USFDA

Vizient, Inc.  has sent a letter to the Food and Drug Administration’s (FDA) Arthritis Advisory Committee endorsing the continued implementation of the U.S. biosimilar pathway. On February 9, 2016, the committee is scheduled to hold an advisory hearing  on an application for a biosimilar version of infliximab, currently only available as the branded biologic Remicade® (Janssen Biotech).

Indian drug major Dr.Reddy's Laboratories Ltd on Monday said its wholly owned US subsidiary Promius Pharma has got the USFDA for a spray to treat plaque psoriasis.

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Bristol-Myers Squibb’s announced that Daklinza™ (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3.

Impax Laboratories, Inc. announced that Impax has received tentative approval from the U.S. Food and Drug Administration (FDA) for its

Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for single-dose EMEND® (fosaprepitant dimeglumine) for injection, Merck’s substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). EMEND has not been studied for the treatment of established nausea and vomiting.

Takeda Pharmaceutical Company Limited  and H. Lundbeck A/S announced that the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that the companies presented substantial evidence to support the effectiveness of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with Major Depressive Disorder (MDD). Earlier today, the committee also discussed that cognitive dysfunction in MDD represents an appropriate drug development target.

Conatus Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company's emricasan development program for the treatment of liver cirrhosis caused by nonalcoholic steatohepatitis (NASH).

ARIAD Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company’s Investigational New Drug (IND) application for AP32788, a tyrosine kinase inhibitor (TKI) designed as a targeted therapy for patients with non-small cell lung cancer (NSCLC) with specific mutations in EGFR or HER2. ARIAD anticipates initiation of its Phase 1/2 clinical trial of AP32788 in patients with NSCLC in the second quarter of 2016.

LivaNova PLC, announced it has been granted approval from the United States Food and Drug Administration (FDA) for its innovative stented aortic bioprosthesis CROWN PRT for the treatment of aortic valve disease.  This is the second valve to be approved in the U.S. this year and is expected to be launched in the coming months.  LivaNova’s Perceval valve, the sutureless biological valve on the market for aortic valve replacement procedures, was approved on January 8, 2016.

Proteostasis Therapeutics, Inc., announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for PTI-428, an investigational oral treatment for cystic fibrosis (CF).