Need to keep on prime of the science and politics driving biotech at the moment? Join to get our biotech e-newsletter in your inbox.
Good morning. At present, we focus on how psychedelics firms are responding to the unfavorable advert comm vote on Lykos’ remedy, outcomes of Zepbound in MASH, and the destiny of Novavax this fall.
Psychedelics firms look on the intense facet
The day after a panel of FDA advisers rejected the usage of MDMA-assisted remedy for post-traumatic stress dysfunction, shares in firms growing psychedelics dropped, whereas analysts stated the choice may hinder the sphere’s skill to lift extra funding.
However, in interviews with STAT’s Meghana Keshavan, psychedelics firms stated their optimism had not been dimmed — and that the considerations expressed in regards to the method utilized by Lykos Therapeutics supplied a clearer blueprint for what it’d take to get such a drug accredited.
“It’s not the drug. It was the execution,” stated Christian Angermayer, a financier who’s deeply concerned within the motion to show long-shunned psychoactive substances, just like the psilocybin derived from so-called magic mushrooms, into accredited medicines for despair and different psychological sicknesses.
Learn extra.
Zepbound improved liver scarring in MASH sufferers
An summary launched yesterday confirmed that Lilly’s blockbuster weight problems drug improved residing scarring, or fibrosis, in a Part 2 MASH examine. This was a key end result observers have been ready for after Lilly in February reported constructive outcomes on MASH decision from this examine, however didn’t disclose actual knowledge on fibrosis.
Analysts famous some caveats with the fibrosis knowledge — there was a excessive proportion (30%) of sufferers on placebo who skilled fibrosis enchancment, and there wasn’t a dose response among the many cohorts taking the drug. Nonetheless, the variations between the remedies teams and placebo have been statistically vital.
How a lot will weight problems medication like Zepbound in the end have an effect on the destiny of liver-directed MASH therapies, although? Some analysts and medical doctors predict that weight problems medication could help use in average MASH sufferers, however extreme MASH sufferers could find yourself benefitting extra from liver-directed medication.
Learn extra.
Novavax will be capable to provide Covid-19 vaccines this fall
From STAT’s Helen Branswell: The Meals and Drug Administration’s vaccine advisory panel voted unanimously yesterday to suggest that this fall’s Covid-19 photographs needs to be up to date to focus on viruses in Omicron’s JN.1 lineage. That suggestion, if accepted by the FDA, is broad sufficient to make sure that Novavax, which has struggled to achieve a considerable share of the Covid vaccine market, will be capable to provide product to the U.S. this fall.
There was some dialogue about whether or not it could be advisable to ask producers to make use of a extra present virus, KP.2 — an offshoot of JN.1 — within the fall vaccine. Each Pfizer and Moderna indicated they might produce both, and ship their product in August. However Novavax, which has an extended manufacturing time than the messenger RNA vaccine producers, stated that if the goal for this fall’s vaccine was KP.2, it could not be capable to provide the U.S. for the 2024-25 vaccination marketing campaign.
Most members of the committee appeared to really feel that the variations between the 2 weren’t massive sufficient to warrant preferentially recommending KP.2.
Antidepressant withdrawal signs will not be as frequent as as soon as thought
A brand new systematic assessment discovered that about 15% of individuals skilled withdrawal signs after weaning from antidepressants, and in 2-3% of the circumstances, the signs have been extreme.
This evaluation is “lengthy overdue,” one exterior researcher says. Whereas it confirms that withdrawal signs do occur with clinically related frequency, it additionally demonstrated a decrease incidence than latest estimates primarily based on on-line surveys. These surveys generated public alarm after they prompt signs could happen in half or extra the sufferers.
Learn extra from STAT’s Annalisa Merelli.
Extra reads
- Federal officers and doctor teams categorical outrage over revelations of latest coercive sterilizations, STAT
- Amgen’s Uplizna succeeds in Part 3 trial for uncommon autoimmune illness, Endpoints
- Opinion: Shut a regulatory loophole within the ACA to offer vaccine entry for all Individuals, STAT
