Pharma News

As the Indian medical device industry braces up for new opportunities, it remains tied up in the restrictive business environment. With the recent announcement on inclusion of coronary stent of all categories in National List of Essential Medicine the industry sentiment has further weakened.

Spark Therapeutics and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to SPK-9001, the lead investigational candidate in the companies' SPK-FIX program, in development for the treatment of hemophilia B. SPK-9001, a novel bio-engineered adeno-associated virus (AAV) capsid expressing a codon-optimized, high-activity human factor IX variant, is being investigated in an ongoing Phase 1/2 trial as a potential one-time therapy.

Relievant Medsystems, Inc., a privately held medical device company pioneering the therapy of nerve ablation within vertebral bodies for the treatment of chronic low back pain, announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the INTRACEPT® Intraosseous Nerve Ablation System.

CytoDyn Inc. announces that it has submitted to the U.S. Food And Drug Administration (FDA) an application for orphan drug designation for the use of PRO 140 (humanized monoclonal antibody to CCR5) in the pretreatment of HIV Type-1 (HIV-1) infection in treatment-naïve adults while they are waiting for drug resistance assay results to construct a subsequent Highly Active Antiretroviral Therapy (HAART) regimen.  The generation of these assay results typically takes approximately two weeks.

Advaxis, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead immunotherapy candidate, axalimogene filolisbac (AXAL), as a Fast Track product for adjuvant therapy for high-risk locally advanced cervical cancer patients. The investigation of AXAL in this under-served population will be conducted in accordance with the Special Protocol Assessment (SPA) recently granted by the FDA.   

Valeant Pharmaceuticals International, Inc. and Progenics Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved RELISTOR® (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Valeant expects to commence sales of RELISTOR Tablets in the U.S. in the third quarter of 2016. 

Lannett Company, Inc. announced that its strategic partner, Sparsha Pharma USA, Inc., has received an Acceptable for Filing letter from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 12 mcg/hour, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the generic equivalent of Ortho McNeil's chronic pain treatment Duragesic®. 

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AveXis, Inc., a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for AVXS-101, the company’s lead development candidate for the treatment of spinal muscular atrophy (SMA) Type 1 in pediatric patients.  

The European Medicines Agency (EMA) has accepted for review, Mylan’s Marketing Authorization Application (MAA) for our proposed biosimilar Pegfilgrastim, which is used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). 

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