The FDA has granted full approval to Pfizer Inc.’s COVID-19 vaccine in a move that is hoped will convince unvaccinated citizens that the shot is safe and effective. The mRNA vaccine, which will be branded as Comirnaty and was first developed by Germany’s Biontech SE, has been available since Dec. 11 last year under an emergency use authorization (EUA) and is the first to receive the FDA’s full endorsement. Read More
Cadila Healthcare Ltd. (also known as Zydus Cadila) has received emergency use authorization (EUA) in India for Zycov-D, making it the world’s first plasmid DNA vaccine for COVID-19. Besides the adult population, the Drug Controller General of India’s nod has also given the South Asian country its first COVID-19 vaccine for adolescents ages 12 to 18. Read More
Pfizer Inc. has turned up the temperature in the already hot CD47 inhibitor space by offering $18.50 per share or $2.26 billion cash to acquire Trillium Therapeutics Inc., a biotech with two clinical-stage CD47 inhibitors. Read More
Building on a March deal leveraging lipid nanoparticle (LNP) technology from Genevant Sciences Corp. to fight liver fibrosis, Takeda Pharmaceutical Co. Ltd. has signed a second agreement with the company for the development and commercialization of therapies for up to two rare liver diseases. The deal includes up to $303 million in up-front and potential milestone payments for Genevant, plus royalties on possible product sales, adding to the first deal's similarly structured $600 million package. Read More
PERTH, Australia – The Australian government is investing AU$79 million (US$56.75 million) in medical research and innovation projects to develop new drugs, devices and digital health technologies through its AU$20 billion Medical Research Future Fund (MRFF). Read More
Adlai Nortye Biopharma Co. Ltd.’s $100 million series D financing in July threw new light on the enticing prospect of targeting EP4 in prostaglandin (PGE2)-driven cancers, and a number of players are lined up in the space. Read More
As the U.S. House of Representatives resumes work Aug. 23 on a budget reconciliation proposal to get a $3.5 trillion fiscal 2022 budget across the finish line, many lawmakers are looking to provisions to reduce prescription drug prices as a way to pay for increased spending in other health care sectors. Read More
The quiet cancellation of an Aug. 24 meeting in which the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) was supposed to discuss COVID-19 vaccine boosters is raising more questions about whether the Biden administration got ahead of the data with its Aug. 18 announcement that it planned to roll out mRNA booster shots to adults beginning next month. Read More
New hires and promotions in the biopharma industry, including: Adverum, Anixa, Arcutis, Aristea, Bioventus, Enanta, Dendreon, GT, Heat, Index, Neuexcell, Pharma Two B, Vaxart. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AB Science, Amyris, Bavarian Nordic, Bionova, Dialectic, Dyadic, Editas, Insilico, Kinarus, Marker, Palisade Bio, Sorrento, Telix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Biontech, Covis, Fibrogen, Gilead, Hebabiz, Ortho, Pfizer, Regeneron. Read More
