Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! Hope you had a delightful weekend. Up today: an exclusive look at the scientific mix-up behind the approval of preterm birth drug Makena. We hear from a mother of a son with Duchenne muscular dystrophy who wants to ensure the FDA’s accelerated approval pathway stays strong, and more. The mix-up behind a controversial drug for preterm birth Last year, the FDA withdrew its approval of Makena, the progesterone-based drug meant to prevent preterm birth, whe ..read more

How does a startup compete with the likes of Eli Lilly and Novo Nordisk in the rapidly evolving field of weight loss drugs? And how did a major telemedicine company fall flat after its pandemic-induced rise? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. We bring on biotech veteran Clive Meanwell to discuss his new obesity startup, Metsera, and running head-to-head trials against Wegovy and Zepbound. We also dissect how Teladoc CEO Jason Gorevic parted ways with the company after spending 15 years building the telemedicine field. Read the rest ..read more

After a tumultuous experience on the public markets, 23andMe CEO Anne Wojcicki is moving to take the company private. Wojcicki disclosed her plans in a filing with the Securities and Exchange Commission late Wednesday, saying that she intends to seek out potential partners and financiers to help. Wojcicki currently holds 49.99% of the voting power in the company, according to the Wall Street Journal, which first reported on the plan. The company was once an industry darling, its star rising — and then falling — with the consumer genetics boom of the 2010s. For many years, the company’s main bu ..read more

A new startup focused on creating vaccines for cancers, influenza, and potentially even HIV launched Thursday with $54 million in funding. Corner Therapeutics’ Series A round was led by Ziff Capital Partners, a little-known family office started by billionaire Dirk Ziff. The biotech is also being led by Spark Therapeutics co-founder Steven Altschuler, who joined Ziff Capital in 2018 as its managing director of health care ventures. Altschuler and Ziff’s relationship goes back to the mid-2010s, when Altschuler was chief executive of the well-known research hospital Children’s Hospital of Philad ..read more

After scouring 200 companies’ pipelines — including a few overlooked pharma shelves — a new company backed by investment firm Population Health Partners and ARCH Venture Partners is launching with one of the most wide-ranging pipelines yet for obesity drug development. Metsera came out of stealth mode Thursday with $290 million in seed and Series A financing. ARCH and Population Health Partners, which launched in 2020 and has several veterans from Pfizer and The Medicines Company on its team, led the round. F-Prime Capital, GV, Mubadala Capital, Newpath Partners, and SoftBank Vision Fund 2 wer ..read more

Cerevel Therapeutics, a neuroscience biotech that AbbVie is acquiring, reported that its drug for Parkinson’s disease improved motor symptom control as an add-on therapy in a late-stage trial. The 27-week study found that patients taking the drug, tavapadon, on top of a common Parkinson’s treatment called levodopa, experienced 1.7 hours of improvement in “on time” without dyskinesia, which is the amount of time patients function well without involuntary movements that can be brought on by levodopa. That compared to 0.6 hours of improvement among patients taking placebo and levod ..read more

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. So the GLP-1s strike again: Eli Lilly’s Zepbound seems to work in obstructive sleep apnea as well. Beyond that, we see up close how Amylyx’s ALS drug — which it is pulling from the market — really didn’t differ much from placebo, and see more market and investment potential for psychedelics. Read the rest ..read more

Eli Lilly reported positive results of its obesity drug Zepbound in obstructive sleep apnea, giving the medication a new edge in the highly competitive obesity market. The results also pave the way for Zepbound to potentially become the first approved treatment for obstructive sleep apnea, or OSA, a common disorder characterized by breathing interruptions during sleep. In one year-long Phase 3 study that looked at patients with obesity who were not on PAP therapy, a form of ventilation, those taking Zepbound experienced a reduction of 25.3 events per hour on the apnea-hypopnea index (AHI), a m ..read more

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello! Today, we dig into Biohaven’s plans and see Humira biosimilar prescriptions shoot up. Read the rest ..read more

Intra-Cellular Therapies reported positive results Tuesday from a late-stage clinical trial seeking to expand the use of its antipsychotic medicine Caplyta to patients with major depressive disorder. In the Phase 3 study, Caplyta reduced depressive symptoms by 4.9 points compared to a placebo on the Montgomery-Asberg Depression Rating Scale (MADRS), a widely used, clinician-rated measure of depression severity. The result was statistically significant and achieved the primary goal of the study. The drug also showed a significant benefit on a patient-reported measure of depression symptom sever ..read more