BioSpace News Archive

The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) to Sandoz, a division of Novartis, for its Biologics Licensing Application (BLA) for its biosimilar to Roche/Genentech’s Rituxan.

Scandals are nothing new in any industry. The pharmaceutical and biotech industry are certainly no strangers to scandals – just ask convicted scandal-magnet Martin Shkreli.

Shares of Achaogen are down more than 30 percent in premarket trading following the results of split support from a U.S. Food and Drug Administration panel for its lead antibiotic treatment, plazomicin, which is being developed for the treatment of adults with complicated urinary tract infections and bloodstream infections.

Venture capital firm Foresite Capital, located in San Francisco, is launching a new fund, its fourth and largest, worth $668 million.

Just about every week has plenty of exciting news in the biopharmaceutical industry, and this week was no different. Here’s a brief look back at some of our top stories.

Regeneron has halted high dose treatment of a Phase III osteoarthritis drug following a risk-benefit assessment conducted by an Independent Data Monitoring Committee.

Ahead of June’s annual American Society of Clinical Oncology meeting Merck said this morning that its Phase III lung cancer trial met a pre-specified secondary endpoint of overall response rate (ORR) in an early cohort of participants at an interim analysis.

According to Biosimilarpipeline, more than 660 companies worldwide have about 700 biosimilars in development.

Bristol-Myers Squibb announced that it has expanded its relationship with Flatiron Health, extending a three-year collaboration agreement.

Casma Therapeutics closed on a Series A round totaling $58.5 million. The company was solely funded by Third Rock Ventures.