR trial, cabozantinib significantly improved progression-free survival as compared to everolimus, a commonly-used standard of care, in both the full study population for the primary endpoint analysis as well as in the subgroup of patients previously treated with sunitinib only. Cabozantinib was also associated with a safety profile similar to other VEGF receptor TKIs used to treat renal cell carcinoma,” said Toni K. Choueiri, M.D., clinical director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, and METEOR’s principal investigator. “Uniquely, treatment with cabozantinib resulted in a strong trend towards improving overall survival, which is unprecedented as compared with other studies to date evaluating TKIs. The totality of the data support cabozantinib as a potential new treatment option for RCC patients whose disease has progressed following VEGF receptor-targeting therapy.” Data pertaining to overall survival (OS) in the entire study population of 658 patients, a secondary endpoint of the trial, were immature at the data cutoff. As previously announced, a pre-specified interim analysis triggered by the primary analysis for PFS showed a strong trend in OS favoring cabozantinib (HR=0.67, 95% CI 0.51-0.89, p=0.005) At the time of the interim analysis, the p-value of 0.0019 to achieve statistical significance was not reached, and the trial will continue to the final analysis of OS anticipated in 2016. Objective response rate, another secondary endpoint, was significantly higher with cabozantinib (21%) as compared with everolimus (5%; p < 0.001). Treatment discontinuations for adverse events unrelated to progressive disease were 9% and 10% for cabozantinib and everolimus, respectively. “These results from the METEOR trial suggest that cabozantinib has the potential to become a new and differentiated treatment option for patients with renal cell carcinoma who have progressed following VEGF receptor tyrosine kinase therapy, the most commonly-utilized treatment in the first-line setting,” said Michael M. Morrissey, Ph.D., Exelixis’ president and chief executive officer. “Exelixis is working quickly to share the data with regulators in the United States and European Union. We are on track to complete our U.S. NDA filing by the end of this year, where cabozantinib has received Breakthrough Therapy Designation, and expect a European filing to follow in early 2016. We look forward to advancing these regulatory processes in hopes of bringing cabozantinib to the renal cell carcinoma community as soon as possible.” 653 patients were evaluable for safety. Median duration of exposure was 7.6 months for cabozantinib and 4.4 months for everolimus. Investigators employed dose reductions to manage adverse events (AE), and 60% of patients on the cabozantinib arm and 25% of patients on the everolimus arm had dose reductions. The median average daily dose was 44 mg for cabozantinib and 9 mg for everolimus. The incidence of adverse events (any grade), regardless of causality, was 100% with cabozantinib and more than 99% with everolimus. Serious adverse events occurred in 40% of cabozantinib patients and 43% of everolimus patients. The most common AEs regardless of causality, grade 3 or higher, for cabozantinib were: hypertension (15%), diarrhea (11%), fatigue (9%), and hand-foot syndrome (8%). The most common AEs regardless of causality, grade 3 or higher, for everolimus were: anemia (16%), fatigue (7%), hyperglycemia (5%), and dyspnea (4%). Grade 5 adverse events occurred in 6.6% of patients in the cabozantinib arm and in 7.8% of patients in the everolimus arm, and were primarily related to disease progression. Treatment-related grade 5 events occurred in one patient (0.3%; death not otherwise specified) in the cabozantinib arm and 2 patients (0.6%; aspergillus infection and aspiration pneumonia) in the everolimus arm. Cabozantinib is currently marketed in capsule form under the brand name COMETRIQ® in the United States for the treatment of progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. COMETRIQ is not indicated for patients with advanced RCC or any other form of the disease. In the METEOR trial, and all other cancer trials currently underway, Exelixis is investigating a tablet formulation of cabozantinib distinct from the COMETRIQ capsule form. Webcast for the Investment Community Exelixis will host a live webcast on Saturday, September 26, 2015, following the METEOR presentation at ECC 2015. The webcast will begin at 12:30 p.m. EDT / 9:30 a.m. PDT (18:30 local Vienna time). During the webcast, Exelixis management and Dr. Toni Choueiri, principal investigator of the METEOR trial, will review and provide context for the data presented at the Congress. To access the webcast link, log onto .exelixis.com and proceed to the Event Calendar page under Investors & Media. Please connect to the company’s website at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, you may access the webcast at this address: edge.media-server.com/m/p/c7qgq2ma/lan/en. An archived replay of the webcast will be available on the Event Calendar page under Investors & Media at .exelixis.com for one year. An audio-only phone replay will be available until 11:59 p.m. EDT on September 28, 2015. Access numbers for the phone replay are: (855) 859-2056 (domestic) and (404) 537-3406 (international); the passcode is 47549145. About Advanced Renal Cell Carcinoma The American Cancer Society’s 2015 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the United States.1 Clear cell renal cell carcinoma is the most common type of kidney cancer in adults.2 If detected in its early stages, the five-year survival rate for RCC is high; however, the five-year survival rate for patients with advanced or late-stage metastatic RCC is under 10 percent, with no identified cure for the disease.3 Treatments for advanced RCC had historically been limited to cytokine therapy (e.g., interleukin-2 and interferon) until the introduction of targeted therapies into the RCC setting a decade ago. In the second and later-line setting, which encompasses approximately 17,000 drug-eligible patients in the U.S. and 37,000 globally,4 two therapies have been approved for the treatment of patients who have received prior VEGF receptor TKIs. However, despite the availability of several therapeutic options, currently approved agents have shown little differentiation in terms of efficacy and have demonstrated only modest PFS benefit in patients refractory to sunitinib, a commonly-used first-line therapy. The majority of clear cell RCC tumors exhibit down-regulation of von Hippel-Lindau (VHL) protein function, resulting in a stabilization of the hypoxia-inducible transcription factors (HIFs) and consequent up-regulation of VEGF, MET, and AXL.5 The up-regulation of VEGF may contribute to the angiogenic nature of clear cell RCC, and expression of MET or AXL may be associated with tumor cell viability, a more invasive tumor phenotype, and reduced overall survival. 6 Up-regulation of MET in clear cell RCC has also been shown to occur in response to treatment with VEGF receptor TKIs in preclinical models, indicating a potential role for MET in the development of resistance to these therapies.7 About Cabozantinib Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGF receptors, AXL, and RET. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment. COMETRIQ® (cabozantinib capsules) is currently approved by the U.S. Food and Drug Administration for the treatment of progressive, metastatic medullary thyroid cancer (MTC). The European Commission granted COMETRIQ conditional approval for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. Similar to another drug approved in this setting, the approved indication states that for patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions. Important Safety Information, including Boxed WARNINGS WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE Serious and sometimes fatal gastrointestinal perforations and fistulas occur in COMETRIQ-treated patients. Severe and sometimes fatal hemorrhage occurs in COMETRIQ-treated patients. COMETRIQ treatment results in an increase in thrombotic events, such as heart attacks. Wound complications have been reported with COMETRIQ. COMETRIQ treatment results in an increase in hypertension. Osteonecrosis of the jaw has been observed in COMETRIQ-treated patients. Palmar-Plantar Erythrodysesthesia Syndrome (PPES) occurs in patients treated with COMETRIQ. The kidneys can be adversely affected by COMETRIQ. Proteinuria and nephrotic syndrome have been reported in patients receiving COMETRIQ. Reversible Posterior Leukoencephalopathy Syndrome has been observed with COMETRIQ. Avoid administration of COMETRIQ with agents that are strong CYP3A4 inducers or inhibitors. COMETRIQ is not recommended for use in patients with moderate or severe hepatic impairment. COMETRIQ can cause fetal harm when administered to a pregnant woman. Adverse Reactions – The most commonly reported adverse drug reactions (>=25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation. The most common laboratory abnormalities (>=25%) are increased AST, increased ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and hyperbilirubinemia. Please see full U.S. prescribing information, including Boxed WARNINGS, at .COMETRIQ.com/downloads/Cometriq_Full_Prescribing_Information.pdf Please refer to the full European Summary of Product Characteristics for full European Union prescribing information, including contraindication, special warnings and precautions for use at .sobi.com once posted. About Exelixis Exelixis, Inc. is a biopharmaceutical company committed to developing small molecule therapies for the treatment of cancer. Exelixis is focusing its development and commercialization efforts primarily on cabozantinib, its wholly-owned inhibitor of multiple receptor tyrosine kinases. Another Exelixis-discovered compound, cobimetinib, a selective inhibitor of MEK, received its first regulatory approval in Switzerland and is being evaluated by Roche and Genentech (a member of the Roche Group) in a broad development program under a collaboration with Exelixis. For more information, please visit the company s web site at .exelixis.com. Forward-Looking Statements This press release contains forward-looking statements that are subject to risk and uncertainty, including, without limitation, cabozantinib’s potential as a new and differentiated treatment option for RCC patients whose disease has progressed following VEGF receptor-targeting therapy; that the METEOR trial will continue to the final analysis of OS in 2016; and that Exelixis will complete our U.S. NDA filing by the end of 2015 and our EU filing in early 2016. Words such as “will,” “potential”, “suggest”, “expect”, “look forward,” “hope”, and “as soon as possible” or other similar expressions identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements are based upon Exelixis’ current plans, assumptions, beliefs, expectations, and projections. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements, which include, without limitation: risks related to the clinical, therapeutic and commercial potential of cabozantinib; risks related to Exelixis ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; risks and uncertainties related to regulatory review and approval processes and Exelixis compliance with applicable legal and regulatory requirements; risks related to market competition, changes in economic and business conditions, and other factors discussed under the caption “Risk Factors” in Exelixis’ quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 11, 2015, and in Exelixis’ other filings with the SEC. The forward-looking statements made in this press release speak only as of the date of this press release. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Exelixis, the Exelixis logo, and COMETRIQ are registered U.S. trademarks. 1 Cancer Facts & Figures 2015. American Cancer Society. Available at .cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf 2 Jonasch et al., BMJ (2014) vol. 349, g4797. 3 .cancer.org/cancer/kidneycancer/detailedguide/kidney-cancer-adult-survival-rates 4 ACS Cancer Facts and Figures 2015; Heng et al., Ann Oncol (2012) vol. 23 no. 6; internal data on file; Motzer et al., N Engl J Med (2007) vol. 356 no. 2; NCIN (UK) report, April 2014, Available at .ncin.org.uk/view?rid=2676. 5 Harschman and Choueiri, Cancer J. 2013 v19 316-323; Rankin et al., PNAS, 2014. 6 Bommy-Reddi et al., PNAS, 2008; Gibney et al., Ann. Oncol. 2013 v24 343-349; Koochekpour et al., Mol. Cell. Biol. 1999, v19 5902-5912; Rankin et al., PNAS, 2014. 7 Ciamporcero et al., MolCancerTher, 2014.

Friday, September 11, 2015

Nipro Corporation to Acquire Infraredx, Inc.

BURLINGTON, Mass.--(BUSINESS WIRE)--Nipro Corporation ([Stock Index]: [TYO: 8086]) today announced it has signed a definitive agreement to acquire Infraredx, Inc., (.infraredx.com), an intravascular imaging company committed to advancing the diagnosis and management of coronary artery disease globally. Buy Zestril (Lisinopril) with no Rx Nipro Corporation offers products and technologies that meet the needs of patients and medical professionals in a wide range of fields, such as artificial organs, circulatory devices, test/diagnostic agents, injection/infusion solutions, ethical pharmaceuticals, and medical glass products. About Biaxin (Clarithromycin) without Rx The agreement combines the strengths of Nipro Corporation and Infraredx, by leveraging Nipro s strong global cardiovascular portfolio and resources along with Infraredx’s industry expertise in near infrared spectroscopy (NIRS) and intravascular ultrasound. Buy Hyzaar (Losartan / Hydrochlorothiazide) with no Rx The agreement will help introduce Nipro’s cardiovascular product line into the United States, and continue Infraredx’s mission to empower interventional cardiologists with the advanced imaging tools required to predict heart attacks and prevent them—catalyzing a global shift from reactive treatment to proactive care of coronary artery disease. “Company Founder James E. Faverin with no prescription Muller, MD, and the Infraredx management team have empowered interventional cardiologists with the NIRS-IVUS imaging system, which is approved to detect the lipid-core plaques that cause most heart attacks,” said Yoshihiko Sano, President, Nipro. About Mentat () with no prescription “Nipro and Infraredx share a strong patient centered focus and the combination of the companies’ global portfolio and cardiovascular expertise will help us deliver the most comprehensive imaging solution available to change how cardiovascular disease is managed. Buy Carnitine online We look forward to bringing together the two companies to deliver the best of medicine and innovation.” “By teaming up with one of the leading global medical equipment manufacturing companies in the world, Infraredx is able to leverage Nipro’s global network and vast resources to enhance its presence and impact a larger audience locally as well globally,” said Jason Bottiglieri, President and CEO of Infraredx. http://pharmaceutical-journal.blogspot.com “We are pleased to combine our strengths to meet the demands of the marketplace and continue to deliver to the medical community cardiovascular imaging systems that hold the potential to revolutionize the management of cardiovascular disease.” Harnessing 30 years of research into the association between heart attacks and lipid-core plaques, Infraredx has been committed to the design, manufacturing, and distribution of technologies that address the needs of practitioners and improve outcomes in the treatment of patients with coronary artery disease. With ongoing investment in several landmark global clinical trials, Infraredx’s mission, to enable cardiologists to predict heart attacks and prevent them, will continue. The acquisition, which is subject to certain conditions, is expected to close in October 2015. About Infraredx Founded in 1999, Infraredx, Inc., is a privately-funded medical device company dedicated to helping provide practitioners with the information needed for enhanced clinical decision making for the treatment of coronary artery disease. The company is committed to improving the safety and efficacy of coronary stenting and ultimately serving as part of a strategy to prevent initial coronary events. Through its TVC Imaging System™, Infraredx is changing the way coronary artery disease is diagnosed and treated. About Nipro Nipro Corporation, headquartered in Osaka, Japan, has been a world leader in providing medical products to the healthcare community for over 50 years. In addition to Nipro-branded products, Nipro provides manufacturing support to some of the biggest names in the medical field. This announcement contains forward-looking statements that involve risks and uncertainties including, among others, the ability to successfully integrate the two companies, and to realize the synergies and other perceived advantages resulting from this acquisition.

Wednesday, September 2, 2015

Nerve Injury Pipeline Review, H2 2015 - 7 Companies & 10 Drug Profiles

. Estrin with no Rx DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/xhsf7n/nerve_injury) has announced the addition of the "Nerve Injury - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Nerve Injury, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. Buy Ortho Tri-Cyclen (Norgestimate / Ethinyl estradiol) with no prescription About Vaniqa (Eflornithine) with no Rx It also reviews key players involved in the therapeutic development for Nerve Injury and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. Buy Bodybuilding Supplements online About Cipro (Ciprofloxacin) without Rx It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Involved in Therapeutics Development Acorda Therapeutics, Inc. Calico LLC F. http://webmd-consult.blogspot.com Buy Voltarol (Diclofenac) with free prescription Hoffmann-La Roche Ltd. Human Stem Cells Institute Kolon Life Science, Inc. Neuralstem, Inc. Neurotune AG Drug Profiles 3K3A-APC ACTX-07 cimaglermin alfa CLP-257 Gene Therapy to Activate Vascular Endothelial Growth Factor for Cardiovascular Disease and Central Nervous System Disorders KLS-Nst NSI-566 NT-1654 Small Molecules to Activate NAMPT for Neurological Disorders Synthetic Peptides to Inhibit PDE-4A4 for Pulmonary Fibrosis and Nerve Injury For more information visit .researchandmarkets.com/research/xhsf7n/nerve_injury

Friday, August 28, 2015

Global Monoamine Oxidase Inhibitors (MAOIs) Pipeline Insights Review 2015

. Buy Professional Pack-20 () with free prescription DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/vt8jjk/monoamine_oxidase) has announced the addition of the "Monoamine Oxidase Inhibitors (MAOIs) -Pipeline Insights" report to their offering. Monoamine Oxidase Inhibitors (MAOIs) Pipeline Insights provides the in-depth analysis of the pipeline assets across the Monoamine Oxidase Inhibitors (MAOIs). Buy Bars online About Sporanox (Itraconazole) without Rx The main objective of this report to track competitor pipeline molecules, related research activities, technology, collaborations, in-licensing and out-licensing deals. http://md-opinion.blogspot.com About Diamox (Acetazolamide) with no prescription The Monoamine Oxidase Inhibitors (MAOIs) Report helps to identify emerging players with potentially strong product information and create effective counter-strategies to gain competitive advantage. Monoamine Oxidase Inhibitors (MAOIs) Pipeline Insights Report covers the Monoamine Oxidase Inhibitors (MAOIs) pipeline molecules at various stages of development like Pre-registration phase, clinical phases (Phase III, Phase II & Phase I), pre-clinical and discovery phases. Vantin (Cefpodoxime) The Report also provides Monoamine Oxidase Inhibitors (MAOIs) related therapeutic assessments by molecule type, route of administration, monotherapy and combination products. About Encript without prescription The Report also highlights the discontinued and inactive projects in pipeline for Monoamine Oxidase Inhibitors (MAOIs). Scope - The report provides a Monoamine Oxidase Inhibitors (MAOIs) Landscape across the globe - The report provides drug profiles which includes product description, MOA, licensors & collaborators, technology, development partner and chemical information - Coverage of the Monoamine Oxidase Inhibitors (MAOIs) pipeline on the basis of target, MOA, route of administration, technology involved and molecule type - The report reviews key players involved in the therapeutics development for Monoamine Oxidase Inhibitors (MAOIs) and also provide company profiling - Pipeline products coverage based on various stages of development from NDA filings to discovery. - Provides pipeline assessment by monotherapy and combination therapy products, stage of development and molecule type For more information visit .researchandmarkets.com/research/vt8jjk/monoamine_oxidase

Wednesday, August 19, 2015

Amneal Launches Aripiprazole Oral Solution, One of the First Generic Liquid Forms Available for Abilify®

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals LLC (.amneal.com) today announced the launch of aripiprazole oral solution in 1 mg/mL strength, allowing prescribers to continue writing for the recently discontinued reference brand. About Risperdal (Risperidone) with free Rx The Amneal generic — one of the first liquid forms on the market — is an AA-rated, therapeutic equivalent to the discontinued Abilify® Oral Solution. Elavil (Amitriptyline) without prescription It is now shipping in 150 mL (5 fl oz) bottles through wholesalers, distributors and directly to the trade. “Healthcare providers can now continue prescribing a therapy they are comfortable with and in a form certain patients require,” explains Jim Luce, Amneal Executive Vice President of Sales & Marketing. About Ampicillin (Acillin) with free prescription “It’s a product that would otherwise be unavailable if not for the generic equivalent.” Annual U.S. Buy Elidel with no prescription sales of aripiprazole oral solution were $62.8 million as of June 2015, according to IMS Health. Visit prd02.apsiva.net/210/GenericCategory/Aripiprazole-pi.pdf for full prescribing information. About Amneal Pharmaceuticals LLC Amneal Pharmaceuticals LLC is a global supplier of generic pharmaceuticals, vertically integrated across the entire supply chain from R&D to finished goods. About Reosto () with free prescription Since its inception in 2002, Amneal has invested extensively in R&D resources, manufacturing infrastructure, and strategic expansion opportunities — all contributing to its significant growth. Buy Arginine online The Company prides itself on its unwavering commitment to quality, strong business relationships, and innovative approach to maximizing value. http://mdreview.wordpress.com Amneal is privately held with U.S. headquarters in Bridgewater, New Jersey, and international headquarters in Zug, Switzerland. For more information, please visit .amneal.com. All trademarks are property of their respective owners.

Monday, August 17, 2015

New data show Spiolto Respimat provides meaningful quality of life improvements in COPD

INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced the publication of new data from the Phase IIIb OTEMTO® 1&2 trials (NCT01964352/NCT02006732), which show Spiolto® Respimat® (tiotropium/olodaterol) provides consistent, clinically meaningful improvements in quality of life versus placebo in patients with COPD*. Norvir (Ritonavir) with no Rx These data are published online in the journal Respiratory Medicine.1 For COPD patients, breathlessness, among other symptoms, limits their ability to keep active and has a negative impact on their daily lives. Buy Intagra (Sildenafil Citrate) without Rx As there is no cure for COPD, improving quality of life is a major goal of treatment. Prometrium (Progesterone) without prescription In COPD, quality of life is measured using the SGRQ†; a reduction in SGRQ score of 4 points or more is deemed clinically meaningful.2 The OTEMTO® trials show Spiolto® Respimat® provides a reduction in SGRQ total score of 4.67‡ versus placebo. “The improvement in quality of life provided by Spiolto® Respimat® in these trials could make a noticeable difference to the daily activity of COPD patients and enable them to maintain a more independent life,” said Dave Singh, Professor of clinical pharmacology and respiratory medicine, University of Manchester and lead investigator of the OTEMTO® trials. Doxazosin with free prescription “For example, this could mean that patients are able to walk up stairs without stopping, go out to socialise with friends or find it easier to wash and dress. Super Pack () with free Rx Essentially, the data show that patients feel much better.” Further data from the 1,600 patient OTEMTO® trials show Spiolto® Respimat® provides: clinically meaningful improvements in breathlessness compared to placebo (measured by a 1.62 point improvement in TDI focal score§), reflecting the meaningful quality of life benefits consistent improvements in lung function, breathlessness and quality of life compared to Spiriva® (tiotropium) a safety profile similar to Spiriva® or placebo. Buy Weightlifting Belts online Incidence of adverse events (AEs) was broadly similar across treatment groups, with a higher incidence of AEs leading to discontinuation in the placebo groups compared to the treatment groups OTEMTO® 1&2 build on the pivotal phase III TONADO® trials that demonstrated Spiolto® Respimat® provides significant improvements in lung function, breathlessness, quality of life and reduction in rescue medication use over Spiriva® Respimat® right from the initial disease stages when patients first need maintenance therapy.3,4 OTEMTO® 1&2 are part of the >15,000 patient TOviTO® Phase III clinical trial programme, one of the largest trial programmes conducted in COPD. U.S. http://anti-infectives-opinion.blogspot.com Food and Drug Administration (FDA) recently accepted for review a Supplemental New Drug Application (sNDA) to include the OTEMTO® quality of life data in the Stiolto™ Respimat®** label. For further information visit: newscentre.boehringer-ingelheim.com/education_hub1/respiratory.html OTEMTO® Respiratory Medicine publication: dx.doi.org/10.1016/j.rmed.2015.08.002 About Spiolto® Respimat® To date, Spiolto® Respimat® has gained approval in more than 20 EU/EEA countries, the US, Canada and Australia for use in the treatment of patients with COPD. Spiolto® Respimat® is built on tiotropium, the active ingredient in Spiriva® - the world’s most prescribed COPD maintenance treatment with over 40 million patient years of real life experience across all COPD severities.5 It is enhanced by olodaterol††, a unique and effective long-acting beta2-agonist with a fast onset of action,6 specifically designed to complement the efficacy of Spiriva®. Spiolto® is delivered by Respimat®, the only inhaler available that actively‡‡ delivers a unique mist, meaning the patient just needs to breathe in naturally for the medication to go deep into the lungs.7-13 Intended audiences This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business. For ‘Notes to Editors’ and ‘References’ please visit: .boehringer-ingelheim.com/news/news_releases/press_releases/2015/17_august_2015_copd.html * Chronic obstructive pulmonary disease † St George’s Respiratory Questionnaire (SGRQ), a disease-specific patient-reported instrument that evaluates symptoms including frequency and duration of cough, wheezing and breathlessness ‡ SGRQ total score after 12 weeks of treatment in the combined data set of the 2 replicate studies OTEMTO®1 and OTEMTO® 2 § Transition dyspnoea index focal score after 12 weeks of treatment in the combined data set ** Spiolto® Respimat® is marketed as Stiolto™ Respimat® in the US and Inspiolto™ Respimat® in Canada †† Marketed as Striverdi® Respimat® ‡‡ Respimat® delivers a metered dose of medication in a mist at the push of a button not requiring the force from the patient’s inhalation

Monday, July 27, 2015

Illinois Biotechnology Industry Organization Makes Notable Additions to Board of Directors

CHICAGO--(BUSINESS WIRE)--The Illinois Biotechnology Industry Organization (iBIO) today announced the election of new additions to its Board of Directors. About Motrin (Ibuprofen) The new Board members, who include senior executives and specialists from highly-recognized organizations, add depth and prestige to an already-strong lineup of medical, agricultural, and industrial biotech representation. Joining iBIO’s Board are Walt Johnston and David Flowers. Walt Johnston is Vice President, US Marketing and Strategic New Product Planning for Astellas Pharma US, Inc., a global research-based pharmaceutical company committed to serving unmet medical needs in Oncology, Cardiology, Immunology, Infectious Diseases, Urology and Neuroscience. Walt has over 20 years of experience in the pharmaceutical industry. Lamprene (Clofazimine) without prescription He leads marketing activities and programs across several therapeutic areas of the Astellas US business to ensure superior commercial performance, with primary responsibility for Urology, Immunology, Cardiovascular and Anti-Infective markets. Gestanin (Progestogen) with free Rx Walt also serves as a member of the Astellas Portfolio Strategic Executive Committee. “I am excited to join iBIO’s board during a period of unprecedented innovation and opportunity across the life sciences,” said Johnston. Buy Divalproex with free prescription “I am looking forward to working with iBIO’s board members and staff to contribute to the future progress of the organization and the industry.” “iBIO is fortunate to have members of Walt Johnston and David Flowers caliber join our board,” said Warren Ribley, iBIO President & CEO, “The leadership and experience that Walt and David bring to our board will be a great benefit to our organization and community.” David Flowers is a Director, Life Sciences Industry, for Deloitte Services LP. Buy Tetracycline (Tetracycline Hydrochloride) with no prescription The subsidiaries of Deloitte LLP provide industry-leading audit, consulting, tax and advisory services to many of the world’s most admired brands, including 80 percent of the Fortune 500. Flowers has more than 26 years of experience serving multi-national and global companies, including 16 years dedicated to the Life Sciences sector. Buy Vitamin C online Additionally, he is on the leadership team contributing to the development of Deloitte’s long-range global and Chicago marketplace strategies for the Life Science sector. “Deloitte and iBIO have a strong collaborative history,” said Flowers. http://cardiobloodreview.wordpress.com “Joining iBIO’s board provides me with the opportunity to continue to expand Deloitte’s contribution to the Illinois life sciences community.” About the Illinois Biotechnology Industry Organization iBIO’s mission is to make Illinois and the surrounding Midwest one of the world’s top life sciences centers: a great place to do business and a great place to grow technology ventures. iBIO, working on its own and through valued partners Promotes sound public policy at the local, state and federal levels; Improves our region’s ability to create, attract and retain businesses Orchestrates industry involvement to help solve America’s math and science education crisis Builds community by providing opportunities to connect and engage with the industry We thereby contribute to the well-being of people worldwide while creating new jobs, attracting firms to the region and generating prosperity. iBIO’s Leadership Sponsors are AbbVie, Astellas US, Baxalta, Horizon Pharma and Takeda Pharmaceuticals North America.

Thursday, July 16, 2015

Exelixis Appoints Chris Senner as Executive Vice President and Chief Financial Officer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Exelixis, Inc. Isordil Sublingual (Isosorbide Dinitrate) without prescription (NASDAQ:EXEL) today announced the appointment of Christopher J. About Niaspan (Niacin) with no prescription Senner as Executive Vice President and Chief Financial Officer. Buy Vigora (Sildenafil Citrate) without Rx Mr. Buy Dexamethasone Senner has nearly 25 years of experience in biopharmaceutical finance, including deep expertise in global financial operations and controls, strategic planning and analysis, supply chain finance and business development. Buy Vigora (Sildenafil Citrate) without Rx He joins Exelixis after five years at Gilead Sciences, where he served as Vice President, Corporate Finance. Buy Stretch Marks online He previously spent eighteen years at Wyeth in a variety of financial roles with increasing responsibility for many of the company’s divisions and regions. http://allegra-opinion.blogspot.com He joins Exelixis in advance of several potentially transformational milestones anticipated this year, including top-line results from the METEOR phase 3 pivotal trial and the potential U.S. and EU regulatory approvals of cobimetinib, a compound discovered by Exelixis and then licensed to Genentech for further development and commercialization. In this role, Mr. Senner will oversee the company’s global finance function, leveraging extensive experience gained earlier in his career. While at Gilead, he was accountable for controllership and operational financial planning and analysis, including research and development, manufacturing, commercial operations, and tax and treasury planning. At Wyeth, he served in a variety of capacities, most notably as CFO of the company’s $10 billion U.S. pharmaceuticals business and the BioPharma Business Unit, a $5 billion global inflammation, oncology and hematology business. “With more than 25 years of service between two of the biopharmaceutical industry’s most highly-regarded companies, Chris Senner is exceptionally well prepared to lead Exelixis’ finance function as our next CFO,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “Chris’ global commercial finance expertise will serve Exelixis well as we prepare for top-line results from METEOR and the potential regulatory approval of cobimetinib, two milestones that we hope will advance and accelerate the company’s transformation into a global commercial organization.” Mr. Senner will succeed Deborah Burke, who has served as Senior Vice President and Chief Financial Officer since September 2014. Ms. Burke joined Exelixis in 2005 and was the company’s Vice President, Finance and Controller before being appointed interim CFO in June 2014. She will remain with Exelixis in the role of Senior Vice President, Finance and Controller. “I’d like to thank Debbie for her many contributions as Chief Financial Officer over this past year. Her support has been invaluable as we have navigated through a challenging time for the company,” continued Dr. Morrissey. “We are fortunate that we will continue to have the benefit of her input and experience as we move forward.” “It is a very exciting time to join Exelixis,” said Mr. Senner. “Should its near-term catalysts prove positive, the company is poised to make additional, important contributions to the treatment of cancer and dramatically advance its commercial presence. I’m looking forward to working with Mike, Debbie and the rest of the Exelixis team to make the most of the potential opportunities that lie ahead.” About Exelixis Exelixis, Inc. is a biopharmaceutical company committed to developing small molecule therapies for the treatment of cancer. Exelixis is focusing its development and commercialization efforts primarily on COMETRIQ® (cabozantinib), its wholly-owned inhibitor of multiple receptor tyrosine kinases. Another Exelixis-discovered compound, cobimetinib, a selective inhibitor of MEK, is being evaluated by Roche and Genentech (a member of the Roche Group) in a broad development program under a collaboration with Exelixis. For more information, please visit the company s web site at .exelixis.com. Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements related to: anticipated developments and timing with respect to Exelixis’ ongoing phase 3 pivotal METEOR trial of cabozantinib in renal cell carcinoma; cobimetinib regulatory filings and future potential approvals; and, Exelixis’ belief that its compounds have the potential to meaningfully improve cancer care. Words such as “potential,” “transformation,” “anticipates,” “will,” “advance,” “hope,” “looking forward,” “believe,” “poised,” or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Exelixis’ actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the availability of data at the expected times; risks related to the potential failure of cabozantinib, cobimetinib and other Exelixis compounds to demonstrate safety and efficacy in clinical testing; the clinical, therapeutic and commercial value of cobimetinib, cabozantinib and other Exelixis compounds; Exelixis’ dependence on its relationship with Genentech/Roche with respect to cobimetinib and Exelixis’ ability to maintain its rights under the collaboration; the uncertainty of regulatory approval processes; the sufficiency of Exelixis’ capital and other resources; the uncertain timing and level of expenses associated with the development of cabozantinib; risks and uncertainties related to Exelixis’ compliance with applicable regulatory requirements, including healthcare fraud and abuse laws and post-marketing requirements; Exelixis’ dependence on third-party vendors; market competition; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Exelixis’ quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on April 30, 2015 and in Exelixis’ other filings with the SEC. The forward-looking statements made in this press release speak only as of the date of this press release. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Exelixis, the Exelixis logo, and COMETRIQ are registered U.S. trademarks.

Wednesday, July 15, 2015

WEST LAFAYETTE, Ind.--(BUSINESS WIRE)--Bioanalytical Systems, Inc. About Glucovance (Glyburide(Glibenclamide)-Metformin) without Rx (NASDAQ:BASI) has entered into an agreement with PDS Life Sciences (PDS) to fully upgrade its laboratory information management system (LIMS) to Ascentos™. About Pamelor (Nortriptyline) The new Ascentos software represents the next generation of preclinical research LIMS and is a fully integrated software solution that includes toxicology, clinical pathology, toxicokinetics and pathology modules that streamline data management and reporting. BASi will also implement the TranSEND™ solution as part of the enhancements being made by the company. Buy Kamagra Soft (Sildenafil Citrate) The new automated software converts study data to the new Standard for Exchange of Nonclinical Data (SEND) format that will be required by the FDA beginning in December 2016. Buy Dermol with no Rx TranSEND effectively aggregates and translates data from multiple LIMS to produce one set of harmonized and validated SEND files as required by the FDA. Buy Women Pack-40 () with no prescription With this sophisticated tool, BASi will now be able to provide SEND study datasets that are ready for electronic data submission to the FDA without any further processing by the client. BASi President and CEO Jacqueline Lemke said, “Upgrading to PDS’ Ascentos and the addition of the TranSEND solution represent vital enhancements to our IT infrastructure that will harmonize data collection and reduce the time to complete a study and deliver our report.” Philip A. Buy Slippery Elm online Downing, vice president of preclinical services at BASi, concluded, “Being able to provide the data in SEND-ready format will shave weeks to months off of clients’ timelines since there is no need to do the SEND conversion themselves.” “We are very excited to expand our relationship with BASi because the company has always been unique in having both sophisticated lab instrumentation and preclinical research services. http://doctor-answers.blogspot.com/ Since PDS already has extensive experience in SEND dataset conversion, we look forward to helping BASi become one of the leaders in the CRO field regarding electronic submission compliance. This capability will be a real value added service for BASi clients,” said Sayed Badrawi, CEO of PDS Life Sciences. BASi expects final installation of the various modules to be completed this summer with validation testing continuing throughout the rest of the calendar year 2015 and full validation being completed well in advance of the FDA-mandated deadline of December 2016. About Bioanalytical Systems, Inc. BASi™ is a pharmaceutical development company with over 40 years of regulatory excellence in providing contract research services and monitoring instruments to the world s leading drug development companies and medical research organizations. The company focuses on developing innovative services and products that increase efficiency and reduce the cost of taking a new drug to market. Visit .BASinc.com for more about BASi. About PDS Life Sciences For more than 30 years, PDS has provided intuitive data management software and solutions for life sciences research and development programs worldwide. Most of the world’s top 10 pharma companies rely on PDS software, as do industry-leading CROs, chemical companies, universities and regulatory agencies. The PDS software lineup is centered on Ascentos™, your integrated preclinical software solution, which is purpose-built to support toxicology, clinical pathology, reproductive toxicology and anatomic pathology. PDS also offers TranSEND™, your complete FDA submission management solution, as well as powerful bioinformatics analysis and other services. Learn more at pdslifesciences.com.

Tuesday, July 14, 2015

Global Motor Neurone Diseases Pipeline Insights Report 2015

. Anafranil (Clomipramine HCI) without Rx DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/ktrcz4/motor_neurone) has announced the addition of the "Motor Neurone Diseases-Pipeline Insights" report to their offering. Motor Neurone Diseases Pipeline Insights provides the in-depth analysis of the pipeline assets across the Motor Neurone Diseases. Buy Protein Blends online Buy Danocrine (Danazol) The main objective of this report to track competitor pipeline molecules, related research activities, technology, collaborations, in-licensing and out-licensing deals. http://doctoranswers.wordpress.com Serevent Inhaler (Salmeterol) The Motor Neurone Diseases Report helps to identify emerging players with potentially strong product information and create effective counter-strategies to gain competitive advantage. Motor Neurone Diseases Pipeline Insights Report covers the Motor Neurone Diseases pipeline molecules at various stages of development like Pre-registration phase, clinical phases (Phase III, Phase II & Phase I), pre-clinical and discovery phases. About Robaxin (Methocarbamol) The Report also provides Motor Neurone Diseases related therapeutic assessments by molecule type, route of administration, monotherapy and combination products. Cytomid without Rx The Report also highlights the discontinued and inactive projects in pipeline for Motor Neurone Diseases. Scope - The report provides a Motor Neurone Diseases Landscape across the globe - The report provides drug profiles which includes product description, MOA, licensors & collaborators, technology, development partner and chemical information - Coverage of the Motor Neurone Diseases pipeline on the basis of target, MOA, route of administration, technology involved and molecule type - The report reviews key players involved in the therapeutics development for Motor Neurone Diseases and also provide company profiling - Pipeline products coverage based on various stages of development from NDA filings to discovery. - Provides pipeline assessment by monotherapy and combination therapy products, stage of development and molecule type For more information visit .researchandmarkets.com/research/ktrcz4/motor_neurone

Monday, July 13, 2015

New imaging technique spots early stages of dangerous artery deposits

Atherosclerosis - where fatty calcium deposits clog up arteries and reduce blood flow and oxygen supply - can lead to heart attacks and strokes. Buy Danocrine (Danazol) Now, a team says it is possible to identify the early stages of this process on a noninvasive imaging system thanks to an inexpensive, repurposed radioactive agent. In some cases of atherosclerosis, pieces can break off from the calcium deposits. In Nature Communications, researchers from the universities of Cambridge and Edinburgh in the UK, describe how they used a radioactive agent that was first developed in the 1960s to detect bone cancer to highlight the build-up of unstable calcium deposits in patients arteries. Study leader Dr. Serevent Inhaler (Salmeterol) Anthony Davenport, of the department of medicine at Cambridge, says this "new emerging technique is the only imaging platform that can noninvasively detect the early stages of calcification in unstable atherosclerosis." He and his colleagues expect the technique - which uses sodium fluoride tagged with a tiny amount of radioactive tracer - will help diagnose atherosclerosis and develop new drugs to treat it. There are several ways atherosclerosis can be dangerous. About Robaxin (Methocarbamol) One way is that the gradual build-up of fatty deposits (known as "plaques") gradually harden and narrow the artery wall, eventually restricting blood flow and oxygen supply. Not clear which patients will develop dangerous, unstable calcium deposits Another way that atherosclerosis can be dangerous is that in some cases, pieces can break off from the calcium deposits. Cytomid without Rx If that happens in an artery that supplies the brain or the heart, it can cause a blockage that results in stroke or heart attack. While it is clear that atherosclerosis can lead to very serious disease, what is not so clear is which people will develop the unstable plaques that allows pieces to break off - so the earlier they can be identified, the better the chances that early treatment will save lives. For their study, the team injected patients with the radiotracer version of sodium fluoride (18F-NaF). Then, using a combination of imaging techniques (positron emission tomography and computed tomography, or PET/CT), they tracked the tracer as it moved around the body. "Sodium fluoride is commonly found in toothpaste as it binds to calcium compounds in our teeth s enamel," Dr. Anafranil (Clomipramine HCI) without Rx Davenport explains, "In a similar way, it also binds to unstable areas of calcification in arteries and so we re able to see, by measuring the levels of radioactivity, exactly where the deposits are building up." Sodium fluoride tracer should revolutionize detection of dangerous calcium deposits After undergoing the scans, the patients had surgery to remove the plaques in their arteries. Buy Protein Blends online The researchers then examined them at a higher resolution using a laboratory PET/CT scanner and an electron microscope. This detailed examination confirmed that the 18F-NaF tracer builds up in areas of active, unstable calcium deposits, and not in surrounding tissue. Co-author, Dr. http://doctoranswers.wordpress.com James Rudd, a cardiologist and researcher at Cambridge, says 18F-NaF is a simple and inexpensive tracer that should "revolutionize" the ability of doctors to detect dangerous calcium deposits in the arteries of the heart and brain. He concludes: "This will allow us to use current treatments more effectively, by giving them to those patients at highest risk. In addition, after further work, it may be possible to use this technique to test how well new medicines perform at preventing the development of atherosclerosis." Most of the funds for the study came from the Wellcome Trust, supplemented with contributions from the British Heart Foundation, Cancer Research UK and the Cambridge NIHR Biomedical Research Centre. In February 2015, Medical News Today learned how researchers are working on a way to get nanomedicines to treat atherosclerosis. Writing in Science Translational Medicine, a Harvard-led team describes how they developed nano-sized "drones" that deliver targeted drugs and repair arteries. The tiny particles were small and sticky enough to push their way under the calcified deposits and effect repair. Written by Catharine Paddock PhD

Sunday, July 12, 2015

Neutralizing antibodies investigated for HIV vaccine

Two studies published in PLOS Pathogens this month shed further light on the effect of neutralizing antibodies in the steep challenge facing researchers to develop a vaccine against AIDS/HIV. Buy Colcrys (Colchicine) Nabs are immune proteins that can recognize, bind to, and trigger the elimination of a virus. About Stromectol (Ivermectin) Image credit: Dr. About Mentat () with no prescription Alexandra Trkola The search for an effective vaccine for AIDS/HIV has long been a battle for scientists and researchers around the world. Buy Cutizone Although HIV incidence have remained stable around the world at 50,000 new infections per year, a cure still remains to be found. Neutralizing antibodies are immune proteins that can recognize, bind to, and trigger the elimination of a virus before it can establish a chronic infection. Ashwagandha () with free prescription Nabs have previously been researched as a tool against HIV and AIDs. Buy Plant Sterols online In a study last year, scientists discovered for the first time how to create Nabs in those already infected with HIV-1. http://future-pharmaceuticals.blogspot.com Dr. Julia Overbaugh, from the Fred Hutchinson Cancer Research Center in Seattle, WA, and her team, focused on the role of Nabs in those "superinfected" with HIV, which is defined as those sequentially infected at least twice with HIV by different sexual partners. Results from 21 women who were tested suggest that Nabs mount a broad and potent response against diverse HIV subtypes. It is hoped that that this particular response can be mediated at least in part by polyclonal antibodies, which can then target different aspects of the virus. These findings follow on from the team s previous research into the superinfected. In that study, it was discovered that those infected twice had a more potent antibody response to the virus - which inhibited the virus from replicating - compared with women who have only been infected once. Dr. Overbaugh hopes further research can be done on those superinfected, stating further research may "provide insight to the development of a diverse Nab response with multiple epitope specificities." Direct cell to cell transmission more prone to mutation strains The second study published in PLOS Pathogens focused on Nabs effect on those infected with HIV/AIDS by cell-to-cell contact. Dr. Alexandra Trkola from the University of Zurich, Switzerland, and her colleagues, developed an assay that can specifically test the potency of Nabs to prevent direct cell-to-cell transmission of HIV. By establishing an assay system, the free virus infection is restricted, resulting in infections only occurring through cell-to-cell transmissions. Researchers were able to test whether a large selection of Nabs could prevent cell-to-cell transmission of different HIV strains. Although Nabs showed an overall decrease in activity, losses varied substantially depending on the antibody and virus strain examined. Scientists also discovered certain Nabs still retained activity during cell-to-cell transmission for individual viruses. However, this was generally not linked to a high potency of the free virus, but instead, displayed Nabs inhibiting prior to the binding of the virus to the CD4 receptor on T cells. Mathematical analysis showed that when the virus was transmitted via cell to cell transmission, it was substantially more prone to give rise to mutation strains that can escape immune control compared to free virus transmissions. Dr. Trkola said: "This highlights the importance of controlling virus replication via the cell-cell transmission pathway even if the contribution of this transmission should provide to occur to a less extent than free virus spread in infected individuals." Written by Peter Lam