Chelsea Therapeutics International Inc. delivered unhappy news Monday morning, acknowledging the FDA had raised questions about safety and efficacy in a briefing document released in advance of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting on the new drug application (NDA) for lead candidate Northera (droxidopa), scheduled for Feb. 23.
Privately held biotech Acetylon Pharmaceuticals Inc. continued its string of successful private investments with a $15 million equity stake by Celgene Corp.
Cytomedix Inc. drew attention to the regenerative medicine space Wednesday afternoon with the acquisition of privately held Aldagen Inc., which is developing autologous cell-based therapeutics for tissue repair and regeneration.
Privately held Synchroneuron Inc. raised $6 million in a Series A financing from Morningside Ventures to advance a candidate targeting tardive dyskinesia (TD) and related movement disorders.
GlaxoSmithKline plc voluntarily suspended enrollment in Phase I and II trials of GSK2251052 (GSK'052), a systemic antibiotic for Gram-negative infections licensed from Anacor Pharmaceuticals Inc., due to a microbiological finding in patients enrolled in the Phase IIb in complicated urinary tract infections (cUTI).
Ardea Biosciences Inc. priced an underwritten public offering of 8.5 million shares of common stock at $17 per share, seeking to raise $144.5 million before expenses. The price represented a 6.5 percent discount to Tuesday's closing price of $18.19.
While it didn't exactly blast the ball out of the park, Biogen Idec Inc. reported solid 2011 revenues, reaching the $5 billion milestone for the first time.
Robert Hugin, chairman and CEO of Celgene Corp., wasn't kidding when he told attendees at this month's J.P. Morgan Healthcare Conference that 2011 was a "year of momentum" for the giant biotech. (See BioWorld Today, Jan. 10, 2012.)
Launched in 2006 after its co-founder pitched the concept at a Federal Express business plan competition, Ablitech Inc., started the New Year in a new location. The small biotech relocated from Hattiesburg, Miss., to the BioPark at the University of Maryland, where it is working to develop treatments for heterotropic ossification (HO) – a painful bone growth that occurs after severe trauma such as a concussion blast or amputation.
Another hepatitis C candidate knocked the socks off investors Tuesday as Jerusalem's BioLineRx Ltd. added a new prong to its pipeline, inking a worldwide, exclusive license agreement with the French firm Genoscience to develop and commercialize the orally available protease inhibitor (PI) BL-8020.
