|
|
|
M T W Thu F |
26 June, 2025 |
|
|
|
|
|
|
|
The newly rebuilt ACIP has concluded its two-day meeting. Need a recap or want to make sense of it all? Tune into Post-Hoc Live at 3:30 p.m. ET for a conversation with Zach Brennan and Max Bayer on the panel’s priorities and the role CDC director nominee Susan Monarez might play. |
|
Alexis Kramer |
Editor, Endpoints News
|
|
|
|
 |
Lyn Redwood at a meeting of the Advisory Committee on Immunization Practices at the CDC (AP Photo/Shelby Lum) |
|
by Max Bayer
|
Clinicians and infectious disease specialists clashed with the majority of the CDC’s remade vaccine advisory committee on Thursday, arguing that the panel’s debate over an ingredient in a small number of flu vaccines was not based on evidence and risked sowing distrust. The Advisory Committee on
Immunization Practices largely dismissed the concerns and voted to recommend that all influenza vaccines be supplied in single-dose vials that don’t contain thimerosal. The ingredient is used as a preservative in a number of biologic products, according to the FDA. Cody Meissner, the sole former member of ACIP included in the rebuilt panel, was the only no vote. Vicky Pebsworth abstained from the votes involving thimerosal because she didn’t agree with the voting language. |
|
|
|
|
by Kyle LaHucik
|
Gilead Sciences has terminated two Phase 2 studies of an RSV treatment candidate called obeldesivir. The California biotech ended a trial of the oral tablet in non-hospitalized adults and another study in infants and children, according to updates this week to the federal clinical trials database. The move was the result of “lower than expected RSV incidence rates during the most recent RSV season in the Northern Hemisphere,” a Gilead spokesperson said in an emailed statement to Endpoints News on Thursday afternoon. The low rates made it “difficult to determine
meaningful rates of symptom reduction, a primary endpoint of the study,” the spokesperson said. The decision wasn’t related to safety or efficacy concerns, they added. A separate Phase 2 trial testing obeldesivir as a post-exposure prophylaxis for Marburg virus is “continuing as planned,” the spokesperson said. |
|
|
|
|
by Nicole DeFeudis
|
A Pennsylvania federal judge ruled that CVS Caremark owes the federal government $95 million in a case that accused the pharmacy benefit manager of conduct that caused Medicare to overpay for prescription drugs. Sarah Behnke, who was an actuary in Aetna’s Medicare department, brought the case on behalf of the US government in 2014. Her case
alleged that Caremark “caused certain health insurers to misrepresent to the government the amount they paid for prescription drugs on behalf of Medicare beneficiaries,” according to an opinion issued Wednesday in the US District Court for the Eastern District of Pennsylvania. While the US did not intervene in the case, Judge Mitchell Goldberg ruled on Wednesday that Behnke met her burden of liability under some counts, but didn’t meet her burden regarding “falsity as to Caremark’s Relationship with CVS Pharmacy” and CVS Health’s liability. |
|
|
|
|
by Max Gelman
|
Opus Genetics and Viatris' eye drug hit the primary endpoint in a Phase 3 study, putting them on track for an FDA filing by the end of the year. The phentolamine ophthalmic solution 0.75% program is known as MR-141. The companies said Thursday that it induced a highly statistically significant difference in visual acuity. When doing an eye exam, more patients who took MR-141 gained the ability to see at least three more lines on an eye chart after one week compared to those who took placebo. The companies did not report specific figures for the trial arms, but they noted the p-value was p<0.0001. MR-141 is a major focus for the companies, which inked a licensing agreement in 2022. Opus is running the clinical trials and
development, and took over that work after a reverse merger with Ocuphire. Viatris will handle commercialization. |
|
|
|
|
by Elizabeth Cairns
|
Novartis has signed up proteomics specialist ProFound Therapeutics to pinpoint “previously unknown” proteins to be investigated as cardiovascular drugs and drug targets in a $25 million upfront deal. The four-year partnership could be quite the money-spinner for ProFound. Novartis has agreed to milestone payments of
$750 million for each target it chooses to take forward, with tiered royalties potentially on top. The deal will involve ProFound, which was launched by Flagship Pioneering in 2022, to use its so-called ProFoundry platform to find novel proteins. ProFoundry can “go beyond traditional target discovery approaches by tapping into the vast, largely unexplored
biology of the expanded human proteome,” ProFound CEO John Lepore said in a Thursday release. The tech has a database of “tens of thousands” of new protein molecules, with information on their connectivity, functionality and effects on human health. |
|
|
|
|