Top Biopharma News for 03/05/2024

Here are the latest stories being discussed in biopharma today:

1. Pfizer indicates the impact of the Inflation Reduction Act (IRA) will be ‘modest.’ Pfizer was among the pharma companies opposing IRA’s provisions for Medicare negotiation. However, a shift in perspective has seen the company view the legislation’s implications on Pfizer’s portfolio products as limited.

2. The FDA approves Sandoz’s first two biosimilars for Amgen’s bone drug denosumab. Despite the uncertainty of launch dates and potential price fluctuation, the approvals signal a decrease in market share for Proloa and Xgeva, Amgen’s blockbusters bringing in over $6 billion last year.

3. The UK’s National Institute for Health and Care Excellence (NICE) declines coverage for AstraZeneca’s and Daiichi’s breast cancer drug Enhertu due to cost-effectiveness. The decision comes after unsuccessful pricing negotiations with the company.

4. The European Commission pushes member countries to work together more effectively for the assessment and payment for new therapies and health technologies. The proposed rule aims to ensure that efficient EU-level assessments are made with the necessary expertise.

5. The FDA refuses Vanda Pharmaceuticals’ hearing request for jet lag indication for sleep disorder drug Hetlioz. The FDA cited trial endpoint issues and lack of debate on the drug’s data, making it an unfeasible application for reconsideration.

6. Johnson & Johnson partners with hip-hop pioneer MC Lyte to raise awareness for multiple myeloma and health equity. The “That’s My Word” campaign aims to share experiences and emphasize the importance of participating in clinical trials.

7. Senator Elizabeth Warren criticizes GlaxoSmithKline’s decision to shift its inhaler from brand to authorized generic. She targets the company’s ‘backdoor deals’ that keep prices high while avoiding competition.