obesity
Novo signs deal with Septerna to develop obesity pills
Novo Nordisk said this morning that it will work with the biotech Septerna to develop oral GLP-1 obesity drugs, as it races to catch up to Eli Lilly's efforts to bring a more convenient weight loss treatment to the market.
Under the deal, Septerna, which specializes in making small molecule drugs, is eligible to receive about $2.2 billion from Novo, including more than $200 million in upfront and near-term milestone payments.
The companies said they'll start with four development programs for potential small molecule treatments directed at targets within a class of receptor called G protein-coupled receptors — including commonly targeted receptors like GLP-1, GIP, and glucagon hormone receptors.
gene editing
First patient treated with prime editing
From my colleague Jason Mast: The first ever patient has been treated with prime editing, a powerful technology for making precise changes to DNA.
Harry Malech, an NIH researcher and investigator on the study, announced the news yesterday during an award speech at the American Society of Gene & Cell Therapy meeting, apparently against the wishes of Prime Medicine, the company that devised the experimental therapy. "They'll probably throw bricks at me," he joked.
The therapy is for chronic granulomatous disease, a very rare genetic disorder that impairs the immune system and leaves patients vulnerable to deadly infections. Researchers are attempting to insert two missing DNA letters into patients' blood cells — a genetic surgery that can only be done with prime editing.
Prime, which has been struggling financially, received FDA clearance for the trial last August. But the rarity of the disease and the complication of the procedure – blood cells have to be removed, edited, and then returned – has likely made recruitment slow. The company has promised to release data this year.
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politics
Trump tucks a subtle threat in his drug pricing order
Anna Moneymaker/Getty Images
Embedded in President Trump's executive order this week is a sentence that appears to threaten that the Food and Drug Administration could withdraw drug approvals if pharma companies don't lower their prices.
The order specifically gives drugmakers 30 days to agree on lower prices with the government, with the aim of bringing prices down to what other countries pay. Notably, the order says that if "significant progress" is not made on lowering prices, FDA Commissioner Marty Makary would be empowered to "review and potentially modify or revoke approvals granted for drugs… that [may be] unsafe, ineffective, or improperly marketed."
Regulatory and legal experts question the legality of that provision, though, since the FDA can only withdraw approval of a medicine if certain statutory criteria are met, like if the drug is unsafe or if there is a lack of data on effectiveness.
Read more from STAT's Ed Silverman.
politics
Can the U.S. get Europe to raise drug prices?
Another aspect of Trump's plan relates to his goal of getting other developed regions like Europe to pay more for drugs, in order to narrow the discrepancy between drug prices in the U.S. and other countries.
U.S. officials have suggested that they could raise the issue of drug prices as part of ongoing trade negotiations with the European Union, but it won't be easy to get European countries to budge, my colleague Drew Joseph reports.
In Europe, drug prices are negotiated and determined country by country, making it harder for the U.S. to exert influence on regions it deems to be bad actors. Additionally, European countries have already been spending more on medicines over time as prices rise, leaving them little room to pay even more for medicines.
Read more.
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