GSK Bio

Priority Review for BLA submission was granted by U.S. FDA for tafasitamab in combination with lenalidomide for relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL) based on positive primary analysis data of L-MIND and Re-MIND studies

Zai Lab Limited announced the China National Medical Products Administration has accepted its supplemental New Drug Application for ZEJULA® as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

Companies strengthen their leadership teams and executive boards with this week’s Movers & Shakers.

As the number of diagnosed cases of COVID-19 continue to increase across the globe and more and more governments are urging citizens to self-quarantine, the pharmaceutical and life sciences industry continues to work toward the development of a vaccine and therapies for the respiratory infection that was declared a pandemic by the World Health Organization last week. Here’s a biopharma industry overview as of late March 16.

Biopharma companies, government regulatory and health agencies and academic centers are stepping forward and working to test or develop vaccines and therapeutics for the disease.

As the coronavirus outbreak that causes COVID-19 escalates, biopharma companies and government agents are working quickly to develop and test a vaccine, although most estimates are it will take 12 to 18 months before it could get to market.

The drugs in question bring in about $200 million annually.

The U.S. Centers for Disease Control and Prevention warned the public yesterday to be prepared for it to spread in the U.S., indicating it was “when,” not “if.”

The FDA is reviewing the sNDA under the Real-Time Oncology Review (RTOR) pilot program, which could speed up the process for potential approval.