After Friday's market close, while much of the U.S. had already turned its attention to the long Memorial Day weekend, Amgen Inc. quietly axed its stake in brodalumab, the much-heralded IL-17 inhibitor that was part of a co-development and commercialization deal with partner Astrazeneca plc. Read More
Mast Therapeutics Inc. has initiated a new open-label extension study to evaluate repeat dosing of its experimental sickle cell disease (SCD) therapy, vepoloxamer (MST-188), in patients who have completed the company's phase III trial, EPIC, and are hospitalized for a subsequent vaso-occlusive crisis, a painful event in which sickled red blood cells "stick" to the endothelium and to each other and leads to blocking circulation and causing tissue damage. Read More
SHANGHAI – The CFDA has an unenviable task on its hands. The agency has an enormous workload supporting the world's second-largest drug market, made more complex given it is still in a developing phase. Regulators not only have to keep up with up an 18 percent year-on-year increase in drug applications that require their review and assessment, they are simultaneously trying to construct the legal architecture necessary to regulate the industry overall. Read More
While it's not a death knell for the life cycle approach of building a drug franchise, an appellate court ruling in People of the State of New York v. Actavis plc could kill one tactic a few drugmakers have used to protect a blockbuster franchise from generic competition: forced switching to the next-generation product. Read More
TOKYO – Japan's National Cancer Center (NCC) and pharma major Takeda Pharmaceutical Co. Ltd. have joined forces to discover and develop cancer drugs in Japan and ensure their quick delivery to patients. Read More
Momenta Pharmaceuticals Inc., of Cambridge, Mass., said it closed its public offering of about 8.3 million shares of common stock priced at $19 apiece, including the exercise in full by underwriters to purchase about 1.2 million additional shares. Read More
Amicus Therapeutics Inc., of Cranbury, N.J., said the EMA's Committee for Medicinal Products for Human Use granted accelerated assessment to the oral small-molecule pharmacological chaperone migalastat HCL monotherapy for Fabry patients who have amenable genetic mutations. Read More
strong>Prima Biomed Ltd., of Sydney, reported that data from the phase II CAN-003 ovarian cancer trial, testing autologous cancer vaccine Cvac, has shown a trend for a clinically meaningful improvement in overall survival (OS) over standard of care in second remission patients. Read More
