USFDA

Tonix Pharmaceuticals Holding Corp. Announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TNX-102 SL* for the treatment of posttraumatic stress disorder (PTSD).

Pain Therapeutics, Inc. announced it plans to meet with the U.S. Food and Drug Administration (FDA) in person on Monday, February 13, 2017 to discuss the regulatory path forward for REMOXY ER.  The Company will provide details of this FDA meeting after receipt of final meeting minutes.

Amedica Corporation, a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced encouraging results from a recent study showing rapid bone growth into porous silicon nitride. Explants of the company's porous silicon nitride from a large-animal model demonstrated bone healing into the material just four weeks after implantation. "We anticipate these preliminary findings will be confirmed with additional retrieval data in the near future.

CytomX Therapeutics, Inc.  announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its lead program, CX-072, a wholly-owned PD-L1-targeting Probody therapeutic for the treatment of cancer.  The company plans to immediately initiate the study and open clinical sites to support patient enrollment.

The U.S. Food and Drug Administration  approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee. Maci is manufactured by Vericel Corporation, headquartered in Cambridge, Massachusetts.

Aurinia Pharmaceuticals Inc. , a clinical stage biopharmaceutical company focused on the global immunology market, announced that it has received the final End of Phase II (EOP2) meeting minutes from the U.S. Food & Drug Administration Division of Pulmonary, Allergy and Rheumatology Products. The minutes are consistent with the preliminary responses that were issued to the Company prior to the meeting which took place on October 25, 2016.

AstraZeneca and its global biologics research and development arm, MedImmune,  announced that the US Food and Drug Administration (FDA) has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (mAb), and granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017.

Exact Imaging, the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, has received FDA 510(k) clearance for its ExactVu micro-ultrasound system.

Roche announced that the US Food and Drug Administration (FDA) has approved Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Women are said to have a ‘platinum-sensitive’ form of the disease if a relapse occurs six months or longer following the last treatment with a platinum-based chemotherapy.

Gilead Sciences, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients. The data submitted in the NDA support the use of the regimen for 12 weeks in DAA-experienced patients with genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis.