| | | |   | Meghana here. Quick programming note: This newsletter will be on hiatus for the Monday holiday but back in your inbox on Tuesday. | | | FDA fast-tracks tirzepatide for weight loss Eli Lilly’s diabetes drug tirzepatide just won a fast-track designation from the FDA for a broad new indication: It’s meant for adults with obesity, as well as people who are overweight with weight-related health problems. Lilly will submit a rolling new drug application next year, based on results from two Phase 3 trials — one of which is still underway. In one study, the company says, tirzepatide helped nearly two-thirds of trial participants reduce their body weight by 20 percent. It’ll be a while yet before the drug, sold under the name Mounjaro, will hit the market. But in a note to clients, UBS analysts said tirzepatide might become “the biggest drug ever,” with potential peak sales of $25 billion. This FDA nod puts pressure on Novo Nordisk and its own approved obesity drug, Wegovy, FiercePharma writes — which was so sought-after following its approval last year that its manufacturing capabilities couldn’t keep up with demand. | What can we learn from mummy DNA? Is Pfizer single-handedly propping up biotech? And how do you get molecules to “click”? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. The newest Nobel laureates got their phone calls from Stockholm this week, and STAT science writer Megan Molteni joins us to explain their prize-winning work in medicine and chemistry. We also discuss the latest news in the life sciences, including the state of biotech dealmaking and the evolution of Amylyx Pharmaceuticals. Listen here. | With mRNA’s exciting therapeutic potential, biopharma prepares to drive vital progress The convergence of mRNA and other advances like CRISPR, immuno-oncology, and intracellular antibodies has created a perfect storm that can change the course of medicine. Now, with the scientific community closer than ever to realizing the power of many exciting areas of research, companies are preparing to support extraordinary progress in therapeutic development and clinical care. Scott Ripley, general manager of nucleic acid therapeutics at Cytiva, tells us more. | A new test for allogeneic CAR-T therapy Allogene Therapeutics has kicked off a Phase 2 trial for its off-the-shelf CAR-T drugs, testing them in patients with relapsed or refractory large B cell lymphoma. Typically CAR-T therapies are, of course, engineered specially for each individual patient. But Allogene’s products are meant to be more cost-effective and accessible than their bespoke cousins. The trial will enroll about 100 patients who have received at least two prior lines of therapy, and haven’t had any sort of anti-CD19 therapy. The company’s framing this as “the industry’s first potentially pivotal” trial for an allogeneic product. That means that if it goes swimmingly — as all trials do, right? — and the FDA agrees, the study may ultimately suffice to win approval. But a lot has to go swimmingly first. | Drugmakers will be penalized if they hike prices on patients in private insurance market Democrats’ drug pricing law will still penalize drugmakers if they hike prices on medicines for patients who have private insurance, STAT's Rachel Cohrs reports.
Some experts and employers have been concerned that the drug pricing policy reforms that will save money in Medicare could incentivize drugmakers to try to charge more to patients with other forms of insurance coverage.
But Center for Medicare Director Meena Seshamani told reporters that “the inflation rebate is determined on the overall price. So it’s including commercial [prices] in there.”
Read more. | More reads - Boehringer and Surrozen seek retinal therapies along the Wnt pathway, BioSpace
- AstraZeneca takes home two more computer-generated drug targets from BenevolentAI, FierceBiotech
- ‘Patchy efforts’ by major insulin makers mean access lags in many poor countries, STAT
| Thanks for reading! Until next week,  | | | |
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