• Entremed Inc., of Rockville, Md., said it started a Phase II study, titled “Phase II Study of Oral ENDM-2076 Administered to Patients with Ovarian Clear Cell Carcinomas.”
• Algeta ASA, of Oslo, Norway, said partner Bayer AG, of Leverkusen, Germany, disclosed third-quarter 2013 U.S. net sales for Xofigo (radium Ra 223 dichloride) of €12 million (US$17 million).
Scientists have developed a method to shield transplanted cells from the transplant recipient’s immune system, enabling them to transplant a diabetic patient with insulin-producing islet cells that remained invisible to his immune system.
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.