Infectious Diseases

Two investigational products have made it onto the European Medicines Agency’s priority medicines scheme so far this year. Meanwhile, of the 14 products that entered the scheme last year, six were advanced therapies.

Nonprofits are finding new ways to address market gaps and develop treatments for rare diseases with little commercial attraction.

GSK’s depemokimab, if approved, could become the first ultra-long-acting drug for treating asthma and chronic rhinosinusitis with nasal polyps. Meanwhile, Sanofi’s teplizumab, which the US approved as the first disease-modifying therapy for type 1 diabetes in 2022, has now been filed for review by the European Medicines Agency.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Inflammatix received US FDA clearance to market its TriVerity Test System to help emergency departments quickly triage patients suspected of having acute infection or sepsis. Medtech Insight spoke with Inflammatix CEO Tim Sweeney about the company’s business strategy and marketing plans.

In this episode of the In Vivo podcast, Harvard immunologist and co-founder of early-stage biotech Corner Therapeutics, Jonathan Kagan, talks about harnessing the power of the innate immune system by weaponizing dendritic cells and creating immunotherapies that are safer and more durable.

The complex landscape of clinical trials, fraught with pressures and risks, and exacerbated by the adoption of new technologies, regulatory burdens, and drug pricing negotiations, is rebounding with aplomb.

Patients in the ICU continue to die from SARS-CoV-2-induced acute respiratory distress syndrome, says InflaRx, which is one of companies whose product the European Medicines Agency today announced should be approved for marketing in the EU.

The European Medicines Agency’s human medicines committee is meeting this week due to decide whether or not to back pan-EU marketing approval for a number of new drugs.

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.