While just an undercurrent in Wednesday's House subcommittee hearing on oversight of the 340B prescription drug discount program, high U.S. drug prices were cited as a factor in the growth of the program and, at the same time, explained as the downstream outcome of that growth. Read More
Symbiomix Therapeutics LLC, which saw its single asset, Solosec (secnidazole, previously SYM-1219), approved by the FDA last month to treat bacterial vaginosis (BV), agreed to a buyout by Lupin Inc., the U.S. subsidiary of Mumbai-based Lupin Ltd., for $150 million, including $50 million up front. Lupin, which has a global presence but focuses largely on generics, earlier this year took an option to acquire privately held Symbiomix, which specialized in therapies to treat gynecologic infections. Read More
Aerie Pharmaceuticals Inc.'s claims about the efficacy of its triple-acting glaucoma drug, Rhopressa (netarsudil), earned uncomplicated support from FDA briefing docs published ahead of the agency's Friday Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) meeting, sending company shares (NASDAQ:AERI) climbing 16.2 percent to $64.30 on Wednesday as the company took another substantive step toward an anticipated Feb. 28 approval or earlier. Read More
A Gordian knot-like approach may be feasible in gene therapy for Rett syndrome. Researchers at the British University of Edinburgh have demonstrated that treating mice with a "radically truncated" gene that encoded about a third of the full-length MeCP2 protein, which is mutated in Rett syndrome, allowed the animals to survive long term with minimal symptoms. Read More
HONG KONG – Chinese biotech company Hybio Pharmaceutical Co. recently received approval from the CFDA to conduct clinical trials for its generic version of GLP-1 analogue liraglutide. Read More
Rhythm Pharmaceuticals Inc., of Boston, closed its IPO of about 8.1 million shares of common stock at $17 each, which includes the exercise in full by the underwriters of their option to purchase up to about 1 million shares of common stock. Read More
Synaffix BV, of Amsterdam, said ADC Therapeutics Sarl, of Lausanne, Switzerland, has triggered a second target-specific license under their commercial license Agreement dated October 2016, to develop an antibody-drug conjugate (ADC) using Synaffix's site-specific ADC technology. Read More
Critical Outcome Technologies Inc., of London, Ontario, said the first patient was dosed in the head and neck squamous cell carcinoma (HNSCC) arm of its phase I trial of COTI-2 at a dosage level of 1 mg/kg. Read More