United States

FDA grants QIDP, Fast Track Designations to MCB3837

Tuesday, July 26, 2016

Morphochem, a clinical-stage pharmaceutical company, has announced that the FDA has designated Morphochem’s intravenous (IV) antibacterial product candidate MCB3837 as a Qualified Infectious Disease Product (QIDP) for the treatment of Clostridium difficile infection (CDI). At the same time, the FDA has granted Fast Track designation to the compound’s development program for the treatment of CDI. MCB3837 is the IV prodrug of MCB3681, an antibacterial targeted at the treatment of CDI, which is a serious and potentially fatal disease regarded as an urgent healthcare threat.

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Puma Biotech submits NDA to FDA for PB272

Monday, July 25, 2016

Puma Biotechnology, a biopharmaceutical company, has submitted a New Drug Application (NDA) to the FDA for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy.

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FDA approves BELVIQ XR weight loss tablets

Thursday, July 21, 2016

The FDA has approved Eisai and Arena Pharmaceuticals’ New Drug Application (NDA) for BELVIQ XR (lorcaserin HCl) CIV extended-release 20mg tablets. The new formulation of lorcaserin will offer patients a once-a-day dosing option that may help them achieve and maintain weight loss. BELVIQ XR is expected to be available in the fall of 2016. In connection with the approval, Arena will receive a $10 million milestone payment.

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EMD Serono to open $115M life science campus in Massachusetts

Tuesday, July 19, 2016

EMD Serono, known as Merck outside of the U.S. and Canada, a science and technology company, has announced plans to build a new campus in Burlington, Massachusetts, that will serve as a major hub for the North American life science business of Merck. The 280,000-square-foot facility will include a customer collaboration laboratory and training center as well as office space.

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Study: Mentorship programs build long-term research careers

Tuesday, July 19, 2016

A public-private mentored research program based at the NIH called the NIH Clinical Research Training Program (CRTP) has helped foster the careers of research-oriented medical and dental students, and similar programs may help bolster the dwindling pipeline of biomedical researchers and clinician-scientists, according to a study now available electronically in Academic Medicine.

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