Policy
In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA’s decisions in 2024.
FEATURED STORIES
As Massachusetts prepares to vote on a measure that would legalize psilocybin and other plant-based psychedelic substances, researchers raise concerns around safety and a lack of epidemiological data.
Women are already underrepresented in clinical trials; the new abortion and IVF laws could make it worse.
Sen. Bernie Sanders’ aggressive targeting of Danish drugmaker Novo Nordisk’s Ozempic and Wegovy pricing, and not Eli Lilly’s rival drugs, is not fair.
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Senator Elizabeth Warren told the Federal Trade Commission that the acquisition of contract manufacturer Catalent could increase Novo’s dominance over the hot GLP-1 market, reducing competition and increasing prices.
The U.S. Department of Justice alleged that Teva violated the Anti-Kickback Statute and the False Claims Act. The payment is in addition to the criminal penalty paid by Teva USA under its deferred prosecution agreement.
WuXi AppTec looks to unload its Philadelphia manufacturing sites and WuXi Biologics slows its rapid expansion in the U.S. as the companies await the Senate’s review of the BIOSECURE Act that threatens to cut them off from U.S. biopharma.
Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents.
The adjusted guidelines will provide drugmakers with more opportunities to engage with the Centers for Medicare and Medicaid Services regarding the initial maximum fair price offers, according to the agency.
Faced with potential monetary fines, Johnson & Johnson said Monday it is abandoning a proposed 340B rebate plan for hospitals involving two of its blockbuster drugs, Stelara and Xarelto.
Despite the settlement, the Securities and Exchange Commission on Thursday sued Cassava Sciences in the Western District Court of Texas, claiming that the company misled investors regarding the Phase IIb performance of its Alzheimer’s disease drug candidate.
In a Tuesday Senate hearing on Novo Nordisk’s drug pricing, CEO Lars Fruergaard Jørgensen said he would be willing to sit down with the three largest pharmacy benefit managers who committed that they would expand coverage of Ozempic and Wegovy if Novo lowers its list prices for the blockbuster drugs.
Many Big Pharma companies including Pfizer, Merck and BMS make the drugs that some researchers expect to be selected by CMS for next year’s Medicare price negotiations alongside analysts’ top pick, Novo Nordisk’s Ozempic.
Novo Nordisk’s blockbuster type 2 diabetes medication is a sure bet for the list of the next 15 drugs whose Medicare prices will be negotiated in 2025 and go into effect in 2027, according to analysts and academics.