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.
Next month, we will be partnering with the Financial Times on its US Pharma and Biotech Summit returns to New York. There are options for both in-person and virtual attendance — you can find the speakers and agenda here.
Nvidia’s biotech moment
Over the last decade, multiple tech giants have tried and failed to get into healthcare. Nvidia, though, appears to be the exception. Is this finally tech’s healthcare moment? Andrew Dunn takes a deep dive into the chipmaker’s plan to dominate biotech’s AI revolution.
Regeneron launches venture arm
Regeneron is getting into venture investing. The storied drugmaker will commit $100 million per year for five years to Regeneron Ventures, which will invest in biotech startups, devices, tools and “enabling technologies.” The fund will be led by former Regeneron execs.
New GLP-1 player enters
ARCH-backed startup Metsera officially launched with $290 million to challenge Novo Nordisk and Eli Lilly’s duopoly atop today’s market for obesity drugs. Its lead asset is a GLP-1 agonist now in the clinic in the US, and it plans to test combinations of various drugs, but the rest of the clinical strategy remains closely guarded.
Sanofi rejigs cancer pact, vaccine ops
Sanofi isn’t done reorganizing its businesses. In addition to trimming its $6.15 billion biobuck pact with California biotech IGM — removing the three targets they had planned in oncology and thus taking $3 billion off the table — it is also overhauling its US commercial operations for its vaccines and will cut an undisclosed number of jobs.
WHAT WE’RE WATCHING NEXT WEEK
Multiple pharma companies are set to report their Q1 earnings, including Sanofi, Roche, Novartis, AstraZeneca, GSK and more.
R&D
- Eli Lilly’s weight loss drug Zepbound hit the primary endpoints in two Phase 3 trials for adults with obstructive sleep apnea and obesity, setting the stage for the first potential approval of a drug for the breathing disorder. The company is planning a filing in mid-2024.
- Vertex, Alpine’s IgAN drug has Humira-like potential. But not all indications are created equal
- Sage nixes program for Parkinson’s disease after Phase 2 failure
- Cerevel notches Phase 3 Parkinson’s win ahead of AbbVie transaction closing
- FDA hits Neumora with clinical hold for schizophrenia drug after preclinical data showed convulsions in rabbits
- Novartis showcases Ph3 data for Fabhalta in IgAN as FDA grants priority review
- GSK unveils long-term Shingrix data as shingles competition heats up
- Roche’s Columvi passes Phase 3 lymphoma test as competition with AbbVie, Genmab continues
- GSK offers glimpse at positive Phase 3 antibiotic data for urogenital gonorrhea
- Intra-Cellular on track for another Caplyta label expansion after positive Ph3 depression data
- Marinus’ IV seizure drug faces efficacy questions as Ph3 continues past interim analysis
#AAN24
- An acute competition is emerging among drug developers looking at a rare neurological disorder known as chronic inflammatory demyelinating polyneuropathy, or CIDP, and Wall Street analysts are taking note. Max Gelman highlights new data that came out of AAN.
- Amylyx reveals full data that drove pivotal failure for ALS drug: #AAN24
- Ultragenyx preps for pivotal trial in Angelman syndrome, an area where others fell short: #AAN24
FINANCING
- In the latest turn to autoimmune therapies, Cullinan Oncology nabbed $280 million to join the lupus space. The biotech, which is also changing its name to Cullinan Therapeutics, is expanding its pipeline from cancer to include immunology.
- Canaan adds $100M+ to boost biopharma investing, brings on former Pfizer exec
- Bristol Myers pitches in to Pathios’ $25M Series B for GPCR inhibitor
- Corner Therapeutics to hyperactivate ‘the brains of the immune system’ with $54M launch
DEALS
- AbbVie is betting on a French biotech’s long-acting injectable technology. The deal gives Medincell $35 million upfront and up to $1.9 billion in milestones for the development of up to six therapeutic long-acting products.
- Bruker to acquire troubled spatial biology company NanoString for $392M
FDA+
- The FDA is ready to eliminate the interchangeability designation for biosimilars. Having two separate classes of biosimilars has been “confusing people for a long time,” Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, told Zach Brennan in an interview.
- Senate bill targeting WuXi won’t affect federal spending, CBO says
- New FDA trial innovation center launches with demonstration to increase industry interactions
- FDA hits Natco with warning letter over India facility, suspends product shipments to US
- Califf talks bolstering domestic drug manufacturing, foreign inspections at House hearing
- Lumicell nabs FDA approval for drug-device breast cancer detection system
- GAO examines state PBM regulation as Congress weighs wider reforms
PHARMA
- Boehringer Ingelheim is putting the spotlight on a pipeline ripe with milestones over the next decade as it eyes overtaking Bayer as Germany’s largest pharma. Here are the key takeaways from the media call earlier this week.
- Even as J&J credited Darzalex and Carvykti, among other multiple myeloma drugs, as growth drivers for its Q1 earnings, execs had to defend slower-than-expected sales of Carvykti, its BCMA CAR-T.
- A majority of pharma and biotech companies prohibit ChatGPT use, survey finds
- Charles River promises $500M for initiative to develop alternative testing methods and reduce use of animals
- Sandoz’s Humira biosimilar nabs significant market share thanks to CVS partnership
- Senators want to know more on why Novo is discontinuing its insulin Levemir
- Astellas writes down another piece of its Audentes gene therapy acquisition
- Roche’s Genentech touts label expansion for blockbuster lung cancer drug Alecensa
MARKETING
- As millions of prescriptions for diabetes and obesity drugs get written, leading to millions of discarded single-use injection pens, patient interest in recycling is building. Beth Bulik has the overview of how drugmakers are handling the new pressure to recycle.
- Consumer trust in physicians and pharma is up, but lower for employers and biotech
- Regeneron and Genentech battle for ophthalmologists’ affinity in Eylea HD, Vabysmo matchup
- CSL Vifor proposes a marketing campaign to settle European Commission investigation
- Gabrielle Union-Wade promotes self-advocacy at media agency health event
MANUFACTURING
- With an “aggressive” investment planned from its parent company, Fujifilm Diosynth Biotechnologies plans to capitalize on antibody-drug conjugates and emphasize “trust” as a key selling point. Meanwhile, it will restructure its early business unit and may cut 240 workers as a result.
- Johnson & Johnson and Bristol Myers Squibb are individually gearing up their lentiviral production and CAR-T product capacities following their recent label expansions in multiple myeloma.
LAW
- Lilly, insulin users end $13.5M settlement plan following federal judge’s decision
- Federal judge grants pause to Pfizer, BioNTech in Covid-19 patent lawsuit trial brought by Moderna
HEALTH TECH
- DNA testing company 23andMe’s CEO Anne Wojcicki is looking to take the company private, According to a securities filing, she plans to speak with partners and other sources that could help finance the take-private, but would not support any “alternative transaction.”
- Exclusive: Ancestry cut 6% of workforce as genealogy giant struggles with subscription revenue
- Exclusive: Eating disorder telehealth startup Equip raises $35M, according to filing
- Maternal mental health startup LunaJoy raises $4.2M
