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BIO CEO’s patriotic pivot
As John Crowley nears 100 days as CEO of the Biotechnology Innovation Organization, he is wrapping himself in the US flag to regain a seat at the table on Capitol Hill. The push for the industry to rethink its relationship with China comes as biotech faces an existential moment in how drugs are developed and sold, Andrew Dunn, Jared Whitlock and Max Bayer reported from San Diego.
Step forward for Lilly’s Alzheimer’s drug
An FDA advisory committee gave its strong backing to Eli Lilly’s Alzheimer’s drug donanemab, giving further support for the agency’s expected approval after a surprise delay earlier this year. During this week’s debate on the drug, many of the panel’s experts noted that while donanemab came with risks, they thought those could be managed and should not stop the agency from making it available to patients.
Pfizer’s gene therapy setback
Pfizer’s Duchenne muscular dystrophy gene therapy failed to meet the primary and key secondary endpoints in a Phase 3 study, pointing to a bleak future for the program. The trial measured motor function as well as 10-meter run/walk velocity and time-to-rise-from-floor velocity.
Foresite’s $900M fund
Foresite Capital closed on its sixth fund at $900 million, just 13 years into its life as an incubator and investor in life sciences startups. It’s already deployed a chunk of the fund, including Alumis, which filed to go public this week ahead of Phase 3 studies for a second-gen TYK2 inhibitor.
Gilead’s CD47 data
Macrolimab, a Gilead cancer drug whose developments have essentially been halted, not only failed to improve survival odds for blood cancer patients but also came with worrying safety risks — including a higher number of deaths in one trial — according to detailed data from two Phase 3 studies presented on Friday.
SPOTLIGHT
- China biotech ban does not make the cut as add-on to defense spending bill
- Stephen Squinto talks writing checks and next-gen obesity drugs as JP Morgan closes first $500M+ biotech fund
- Exclusive: Former Merck scientists raise $85M to map and drug protein interactions in cancer and autoimmune disease
FINANCING
- Radiopharmaceutical company Telix Pharmaceuticals pulled its Nasdaq listing plans just before trading was slated to start. In an exclusive interview, CEO Christian Behrenbruch told Lei Lei Wu that Telix pulled its US IPO because it didn’t agree with the share price.
- New obesity biotech Syntis Bio launches with early-stage alternative to GLP-1s
- ‘Speed is everything’: Versant-backed immunology startup raises $125M with plans for quick data
- ARCH backs lab instrument company that wants to help demystify how cells talk to each other
- Pivoting to ‘ADC-like’ approach, Versant-backed startup gets $90M Series C
- AI drug discovery startup goes public in Hong Kong, nabbing $115M to build on pharma partnerships
- UK medtech raises $100M for two-in-one urinary incontinence treatment
- Vaxart wins $453M in BARDA funding for oral Covid-19 vaccine
DEALS
- Pfizer is opening up another road to the obesity market, announcing a partnership with Flagship Pioneering’s ProFound Therapeutics to identify new molecules and targets for the condition.
- Gilead’s M&A appetite is for deals in the ‘mid-single-digit billions,’ CEO says
- AbbVie banks on second-gen TL1A program, licensing antibody from FutureGen
- J&J returns bispecific T cell engager to Xencor, reducing scope of partnership
- GSK nixes SpringWorks licensing deal focused on Blenrep-Ogsiveo for blood cancer
R&D
- Biotechs presented a series of studies using CAR-T therapy to treat autoimmune disease at the European Alliance of Associations for Rheumatology annual meeting in Vienna this week. The early datasets — including one of the largest in the nascent space — come at a time of ballooning interest in the concept. However, the unveiling didn’t impress investors.
- Avidity’s early-phase data for rare muscle disease drug spur registrational plans
- Moderna’s Covid and flu combo vaccine succeeds in Phase 3 study
- Paxlovid did not beat placebo in Stanford-led long Covid study
- Skye’s stock sinks following eye disease failure as company shifts focus to obesity
- Innovent details Phase 3 weight loss data from Lilly-partnered GLP-1 in Chinese patients
- Oculis touts Phase 2 results in dry eye disease, but most data aren’t statistically significant
- Surprise flop for Cara’s oral pruritus drug forces company to cut its last R&D program
- Ultragenyx touts Phase 2 data for Mereo-partnered rare bone disorder drug as Phase 3 gets underway
- Roche details Columvi OS data in quest for expanded lymphoma approval
- UroGen touts long duration of response for its bladder cancer chemotherapy gel
LAW
- A federal judge in New Jersey ruled that five of Teva’s inhaler patents are “improperly listed” in the Orange Book. The ruling is a win for the FTC, which has been cracking down on what it calls “junk listings.” Earlier in the week, GSK told Endpoints that it had no current plans to pull the patents that the FTC asked to rescind.
- Pharma industry praises Supreme Court’s rejection of abortion pill challenge
- J&J agrees to $700M talc settlement with 42 states and DC
- States join Oklahoma effort to convince Supreme Court to let them regulate PBMs
PHARMA
- Senate HELP Committee chair Bernie Sanders (I-VT) is moving to subpoena a Novo Nordisk executive to testify, following an investigation by the committee this spring over what he calls “outrageously high” prices for the company’s diabetes and obesity treatments.
- Lilly exec points to Medicare as more pay full list price for Zepbound than Mounjaro
- GSK wins expanded FDA approval for RSV shot in at-risk adults ages 50 to 59
- Bristol Myers’ cancer drug Augtyro wins new accelerated approval in solid tumors
- Ending ‘product hopping’ and other patent changes could save US $3B over a decade, CBO says
- EU launches two advice pilots for clinical trial applications as part of R&D push
FDA+
- Alzheimer’s drug manufacturers including Eli Lilly, Eisai and Biogen are asking the FDA to give them more clarity on the different stages of the disease in comments they’ve submitted on the agency’s draft guidance for developing drugs for early Alzheimer’s disease.
- Rare pediatric disease vouchers face uncertain future after September
- FDA establishes new meeting type to advise on drug safety technology
- Updated: FDA funding would stay flat under House appropriations bill
- Stakeholders weigh in on potential reforms to FDA advisory committee process
- Ipsen and Genfit secure FDA thumbs up for rare liver disease asset
- Ultragenyx to seek accelerated approval for rare disease gene therapy
HEALTH TECH
- Verily is getting into the GLP-1 business with a new virtual program to help patients manage cardiometabolic diseases with care teams and medications. Like many other virtual care programs, it’s being marketed to insurers and employers as an add-on service to traditional insurance. But companies still aren’t rushing to pay for their workers’ GLP-1 drugs for weight loss : a new report suggests that only a third of employers and health plans cover them.
- Oscar stakes its future on companies dumping worker health benefits
- Is $13B Devoted Health succeeding where other insurance upstarts have failed?
- Telehealth startup Done’s execs arrested and charged for alleged Adderall scheme, DOJ says
- Teladoc names insurance executive as new CEO
- Exclusive: Auxilius raises $10M to help biotechs manage clinical trial finances
MANUFACTURING
- The radioisotope lutetium-177 is at risk of slipping into shortage due to rapidly increasing demand, outdated manufacturing infrastructure and vulnerable supply chains, some radiopharma manufacturer and isotope supplier executives told Endpoints’ Anna Brown.
- Kyowa Kirin invests $530M in first manufacturing site in North America
- Alchem faces fines over price-fixing allegation from the European Commission
PEOPLE