The cuts amount to just over 11% of the company’s workforce, Novo announced on Wednesday. A majority, or around 5,000, will be in Denmark. New CEO Mike Doustdar said in a video that “every krone” saved will “be reinvested into growth, advancing R&D, expanding manufacturing and improving commercial execution and patient access worldwide.” 

Novo has been feeling the heat from compounders and its GLP-1 rival Eli Lilly. Analysts from BMO Capital Markets who spoke with Novo’s leadership wrote in a note that the goal is to remove “middle layers” of the organization, and said that a majority of job cuts will affect support staff and back-office functions.

The biotech’s long-awaited lung cancer data in Western patients came up short of investor expectations this week, with Summit’s stock falling about 20% in response. Summit trumpeted a new analysis in which its drug ivonescimab, when added to chemotherapy, reduced the risk of death by a statistically significant margin compared to chemo alone. But the new post-hoc analysis involves different data cutoff times for the China and Western populations, and detailed breakdowns of geographic subgroups also showed the drug might be less effective in those Western patients. 

It left Summit to play defense for the first time. After plenty of hype as a potential Keytruda killer, company execs acknowledged the lack of a clean outcome for ivonescimab. However, they said there was still interest from physicians in using the therapy. They noted the challenge of trying to enroll Western patients after the China trial had already started, and co-CEO Bob Duggan chimed in to say the FDA’s allowance of sequential enrollment was unexpected in the first place. 

Summit’s earlier data still energized the PD-1xVEGF bispecific space, as BioNTech teamed up with Bristol Myers Squibb while Pfizer and Merck in-licensed drugs from China. Elsewhere in the field this week, BioNTech and Bristol Myers also presented new data from their program, while Pfizer’s development strategy is lining up to be different from Summit’s. 

Lilly debuted a new initiative this week, called TuneLab, allowing biotechs to essentially trade data for AI access. There are already a dozen biotech partners on board, including Firefly Bio, Superluminal Medicines and Circle Pharma. With troves of historic data, Lilly is initially providing access to 12 machine learning models to predict in vitro properties of small molecules known as ADMET (absorption, distribution, metabolism, excretion and toxicity). It’s also providing access to six models for antibody developability properties.

HHS and the FDA announced plans this week to “rein in misleading direct-to-consumer pharmaceutical advertisements.” An executive memo signed by President Donald Trump instructs HHS “to ensure transparency and accuracy” in direct-to-consumer drug ads and the FDA commissioner to “take appropriate action” to enforce existing laws and “ensure truthful and non-misleading information.”

As part of the directive, the FDA said it would send approximately 100 cease-and-desist letters to companies and “thousands” of warning letters, Max Bayer reported on Tuesday. The agency also laid out plans to change the “adequate provision” requirement, which allows companies to provide only “the most important risk information” in a broadcast ad so long as advertisers point consumers to another place to get the full prescribing information. 

The patient was the first dosed in a study testing Capsida’s CAP-002 for a rare pediatric disease. The condition, called STXBP1 developmental and epileptic encephalopathy, causes seizures, developmental delay and intellectual disability. Capsida said it alerted the FDA and paused the trial. The company declined to answer questions about the patient’s cause of death and age. Its treatment was designed to be given through an IV, yet still cross the blood-brain barrier, Jared Whitlock reported.