Two biologic therapeutic candidates met their primary endpoints in separate Phase III trials: AstraZeneca’s Ultomiris and Argenx’s Vyvgart.

On the day the public and members of the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee were going to get a look at Pfizer and BioNTech’s COVID-19 vaccine data for children under 5 years old, the companies pulled the Emergency Use Authorization (EUA) submission.

While wealthier countries have come a long way to boosting their populations with an extra shot of COVID-19 vaccines to protect against Omicron, studies in Israel are evaluating whether a fourth dose of an mRNA vaccine offers additional protection. Although the data is still early, research suggests that it might not. 

Although it’s difficult, when faced with a cancer diagnosis, it’s important to find the best health care facility to receive treatment. Improving the future of cancer tech, this posting looks at some of the most high-tech cancer hospitals in America.

The mRNA vaccine from Pfizer and BioNTech may be less effective than Moderna’s against the Delta variant of the coronavirus, according to two reports posted on medRxiv on Aug. 8 ahead of peer review.

Two members of a panel of outside advisors to the U.S. Food and Drug Administration resigned in protest at the regulatory agency’s decision to approve Biogen Inc.’s Aduhelm for the treatment of Alzheimer’s disease despite the committee’s recommendation against doing so.

Burlingame, California-based Humanigen reported positive data from the company’s Phase Ib ZUMA-19 trial of lenzilumab in patients treated with CAR-T in diffuse large B-cell lymphoma (DLBCL). Lenzilumab is being investigated for the drug compound’s ability to tamp down the hyper-immune response known as a cytokine storm.

Mayo Clinic launched two new tech venture companies designed to harness artificial intelligence (AI) and medical algorithms and create “software as medical devices” that clinicians can use to improve treatment across different diseases. 

Researchers at Northwestern University identified a compound that appears to reverse the ongoing degeneration of upper motor neurons associated with amyotrophic lateral sclerosis (ALS).

Biogen

The U.S. Food and Drug Administration, citing conflict of interest, recused a member of an 11-person advisory committee set to review Biogen Inc.’s experimental Alzheimer’s drug aducanumab.