BioCentury | Oct 17, 2020

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 13, 2020
Product Development

Oct. 13 Quick Takes: J&J pauses dosing in COVID-19 vaccine trials; plus Voyager, Avenue and Surface Oncology

J&J pauses COVID-19 vaccine trial dosing Johnson & Johnson (NYSE:JNJ) said it has temporarily paused dosing on its COVID-19 vaccine trials, including the Phase III ENSEMBLE trial, due to “an unexplained illness in a study participant,”...
BioCentury | Oct 12, 2020

Priothera raises €30 million to develop onetime Novartis candidate in AML transplantation setting

A VC syndicate is backing Priothera with a €30 million ($35.5 million) series A round to develop a clinical S1PR modulator for acute myelogenous leukemia patients undergoing hematopoietic stem cell transplantation. The group believes mocravimod,...
BioCentury | Oct 9, 2020
Product Development

COVID-19 Quick Takes: Moderna won’t challenge vaccine IP, wins contract for mobile GMP manufacturing

Moderna won’t enforce COVID-19 IP during pandemicModerna Inc. (NASDAQ:MRNA) said on Thursday it will not enforce its COVID-19 related patents against vaccine developers addressing SARS-CoV2 while the pandemic continues. It added that it is willing...
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

Trump receives Regeneron COVID-19 mAb, EUA could be imminent

President Donald Trump received an infusion of Regeneron’s investigational COVID-19 mAb cocktail Friday after receiving a diagnosis of infection with SARS-Cov2 and exhibiting symptoms, the White House said. Trump was taken to the Walter Reed...
BioCentury | Oct 1, 2020
Management Tracks

CVS’s Asgarian joins Thrive as CMO; plus Black Diamond names Ingram chairman and updates from MorphoSys, G1 and more

Liquid biopsy company Thrive Earlier Detection Corp. hired Sam Asgarian as CMO, Frank Diehl as EVP of product solutions and Dina Ciarimboli as chief legal officer. Before joining Thrive, Asgarian was VP of the transformation health product organization at...
BioCentury | Sep 30, 2020
Product Development

Sept. 29 Quick Takes: Ironwood reduces headcount following Phase III miss; plus Sandoz, Catalyst, Myovant, Orphazyme, Synklino, WHO, BridgeBio, Kurma, Junshi, Arcutis, Genfit-LabCorp and GSK

Ironwood to downsize after Phase III GERD failureIronwood Pharmaceuticals Inc. (NASDAQ:IRWD) said it plans to discontinue development of IW-3718 after the therapy missed the primary endpoint in a Phase III trial to treat refractory gastroesophageal...
BioCentury | Sep 29, 2020
Product Development

Alzheimer milestones & vaccine politics: a BioCentury podcast

Alzheimer’s disease therapies continue to tease and torment biotech investors. In the latest BioCentury This Week podcast, BioCentury editors discuss the road ahead for Biogen’s closely watched therapy aducanumab and anti-tau therapies, whose most significant...
BioCentury | Sep 26, 2020
Politics, Policy & Law

Warp Speed’s Slaoui expects two COVID-19 vaccines this year, rebuts Sen. Warren

Two COVID-19 vaccines and two drugs that reduce mortality from the disease will be authorized by the end of 2020, Moncef Slaoui, chief scientific adviser to Operation Warp Speed, predicted in an interview...
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