Opting for an ounce of prevention rather than a pound of cure, the FDA unveiled a proposed rule and strategic plan Thursday to keep drug shortages from happening.
Stallergenes SA could receive up to $120 million in regulatory and sales-based milestones from a U.S. commercialization agreement with Greer Laboratories Inc., involving its investigational grass allergy treatment Oralair. Antony, France-based Stallergenes will be responsible for the production of the Oralair sublingual tablets, for which it will receive an undisclosed transfer price. It also stands to receive sales royalties on the product.
Partnered with Adimab LLC for antibody development in dementia and Alzheimer’s disease (AD), Alector LLC raised an undisclosed amount of money in its Series A round, enough to last “two or three years, we think,” said CEO Arnon Rosenthal, who estimated “at least four years before we are in the clinic” with a drug that might succeed where so many others have not.
• Baxter International Inc., of Deerfield, Ill., said it submitted a marketing authorization application to the European Medicines Agency for Rixubis, (recombinant Factor IX [nonacog gamma]) to treat and prevent bleeding in patients with hemophilia B.
Ariad Pharmaceuticals Inc. suspended sales of its leukemia drug Iclusig (ponatinib) due to potential blood clot issues upon request from the FDA. The discouraging news follows termination of Ariad’s Phase III EPIC trial in first-line chronic myelogenous leukemia (CML), and a clinical hold due to those same safety issues.
As further proof that cancer immunotherapy is no longer the biopharma pariah of several years ago, Immune Design Corp. closed a $49 million Series C round to advance its lead candidates into the clinic.
Arno Therapeutics Inc. hauled in $30.7 million through a private placement of common stock and warrants, more than doubling the amount raised by the company in last year’s $14.9 million private placement of convertible debentures.
A Gilead Sciences Inc. earnings report filled with confidence about the upcoming launch of sofosbuvir and solid bottom-line beats boosted the company’s stock by 4.6 percent Wednesday.
Several lawmakers have put aside their political differences to come together on the Innovation Act, a sequel that takes up where the 2011 America Invents Act (AIA) left off in its reform of the U.S. patent system.
LONDON – Immunocore Ltd. has opened a Phase IIa trial of its T-cell cancer vaccine, IMGgp100, after demonstrating immune responses and evidence of tumor shrinkage in some of the 31 patients with late-stage melanoma who took part in the Phase I single-dose study.