BioCentury | Feb 5, 2020
Product Development

Leaner GSK ups R&D investments in immunology, genetics

GSK has formally started the process of splitting its innovative R&D and consumer health businesses into two companies, while continuing to cull down its clinical pipeline. In its 4Q19 earnings Wednesday, GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)...
BioCentury | Jan 1, 2020
Regulation

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...
BC Extra | Dec 24, 2019
Company News

Regulatory roundup: BioMarin poised to have first U.S., EU hemophilia gene therapy; plus Allergan, Eisai, FibroGen, ViiV and Vero

Monday's basket of regulatory news includes two landmark regulatory applications for BioMarin's hemophilia gene therapy in the U.S. and EU, and FDA approval of Allergan's migraine drug. BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) submitted a BLA to...
BC Extra | Oct 8, 2019
Tools & Techniques

Nobel Prize for cell response to oxygen, a two-sided therapeutic target

Cellular responses to oxygen levels, the focus of this year's Nobel Prize in Physiology or Medicine, are the targets of both inhibiting and activating therapies in clinical development for multiple diseases. William Kaelin, Peter Ratcliffe...
BC Extra | Sep 20, 2019
Company News

Sept. 20 Company Quick Takes: Three Japanese approvals, plus AZ-Ironwood, Boehringer-Inflammasome, China Biologics and a Sino-Russian JV

Japanese approvals include Tecentriq for TNBC  Japan’s Ministry of Health, Labour and Welfare expanded the label of Tecentriq atezolizumab from Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) to include PD-L1-positive triple-negative breast cancer. MHLW also approved serotonin...
BC Extra | Aug 26, 2019
Company News

FibroGen’s Neff passes away

FibroGen Inc. (NASDAQ:FGEN) said Chairman and CEO Thomas Neff passed away unexpectedly over the weekend. Neff founded FibroGen in 1993 to tackle fibrotic diseases, such as idiopathic pulmonary fibrosis. Since then he has led the...
BC Extra | Aug 22, 2019
Company News

Aug. 21 Company Quick Takes: GSK, FibroGen take regulatory steps forward for HIF-PH inhibitors in Asia; plus Xtandi, Biotheus/Alligator and more

GSK seeking approval of HIF-PH inhibitor in Japan  GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said it submitted an NDA to Japan's Ministry of Health, Labour and Welfare for daprodustat to treat patients with renal anemia due to...
BioCentury | Jun 29, 2019
Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
BioCentury | May 17, 2019
Product Development

Pushing China to the forefront: When a first-in-China regulatory strategy makes sense

As reforms in China shorten clinical and regulatory timelines for biotechs across the board, the country has a growing chance to become the first stop for regulatory approvals of first-in-class drugs. The decision to do...
BC Extra | May 11, 2019
Clinical News

FibroGen falls on U.S. safety data for roxadustat

FibroGen lost $9.28 (20%) to $36.39 on Friday after pooled safety analyses of Phase III data of anemia therapy roxadustat raised concerns for investors ahead of planned regulatory filings this fall. Omega Funds’ Otello Stampacchia...
Items per page:
1 - 10 of 144