LONDON – Alkermes Inc. is acquiring the drug delivery arm of Elan plc in a cash and shares deal valued at $960 million. Of that Elan will receive $500 million cash, with the balance coming in the form of 31.9 million shares. Read More
Shares in Diamyd AB plunged 85 percent Monday on news that its immunotherapy treatment for Type I diabetes, also called Diamyd, missed the primary endpoint of a European Phase III trial. Read More
Merrimack Pharmaceuticals Inc. consolidated its development and commercialization program for MM-398/PEP02 by acquiring rights for Europe and Asia from PharmaEngine Inc., of Taipei, Taiwan, for $10 million up front, a potential $210 million in milestones, and tiered royalties on sales. Read More
WASHINGTON – The FDA sees a $150,000 annual biosimilar product development fee as the solution to a unique challenge posed by the new 351(k) approval path. Read More
Advaxis Inc., of Princeton, N.J., said it sold about $6 million in convertible promissory notes with an aggregate principal value of about $7.1 million. The company said the notes have an original issue discount of 15 percent and will mature after one year. Read More
OPKO Health Inc., of Miami, was awarded a grant from the Dravet Syndrome Foundation to support development of potential therapeutics for Dravet syndrome, also called severe myoclonic epilepsy of infancy, a rare genetic disorder that causes a severe form of epilepsy. Read More
Inhibitex Inc., of Atlanta, said partner Pfizer Inc. presented Phase I data showing SA3Ag, a three-antigen Staphylococcus aureus vaccine, elicited a positive immune response to each of the three components. Read More
ImmusanT Inc., of Cambridge, Mass., presented Phase I data showing that Nexvax2 was well tolerated and induced a T-cell response confirming bioactivity in HLA-DQ2 genotype celiac disease patients. Nexvax2 is a therapeutic vaccine that combines three peptides that elicit an immune response in patients with the immune recognition gene HLA-DQ2. A Phase IIa trial is expected to begin within a year. Read More
Chelsea Therapeutics International Ltd., of Charlotte, N.C., said an independent data safety monitoring board recommended continuation of its ongoing Phase II trial of CH-4051 in rheumatoid arthritis and that it should initiate enrollment in the 3-mg dose group. Ten patients have completed treatment in the 0.3-mg and 1-mg dose cohorts, with no negative safety signals found by the DSMB. For the remainder of the trial, patients will be randomized to 0.3 mg, 1 mg or 3 mg of CH-4051 daily, 3 mg CH-4051 daily with folate supplement, or methotrexate weekly with folate supplement for 12 weeks. Read More
