Anti-infective
While a record number of China-originated first-in-class drugs were approved domestically in 2025, only one has so far entered clinical development overseas with its originator as the sole sponsor. But more progress is expected this year.
Valneva's withdrawal of its chikungunya vaccine leaves Bavarian Nordic as the only remaining firm producing a shot for the condition in the US.
Novavax will get $30m up front for a non-exclusive license for its Matrix-M adjuvant, but the deal could bring in billions long-term. The biotech is negotiating similar deals with multiple firms.
The US giant is narrowing its focus on obesity and cancer.
Bepirovirsen, which GSK licensed from Ionis in 2019, is one of the 15 pipeline products that the British drugmaker has said could cross over £2bn in peak annual sales.
A year after Valneva entered a tech transfer agreement for its chikungunya vaccine with Serum Institute, the deal has been called off. Regulatory approvals for the vaccine in Asia are yet to be obtained and the biologics license for Ixchiq remains suspended in the US. What happens hereon?
The Flagship Pioneering founder warned the assault on science would not stop at mRNA technology or vaccines and urged the biopharma sector to speak up.
“We are not going back to Pasteur,” CEO Albert Bourla said, criticizing the US government’s current anti-vaccine rhetoric.
Innoviva’s Nuzolvence looks to have a convenience edge as it and GSK’s Blujepa step into a growing market that has seen little in the way of innovation for decades, but neither is likely to displace low-cost alternatives.
Still betting on its vaccines portfolio, Moderna is also hoping to deliver on its ambitions in oncology with a Phase III candidate partnered with Merck, while cutting pipeline programs and seeking manufacturing efficiencies.
Cidara’s long-acting antibody candidate could help protect millions of immunocompromised patients against flu – and could work around growing vaccine hesitancy in the US.
Merck & Co. is looking to bolster its respiratory portfolio with Cidara’s Phase III antiviral conjugate CD388, previously owned by Janssen. Phase III data are expected in 2027.
The company is discontinuing congenital CMV development for its mRNA-1647 vaccine but still running a Phase II trial in bone marrow transplant patients.
The German company is now gearing up for a US filing for a product that overcomes drug resistance issues in herpes simplex, and which it believes could transform its business.
The France-based firm shrugs off the disappointment of the FDA's suspension of Ixchiq.
The company announced Phase IIb results for the RSV drug that showed positive data across multiple key secondary endpoints, some of which could serve as a primary endpoint in Phase III.
Chief commercial officer Luke Miels to take over in 'seamless succession'.
The biotech is to cut a quarter of its workforce, extending its cash runway to Q2 2026 as it plans a Phase II study for its live biotherapeutic to prevent bloodstream infections.
The US political environment and vaccine hesitancy by the general population have affected the sale of safe vaccines with clinical utility and no competition. The confusion and contradictions in the recent ACIP meeting are likely to stoke these pressures further.
The companies said preliminary data showed a fourfold increase in LP.8.1-neutralizing antibody titers from the latest formula of Comirnaty, which the FDA approved last month.