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Prasad stepped down from his role as head of the FDA’s Center for Biologics Evaluation and Research (CBER) on 29 July. Credit: Jeppe Gustafsson / Shutterstock

In a U-turn that caught many in the industry off guard, Vinay Prasad is back at the US Food and Drug Administration (FDA).

On 29 July, Prasad stepped down from his role as head of the FDA’s Center for Biologics Evaluation and Research (CBER), the department responsible for regulating medical products such as vaccines and gene therapies.

Though not much was known at the time of the resignation, it has since emerged that his exit was amid a slew of social media attacks against him from controversial conservative activists, including Laura Loomer and former senator Rick Santorum. They took issue with Prasad’s handling of Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy, Elevidys.

At the request of the FDA, Prasad is now back at the agency. The move likely means FDA commissioner Marty Makary is willing to test political backlash to bring his ally back into the fold. Prasad and Makary align on many healthcare views from a regulatory standpoint.

WeightWatchers has confirmed it no longer offers compounded semaglutide, instead providing patients with Novo Nordisk’s branded drug Wegovy.

In its Q2 results, the telehealth company said it started transitioning patients from compounded semaglutide to branded semaglutide from 22 May.

Compounded drugs are custom-made and unbranded medications that contain the same active ingredient as a marketed drug.

The move means WeightWatchers is in line with US Food and Drug Administration (FDA) deadlines for pharmacies and outsourcing facilities to cease production of compounded semaglutide by April and May, respectively.

WeightWatchers became one of a long list of telehealth platforms offering compounded semaglutide in the past few years. The company pursued this strategy amid waning interest in diet and lifestyle changes, with people preferring to take weight loss medication instead.

Novo Nordisk’s Wegovy (semaglutide) generated sales of $22.57bn in Q2 2025 alone.

Robert F Kennedy, Jr (RFK Jr) has announced plans to cut government funding to messenger RNA (mRNA) vaccine development run by the US emergency health preparedness agency. 

Impacting the work of the Biomedical Advanced Research and Development Authority (BARDA), the health secretary will terminate 22 mRNA vaccine development initiatives worth $500m – including projects with big pharma players such as Sanofi and Pfizer. 

When asked about contract cancellations with BARDA, a Moderna spokesperson told Pharmaceutical Technology that the company was unaware of any impact from the BARDA funding halt, stating the only termination due to funding cuts from the US Government from 2025 was with its bird flu contract, which was announced in May.

The HHS announcement, however, states that restructuring of collaborations with the US Department of Defense’s Joint Program Executive Office (DoD-JPEO) will affect nucleic acid-based vaccine projects with Access to Advanced Health Institute (AAHI), AstraZeneca, HDT Bio, Moderna and the University of Texas Medical Branch (UTMB).

Despite analyst warnings of heightened financial risk, pharma CEOs across the US and Europe remain confident that the latest US-EU trade deal and associated tariffs will have limited impact.

As per a new deal between the two global economic powerhouses, the EU will pay the US a tariff rate of 15% for pharmaceuticals. Medicines are the largest European exports to the US by value, and the EU accounts for approximately 60% of all pharmaceutical imports to the US.

Top-selling drugs such as AbbVie’s Humira (adalimumab), MSD’s Keytruda (pembrolizumab), and Novo Nordisk’s Ozempic (semaglutide), for example, are manufactured in Europe and sent to the US, representing billion-dollar markets.

Analysts from GlobalData’s Pharma Strategic Intelligence team say that: “Companies manufacturing pharmaceutical products in Europe will need to anticipate financial exposure when planning launches in the US due to the unfavourable gross to net dynamics, weakened pricing leverage with US payers, and slower commercial uptake as insurers reassess cost effectiveness due to the tariffs.”

The upcoming EpiPen patent expiration on 11 September 2025 sets the stage for a pivotal shift in the epinephrine delivery market. 

Mylan acquired the rights to the injector pen for treating anaphylactic reactions following the $6.7bn acquisition of Merck KGaA’s generics business, Merck Generics, in 2007. 

Mylan has since faced criticism for inflating the price of EpiPen and constraining patient access. The company has faced numerous lawsuits over the years in relation to overcharging drug wholesalers for access. 

According to Dr Stuart Grant, principal consultant at UK-based medtech consultant Archetype MedTech, the patent expiration’s immediate effect will lead to a rise in generic competitors. 

“An increase in generic options is likely to lower prices considerably, expanding choices for consumers and healthcare providers. Greater availability of affordable options could improve access for individuals and families who previously found it too expensive,” Grant said.