The scientific teams of Regeneron Pharmaceuticals Inc. and Alnylam Pharmaceuticals Inc. have "enough work to occupy us for the next 10 years comfortably," thanks to known genetically validated targets, according to the latter's R&D chief, Akshay Vaishnaw. "Having said that, new targets will continue to emerge." Read More
United Therapeutics Corp. is discontinuing development of esuberaprost (beraprost 314d), an oral prostacyclin analogue, after its phase III Beat study in patients with pulmonary arterial hypertension (PAH) failed to meet the primary endpoint. Read More
Privately held Ocugen Inc. and publicly held Histogenics Corp. have entered a definitive merger agreement to create a publicly traded, clinical-stage biopharmaceutical company using Ocugen as its name, with a focus on eye diseases. Read More
Audentes Therapeutics Inc. is adding two new tools to its adeno-associated virus (AAV)-based gene therapy toolkit, enlisting expertise from Nationwide Children's Hospital and its own team to develop new vectorized antisense therapies for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1). Read More
Noninvasive electrical stimulation of the brain to synchronize the activity of distant cortical regions could boost the working memory of trial participants in their sixties to resemble a group of individuals in their twenties. Read More
On the eve of Monday's comment deadline on a proposed rule that would drain the safe harbor for prescription drug rebates in certain federal programs, the U.S. Centers for Medicare & Medicaid Services (CMS) offered some breathing room if the rule is finalized. Read More
Medtronic plc, of Dublin, highlighted results of a study that demonstrated a reduction in health care utilization and cost for cancer pain patients using targeted drug delivery (TDD) and conventional medical management (CMM) vs. CMM alone. TDD was delivered by the Medtronic Synchromed II infusion system, which is an implantable pump that delivers medication directly to the fluid around the spinal cord. Read More
Coherus Biosciences Inc., of Redwood City, Calif., said its biosimilar, Udenyca (pegfilgrastim-cbqv), had preliminary unaudited net sales for the quarter that ended March 31 that are expected to be in the range of $36 million to $38 million. The drug gained FDA approval late last year. Read More
Jazz Pharmaceuticals plc, of Dublin, Lundbeck LLC, part of Copenhagen-based H. Lundbeck A/S, and Alexion Pharmaceuticals Inc., of Boston, agreed to pay a total of $122.6 million to resolve separate allegations that they violated the U.S. False Claims Act by paying kickbacks to Medicare and Civilian Health and Medical Program (ChampVA) patients through what were purportedly independent charitable foundations. Read More
Enlivex Therapeutics Ltd., of Nes Ziona, Israel, said it closed a private placement of ordinary shares at $12.25 each, raising a total of approximately $8.4 million. Read More
