Anti-infective
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.
With no advances for decades, the STI could soon be facing two new antibiotic threats, while a third novel therapy has just entered the clinic.
The Danish firm’s board unanimously supports a $2bn take-private offer by PE firms Nordic Capital and Permira. A revised offer would seek to bypass the opposition of a major shareholder.
After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.
The drugmaker announced the launch of an at-home version of its nasal FluMist vaccine, as more companies are looking into direct-to-patient drug sales in response to Trump’s most favored nation pricing proposals.
The news will have a big impact on pandemic preparedness but less immediate financial impact. Tiba Biotech was even “caught off guard” by its inclusion in the department’s culling of mRNA vaccine projects under BARDA, as its project was neither a vaccine nor mRNA-based.
Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.
Pointing to data that show a benefit in reducing viral load and the histological signs of the infection, Memo says its drug, potravitug, could become the first therapy to treat BK polyomavirus in kidney transplant recipients.
The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.
Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.