BioCentury | Oct 17, 2020
Regulation

CHMP’s October recommendations

EMA’s CHMP has backed autologous cells therapies Tecartus, from Gilead, and Lebmeldy, from Orchard, in its October set of opinions. The agency recommended conditional marketing approval for Tecartus brexucabtagene autoleucel from the Kite Pharma Inc....
BioCentury | Oct 7, 2020
Product Development

Oct. 6 Quick Takes: BARDA whistleblower quits NIH; plus COVID-19 updates from Vir-GSK, BioNTech, Pfizer, $115M B round for Talaris and more

Former BARDA Director Bright leaving NIH Rick Bright, the former director of the Biomedical Advanced Research and Development Authority and HHS deputy assistant secretary for preparedness and response, has resigned from NIH, according to a...
BioCentury | Oct 2, 2020
Regulation

Oct. 1 Quick Takes: Setback at FDA for Mesoblast; plus AMAG, Solid, COVID updates from Gilead, AZ and more

Bucking ODAC recommendation, FDA wants another trial from MesoblastMesoblast Ltd. (ASX:MSB; NASDAQ:MESO) said FDA issued a complete response letter to a BLA for remestemcel-L to treat pediatric steroid-refractory acute GvHD. FDA’s Oncologic Drugs Advisory Committee had voted 9...
BioCentury | Sep 29, 2020
Financial News

Sept. 28 Quick Takes: Biogen gains $1.4B on aducanumab update; plus Zai, XtalPi, InventisBio, Galecto, Innovent, Galapagos-Gilead, Biocytogen and ACT Accelerator

FDA moving quickly on Biogen’s aducanumab Biogen Inc. (NASDAQ:BIIB) added $1.4 billion in market cap Monday, as its shares rose $8.73 (3.2%) to $282.04, after FDA said it will hold an advisory...
BioCentury | Sep 19, 2020
Regulation

Data Bytes: CHMP’s September recommendations

EMA’s CHMP endorsed the use of dexamethasone as treatment for hospitalized COVID-19 patients who require oxygen therapy. The recommendation came with the agency’s latest round of opinions Friday. In the adaptive RECOVERY trial, the steroid reduced...
BioCentury | Sep 2, 2020
Product Development

EMA evaluating dexamethasone for COVID-19 as WHO meta-analysis of three steroids reiterates benefit

EMA includes RECOVERY data in review of dexamethasone MAAEMA said it has begun evaluating dexamethasone from Taw Pharma to treat hospitalized COVID-19 patients, and is considering CHMP’s review of the U.K’s RECOVERY trial data in...
BioCentury | Aug 19, 2020
Product Development

Filgotinib setback a blow to building franchise around Gilead-Galapagos therapy

After a surprise setback at FDA for filgotinib in rheumatoid arthritis caused Galapagos to lose more than $3 billion in market cap, two investors who spoke with BioCentury questioned whether the JAK inhibitor still had a chance to...
BioCentury | Jul 24, 2020
Regulation

Data Bytes: CHMP’s July recommendations

Among the 11 new medicines recommended for approval by EMA’s CHMP is the first antibody-drug conjugate, and most advanced BCMA-targeted agent, for multiple myeloma patients: GSK’s Blenrep belantamab mafodotin. FDA’s Oncologic Drugs Advisory Committee unanimously...
BioCentury | Jul 24, 2020
Product Development

July 23 Quick Takes: Priority Review for Aurinia; plus Jazz, CymaBay, Biogen, Vertex, Grünenthal, Mesoblast, BMS and Genfit

Priority Review for Aurinia’s lupus nephritis therapy FDA accepted and granted Priority Review to an NDA for voclosporin from Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH; TSX:AUP) to treat lupus nephritis. The PDUFA date for the immune-suppressing, IL-2-blocking...
BioCentury | Jul 13, 2020
Politics, Policy & Law

Cipla’s withdrawal of antibiotic marketing application latest sign of AMR market failure

Cipla has withdrawn its application for EMA approval of Zemdri, an antibiotic it acquired in a fire sale from Achaogen after the biotech declared bankruptcy. Cipla stated that the costs of meeting pre- and post-approval...
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