USFDA

DBV Technologies announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Viaskin Milk, the Company’s investigational treatment for pediatric patients two years of age and older with Immunoglobulin E (IgE)-mediated cow’s milk protein allergy (CMPA), currently under clinical investigation in a Phase IIb trial. There are currently no approved treatments for CMPA, the most common food allergy in infants and young children. Fast Track is a process designed by the FDA to facilitate the development, expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Lannett Company, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, the therapeutic equivalent to the reference listed drug, Suboxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg.  According to IMS, total U.S. sales in 2015 of Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, at Average Wholesale Price (AWP) were approximately $270 million.

Viamet Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to VT-1598, a novel candidate for the oral treatment of coccidioidomycosis, or valley fever. Valley fever is an invasive fungal infection found primarily in the southwest United States that affects an estimated 150,000 people annually.

Active Biotech provided an update on laquinimod which is being developed in multiple sclerosis (MS) and Huntington's disease (HD) by Teva Pharmaceutical Industries, Ltd. The U.S. Food and Drug Administration (FDA) has informed Teva that the Special Protocol Assessment (SPA) for the Phase III CONCERTO clinical trial evaluating laquinimod in relapsing remitting multiple sclerosis (RRMS) was rescinded.

Varian Medical Systems announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Nexus DR, a high resolution imaging system for X-ray imaging using a digital X-ray detector. The Nexus DR is designed to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications. The system is a single common imaging platform intended for general radiographic procedures (excluding fluoroscopy, angiography, and mammography).

Array BioPharma announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) related to BEACON CRC, a global Phase 3 trial of encorafenib and Erbitux® (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant colorectal cancer (CRC) who have previously received first-or second-line systemic therapy.

Medtronic plc announced that the U.S. Food and Drug Administration (FDA) approved the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB) as a treatment for in-stent restenosis (ISR) in patients with peripheral artery disease (PAD). This is the first DCB that has gained approval to treat ISR in the U.S. FDA approval was based on ISR data from the IN.PACT Global Study compared to a standard percutaneous balloon angioplasty (PTA) control.

BioXcel, a privately held biopharmaceutical company based in Connecticut, announced that the U. S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BXCL101 for the treatment of Neurofibromatosis Type 2 (NF2), an orphan disease with significant unmet medical need. BXCL101 is the first and only systemic therapy being developed to eliminate existing lesions and prevent the formation of new lesions by targeting the molecular mechanism of NF2 pathophysiology.