USFDA

Amgen and UCB announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Romosozumab works by binding and inhibiting sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption.

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.  

Ajanta Pharma Limited received final approval from US FDA and launched Omeprazole and Sodium Bicarbonate Capsules in the US market, through its wholly owned subsidiary Ajanta Pharma USA Inc.

Oncternal Therapeutics, Inc., a clinical-stage oncology company developing first-in-class therapies for rare and common malignancies, announced that TK216 has received Orphan Drug designation from the US Food and Drug Administration (FDA) for the treatment of Ewing sarcoma.

Loxo Oncology, Inc, a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK), “for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.”

Amgen announced that the company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the US Food and Drug Administration's (FDA) Arthritis Advisory Committee. ABP 501 is a biosimilar candidate to Humira (adalimumab), an anti-tumour necrosis factor-alpha (TNF-a) monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases.

Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) to begin a prospective, multicenter, randomized clinical trial for its Sylys® Surgical Sealant device.

Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT Admiral drug-coated balloon (DCB) in longer, 150 mm lengths. The new 150 mm length balloon, available in four, five, and six mm diameters, will provide greater treatment options for long lesions in patients with peripheral artery disease (PAD).