Perrigo Co. plc, of Dublin, said it settled the Hatch-Waxman litigation relating to acne product Onexton Gel (clindamycin phosphate 1.2 percent and benzoyl peroxide 3.75 percent) brought by Valeant Pharmaceuticals North America LLC and Dow Pharmaceutical Sciences Inc.
Adial Pharmaceuticals Inc., of Charlottesville, Va., has filed to raise $16 million in its IPO, offering 1.4 million shares of common stock in the price range of $9 to $11 each.
CLEVELAND – Coming into the Cleveland Clinic's 15th annual Medical Innovation Summit, gene therapy had been making headlines, most recently the unanimous recommendation by the FDA's Cellular, Tissue and Gene Therapies Advisory Committee in favor of Spark Therapeutics Inc.'s Luxturna (voretigene neparvovec) in RPE65-mediated inherited retinal disease. But back in the early 2000s, when Casey Cunningham, of Sante Ventures, was working as a clinical investigator, the gene-based technologies weren't exactly hot property.
Calling it a "human tragedy," a "terrible affliction" and a "national shame," President Donald Trump officially declared the U.S. opioid epidemic a national public health emergency Thursday.
Macrogenics Inc. landed Incyte Corp. as an immuno-oncology (I-O) partner, securing $150 million up front for a collaboration and license agreement covering MGA-012, its phase I monoclonal antibody (MAb) that inhibits programmed cell death protein 1 (PD-1). Incyte gained exclusive global rights to develop and commercialize MGA-012 in all indications, although Macrogenics held on to the right to develop the asset in combination with other candidates in its pipeline. Should any of these combinations gain approval, Incyte will commercialize MGA-012 and Macrogenics will commercialize its internal assets.
CLEVELAND – A technology so promising it took the FDA barely 100 days to clear it for marketing approval topped the Cleveland Clinic's list of 10 innovations expected to have significant impacts on health care in 2018. Unveiled on the last day of the 15th annual Medical Innovation Summit, the list leads with the closed-loop insulin delivery system for type 1 diabetes and includes advances such as gene therapy and telehealth that have been years in the making.
DUBLIN – Ablynx NV joined the great European biopharma migration to Nasdaq, grossing just over $200 million in an upsized IPO of 11.43 million shares, which it priced at $17.50 per American Depository Share (ADS). The offering brings its total number of shares outstanding to over 72.8 million and implies a market cap just shy of $1.3 billion.
U.S. Democratic lawmakers delivered on a long-touted promise Wednesday as they introduced legislation to allow Medicare to directly negotiate Part D prescription drug prices. Now they're calling on President Donald Trump to keep his promise to support Medicare negotiations.
HONG KONG – For the first time in 16 years, China is planning to implement an updated version of its drug administration law. The CFDA also is set to revise the country's provisions for drug registration in efforts to upgrade its health care industry. Major proposed changes to the drug administration law which covers both pharmaceuticals and medical devices –are intended to reduce regulations in line with other major markets.
Two separate papers reported advances in nucleic acid editing today that further expand the read of such editing, which has already been transformed since the onset of CRISPR in ways that are only beginning to be understood, and exploited.