Alkermes plc posted its most impressive quarter so far since last fall's acquisition of Elan Corp. plc's drug delivery unit and relocation of its headquarters to Dublin, Ireland, reporting total revenues of $152.2 million, a 146 percent jump over the same three-month period in 2011.
Amgen Inc.'s second-quarter figures blasted past expectations, as the Thousand Oaks, Calif.-based firm reported after market close Thursday total revenues of $4.5 billion, with adjusted earnings per share of $1.83, compared to consensus estimates of $4.1 billion and $1.54 per share.
Only days after the first gene therapy finally cleared regulatory hurdles in Europe, Cambridge, Mass.-based gene therapy firm bluebird bio closed a $60 million Series D financing round.
Shares of Onyx Pharmaceuticals Inc. jumped 11.7 percent Friday after its multiple myeloma drug Kyprolis (carfilzomib) won accelerated approval as a third-line treatment.
Nearly two years after a complete response letter (CRL) delayed Lux Biosciences Inc.'s plans for oral voclosporin in noninfectious uveitis, the Jersey City, N.J.-based biotech completed patient enrollment in a new Phase III study aimed at addressing the FDA's request for additional clinical data.
Six months after signing an option agreement on a Phase I-stage antisense program in spinal muscular atrophy (SMA), Isis Pharmaceuticals Inc. and Biogen Idec Inc. agreed to a similarly structured deal for an earlier-stage rare disease program targeting myotonic dystrophy Type I (DM1), a muscular wasting disease also known as Steinert disease.
With a district court judge ruling in favor of Teva Pharmaceutical Industries Ltd.'s patent infringement lawsuit, the Jerusalem-based big pharma should be able to prevent generic competition to its multiple sclerosis (MS) drug Copaxone (glatiramer acetate) from hitting the market until at least Sept. 1, 2015.
BOSTON – Lawmakers reached agreement late Monday on PDUFA V. The House is expected to pass the legislation, S. 3187, Wednesday, followed by the Senate late this week or early next week, coming in well ahead of their self-imposed July 4 goal.
BOSTON – Ambrx Inc. helped kick off the BIO International Convention Monday by disclosing a potential $303 million collaboration with Merck & Co. Inc. using its EuCODE platform to develop antibody-drug conjugates (ADCs) against oncology and other indications.
BOSTON – When the Biotechnology Industry Organization's (BIO) annual international convention opened in Boston five years ago, the industry was basking in all its pre-recession glory, with plenty of money flowing into both new and existing ventures – some said too much – and one of the biggest concerns heading into the BIO meeting was whether lawmakers would quit locking horns and finally pass PDUFA IV.
