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.
The phase III win in March testing oral CFTR corrector tezacaftor and approved CFTR potentiator Kalydeco (ivacaftor) in cystic fibrosis (CF) patients left investors and analysts predicting success in early stage testing for triple-combo regimens featuring ivacaftor, tezacaftor and one of four possible next-generation CF correctors. But the phase I and phase II data unveiled late Tuesday by Vertex Pharmaceuticals Inc. simply blew away expectations. (See BioWorld Today, March 30, 2017.)
A cardiovascular signal that earned a second complete response letter (CRL) for Dynavax Technologies Corp.'s hepatitis B vaccine, Heplisav, was determined by members of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) largely to be a "spurious" finding that should be investigated more fully in a required postmarketing study.
Having spent the last several years advancing its potentially disease-modifying nitrated fatty acid cell signaling approach targeting inflammatory and fibrotic indications, privately held Complexa Inc. is gearing up for phase II proof-of-concept trials after closing a $62 million series C round, by far its most substantial fundraising to date.
