Just three days before the U.S. CDC’s reconstituted Advisory Committee for Immunization Practices (ACIP) is scheduled to discuss and possibly vote on the COVID-19, hepatitis B and MMRV vaccines, Health and Human Services Secretary Robert Kennedy added five new members to the panel.
Two months after it was launched, the wheels are coming off the U.K. government’s 10-year life sciences strategy, with pharma companies withholding promised capital investments in protest at the row over drug pricing. Merck & Co. Inc., Astrazeneca plc and Eli Lilly and Co. Inc. have said they are not going ahead with previously announced investments.
In its second deal with Novartis AG of the past 11 months, Monte Rosa Therapeutics Inc. is getting $120 million up front to collaborate on developing molecular glue degraders to treat immune-mediated diseases. The agreement could swell to $5.7 billion for Monte Rosa.
Activity in some clinical parameters is leading Atyr Pharma Inc. to plan a sit-down with regulators, even though the tRNA synthetase-derived drug efzofitimod missed its primary endpoint of steroid tapering in the phase III Efzo-Fit study against the interstitial lung disease pulmonary sarcoidosis (PS). CEO Sanjay Shukla said his firm maintains “a high degree of conviction” regarding the candidate. “But I want to make sure we have the best briefing book possible” before consulting with the U.S. FDA, which will happen as soon as possible.
In August, a press release from HHS announced the cancellation of 22 vaccine research projects based on mRNA, the latest available technology aimed at developing therapies for viral infections, cancer, and genetic conditions. What happens to mRNA innovation when funding dries up? This series explores how reductions in funding could impact mRNA technology, affecting innovation, research and future therapies.
Health Canada posted a report on reduction of red tape, which includes a proposal for mutual recognition of other regulators’ inspections of device and drug manufacturing facilities.
Loss of function variants in the lipid transporter gene ATP-binding cassette ABC transporter A7 (ABCA7) nearly double the risk of developing Alzheimer’s disease (AD), which makes ABCA7 the strongest AD genetic risk factor after ApoE4.