Anthera Pharmaceuticals Inc. reported disastrous results from phase III RESULT study of Sollpura (liprotamase), which failed to reach the noninferiority margin of the coefficient of fat absorption (CFA) primary endpoint in individuals with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). Sollpura did achieve the secondary endpoint of coefficient of nitrogen absorption (CNA), which measures protein absorption. Read More
Aptevo Therapeutics Inc., of Seattle, reported outcomes data from a study of Ixinity (coagulation factor IX) at the Thrombosis and Hemostasis 2018 Summit of North America San Diego. Read More
Biogen Inc. has moved to buy a midstage neuropsychiatric drug from Pfizer Inc. for $75 million up front, up to $515 million in potential milestones, and tiered royalties in the low to midteens. Read More
AMSTERDAM – Dutch delegates to international biotech conferences routinely express their ebullient sense of identity by attaching their conference badges to their own orange-colored lanyards. Everyone is an honorary Amsterdammer for the duration of the 2018 BIO-Europe Spring meeting, which opened Monday at the RAI conference center in the southern quarter of the city. Read More
Despite warnings of unintended consequences, the U.S. House could take another step this week toward making right-to-try legislation the law of the land. Read More
AMSTERDAM – As the Chinese ecosystem continues to evolve with an increasing focus on innovative drugs and a rapidly changing regulatory environment, American and European biopharma executives have kept a keen but wary eye on the possibilities. Read More
LONDON - The U.K. government has announced a total of £30 million (US$41.7 million) for the formation of three specialist academic centers to work in collaboration with the Cell and Gene Therapy Catapult in laying the groundwork for advanced therapies to be applied at scale in the National Health Service (NHS). Read More
HYDERABAD, India – India's drug regulator is working to launch this month a new unit that would facilitate access to regulatory information and, hopefully, shore up the willingness of Indian drug companies to take more risks. Read More
Race Oncology Ltd., of Victoria, Australia, completed a placement of about 9.9 million shares priced at A32 cents (US25 cents) apiece for gross proceeds of about A$3.2 million. Read More
Mannkind Corp., of Westlake Village, Calif., said it is restructuring certain of its outstanding debt obligations, reducing outstanding principal by an aggregate of $14.5 million along with the corresponding interest expense. Read More