Today, a brief rundown of news involving the Food and Drug Administration and Amgen, as well as updates from Vincentage Pharma and Parabilis Medicines that you may have missed.
The Food and Drug Administration has again shaken up its leadership ranks, as the acting directors of two main drug review offices, Tracy Beth Høeg and Katherine Szarama, have left the agency following the sudden resignation of commissioner Marty Makary. Høeg posted on the social media platform X that she was fired. According to Reuters, the move was part of a broader overhaul meant to place more traditional selections in top FDA positions. The regulator’s website now lists Michael Davis, a former agency deputy center director, as the acting head of the CDER office that regulates drugs and certain biologics. Karim Mikhail, the one-time leader of biotech Amarin, is now serving as the acting director of the CBER office in charge of vaccines and gene therapies. — Ben Fidler
Twenty people in Japan have died after receiving Amgen’s rare disease drug Tavneos, the biotech’s partner Kissei Pharmaceutical revealed Friday. Kissei, which sells the medicine in Japan, said that the majority of the deaths were attributed to a condition known as vanishing bile duct syndrome. It’s warned doctors there to not prescribe Tavneos to new patients. The FDA has already asked Amgen to withdraw Tavneos in the U.S. due to safety concerns and an alleged manipulation of study data by the drug’s original developer, ChemoCentryx. It will remain on the market in the U.S. until Amgen chooses to remove it or is forced to do so by the FDA. — Ben Fidler
An experimental oral obesity medicine from Vincentage Pharma succeeded in a late-stage study in China, positioning the company to seek approval there. According to Vincentage, treatment with its therapy VCT220 was associated with roughly 12% weight loss over a year, versus about a 1% loss for placebo recipients. Some 1.8% of participants receiving either low or high doses dropped out of the trial due to side effects, which Vincentage described as “generally mild to moderate” and consistent with what’s been seen with other GLP-1 medications. Startup Corxel Pharmaceuticals, which recently raised a $287 million venture financing, owns most rights to VCT220 and is running a global Phase 2 study. Results are expected by the end of 2026. — Ben Fidler
Regeneron has inked a deal with privately held cancer drugmaker Parabilis Medicines to develop specialized medicines the startup refers to as “antibody-helicon conjugates.” Like antibody-drug conjugates, these medicines link a targeting molecule to a drug payload. But Parabilis’ therapies deliver a type of peptide the company claims can affect intracellular proteins, including those long viewed as “undruggable” by conventional methods. Regeneron is handing Parabilis $50 million up front, investing $75 million in the company’s next equity financing, and could shell out up to $2.2 billion in total downstream payments, according to a Monday announcement. — Gwendolyn Wu
