United States

Alere hit with subpoena for Medicare billing practices

Thursday, July 28, 2016

Investors were temporarily shaken after news of a federal investigation into Medicare billing practices. Alere received a U.S. Department of Justice subpoena addressed to Alere Toxicology Services on July 1, 2016. The subpoena seeks records related to Medicare, Medicaid and Tricare billings dating back to 2010 for patient samples tested at the company’s Austin, Texas pain management laboratory.

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Embera wins $11M NIDA grant for cocaine addiction treatment EMB-001

Wednesday, July 27, 2016

Embera NeuroTherapeutics, a specialty pharmaceutical company developing novel treatments for cocaine, nicotine, and other addictions, has received an $11.1 million, three-year grant from the National Institute on Drug Abuse (NIDA), part of the NIH. The grant will support continued clinical development of EMB-001 for the treatment of cocaine addiction, which is clinically termed “cocaine use disorder.”

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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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