After what Amicus Therapeutics Inc. characterized last month as an upbeat pre-new drug application (NDA) meeting, U.S. regulators have sent word that the package for migalastat, its oral small-molecule pharmacological chaperone to treat the alpha-galactosidase A shortage in Fabry disease, needs to include more, and the company said the NDA won’t be submitted by the end of this year as planned. Read More
Two weeks after disappointing the Street with higher-than-expected adverse event (AE) rates in its phase II trial of XP23829 in moderate to severe chronic plaque-type psoriasis, Xenoport Inc. changed course in dramatic fashion. Bowing to analyst recommendations, the company halted internal development of XP23829 while seeking to outlicense the candidate and other development-stage assets to focus, instead, on maximizing the commercial value of Horizant (gabapentin enacarbil). Read More
CCR5’s claim to fame in the clinical world is that it is a co-receptor that HIV uses to enter T cells, and that cells with two copies of a particular CCR5 variant, CCR5-delta32, are naturally resistant to HIV. Read More
SHANGHAI – Suzhou Ribo Life Science Co. Ltd., a Chinese siRNA drug company established in 2007, has raised $20 million in venture capital financing. Read More
Public and private biotech companies are still having no difficulty raising cash despite the horrendous performance of the capital markets during the third quarter. The sector collectively raised a whopping $34 billion, an amount swollen by three major debt offerings. Read More
Horizon Pharma plc, of Dublin, said that its affiliate Horizon Pharma Switzerland GmbH has entered a settlement and license agreement with Actavis Laboratories FL Inc., part of Allergan plc, of Dublin, to resolve pending patent litigation involving Rayos (prednisone) delayed-release tablets. Read More
Cellectar Biosciences Inc., of Madison, Wis., closed its registered direct offering of approximately 1 million common stock and series B pre-funded warrants to purchase 482,728 additional common shares at $2.20 apiece. Read More
Coherus Biosciences Inc., of Redwood City, Calif., reported results from its pharmacokinetic and pharmacodynamic (PK/PD) clinical study of CHS-1701, a pegfilgrastim (Neulasta, Amgen Inc.) biosimilar candidate. Read More
Researchers from Stanford University have discovered that the enzyme aldehyde dehydrogenase 1a1 (ALDH1a1), whose activity is influenced by alcohol, is responsible for synthesis of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in midbrain structures that are involved with reward and addiction. Read More
