Infectious Diseases

Since taking on the CEO role at Theratechnologies in 2020, Paul Lévesque has made it his priority to beef up the company’s commercial portfolio and look for partnerships on potentially high-value programs. Now, the Canadian biotech is turning a profit for the first time in many years.

The US CDC committee appears on track to recommend GSK’s five-in-one vaccine when use of both a quadrivalent vaccine and a separate meningitis B vaccine are indicated at the same visit, the approach adopted for Pfizer’s Penbraya.

Advisory Committee on Immunization Practices wants to shift from a risk-based to an age-based recommendation for PCV-naïve adults between the ages of 50 and 64. The recommendation would put Merck’s recently approved Capvaxive and Pfizer’s market-leading Prevnar 20 on equal footing.

Charles Cooper, CMO of the diagnostics firm bioMérieux, talks to In Vivo about the vital nature of partnerships to fight the global AMR crisis.

The sponsors of medicines that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.

Concizumab sponsor Novo Nordisk and a number of other companies could soon learn whether or not the European Medicines Agency will give their respective drugs the marketing thumbs up.

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

Pink Sheet reporter and editors discuss experts’ experience helping drug sponsors negotiate prices with CMS and the FDA’s proposal for a new pathway to update vaccines before a pandemic is declared.

The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.

The FDA’s vaccine advisory committee endorsed a new plan to update pandemic influenza vaccines “inter-pandemic,” but encouraged the agency to consider how to make the approach feasible for novel vaccine technologies.