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Earnings season officially kicked off this week with Johnson & Johnson reporting its Q3 results. Endpoints will have our regular wall-to-wall coverage of the rest of the industry’s earnings, so keep checking your inboxes the next couple weeks for all the latest. — Max Gelman
A Q&A with a Nobel laureate
Endpoints hosted our first-ever AI Day in New York this week, with senior biopharma correspondent Andrew Dunn moderating. One of his discussions, with recently crowned Nobel Prize winner David Baker, is available as a Q&A on our website. The two chatted about the AI space, the future of protein design, and more. You can check it out here, and all of the recordings should be available online next week.
Pfizer meets with Starboard
Pfizer met with Starboard Value this week, after the activist investor took a $1 billion stake in the pharma giant. While the companies have not responded to requests for comment on how the meeting went, sources have described Starboard as a tenacious activist firm willing to engage in drawn-out, complex fights. Endpoints’ Max Bayer has the latest.
J&J trims pipeline, medtech slump continues
Johnson & Johnson revealed a handful of pipeline cuts in its third-quarter earnings, including a Phase 2 study of seltorexant in patients with probable Alzheimer’s disease, a Phase 2 bipolar treatment, and a Phase 2 treatment for Parkinson’s. In oncology, J&J ended a Phase 3 study of Imbruvica for relapsed or refractory patients with mantle cell lymphoma in combination with venetoclax. Overall, the company beat investor expectations despite underperformance for its medtech unit.
FDA reconsiders tirzepatide shortage
The FDA said in court documents last week that it would reconsider its decision to remove Eli Lilly’s blockbuster GLP-1 tirzepatide from its shortage list, potentially reopening the door for compounders to distribute their own versions of the drug. Following a request for clarity from the Alliance for Pharmacy Compounding, US regulators said on Thursday that they do not plan to take action against compounders while it reconsiders. But the APC has made clear that the announcement doesn’t protect pharmacies from state actions or challenges from Eli Lilly.
Merck, Pfizer present new RSV data
At IDWeek 2024, both Merck and Pfizer reported results for their RSV antibody and vaccine, respectively. Merck said its experimental therapy reduced infants’ risk of certain lower respiratory infections by 60.4% compared to placebo in a Phase 2b/3 study, while Pfizer said its approved shot was 90% effective at preventing the most severe outcomes in the first-ever vaccination season.
SPOTLIGHT
Q&A: Sanofi’s R&D head reflects on his first year, a post-Dupixent future, and finding an identity
BenevolentAI CEO is out after less than a year on the job
MORE IN R&D
- Seraxis got the OK to start a clinical trial for its pancreatic organoids in people with type 1 diabetes. The biotech will recruit six to nine people with type 1 diabetes and severe hypoglycemia, in the hopes that the treatment will restore their ability to make insulin.
- First clinical test of RNA editing restores missing protein in genetic disease, Wave says
- Pfizer details results from failed Phase 3 trial of Duchenne muscular dystrophy gene therapy
- Sage shakes up senior management, slashes pipeline, sheds 33% of staff
- Novartis ends mid-stage IPF trial, will keep testing drug in PAH
MORE IN DEALS
- Danish drugmaker Lundbeck announced Monday that it will buy Longboard Pharmaceuticals for $2.6 billion in cash, marking the largest biopharma M&A deal since July. The deal would give it bexicaserin, which entered Phase 3 last month for patients with Dravet syndrome and other developmental and epileptic encephalopathies.
- Pfizer partners with molecular glue startup Triana in $49M upfront deal
- Novartis pays $70M upfront to license Chinese biotech’s antitumor drug
- Sanofi invests in new radioligand partner Orano Med, buying 16% stake for €300M
MORE IN FINANCING
- Josh Bilenker and Jeff Engelman’s secretive startup Treeline Biosciences has another $421 million, according to a new SEC filing. The funding ranks as one of the biggest this year in biotech.
- Exclusive: British startup raises $16M to find genes that rewind the epigenetic clock
- Forbion raises €2.1B for two new biotech funds after series of company exits
- Mark Pruzanski gets another shot at MASH, joining as chair of Inventiva as it gets ‘much-needed funding’
MORE IN PHARMA
- GSK has filed a lawsuit against Moderna in Delaware federal court, arguing that its patented inventions provide the “foundation” for Moderna’s mRNA vaccine portfolio.
- Novo Nordisk files 18 lawsuits against GLP-1 compounders in 44 days
- Sacklers call opioid-related fraud claims ‘utterly meritless’
MORE IN FDA+
- FDA officials, including the directors of CBER and CDER, kicked off a rare disease innovation hub, aiming to better collaborate and communicate across the two centers.
- FDA approves AbbVie’s 24-hour Parkinson’s infusion therapy after two CRLs
- FDA approves Astellas’ gastric cancer drug Vyloy ahead of schedule
- FDA places hold on Novavax’s Covid-flu and standalone influenza vaccines
MORE IN MANUFACTURING
- A European CDMO is acquiring a factory in Somerset, NJ, from Catalent. The sale also means Catalent is looking for a new corporate headquarters.
- Merck KGaA eyes more manufacturing M&A as it faces headwinds in China
- Exclusive: Biotech tools company raises $75M for protein manufacturing tech
- Eli Lilly reveals £279M investment in the UK through new government deal
MORE IN HEALTH TECH