Biomarin Pharmaceutical Inc., of San Rafael, Calif., said the EMA granted access to its Priority Medicines (PRIME) regulatory initiative for the company's investigational gene therapy treatment for severe hemophilia A, BMN 270. Read More
Hemispherx Biopharma Inc., of Philadelphia, said it entered definitive agreements with several institutional investors for an offering of shares of common stock with gross proceeds of about $1 million in a registered direct offering. Read More
Merck & Co. Inc., of Kenilworth, N.J., fell 1 percent short of expectations in the fourth quarter of 2016, mainly blamed on lower sales of Januvia/Janumet (sitagliptin), Zetia (ezetimibe), Zostavax (zoster vaccine live) and Cubicin (daptomycin), though sales of PD-1 inhibitor Keytruda (pembrolizumab), at $483 million, marginally beat the consensus guess of $470 million. Read More
President Donald Trump's two-for-one regulation memo is now an executive order. Slated for publication in Friday's Federal Register, the order instructs federal agencies to identify at least two regulations to be withdrawn for every new regulation issued. Read More
Factor XI, a coagulation factor that is part of the intrinsic blood clotting pathway, is part of a newly discovered circuit that links coagulation, inflammation and hypertension. Researchers described the circuit, which breaks ground scientifically as well as offering potential therapeutic strategies to treat often-co-morbid diseases, in the Feb. 1, 2017, issue of Science Translational Medicine. Read More
Fortress Biotech Inc. subsidiary Mustang Bio Inc. closed on a $94.5 million private placement financing. It plans to use the funds to advance its two lead chimeric antigen receptor T-cell (CAR T) immunotherapies, MB-101 and MB-102, through phase I data readouts early next year and to grow its pipeline by exploring additional applications for its CAR T technology beyond its initial focus in brain cancer and acute myeloid leukemia. Read More
Shares (NASDAQ:AVIR) of Aviragen Therapeutics Inc. took a drubbing after the company reported following Wednesday's market close that its double-blind, placebo-controlled phase IIa study of BTA585 in adults challenged intranasally with respiratory syncytial virus (RSV) missed the primary endpoint of reducing viral load. Read More
LONDON – Arix Bioscience Ltd. is to float on the main market of the London Stock Exchange, raising up to £100 million (US$125.6 million) to form and fund drug discovery and development companies from startup to maturity. Read More
Cytokinetics Inc. kept mum on the eventual sales force for omecamtiv mecarbil, possible changes in the Royalty Pharma deal's assigned percentage, and an additional safety trial with the phase III candidate, as well as potential reimbursement from Amgen Inc. for "certain activities" in co-promoting. Read More
Amag Pharmaceuticals Inc., of Waltham, reported results from its pharmacokinetic study designed to demonstrate comparable bioavailability of the subcutaneous auto-injector product and the current intramuscular (IM) injection form of Makena (hydroxyprogesterone caproate injection) in about 120 healthy postmenopausal women. Read More
