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Good morning. Apologies that this article is coming late to you this morning — we had some technical difficulties. However we’ve nonetheless bought the information for you as we speak.GLP-1
Novo’s advertising and marketing push with telehealth sparks concern
As pharma corporations attempt to get extra compounded GLP-1 customers on branded variations of the medicine, they’re embracing sure telehealth suppliers as advertising and marketing companions.
On the finish of April, Novo Nordisk introduced it might collaborate with three telehealth corporations to supply Wegovy by way of its personal mail-order pharmacy at a decrease cash-pay value. And yesterday, it doubled down with a limited-time coupon — concurrently promoted by two of the telehealth corporations, Ro and LifeMD — to seize extra of these sufferers.
Whereas these decrease money costs aren’t an unique providing from these choose telehealth corporations, the worry is that sufferers might simply be led to imagine the offers belong to these companions solely, accruing advantages these telehealth corporations.
Legislators and well being consultants have already been elevating considerations that the rising variety of pharma and telehealth offers might result in overprescribing of medication.
Learn extra from STAT’s Katie Palmer.
GSK drug’s new approval units up competitors with Dupixent
From my colleague Drew Joseph: The FDA yesterday authorised GSK’s Nucala for COPD, giving the drug a serious new indication and organising competitors with Dupixent.
Nucala, which was already authorised for bronchial asthma and quite a lot of different circumstances, will now be out there for choose sufferers with COPD as an add-on upkeep remedy. In scientific trials, the drug reduce exacerbations amongst contributors, whereas additionally decreasing emergency division visits and hospitalizations. GSK has touted the drug’s influence on hospital visits as a key victory.
Nucala gross sales in 2024 reached $2.4 billion, and GSK has forecast peak gross sales for the drug in COPD of round $675 million.
Dupixent, the juggernaut collectively marketed by Sanofi and Regeneron, was authorised for sure COPD sufferers in September.
Whereas Nucala’s approval was anticipated, there was one level of intrigue across the determination. The FDA was initially meant to rule on the indication by Could 7, and the delay raised questions on whether or not the latest cuts on the FDA had slowed down the method. It’s not clear if that was the case, but it surely’s an indication of how individuals will likely be carefully following any perceived delays on the company.
Merus drug reveals preliminary survival enhance in head and neck most cancers
From my colleague Adam Feuerstein: Merus mentioned Thursday {that a} mixture of its experimental drug petosemtamab with the checkpoint inhibitor Keytruda has stored 79% of sufferers with newly recognized metastatic head and most cancers alive for a minimum of one yr, in line with a brand new evaluation of a mid-stage scientific trial.
The survival knowledge are solely a snapshot. Merus, a Dutch biotech, might want to full a bigger, randomized research to show extra definitively that its drug can lengthen the lives of sufferers with head and neck most cancers past the power of present remedies. However for now, the preliminary survival outcomes are encouraging and matched the expectations of traders.
Merus shares had been greater in early Friday buying and selling.
Head and neck most cancers is the sixth most-common most cancers worldwide. For sufferers with metastatic however newly recognized illness, normal remedy is usually Keytruda, the checkpoint inhibitor made by Merck, or a mixture of Keytruda and chemotherapy. Merus is growing the mix of petosemtamab and Keytruda with the objective of serving to sufferers with head and neck most cancers reside longer in comparison with the present normal remedy. A randomized, managed Part 3 research is underway, with preliminary outcomes anticipated subsequent yr.
FDA recommends new pressure for Covid vaccines
The Meals and Drug Administration gave Covid vaccine producers directions on what strains needs to be included in subsequent fall’s photographs, however not with out a few of the drama that now appears requisite for the FDA.
The company mentioned that photographs needs to be up to date to the model of the virus that’s circulating broadly, LP.8.1, however left an out for Novavax, which requires extra lead time for manufacturing its vaccine than do Pfizer/BioNTech and Moderna, who make the mRNA-based vaccines.
What wasn’t clear, even thought it was introduced up twice in the course of the panel: Precisely how these adjustments would mesh with a brand new framework for Covid vaccines that was outlined by Vinay Prasad, the brand new head of the FDA heart that regulates vaccines, and Marty Makary, the FDA commissioner, earlier this week.
At an advisory panel held yesterday to debate pressure adjustments, panel members twice requested about how this new framework would work together with altering strains and whether or not recommending a pressure change would require new scientific trials or decelerate vaccine availability, however had been advised that the query was outdoors the scope of that means, in line with STAT’s Helen Branswell.
What was the temper like at an enormous gene remedy convention final week?
And is that this biotech M&A what’s placing Adam in a superb temper?
I focus on this with my colleagues Adam and Allison on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. Our colleague Jason Mast joins us for a rundown of his journey to a gene remedy convention in New Orleans. Should you recall, he’s beforehand reported that the CRISPR corporations aren’t OK. Each CRISPR Therapeutics and Prime Medication introduced strategic shifts earlier this week. Spoiler alert: It appears that evidently there’ll doubtless be extra enterprise strikes within the months to come back.
On the regulatory aspect, Adam breaks down the result of two days of FDA advisory committee conferences held to overview 1 / 4 of most cancers medicine. One of many points mentioned: The applicability of research knowledge collected in China for U.S. sufferers.
Take heed to the Readout Loud right here or wherever you get your podcasts.
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