regulation
FDA's new pathway for bespoke therapies appears at odds with recent actions
The FDA yesterday released detailed guidance for the approval of bespoke medicines crafted to treat patients' individual mutations.
This new "plausible mechanism pathway," which was previewed by top FDA officials in a journal article last year, has been greeted enthusiastically by companies and patient groups who see it as a way to usher in gene therapies for patients with mutations too rare to interest pharma.
The announcement, however, comes after regulators rejected or seemingly reversed course on several gene therapies over the past year that seemed on track for approval, angering patient groups.
Read more from STAT's Jason Mast and Lizzy Lawrence.
OBesity
Novo reports 'triple G' obesity drug study results
Fresh off a failed trial that sent its shares plummeting Monday, Novo Nordisk on Tuesday said that one of its experimental obesity drugs — one with three targets — helped patients lose nearly 20% of their weight after 24 weeks in a midstage trial, versus 2% for those who received a placebo.
The drug, which works on GLP-1, GIP, and glucagon, is being developed by Novo and China's United Biotechnology. The new results came from a Phase 2 trial of the medicine, known as UBT251, conducted in China. Side effects were similar to those seen with other weight loss medications, the companies said.
Novo is conducting a global Phase 1/2 trial of the drug in obesity, with results expected next year. The company is also starting a Phase 2 trial of UBT251 in type 2 diabetes later this year.
"We are very encouraged by these data from the trial in China, which demonstrate the potential of UBT251 and its differentiated clinical profile and safety and tolerability profile," Martin Holst Lange, Novo's head of R&D, said in a statement.
telehealth
Hims CEO stresses products outside of weight loss
As Hims & Hers faces scrutiny from regulators for its compounded GLP-1 products, CEO Andrew Dudum is trying to draw attention towards the telehealth company's other offerings.
"The reality is that Hims & Hers has always been and continues to be more than one treatment," Dudum said on Hims' earnings call yesterday. "And really, the amount of patients actually on the compounded GLP-1s is actually quite a small minority of the aggregate subscriber base."
Hims drew criticism from doctors and regulators when it tried to launch what it called a compounded version of Novo Nordisk's Wegovy pill earlier this month.
Over the past year, Hims has attempted to broaden its business with a pitch around longevity. It bought peptide and at-home lab testing facilities, launched products for low testosterone and menopause, and invested in Grail before launching its blood-based cancer screening test.
Read more from STAT's Katie Palmer.
biotech
The Chinese licensing streak continues
A startup called Slate Medicines announced today that it's licensed a headache drug from DartsBio Pharmaceuticals, making it the latest U.S. company to hunt for candidates in China.
Slate also raised a $130 million Series A round co-led by RA Capital Management, Forbion, and Foresite Capital.
The drug, SLTE-1009, is a monoclonal antibody targeting the PACAP neuropeptide to prevent migraine and other headache disorders.
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