Policy
Days after suffering a rejection in Australia, the Alzheimer’s drug hit another roadblock in the U.K., which found the drug not cost-effective.
FEATURED STORIES
RFK Jr. as HHS head is perhaps President-elect Donald Trump’s most controversial Cabinet pick now that Matt Gaetz has withdrawn as nominee for Attorney General. With Dr. Oz tapped to lead CMS and maybe Marty Makary at the FDA, it’s going to be quite the show.
While the full impact of the Supreme Court decision remains unknown, the new regulatory landscape could be a net positive for drug developers.
Suggestions that the U.S. should emulate other countries on drug price controls or patents obscure how our present policies have allowed drug development to flourish.
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At J.P. Morgan, most biopharma executives expressed a neutral stance on the incoming administration, but just days later, President Trump issued multiple executive orders that concern the industry.
Biopharma executives shared their thoughts on the potential impacts of the new administration; Annalee Armstrong recaps JPM and her talks with Biogen, Gilead, Novavax and more; Wegovy’s higher dose induces more weight loss; AstraZeneca and Daiichi Sankyo’s Dato-DXd scores its first FDA approval.
Drugmakers will have until the end of February to decide whether they want to participate in the second round of Medicare negotiations or not. CMS has until June 1 to send an initial offer for the adjusted prices.
Novartis is locked in a legal back-and-forth with MSN Pharma over alleged patent infringement of its heart failure drug Entresto.
Along with its gene editing therapy Casgevy, Vertex is offering fertility preservation support for its patients—a program that the HHS claims violates anti-kickback statutes.
A report published Tuesday shows hundreds and thousands of percent markups on HIV, hypertension and cancer drugs for Medicare and commercial claims alike.
Concurrently, a preprint from the industry-backed Vital Transformation found a 50% drop in company investments into small-molecule drug development.
According to BMO Capital Markets, Medicare coverage of Lilly’s Zepbound opens the door to using secondary indications to secure CMS coverage for obesity drugs.
Eli Lilly’s request to intervene in a suit filed by compounding pharmacies against the FDA reflects a belief the outcome could affect its business and that the FDA does not adequately represent its interests.
Other notable greenlights this year include Bristol Myers Squibb’s Cobenfy, the first novel therapeutic for schizophrenia in 35 years, and Madrigal Pharmaceuticals’ Rezdiffra, the first-ever treatment for MASH.