According to the White House, the FDA is poised to allow COVID-19 booster shots from Pfizer Inc. and Moderna Inc., the two mRNA vaccines, but only for those people with compromised immune systems. The FDA announcement was anticipated to be as early as today, Aug. 12, and the boosters could be available as quickly as this coming weekend.
Fibrogen Inc. was braced for receiving a complete response letter (CRL) and it got one. The FDA suggested it would not approve roxadustat’s NDA for treating anemia of chronic kidney disease until more clinical work is conducted. In July, the FDA’s Cardiovascular and Renal Drugs Advisory Committee said basically the same thing as it voted 13-1 against approval for the nondialysis population and 12-2 against approval for patients on dialysis unless more trial data are submitted.
Seagen Inc. and Remegen Co. Ltd. will collaborate to exclusively develop and commercialize disitamab vedotin, a humanized antibody-drug conjugate (ADC) targeting HER2, giving Remegen the chance to earn up to $2.4 billion in total milestone payments.
MRNA’s the thing and special purpose acquisition company (SPAC) Environmental Impact Acquisition Corp. is following as it will merge with privately held mRNA-developer Greenlight Biosciences Inc.
Seagen Inc. and Remegen Co. Ltd. will collaborate to exclusively develop and commercialize disitamab vedotin, a humanized antibody-drug conjugate (ADC) targeting HER2, giving Remegen the chance to earn up to $2.4 billion in total milestone payments.
Novavax Inc. now says it plans to submit an emergency use authorization (EUA) to the FDA for its highly efficacious COVID-19 vaccine, NVX-CoV2373, sometime in the fourth quarter, backing off previous plans of a second-quarter and then a third-quarter filing.
Positive phase III top-line results for Valneva SA’s chikungunya virus vaccine candidate, VLA-1553, show the study met its primary endpoint of inducing neutralizing antibody titers, setting it up for possible accelerated approval.
There’s a lot of competition in the regulatory T cells (Tregs) space and that’s a sign that something good is happening. Sonoma Biotherapeutics Inc. CEO Jeff Bluestone likened it to a typical drive leading to an everyday observation.
Positive top-line data from Beyondspring Inc.’s phase III study of plinabulin combined with docetaxel to treat second- and third-line non-small-cell lung cancer (NSCLC) compared to docetaxel alone propelled the company value dramatically higher Aug. 4.
Minovia Therapeutics Ltd. will collaborate with Astellas Pharma Inc. to research, develop and commercialize cell therapy programs for treating diseases brought on by mitochondrial dysfunction. The candidates will come from Astellas’ genetically engineered, induced pluripotent stem cells. Haifa, Israel-based Minovia will receive $20 million in cash up front.
