Infectious Diseases

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.

A GSK-Bharat Biotech deal on a shigella vaccine candidate has cast a spotlight on the disease, which is the second leading cause of diarrheal deaths in children below five. Scrip looks at data from Pharmaprojects, WHO and other sources to highlight why a vaccine matters and what pharma is doing.

The US FDA approved Merck’s Enflonsia (clesrovimab) to prevent RSV in newborns and infants on the same day Sanofi assured that it would ship Beyfortus in time for the 2025-2026 RSV season.

The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

From billion-dollar COVID antibody to a strategic reset, Marianne De Backer is navigating Vir's comeback through pipeline focus and disciplined leadership.

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

The drugmaker said in its first quarter earnings that it did not foresee negative effects on potential approval and launch of lenacapavir for PrEP later this year.

Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.

Several new drugs that are yet to be approved anywhere in the world are now under review by the European Medicines Agency for potential pan-EU marketing authorization.