Prospects for Durect Corp.’s Posimir (Saber-bupivacaine) dimmed dramatically with the late Thursday disclosure of a failed phase III study of the extended-release analgesic. Data from the PERSIST study, which had been designed to address a 2014 FDA complete response letter (CRL), showed a favorable trend but fell short of statistical significance on the primary endpoint of reducing pain on movement over the first 48 hours after surgery.
Curevac AG's efforts in upgrading its mRNA vaccine platform over the past decade helped lead to its largest collaboration to date, a pact with Eli Lilly and Co. that comes with a $50 million up-front payment, an equity investment of €45 million (US$53 million) and up to $1.7 billion in potential milestones if all five cancer vaccine candidates are developed, plus tiered royalties on any products that make it to market.
Warp Drive Bio LLC's back-to-nature drug discovery approach landed another deal, this time a potential $387 million pact with Roche Holding AG to discover new classes of antibiotics for drug-resistant gram-negative pathogens. Warp Drive CEO Laurence Reid called it a "huge opportunity to make a contribution to a global problem."
Biocon Ltd. said Tuesday the FDA issued a complete response letter (CRL) for partner Mylan NV's BLA for MYL-1401H, a proposed biosimilar of Amgen Inc.'s Neulasta (pegfilgrastim), the latest biosimilar version of the long-acting G-CSF drug to hit a regulatory snag.
In a move that caught many by surprise, the FDA late Tuesday approved Mylan NV’s generic version of Copaxone (glatiramer acetate injection), both the 40-mg and 20-mg formulations, sending shares of Mylan (NASDAQ:MYL) up 16 percent. The Hertfordshire, U.K.-based firm said it planned to begin shipping its AP-rated – i.e. substitutable – versions of the relapsing multiple sclerosis drug “imminently.”
Eli Lilly and Co.'s abemaciclib won FDA approval Thursday, making it the third CDK 4/6 inhibitor indicated for treating adults with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine therapy.
To uncover the mission of GRO Biosciences Inc., one has to look no further than its name. The acronym stands for "genomically recoded organisms" and describes the way in which the Boston-based startup seeks to go beyond the standard 20 amino acids to rewrite the genomes of bacterial strains to produce therapeutics with improved profiles.
Bayer AG's P13K inhibitor, copanlisib, won FDA approval Thursday for use in adults with relapsed follicular lymphoma who have received at least two prior systemic therapies.
With would-be competitor Alnylam Pharmaceuticals Inc. hot on its heels, Ionis Pharmaceuticals Inc. has little time to spare if it wants to maintain potential first-mover advantage after partner Glaxosmithkline plc bailed on transthyretin (TTR) antisense inhibitor inotersen, only a few months after the drug yielded positive phase III data.
As the first PARP inhibitor approved for maintenance therapy in ovarian cancer, Tesaro Inc.'s Zejula (niraparib) blasted past consensus estimates for the second quarter, recording U.S. sales of $25.9 million following its April launch, well above the $11 million predicted by analysts.
