Industry News

ProNAi Therapeutics, Inc. announced that its oncology drug candidate PNT2258 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of diffuse large B-cell lymphoma (DLBCL).

GW Pharmaceuticals plc, announced the positive results of the first pivotal phase 3 study of its investigational medicine Epidiolex (cannabidiol or CBD) for the treatment of Dravet syndrome. In this study, Epidiolex achieved the primary endpoint of a significant reduction in convulsive seizures assessed over the entire treatment period compared with placebo (p=0.01). Epidiolex has both Orphan Drug Designation and Fast Track Designation from the US Food and Drug Administration (FDA) in the treatment of Dravet syndrome, a rare and debilitating type of epilepsy for which there are currently no treatments approved in the US.

KemPharm, Inc. announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for May 5, 2016, to review KemPharm’s New Drug Application (NDA) for KP201/APAP, its lead investigational drug candidate for the short-term management of acute pain.

Suven Life Sciences Ltd (Suven) announces that the grant of one (1) product patent from China (CN103380131), one (1) product patent from Eurasia (9 Countries) (22043) and one (1) product patent from Hong Kong (HK 1180955)) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases and these Patents are valid through 2032.

Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's supplemental Biologics License Application (sBLA) for the expanded use of Enbrel® (etanercept) to treat pediatric patients with chronic severe plaque psoriasis.

Merck, known as MSD outside the United States and Canada, applauds the U.S. Department of Veterans Affairs (VA) for broadening access to treatment for Veterans with chronic hepatitis C virus (HCV) infection.

Teva Pharmaceutical Industries Ltd. announced the launch of the generic equivalent to Pulmicort Respules® (budesonide inhalation suspension), 1 mg/2 mL, in the United States.

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) and TR-Pharm announced today a strategic collaboration agreement involving 3 biosimilar products. A total of three products will be registered and subsequently commercialized as a part of this agreement by TR-Pharm in Turkey. TR-Pharm will also manufacture the drug substance and drug product upon completition of its facility investment.

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. In 2015, the FDA granted Breakthrough Therapy and Priority Review designations for this indication. XALKORI also is indicated for patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Vericel Corporation announced top-line results from the company's Phase 2b ixCELL-DCM clinical trial of ixmyelocel-T in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM).  The trial met its primary endpoint of demonstrating a reduction in the total number of deaths, cardiovascular hospitalizations or unplanned outpatient and emergency department visits to treat acute decompensated heart failure during the 12 months following treatment with ixmyelocel-T compared to placebo.  All clinical events in the primary and secondary endpoints were adjudicated in a blinded fashion by an independent adjudication committee.  The incidence of adverse events, including serious adverse events, in patients treated with ixmyelocel-T was comparable to patients in the placebo group.  Ixmyelocel-T has been granted orphan product designation by the U.S. Food and Drug Administration for use in the treatment of DCM.