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.
It's not just for cancer anymore. Imbruvica (ibrutinib), the blockbuster BTK inhibitor for hematological cancers, won FDA approval today as the first therapy for patients with chronic graft-vs.-host disease (cGVHD) who have failed first-line corticosteroid treatment.
Spark Therapeutics Inc. is having a very good summer. Its BLA for Luxturna (voretigene neparvovec) in RPE65-mediated inherited retinal disease was accepted for priority review, as well as receiving a rare pediatric disease designation, while its hemophilia B gene therapy wowed with interim data at the International Society on Thrombosis and Haemostasis (ISTH) meeting in Berlin.
