An internal restructuring at Novartis AG moved the company to unwind its cell and gene therapies unit, established in 2014 to streamline the complex process of combining clinical development, technical operations and manufacturing. Read More
"The more technical explanation is not achieving a pre-specified boundary condition for stopping the trial early," Clive Meanwell, CEO of The Medicines Co. (MDCO), told BioWorld Today, referring to the recommendation of an independent data monitoring committee to continue the phase II MILANO-PILOT study of MDCO-216 following a planned interim analysis of the first 40 patients who completed treatment. Read More
What's been deemed improper payments to doctors and local officials in China and Russia will cost Astrazeneca plc (AZ) more than $5.5 million. Read More
Data due by the end of the year from the phase Ib trial testing Proteostasis Therapeutics Inc.'s cystic fibrosis (CF) prospect PTI-428 could trigger moves by developers in the space looking to pair the drug with therapies such as Orkambi (lumacaftor/ivacaftor) from Vertex Pharmaceuticals Inc. Read More
Since the FDA's breakthrough therapy designation came into existence as part of the FDA Safety and Innovation Act in July 2012, the agency has granted the designation to 145 drugs. Read More
Provectus Biopharmaceuticals Inc., of Knoxville, Tenn., said it completed its public offering of 240,000 shares of series B convertible preferred stock and warrants to purchase 24 million shares of common stock at $25. One share of series B convertible preferred stock is combined with 100 warrants to purchase one share of common stock each with an exercise price of $0.275 per share. Read More
Genmab A/S, of Copenhagen, Denmark, won a supplemental biologics license application for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). Read More
