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We’re in the dog days of August, but we’ll be watching for when Fed Chair Jerome Powell cuts interest rates. Powell said Friday that the “time has come” for rate cuts, though he did not specify by how much.
Tome plans layoffs amid struggle
High-profile gene editing startup disclosed late Friday that it plans to terminate nearly its entire workforce during the first two weeks of November. The filing came just hours after Tome Bio CEO Rahul Kakkar confirmed to Ryan Cross in an interview that the company stopped all lab work and is shifting focus to seeking a partner or buyer, while remaining scientists would be preparing data packages or publications.
FDA rejects Regeneron drug over manufacturing
US regulators rejected linvoseltamab, Regeneron’s experimental antibody for multiple myeloma, after issues arose related to “another company’s product candidate” at a third-party manufacturing site. It’s the second time the FDA has rejected a Regeneron bispecific antibody this year after odronextamab was turned away in diffuse large B cell lymphoma.
Next-gen obesity startup launches from Array vets
Just a few months after Pfizer ended research operations at Array BioPharma’s site in Boulder, CO, some former employees already found a new home: Ambrosia Biosciences. The next-gen obesity biotech is chaired by a co-founder of Array, which Pfizer bought for $11.4 billion in 2019. It will focus on oral small molecules.
James Sabry joins BioMarin
Several months after announcing his retirement from Roche, James Sabry has found his next role at BioMarin. The prominent dealmaker will become BioMarin’s chief business officer, tasked with hunting for “important and appropriately sized transactions.” Amgen rare disease veteran Greg Friberg also joins the organization as chief R&D officer, succeeding the retiring Hank Fuchs.
Q&A with Lilly’s Dan Skovronsky and Andrew Adams
Last week, Ryan Cross brought you the news of Eli Lilly’s opening of a new research center in Boston largely focused on genetic therapies — where CSO Dan Skovronsky said genetic medicines now make up nearly one-third of Lilly’s pipeline. This week, he’s back with a Q&A with Skovronsky and Andrew Adams, co-director of the Lilly Institute for Genetic Medicine, about the company’s ambitions — and how they’re not just for rare diseases.
SPOTLIGHT
Q&A: GSK CSO Tony Wood on staying out of obesity, ‘careful’ cancer ambitions, and AI’s future in R&D
Indian CDMOs unlikely to see sudden surge in clients if China bill passes, execs say
STARTUPS
- Versant launched a second-generation kidney biotech, called Borealis Biosciences, five years after Chinook. Novartis, which acquired Chinook, is a partner on the venture, and Borealis got $150 million to start.
- IPO doubleheader: Autoimmune biotech Zenas filed for an IPO, on the same day oncology startup Bicara unveiled its own Nasdaq pitch.
- TCGX and JPM help Pathalys raise $105M to go up against Amgen in subset of kidney disease
- BridgeBio forms another offshoot with $300M in commitments
- Illumina Ventures sets out for $300M third fund
PHARMA
- A new observational study found an increased risk of suicidal ideation among patients who take Novo Nordisk’s flagship weight loss drug semaglutide compared to other drugs. Researchers downplayed the findings, however, as other studies conducted earlier this year did not find a link between the drug and suicidal thoughts, Katherine Lewin reports.
- Half of IRA negotiation savings to come from three drugs, Brookings finds
- J&J scores approval for Rybrevant combo in first-line lung cancer, stoking rivalry with Tagrisso
- Biogen, Eisai’s Leqembi wins UK approval, but not immediate NHS coverage
- Emergent joins broader efforts for mpox vaccine drive in Africa
MANUFACTURING
- Both WuXi Biologics and its ADC spinout reported earnings this week as the Biosecure Act continues to brew. While WuXi Biologics’ net and gross profits were both down despite still signing on new US customers, WuXi XDC saw a revenue jump and outlined expansion plans.
- CDER chief says ‘standards have not changed,’ explaining increase in CRLs for biologics
- Fujifilm Diosynth opens new UK facility; Bora completes Emergent factory buy
DEALS
- More than two years into its antibody-drug conjugate partnership with China’s Kelun-Biotech, Merck made further choices on which part of the sprawling early-stage pipeline it wants to move forward, grabbing one early-stage program and returning another.
- J&J buys another medtech company, this time paying $600M upfront for Israel-based V-Wave
- Walgreens nabs $100M BARDA partnership to expand decentralized clinical trials
- Dr. Reddy’s and Stanford spinout Kainomyx partner up on anti-malarial program
R&D
- After recently reporting soaring sales of its diabetes franchise, Eli Lilly is back with Phase 3 data suggesting its GLP-1/GIP dual agonist tirzepatide could lower the risk for obese and overweight people of developing type 2 diabetes.
- BioNTech, MediLink to resume trial enrollment for HER3 antibody-drug conjugate after FDA pause
- Timber Pharmaceuticals’ candidate for rare skin disorder flunks all endpoints in late-stage trial
- Jazz will still file anti-seizure med Epidiolex in Japan despite trial setback
FDA+
- Days after Liquidia scored tentative approval for its treprostinil inhalation powder, the company filed a lawsuit against the FDA over its decision to grant three years of exclusivity to United Therapeutics’ drug Tyvaso, which will bar Liquidia’s Yutrepia from the market until 2025.
- FDA approves reformulated Covid boosters for fall season
- House lawmakers call on FDA to investigate clinical trials run alongside China’s military
- FDA to host adcomm on PD-L1 as a predictive biomarker for checkpoint inhibitors
- FTC backs FDA plan to remove switching study requirement for interchangeable biosimilars
- FDA warns hospitals against using Pfizer’s remaining potassium injections for children
LAW
- Pfizer brings Indian generics maker to court over Xeljanz patent
- Lawsuit alleges Biogen schemed with PBMs to preserve Tecfidera market
- J&J grants ‘short extension’ for certification of talc settlement vote
HEALTH TECH
- How Walgreens plans to revive retail pharmacy within three years
- Big employers are spending even more money on pharmacy costs, driven by GLP-1s and other high-cost therapies, survey says
- Digital health startup Sesame starts offering compounded weight loss shots
DON’T MISS