Pharmaceuticals, Biotechnology and Life Sciences
The new efforts the FDA is making will provide a solid foundation for recruitment and for responsibly managing our user fee resources, Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration said at the beginning of the week.
Diplomat Pharmacy will distribute Puma Biotechnology’s new product, Nerlynx, a kinase inhibitor approved by the US Food and Drug Administration (FDA).
The global Alzheimer’s drugs market to grow at a CAGR of 1.90% during the period 2017-2021, according to ResearchandMarkets, with Key vendors being Allergan, Eisai Pharmaceuticals, Johnson & Johnson, and Novartis, with other other prominent vendors Amgen and Pfizer.
Pharming Group N.V. has completed the replacement of its recently announced $100 million bridge finance with OrbiMed Advisors with a $100 million permanent facility agreement with OrbiMed Advisors.
The European Commission has approved patriometer to be marketed as Veltassa in the 28 EU countries for treating hyperkalaemia in adult patients.
SillaJen and Lee’s Pharmaceutical Holdings have said that they’ve gotten the approval from the China Food and Drug Administration (CFDA) to get a Phase 3 clinical trial for advanced liver cancer using its oncolytic immunotherapy called Pexa-Vec, the PHOCUS study.
GSK on Wednesday set out several announcements made by the company to improve the efficiency and competitiveness of its manufacturing network, including investments for respiratory and HIV medicines manufacturing in the UK and strategic reviews. This includes the sale of several products and a proposal to close a UK manufacturing site.
Celyad has kicked off the SHRINK trial, a third clinical trial with its lead product candidate CYAD-01 (CAR-T NKG2D), targeting metastatic colorectal patients, the company said Thursday.
Ablynx and Sanofi have made a deal for research collaboration and global exclusive licensing agreement related to Nanobody-based therapeutics for the treatment of various immune-mediated inflammatory diseases.
Cellectis S.A. and Calyxt, Inc. announced on Thursday the pricing of Calyxt’s initial public offering of 7,000,000 shares of its common stock at the initial public offering price of $8.00 per share.