Latest Developments in the Pharmaceutical Industry: EMA Lifts Restrictions, Jazz Names New CEO, and Clinical Trial Updates

EMA Removes Age Restriction on Valneva's Chikungunya Vaccine

The European Medicines Agency (EMA) has lifted its order to pause the use of Valneva's chikungunya vaccine, Ixchiq, in people aged 65 years and older. This decision follows a review by the regulator's safety committee, which concluded that the vaccine should be administered to individuals of any age if there is a significant risk of chikungunya infection, after careful consideration of the benefits and risks.

The EMA had initially limited the vaccine's availability in May after 17 severe adverse events were reported, including two deaths. The Food and Drug Administration (FDA) had also temporarily suspended the use of the vaccine in people at least 60 years of age.

Leadership Changes and Clinical Trial Updates

Jazz Pharmaceuticals Announces New CEO

Jazz Pharmaceuticals has named Renee Gala as its new CEO, succeeding retiring CEO Bruce Cozadd. Gala, who joined Jazz in 2020, will transition from her current role as president and chief operating officer to CEO next month. The board of directors considered both internal and external candidates, with lead independent director Rick Winningham stating that Gala was "the clear standout" among highly capable and qualified candidates.

Cozadd, who co-founded Jazz more than two decades ago, led the company through significant milestones, including a $7 billion acquisition, a corporate tax inversion, and the approval of several medicines.

Ultragenyx and Mereo BioPharma's Osteogenesis Imperfecta Trial Continues

A closely watched clinical trial testing setrusumab, a drug developed by Ultragenyx Pharmaceutical and Mereo BioPharma for osteogenesis imperfecta, will continue past a second interim analysis. This news disappointed both companies and their investors, who had hoped the study would reach its goal early. The Phase 3 study, called Orbit, is testing the drug in children and young adults with osteogenesis imperfecta, a cluster of genetic disorders that increase bone brittleness and cause frequent fractures.

Funding and Pipeline Updates in the Pharmaceutical Sector

Radiopharmaceutical developer Nuclidium has raised 79 million Swiss francs (approximately $99 million) in a Series B venture financing round. The funding, co-led by Angelini Ventures, Kurma Growth Opportunities Fund, Wellington Partners, and Neva SGR, will support the company's advancement into clinical trials, develop both medicines and diagnostics, and expand its manufacturing capabilities. Nuclidium is currently testing its experimental copper isotopes in breast and prostate cancers, as well as neuroendocrine tumors.

In other pipeline news, Pharvaris expects to report the first Phase 3 results for its experimental hereditary angioedema therapy, deucrictibant, later this year. This is earlier than the originally anticipated 2026 timeline. Deucrictibant is an oral therapy being tested to either prevent the disease's hallmark swelling attacks or quickly treat associated symptoms. If the results from the late-stage study evaluating it as an on-demand treatment are positive, Pharvaris could be positioned to challenge Kalvista Pharmaceuticals' recently approved Ekterly. The company expects to file an approval application in the first half of next year, pending successful study outcomes.