Medical Tidbits, Alnylam and Genzyme Announce that Genzyme Opts into ALN-AT3 Hemophilia Program for Development and Commercialization Outside of North America and Western Europe

CAMBRIDGE, Mass.–(EON: Enhanced Online News)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, and Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), today announced that Genzyme has elected to opt into Alnylam’s investigational ALN-AT3 hemophilia program for development and potential future commercialization in territories outside of North America and Western Europe. This marks the first product from Alnylam’s Genetic Medicines pipeline to which Genzyme has opted in since the formation of the companies’ global alliance in January 2014, and the third product opt-in overall. Genzyme’s opt-in decision was based on encouraging clinical data from the Phase 1 trial of ALN-AT3, including positive interim data that were presented at the International Society on Thrombosis and Haemostasis (ISTH) 2015 Congress in June 2015. read more

Enanta Pharmaceuticals Announces Data Presentations at The Liver Meeting® 2015

WATERTOWN, Mass.–(EON: Enhanced Online News)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that 34 abstracts from AbbVie’s chronic hepatitis C clinical development program have been accepted for presentation at the Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) taking place November 13-17, 2015 in San Francisco. read more

Pharmatech and Cure Forward to Accelerate Oncology Clinical Trial Enrollment

DENVER & CAMBRIDGE, Mass.–(EON: Enhanced Online News)–Pharmatech, Inc., with its large network of research-oriented oncology practices, announced today a new collaboration with Cure Forward, a patient activation company. Pharmatech will access Cure Forward’s large network of cancer patients to identify clinical study candidates. Through the collaboration, the two companies aim to make clinical trials more accessible in community healthcare settings and support faster approval of targeted therapies for cancer patients. read more

Sarepta Therapeutics Announces Collaborative Research Agreement with Murdoch University Researchers Steve Wilton and Sue Fletcher

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Oct. 1, 2015– Sarepta Therapeutics (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced a four year collaborative research agreement to establish the Sarepta Translational Laboratory with Murdoch University, Perth, Western Australia. The Laboratory, led by Murdoch University professors Steve Wilton, Ph.D. and Sue Fletcher, Ph.D., will explore the applicability of the Company’s phosphorodiamidate morpholino oligomer (PMO) technology for disease targets beyond Duchenne muscular dystrophy (DMD), such as cystic fibrosis and spinal muscular atrophy. read more

Pfizer Completes Acquisition Of Nimenrix And Mencevax From GlaxoSmithKline

Pfizer Inc. (NYSE:PFE) today announced that it has completed the acquisition of GlaxoSmithKline’s quadrivalent meningococcal ACWY vaccines Nimenrix and Mencevax.

“The addition of Nimenrix and Mencevax helps us to fulfill our vision to protect lives with innovative vaccines to fight serious diseases worldwide,” said Susan Silbermann, president and general manager, Pfizer Vaccines. “These vaccines add high-quality and complementary vaccines to our existing portfolio, allowing us to reach a broader global population.”

Allergan Successfully Completes Kythera Acquisition; Adds Game-Changing KYBELLA Treatment for Double-Chin

DUBLIN, Oct. 1, 2015 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that it has successfully completed the acquisition of Kythera Biopharmaceuticals, Inc., a company focused on the discovery, development and commercialization of novel prescription products for the medical aesthetics market. Allergan acquired Kythera in an all-cash transaction valued at approximately $2.1 billion.  read more

FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

Holzkirchen, October 2, 2015 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Enbrel®* (etanercept) – a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz is seeking approval for all indications included in the label of the reference product  which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis affecting approx. 1.3 million[1] and 7.5 million[2] people (respectively) in the US.

 

Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz said “anti-TNFs will continue to play a leading role in immunology treatment and the acceptance of our regulatory submission by the FDA today is a significant step towards increasing patient access to these life-changing medicines.” McCamish continued “we believe we are the first company to receive FDA file acceptance of a biosimilar version of etanercept.”

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