June 27, 2024

The need-to-know this morning

The FDA rejected a HER3 antibody drug conjugate from Daiichi Sankyo and Merck. The two companies, which signed a multibillion-dollar partnership last year, blamed the rejection on manufacturing issues.
AbbVie and Genmab won accelerated approval for Epkinly, a bispecific antibody; it will compete with CAR-T therapy and a Roche bispecific.
Verona Pharma won approval for an inhalable COPD drug, now marketed as Ohtuvayre.

infectious disease

CDC advisers opt for go-slow approach with RSV vaccine recommendation

Though the current RSV vaccines on the market (from GSK, Pfizer, and Moderna) are approved for adults 60 and older, a CDC advisory panel yesterday recommended the vaccines for a just a subgroup of that population — people 75 and older and people 60 to 74 years old with a high-risk condition. Those aged 60 to 74 who aren't at high risk may still get a vaccine if they want to, but insurers are unlikely to cover it for them without the recommendation of the CDC and its advisory panel, the Advisory Committee on Immunization Practices.

GSK's vaccine, Arexvy, was also recently approved for adults aged 50 to 59, but the advisory panel didn't make a recommendation on that age group, saying there wasn't have enough data. That's a blow to GSK's efforts to gain greater market share. Read more from STAT's Helen Branswell.

During the day-long meeting, advisers were also presented with new data suggesting that the efficacy for Moderna's RSV vaccine would wane more quickly than GSK's and Pfizer's vaccines. Moderna's stock tumbled 11% yesterday on that update.

venture capital

Exclusive: European VC Forbion hires Dyne CEO, expands into US

From STAT's Allison DeAngelis: Forbion, a European venture capital firm that manages around $3 billion, has recruited former Dyne Therapeutics CEO Josh Brumm as it expands into the U.S.

Brumm stepped down as Dyne's chief executive in March, turning the reins over to John Cox. As a general partner at Forbion, Brumm will now invest in both U.S. and European biotechs.

Dyne has been developing oligonucleotide therapies for rare muscle disorders; Brumm says that rare diseases still hold a place in his heart, and will be something he pursues at Forbion. But overall, he wants to work with companies pursuing "fearless innovation," particularly in new modalities.

Forbion was founded in the Netherlands in 2006, with a focus on health care investing. The vast majority of its investments has been in European companies, though the firm has also invested in companies like Dyne.

The firm is currently investing the $1.5 billion it raised for two funds in 2023.

Forbion is expanding in many directions. Earlier this month, the firm announced it will begin investing in agriculture, environmental, and biomaterial companies. The firm has raised around $80 million for a new BioEconomy Fund, and hopes to double it by the end of the year.

Forbion generally makes about six early-stage and six growth investments each year. It hopes to make about five investments from its BioEconomy fund this year, and hopes to announce its first investments in the next two months.

GLP-1s

Key House panel to vote on Medicare coverage of obesity drugs

Medicare is currently barred from covering obesity drugs such as Wegovy and Zepbound, and for years, some legislators have tried to pass a bill to change that. Tomorrow, a key House committee will vote on the bill, called the Treat and Reduce Obesity Act — the first time the bill has reached that milestone.

The version of the bill that will be voted on is significantly more restrictive than previous proposals, though. It would apply only to seniors with obesity, not also to people who are overweight with a comorbidity. And it would only cover drugs for people who had been taking them for a year prior to going on Medicare. Read more from STAT's Rachel Cohrs.

Note that even though currently Medicare can't cover obesity drugs for weight loss indications, there is a "backdoor" way of getting coverage — if the drugs are approved for other indications. For example, Novo's Wegovy recently got cleared to prevent cardiovascular complications and Medicare can cover that usage specifically. Novo and Lilly are also seeking approval for their medications in other conditions like heart failure and sleep apnea.

regulation

FDA issues draft guidance on clinical trial diversity plans

The FDA has put out long-awaited draft guidance aimed at getting drug companies and device makers to enroll more people of color and women in clinical trials.

It's the first step in carrying out a law that requires companies to submit plans to the FDA on how they will enroll participants who are representative of the relevant patient population. The public now has three months to provide feedback on the draft before the agency finalizes the guidance.

Liquid biopsy

Nature retracts high-profile study on microbial cancer detection

The journal Nature has retracted a high-profile paper that served as part of the scientific groundwork for a cancer diagnostic startup called Micronoma. This comes after a team of researchers published findings critiquing the paper, saying they found "fatal errors."

The original Nature paper showed data suggesting that microbes colonize tumors, and scientists could potentially use microbial signatures to identify cancers with a high degree of accuracy. That idea was the foundation for Micronoma, which is developing blood tests to detect early stage cancers and has raised tens of millions of dollars.