Some of the biggest news and trends captured in PharmaVoice’s newsletter this week. Sign up here to receive the newsletter daily.
HHS’ need for R&D speed
HHS is pulling multiple levers to speed drug R&D. Last week, it launched a new program aimed at finding “groundbreaking” ideas to speed clinical trials.
Called SURPASS, the program is being run by HHS' Advanced Research Projects Agency for Health with the goal of uniting “expertise across biostatistics, artificial intelligence, clinical operations, regulatory science, and patient-centered trial design” to create adaptive platforms trials. The agency is hosting an informational webinar about the program on Oct. 15.
The FDA has also kicked off a pilot program that will pair drug developers with qualified research organizations to speed the IND application process. This week, we looked at what pharma needs to know about that expedited IND effort.
Weird GLP-1 side effects
Weight loss drugs are increasingly being linked to a slew of strange side effects.
One recent study suggested they could make your nails fall off. The research, which was presented at a conference last week but hasn’t been peer reviewed, included nearly 1.900 people, 575 of whom were GLP-1 users. The GLP-1 cohort was four times as likely to report nail detachment compared to diabetes and obesity patients not on the medication.
Hair loss has also been reported by patients taking obesity drugs. In one survey from last year, nearly 40% of respondents reported “hair changes” including shedding or thinning.
The causes of these effects are still being sorted out and may more be tied to dramatic weight loss than the medications themselves. But they illustrate why drug developers are still tinkering with formulations, dosing and targets in obesity R&D. And on top of minimizing side effects, researchers are also working on ways to make the efficacy of the drugs last longer — an effort we examined this week.
Merck’s patent battles
Merck is fighting its looming patent problem on two fronts.
On Wednesday, a Dutch court sided with Halozyme in a patent dispute related to delivery technology for the subcutaneous formulation of Keytruda, ordering Merck to halt manufacturing and sales of the product in eight European markets. The ruling doesn’t affect the original IV version, but it complicates one of the lifecycle-management strategies Merck is pursuing as patents for its cancer blockbuster start to expire in 2028.
At the same time, Merck is spending heavily on what could come next. Just over a week ago, the pharma giant agreed to pay $400 million upfront for global rights to SciBrunch Therapeutics’ preclinical KRAS G12D inhibitor in a deal that could ultimately be worth over $2 billion.
One move is about defending Keytruda’s franchise. The other is about building a pipeline capable of replacing it.
And Merck is hardly alone in pharma’s patent cliff crunch. More than $500 billion in worldwide prescription-drug sales are potentially at risk from generic competition between 2026 and 2032, and the exposure will come in waves.
This week, we broke down the numbers behind pharma’s half-a-trillion dollar patent problem and how drugmakers are already maneuvering to soften the blow.
