USFDA

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.

Akari Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted to Akari an Orphan Drug Designation for recombinant protein inhibitor of complement factor 5 for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). Coversin, Akari’s lead clinical product, which falls within the Orphan Drug Designation, is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC).

[adsense:336x280:8701650588]

Dr. Reddy’s Laboratories Ltd has launched Bupropion HCl extended-release tablets, USP (SR) in 100 mg, 150 mg and 200 mg, a therapeutic equivalent generic version of Wellbutrin® SR (bupropion HCl) Sustained-Release Tablets in the United States market approved by the U.S. Food & Drug Administration (USFDA).

Boehringer Ingelheim announced that the European Commission (EC) and U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to nintedanib for the treatment of systemic sclerosis (SSc, also known as scleroderma), including the associated interstitial lung disease (SSc-ILD).

HSRx Biopharmaceutical, a leading developer of polyfunctional-powered combination drugs for infectious and age-related chronic disease conditions, confirmed its orally administered broad-spectrum antiviral drug candidate, HSRx 431, is effective against the Zika virus. HSRx expects to begin human trials early in 2017 and will seek accelerated drug approval from the US Food & Drug Administration.

The health tech company icometrix obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their image quantification software. Outside the US, the software is already extensively used and offered via MSmetrix.

Evoke Pharma, Inc. announced that it has completed a pre New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, Gimoti™, its patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The focus of this pre-NDA meeting with the FDA was the content of the regulatory, chemistry, manufacturing, and control (CMC), and non-clinical sections of the Company's planned 505(b)(2) NDA for Gimoti.

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA, or target action, date of Dec. 24, 2016. Additionally, the FDA granted Breakthrough Therapy Designation for this indication. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for this indication.

Matinas BioPharma Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead drug candidate, MAT2203, as a Qualified Infectious Disease Product (QIDP) with Fast Track status for prophylactic treatment of invasive fungal infections due to immunosuppressive therapy.