The FDA has rejected Regeneron's application for odronextamab, aimed at treating two forms of lymphoma, due to incomplete confirmatory trial enrolment.

Illumina's appeal against European Commission’s fine has seen a positive development after it was suggested by the Court of Justice of the European Union (ECJ) that the EC lacked jurisdiction over the Grail takeover, as Grail's revenue did not meet EU turnover thresholds.

Following on from the lead story in this newsletter, BioNTech are facing issues related to their success during the pandemic. The company has received a notice of default from the National Institutes of Health (NIH), the U.S. medical research agency, alleging unpaid royalties on its COVID-19 vaccine Comirnaty, developed in partnership with Pfizer.

As election campaigns in the US begin to ramp up, Big Pharma continues to battle Biden’s plans to introduce negotiations for drug pricing.

A lawsuit led by a cystic fibrosis patient will see Vertex accused patent abuse and of violating patients’ human rights under the country’s constitution.

The company has received approval for Trikafta, a drug that can transform the lives of people with cystic fibrosis, but costs more than $300,000 per patient, per year.

Recent FDA warning letters have highlighted data integrity issues at pharmaceutical manufacturing sites, particularly concerning microbiology and environmental monitoring.

The FDA has granted breakthrough therapy status to the LSD-like substance MM120, developed by Mind Medicine Inc., to speed up the development and review for the treatment for generalized anxiety disorder (GAD).

Initially developed for type 2 diabetes - and its effectiveness in reducing food cravings and slowing stomach emptying - Wegovy has found fame in its ability to aid weight loss.

The UK's MHRA has authorized a new formulation of XGEVA (denosumab) through the new International Recognition Procedure (IRP) in just 30 days.

The MHRA recently issued new guidance designed to streamline the assessment process for established medicines, implemented since March 1, 2024.

The FDA is proposing to waive device registration fees for companies with annual revenues less than $1 million or those in bankruptcy. The move aims to alleviate financial burdens for smaller firms and those facing financial difficulties.

AstraZeneca's Tagrisso has received FDA approval for use with chemotherapy in treating advanced lung cancer with specific mutations.

Despite controversies and a failed study, Sarepta's Duchenne gene therapy, Elevidys, may soon expand its use beyond the initial age group.

The U.S. FDA recently intensified its regulatory actions by issuing warning letters for manufacturing violations and the sale of counterfeit weight loss medications online. 

The UK Competition and Markets Authority (CMA) is investigating Vifor Pharma over concerns of potential anti-competitive practices, focusing on the availability and affordability of essential anaemia treatments.

The U.S. government is set to propose drug price cuts for the pharmaceutical industry in a move already anticipated by drugmakers. This initiative is part of a broader effort to reduce healthcare costs, with the government leveraging its Medicare program to negotiate prices directly with pharmaceutical companies for certain expensive medications.

Stephen J Ubl, president and chief executive officer of the Pharmaceutical Research and Manufacturers of America (PhRMA) will join Fierce for a Fireside chat. Ubl is known as a leading health care advocate and policy expert, and represents the U.S. biopharmaceutical industry, which employs more than 800,000 Americans and invests more than $100 billion each year in R&D.