Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.
We honored 20 women making lasting impacts on biopharma R&D this week. Read their profiles here. A recording of our event celebrating this year’s honorees will be available to re-watch or share with your colleagues. — Nicole DeFeudis
Pfizer’s situation with Starboard
Starboard Value took a $1 billion stake in Pfizer this week, in the wake of the company’s struggles to chart its post-pandemic path. Endpoints’ Max Bayer and Drew Armstrong have been closely following the situation, including the accidental email that tipped Pfizer off on the plans and claims from Starboard that Pfizer’s former CEO and CFO were pressured to flip sides. In recent months, Pfizer has shaken up its executive teams and repeatedly cut costs. Stay tuned for more updates.
Meet Endpoints’ 2024 Women in Biopharma
This week, we revealed our annual honorees for our Women in Biopharma R&D feature, highlighting 20 women driving change throughout the industry. Among the selections were a top Pfizer RSV executive, Merck’s new chief of AI, the head of Vertex’s regulatory affairs and a biotech CEO whose son was diagnosed with Duchenne. Read more about all the honorees.
Nobel Prizes highlight AI era in biotech
This year’s Nobel Prize in Chemistry went to David Baker, Demis Hassabis and John Jumper: three scientists whose research is behind the creation of some of biotech’s most ambitious startups. The prize reflects the rise of AI in biotech. If you’re interested in learning more, tune in to Endpoints’ AI Day on Wednesday, where Andrew Dunn will interview Baker and other AI leaders.
Judo Bio launches with $100M to target kidneys
The kidneys can be a tough target for drug developers. But a new startup says it’s figured out how to shuttle RNA-based medicines directly into specific cells of the kidney. Judo Bio emerged from stealth on Monday with $100 million in seed and Series A cash.
FDA’s principal deputy commissioner on potentially taking over for Califf
Endpoints’ Zachary Brennan sat down with FDA Principal Deputy Commissioner Namandjé Bumpus, who would be next in line to lead the agency if current Commissioner Robert Califf steps down after the election. They discussed accelerated approvals, foreign inspections, diversity in clinical trials, advisory committee votes and more.
SPOTLIGHT
AI biotech insitro partners with Lilly on metabolic disease drugs
Exclusive: A small San Diego biotech wants to change how Parkinson’s disease is diagnosed
R&D
- In addition to the activist drama, Pfizer ended development of the RSV treatment it picked up in its up to $525 million acquisition of ReViral in 2022.
- Sage faces third study fail in six months as Alzheimer’s candidate misses Phase 2 goal
- Scholar Rock claims success in Phase 3 spinal muscular atrophy study
- Sanofi discontinues Denali-partnered MS trial after Phase 2 failure
- FDA puts Kezar lupus trial on hold after earlier report of patient deaths
FDA+
- The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-6 that Stealth BioTherapeutics’ drug elamipretide was effective at treating Barth syndrome, likely setting up a tough decision for regulators. The FDA raised concerns in briefing documents released ahead of the adcomm. Stealth CEO Reenie McCarthy told Endpoints the vote was a win.
- Updated: FDA approves Roche’s new treatment for subset of breast cancer patients
- CMS looks to $2 out-of-pocket cap for some commonly used generic drugs
- Zealand Pharma hit with second CRL for glucagon receptor agonist
- Many drug price proposals from candidates and Congress won’t have much effect, analysis finds
PHARMA
- The pharma industry’s DC-based lobbying group urged the federal government on Friday to get on board with alternative models for 340B drug price discounts.
- This week, Novo Nordisk and Viatris settled their patent dispute over Novo’s blockbuster diabetes drug Ozempic.
- Sanofi lands on private equity firm CD&R as potential buyer of consumer health unit
- GSK to pay up to $2.2B to settle almost all Zantac-related court cases
- J&J’s ‘pretzel’ drug-device therapy fails in certain bladder cancer patients
FINANCING
- Eli Lilly backed a new biotech’s $43 million Series A, as the startup looks to apply antibody-drug conjugates in fibrosis.
- Purespring nabs $105M to take gene therapy into the clinic as IgAN field matures
- John Maraganore’s RNAi biotech City Therapeutics debuts with $135M Series A
- Exclusive: Tiny startup with big vision to extend healthspan by 20 years says it discovered an ‘Atlas of Rejuvenation’
DEALS
- AstraZeneca strengthened its cardiovascular disease pipeline, paying $100 million upfront for a lipid-targeting drug.
- Kevin Tang’s Concentra swoops in on another struggling biotech, offering to buy Kezar
- Jim Wilson secures $100M for global approach aimed at reviving gene therapy field
MANUFACTURING
- From #CPHI24: CDMOs are increasingly fielding inquiries from biopharma clients on how reliant they are on China for their raw materials, manufacturing executives told Endpoints.
- #CPHI24: European drugmakers look to reshore manufacturing but warn of price hikes
- Sen. Warren urges FTC to ‘carefully scrutinize’ Novo-Catalent deal over competition concerns
- Baxter plots recovery after Hurricane Helene, MilliporeSigma’s €290M facility
HEALTH TECH
- The three major PBMs being sued by the FTC have filed motions to disqualify the Democratic commissioners who would rule on the case, accusing them of bias.
- Compounding pharmacy group sues FDA for ending Eli Lilly’s GLP-1 drug shortage
- Exclusive: Reema Health raises $7.6M to reach people on Medicaid
DON’T MISS
- Illumina unveiled what it called its simplest machines yet for DNA sequencing, in the hopes of attracting those who are interested but not well-versed in the technology.
- Gritstone bio filed for Chapter 11 bankruptcy on Thursday morning in a bid to keep itself afloat as it seeks a buyer or other transaction to continue running R&D of its cancer and infectious disease vaccines.