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This week brought us a number of fast-moving stories, from new drug prices following historic negotiations to a shakeup at MDMA biotech Lykos — which those of you subscribed to our breaking news alerts were among the first to know. If you don’t already get the alerts, be sure to adjust your preferences in your Reader Profile.
Unpacking IRA price negotiations results
The US government announced highly-anticipated final prices for the first 10 drugs negotiated by Medicare under the Inflation Reduction Act, following months of back-and-forth with pharma companies. This round of negotiations will save Medicare $6 billion in 2026, the Biden administration said. Looking beyond the deep reductions claimed on the list price, Zach Brennan and Nicole DeFeudis spoke to experts about which drugs may have made up the largest portion of the savings, and what’s next for the court cases against the IRA.
Lykos’ tough week
Lykos Therapeutics is facing an existential moment after the FDA rejected its MDMA-assisted therapy. After a medical journal retracted three articles detailing mid-stage trial results of the drug, the company revealed it’s cutting 75% of the staff and a key founder is leaving. Max Bayer spoke with CEO Amy Emerson just a few hours after a town hall in which employees were told about the layoffs — don’t miss the interview.
Genentech rethinks cancer immunology
Genentech is dismantling its cancer immunology team in a reorganization of its work in the field, and its VP of cancer immunology, Ira Mellman, will leave, Lei Lei Wu reports. Mellman is a prominent academic-turned-executive who oversaw the discovery and development of Tecentriq, Roche’s checkpoint inhibitor.
Lilly’s new Boston hub
Eli Lilly officially opened its gleaming new 12-story research center in Boston on Tuesday. The $700 million facility, first announced in 2022, will ultimately accommodate 700 people, mostly scientists working on some of the company’s earliest drug discovery programs. While genetic medicines will be a focus, researchers working on other kinds of drugs will also share the space, Ryan Cross reports from Seaport.
SPOTLIGHT
Pressure from anti-China legislation begins to ripple through biopharma
Exclusive: Gates Foundation backs startup using optogenetics to manufacture biologics
In a reality check for the field, AI underwhelms in Leash Bio’s binding contest: ‘No one did well’
PHARMA
- Evotec plans to lay off 400 workers and shutter facilities as the German manufacturer and biotech continues to grapple with pharma’s cutback on R&D activities.
- FDA approves AstraZeneca’s Imfinzi before and after lung cancer surgery
- AstraZeneca’s Imfinzi, Lynparza combo approved in EU for certain endometrial cancer patients
- Bavarian Nordic returns to the spotlight as mpox outbreak reaches emergency state
CELL/GENE TX
- Slow launches appear to be a theme among gene therapy makers reporting earnings this week. For bluebird, the modest uptake of its sickle cell treatment forced a rework of a much-needed loan, putting cash runway at risk. At CSL Behring, execs said it’s taking longer than expected to navigate the US’ “fragmented” healthcare system with its hemophilia B gene therapy.
- Metagenomi tinkers with pipeline after CSO departure, says Affini-T and Ionis pacts are progressing
- Avenge Bio, a cell therapy biotech from Rice, is closed
FDA+
- Six months after buying CymaBay Therapeutics for $4.3 billion, Gilead secured accelerated approval for seladelpar, the primary biliary cholangitis drug that was at the heart of the takeover.
- FDA warning letter targets doctor who worked on a Takeda Phase 3 study
- Past and present FDA adcomm members weigh in on potential reforms
- Galderma wins FDA approval for IL-31 drug in chronic skin disease
- Incyte gets another graft-versus-host disease drug approval, this time with partner Syndax
- Ascendis scores FDA approval for hypoparathyroidism candidate to replace Takeda’s pulled drug
- FDA delays approval decision on Humacyte’s lab-grown blood vessels
R&D
- Pfizer’s vaccine portfolio saw two readouts this week. The first zeroed in on the effects of its RSV vaccine in a subgroup of younger immunocompromised patients. The second was less positive: Its BioNTech-partnered Covid and flu combo vaccine came up short against influenza, even though it did meet the primary endpoint on Covid. The companies are reviewing next steps.
- Arrowhead lays out early-stage obesity strategy, including new target on fat-storing cells
- Zealand joins next-gen club aiming to ‘accelerate’ obesity drug development
- Rivus posts a win for its experimental obesity drug in heart failure patients
- Incyte plans label expansion for cancer drug Monjuvi following positive topline data
- Updated: NIH says SIGA’s antiviral didn’t improve resolution in mpox lesions in the DRC
- Corrected: Novo Nordisk to file in EU and China with late-phase insulin plus semaglutide data – but not yet in the US
- Verrica’s stock dips despite Phase 2 skin cancer drug clearing more than 50% of lesions
DIAGNOSTICS
- To get back to growth, Illumina CEO says it’s simplifying DNA sequencing and analysis
- In bid to save cash, Grail says it will cut 350 jobs and focus on multi-cancer test
PEOPLE
- Lexicon cuts about 75 sales jobs to prep for drug launch early next year
- Carbon Health CEO Eren Bali steps down
- Esperion’s CMO hits the exit; Pfizer appoints Nvidia alum as AI chief
DEALS
- Revance to be acquired for $900M+ as Botox trade secrets lawsuit continues
- Avantor sells off CRO for $650M to private equity firm
FINANCING
- Connecticut biotech Halda Therapeutics, created by Arvinas founder Craig Crews, reeled in another $126 million to start clinical testing of its oral molecules for solid tumors, starting with prostate and breast cancer.
- Why a new health tech venture firm is investing only in founders with a healthcare background
- Sanofi backs AnaptysBio’s $100M offering, helping catapult the biotech’s stock
- Investment in early-stage health tech startups climbed in the first half of 2024, report shows
MANUFACTURING
- Legend continues Carvykti factory builds to cement CAR-T territory with J&J
- Novo Nordisk subsidiary to build $220M API facility for chronic disease drugs
LAW