Here are the latest stories being discussed in biopharma today:

1. Marks reaffirms Covid-19 approval timeline, defends vaccines for children
At a House panel session, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research defended the timeline for the approval of Covid-19 vaccines for adolescents and children. He emphasized the need for a more centralized safety surveillance system for medical products to avoid mishaps in future crisis situations.

2. FDA suggests future approvals for Wegovy and Lilly’s new Alzheimer’s drug
FDA Commissioner Rob Califf has indicated potential developments for two key drugs – an expanded label for Novo Nordisk’s Wegovy highlighting cardiovascular benefits, and full approval for Eli Lilly’s upcoming Alzheimer’s drug, Donanemab. The latter is expected to achieve blockbuster status.

3. Eshoo demands FDA progress on diversity action plan guidance
House Energy and Commerce health subcommittee chair, Rep. Anna Eshoo, has called out the FDA for failing to publish diversity action plan guidance for clinical trials, a requirement under the Food and Drug Omnibus Report Act (FDORA) of 2022. So far, it has yet to do so within the 2023 deadline.

4. GSK revisits ‘Shingles doesn’t care’ campaign
GSK has renewed its campaign for Shingrix vaccine, retaining its ‘Shingles doesn’t care’ tagline. The new version emphasizes even more on the potential disruption shingles can cause to daily activities. The firm intends to bolster vaccine take-up rates even more, especially in the Black and Hispanic communities.

5. FDA cracks down on unauthorized semaglutide, tirzepatide websites
The FDA has issued warnings to two websites, Synthetix and US Chem Labs allegedly marketing unapproved versions containing the active ingredients of the weight loss and diabetes drugs semaglutide and tirzepatide. Both drugs have been very popular, with companies improperly marketing compounded versions of the drugs.

6. Insider’s view on Novo-Catalent deal
The $16.5 billion purchase of Catalent by Novo Holdings is unlikely to be repeated as pharmaceutical companies often divest in-house manufacturing assets. However, similar deals could potentially occur within the realm of GLP-1s and manufacturers with underused Covid-19 sites.