Two different approaches to mRNA vaccines for babies, toddlers and preschoolers are being presented to the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee today. Moderna Inc. is seeking authorization for a two-dose primary series, at 25 μg per dose, for children ages 6 months through 5 years. Pfizer Inc. is proposing a three-dose series, 3 μg per dose, of the vaccine it partnered with Biontech SE for children ages 6 months through 4 years. In explaining the three-dose series, Pfizer Senior Vice President William Gruber said emerging evidence shows that three doses of the vaccine are needed to protect against omicron. Although Moderna has requested authorization for two doses, it is evaluating a third dose, or booster, in the young age group. “I think all of us recognize a third dose will be necessary,” Moderna Senior Vice President Jacqueline Miller told the adcom. But at this point, it’s important to begin vaccinating the youngest children, she added.
Despite some non-significant data, Pfizer plunges ahead with Paxlovid NDA
A day after announcing it would pump $120 million into a Michigan manufacturing facility for Paxlovid (nirmatrelvir/ritonavir), Pfizer Inc. produced new data it plans to use in an NDA submission. Some of that data fell short of statistical significance. The company said an updated analysis of the phase II/III Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients study showed a non-significant 51% relative risk reduction in participants who may develop severe COVID-19. That’s a drop from interim analysis data from the study released in December showing a non-significant 70% relative risk reduction in preventing hospitalization or death. The planned NDA submission is for treating high-risk patients with Paxlovid.
Adcom briefing docs surface for Acadia’s Nuplazid sNDA in ADP
The FDA’s Psychopharmacologic Drugs Advisory Committee posted briefing documents related to the June 17 meeting, which will consider Acadia Pharmaceuticals Inc.’s sNDA for Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. In April 2016, the non-dopaminergic, selective serotonin inverse agonist was cleared for Parkinson’s disease psychosis. Acadia’s original sNDA, which garnered a complete response letter in April of last year, sought a label expansion into dementia-related psychosis. Shares of Acadia (NASDAQ:ACAD) were trading midday at $18.04, up $1.79, or 11%
BIO 2022: Push to model disease biology advancing, but slowly
With just 10% of therapeutic programs successfully moving from first toxicity dose to market, drug developers are on a constant hunt for new tricks to put the odds in their favor. Strategies abound, from biomarker-guided patient selection to deeper regulatory engagement. But big pharma executives and an academic expert weighing the challenge at the BIO International Convention said June 14 they see another tool slowly gaining traction with the potential to decrease timelines and boost chances for approval: in-silico modeling.
Gimv launching independent life sciences arm, expanding portfolio
Quoted European tech investor Gimv is setting up an independent life sciences arm and said it will increase both the size of its investments and the number of companies it backs. Whereas currently there is a ceiling of €10 million (US$10.4 million), in the future typical initial investments will be up to €15 million. At the same time, the number of companies in the portfolio at any one time will double, to around 20. The strategy of investing in series A and B rounds will stay the same, with most of the money devoted to drug development, but med-tech, digital health and life science tools also will feature.
SCOTUS: US HHS wrong in reducing reimbursement to 340B hospitals
The U.S. Supreme Court today shot down a rule that allowed the Department of Health and Human Services (HHS) to sharply reduce Medicare reimbursement for Part B drugs to hospitals participating in the 340B prescription drug discount program. In an unanimous opinion in an appeal brought by the American Hospital Association, the court said, “Because HHS did not conduct a survey of hospitals’ acquisition costs, HHS acted unlawfully by reducing the reimbursement rates for 340B hospitals.”
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