USFDA

The U.S. Food and Drug Administration  approved the Amplatzer PFO Occluder device. The PFO Occluder reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart, called a patent foramen ovale (PFO), and then traveled to the brain. The Amplatzer PFO Occluder device is manufactured by St. Jude Medical Inc. based in Plymouth, Minnesota.

Sanofi and Regeneron Pharma Inc. announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Applications (BLA) for sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Allergan plc announced that it has received approval from the US Food and Drug Administration (FDA) for Restasis Multidose (Cyclosporine Ophthalmic Emulsion) 0.05%, a preservative-free, multi-dose bottle offering the same preservative-free formulation of Restasis since the launch in 2003. Restasis is the one and only prescription treatment FDA approved to help patients with a type of chronic dry eye make more of their own tears.

Medtronic plc announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve(TM) Evolut(TM) R 34 mm valve-the largest sized transcatheter aortic valve replacement (TAVR) system available in the U.S. The new Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm. This large valve segment is estimated to account for approximately 25-30 percent of the eligible global TAVR patient population. Previously, some of these patients were unable to receive a TAVR due to the larger size of their native diseased aortic valve.

Daiichi Sankyo, Inc. and Inspirion Delivery Sciences LLC (Inspirion) have entered into a strategic collaboration agreement in the US to commercialize FDA-approved MorphaBond (morphine sulfate) extended-release tablets, CII. The agreement also provides Daiichi Sankyo, Inc. with the rights to commercialize a separate investigational Inspirion compound in the US, if approved by the US Food and Drug Administration (FDA).

Astellas Pharma Inc. and Pfizer Inc. announced the US Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the US product labeling for Xtandi (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study. The data demonstrate improvement in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (CRPC) who were treated with enzalutamide compared to patients who were treated with bicalutamide.

 Portola Pharmaceuticals Inc.  announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. Betrixaban, an FDA Fast Track-designated investigational drug, is an oral, once-daily Factor Xa inhibitor anticoagulant.

Abeona Therapeutics Inc. Announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for ABO-102, a single intravenous injection of AAV gene therapy for subjects with MPS IIIA (Sanfilippo syndrome type A), a rare autosomal recessive disease affecting every cell and organ in the body causing neurocognitive decline, speech loss, loss of mobility, and premature death in children.

Inovio Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its proposed phase III clinical program for VGX-3100.

Mersana Therapeutics, Inc., a biotechnology company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) based on its proprietary Fleximer® platform technology,  announced that the U.S. Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) application to begin Phase 1 clinical trials for its lead oncology drug candidate XMT-1522.The compound is Mersana’s first pipeline product, and defines a new class of HER2-targeted therapies.