Daiichi Sankyo x Merck, AbbVie, GSK, etc.

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Good morning. Read on today for exclusive staff news and a retraction of a high-profile article on cancer detection.

The must-know this morning

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

CDC advisors take a slow approach with RSV vaccine recommendation

Although 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 only a subset of that population – people 75 and older and people aged 60 to 60. 74 years old with a high-risk condition. Those between the ages of 60 and 74 who are not high risk can still get a vaccine if they want, 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.