Pharma News

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.

Vertex Pharmaceutical Incorporated announced that the Therapeutic Goods Administration (TGA) of Australia has approved ORKAMBI® 200/125 (lumacaftor 200mg and ivacaftor 125mg), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation. In Australia, there are approximately 1,000 people with CF ages 12 and older who have two copies of this mutation. The Australian reimbursement process for ORKAMBI is already underway as part of the parallel regulatory and reimbursement processes between the TGA and the Pharmaceutical Benefits Advisory Committee (PBAC).