BioWorld’s Biopharmaceutical Index is at its highest point this year, up 7.85%, showing one of its sharpest rises within the last week. Out of 22 component stocks, 13 are trading above where they were at the end of 2021, as of Aug. 8. This is an improvement from June, when only nine were in such a position. Read More
The U.S. FDA’s effort to push companies toward more and better randomized, controlled trials ahead of accelerated approvals – apparently driven by the lack of confirmatory studies done afterward – is “an important and meaningful move by the agency,” said Day One Pharmaceuticals Inc. CEO Jeremy Bender. “The industry’s history in that space has been a little mixed.” Bender’s remarks came Aug. 9 as part of a wide-ranging panel discussion hosted by analyst Robert Driscoll during the Wedbush Pacgrow Healthcare Conference. Read More
Women now have a new treatment option for dealing with the pain associated with endometriosis with U.S. FDA approval of Myfembree (relugolix/estradiol/norethindrone acetate) for managing moderate to severe pain associated with endometriosis in premenopausal women. Read More
Beigene Ltd.’s tislelizumab met its primary endpoint of noninferior overall survival vs. sorafenib as a first-line treatment in hepatocellular carcinoma (HCC), marking the eighth positive phase III trial readout for the anti-PD-1 drug across multiple cancer types and lines of therapy. Read More
Glubio Therapeutics Inc. has raised $22 million in a series A+ round to support the development of its targeted protein degradation drugs. With the investment, Glubio expects to file INDs for two molecular glue degraders for hematological malignancies in early 2023 in both China and the U.S. Read More
As biopharma and med-tech companies grapple with restrictive data privacy laws in the EU and China while trying to meet the demand for greater diversity reflective of the U.S. population, there’s been more of an interest in conducting clinical trials in the U.S., Stacy Amin, a partner at Morrison & Foerster LLP, told BioWorld. Read More
New hires and promotions in the biopharma industry, including: ARM, Aquestive, Askbio, Curate, Eli Lilly, Evelo, Gritstone, Innovation1, Viracta. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 2seventy, Arbele, Arthrosi, Artios, Bioatla, Bridge, Disc, Gamida, Innovent, Lianbio, Olema, Peel, Tracon, Upstream, Vyne. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpine Immune, Intron, Evotec, Proqr, Psilera, SAB, Starpharma, Tetra, Vir, Volitionrx, Zai Lab. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aro, Bavarian, Bridgebio, Lexaria, Sentynl, Trethera. Read More
