USFDA

Intercept Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA)'s Gastrointestinal Drugs Advisory Committee voted 17 to 0 to recommend accelerated approval of Ocaliva™ (obeticholic acid) for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). The target date for the FDA to take action under the Prescription Drug User Fee Act (PDUFA) is May 29, 2016. The FDA is not bound by the Advisory Committee's guidance, but takes its advice into consideration when reviewing investigational medicines. If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.

Hikma Pharmaceuticals PLC (Hikma) confirms that its abbreviated new drug application (ANDA) for fluticasone propionate and salmeterol inhalation powder has been accepted for filing by the U.S. Food and Drug Administration (FDA).

Anavex Life Sciences Corp. announced that the U.S. Food and Drug Administration (FDA) has granted that Orphan Drug Designation for ANAVEX 3-71 for the treatment of Frontotemporal dementia.

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Polymyxin B for Injection USP, 500,000 units/vial. This product is expected to be launched in Q2 FY16-17

Corbus Pharmaceuticals Holdings Inc. announced that a protocol amendment has been added to one of the Company's existing Investigational New Drug ("IND") Application with the U.S. Food and Drug Administration ("FDA") for a Phase 2 clinical trial of Resunab in systemic lupus erythematosus ("SLE").

The U.S. Food and Drug Administration  approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation (HSCT). This is the first FDA-approved therapy for treatment of severe hepatic VOD, a rare and life-threatening liver condition. Defitelio is marketed by Jazz Pharmaceuticals based in Palo Alto, California.

The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus. The test is manufactured by Roche Molecular Systems, Inc., based in Branchburg, New Jersey.

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Adaptimmune Therapeutics plc announced that the U.S. Food and Drug Administration (FDA)'s Office of Orphan Products Development has granted orphan drug designation for the company’s affinity enhanced T-cell therapy targeting NY-ESO for the treatment of soft tissue sarcoma, a solid tumor cancer.

KemPharm, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a fee waiver and has refunded the full user fee amount of $2,374,200 for its New Drug Application (NDA) filing for KP201/APAP, the Company’s investigational immediate release combination of its hydrocodone prodrug, KP201 (benzhydrocodone hydrochloride), and acetaminophen (APAP), which is currently under priority review by the FDA.  The FDA has set a target action date under the Prescription Drug User Fee Act of June 9, 2016.