Novavax Inc. backed off its guidance of submitting an EUA for its COVID-19 vaccine in June, pushing the anticipated date to this fall. “We expect to complete regulatory filings in the third quarter,” Stan Erck, Novavax’s president and CEO, told investors on a May 10 conference call. “We hope to have market authorizations in multiple countries in the third quarter, as early in the quarter as possible.”
Despite two recent clinical trial failures, Orphazyme A/S’s arimoclomol is still on track for its June 17 PDUFA date in treating Niemann-Pick disease type C. The newest stumble is in the pivotal study of arimoclomol for treating amyotrophic lateral sclerosis (ALS) as it failed to hit its primary and secondary endpoints.
Sporos Bioventures LLC closed a $38.1 million series A financing to develop a pipeline of therapies for treating cancer and immune diseases through four companies with a business structure that its chief financial officer, Michael Wyzga, described as a hub-and-spoke model that leans on diversification.
Beigene Ltd.’s selective inhibitor, Brukinsa (zanubrutinib), made up for a 2019 miss in a head-to-head study against Johnson & Johnson and Abbvie Inc.’s Imbruvica (ibrutinib) with positive new data from a phase III trial.
Beigene Ltd.’s selective inhibitor, Brukinsa (zanubrutinib), made up for a 2019 miss in a head-to-head study against Johnson & Johnson and Abbvie Inc.’s Imbruvica (ibrutinib) with positive new data from a phase III trial in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma.
New phase IIb clinical trial data show the antigen R-21, a malaria vaccine candidate created by the University of Oxford that uses Novavax Inc.'s Matrix-M adjuvant, demonstrated 77% efficacy in children.
Being in a crowded space doesn’t bother recently installed Arch Oncology Inc. CEO Laurence Blumberg. As a matter of fact, he’s reassured by it. “There’s a lot of competition in CD47, that’s correct,” Blumberg told BioWorld. “But having been in industry for a long time, competition and the magnitude of that competition in pursuit of a target usually means there’s a good reason for that interest and that there’s compelling evidence it has utility.”
One of the keys to making a schizophrenia drug work is reducing the side effects, which, if they are powerful enough, will often cause patients to cease the treatment. Laxminarayan Bhat, Reviva Pharmaceuticals Holdings Inc.’s CEO, told BioWorld that new phase II data of the company’s lead candidate shows the drop-out rate was low compared to other schizophrenia drugs.
New phase IIb clinical trial data show the antigen R-21, a malaria vaccine candidate created by the University of Oxford that uses Novavax Inc.'s Matrix-M adjuvant, demonstrated 77% efficacy in children.
After cutting a deal worth up to $1.1 billion with Crispr Therapeutics AG, it took Vertex Pharmaceuticals Inc. only two days to come up with another collaboration that could top the $1 billion mark, this time with Obsidian Therapeutics Inc.
