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Los seres humanos nos consideramos la cumbre de la evolución. Hemos construido ciudades, pisado la Luna y descifrado el genoma. Sin embargo, si nos despojamos de la tecnología y competimos puramente con nuestra biología, somos una especie bastante vulnerable.   En la natu …

Investment and a maturing talent base have propelled Denmark ahead of its Nordic peers, drawing Swedish companies and exposing regional gaps in capital and scale.

The FDA will hold advisory committee meetings this week for previously rejected investigational therapies from Replimune and Capricor Therapeutics. Some industry leaders were surprised the meetings were called at all, while many have questioned the rationale behind them and other adcomms on deck.

Summit Therapeutics revealed positive Western data last week from a Phase 3 trial of lung cancer candidate ivonescimab. In a flipped geographical clinical trials landscape, what more will be required for Summit and China-based partner Akeso—and other transnational tandems—to secure FDA approval?

Safety will be the key determinant of in vivo CAR T therapies, according to H.C. Wainwright’s Mitchel Kapoor, who noted that convenience and efficacy won’t be enough to impress investors in this space. Eli Lilly, AbbVie, AstraZeneca and more are up for the challenge.

Multiple factors could get in the way of confirming a new commissioner before the midterm elections, experts said, leaving the agency’s long-term initiatives in limbo.

An upcoming Medicare coverage decision for transcatheter aortic valve replacement devices and study readout for patients with moderate disease are expected to help the company maintain its momentum.

An analyst said Saccaro’s decision was “surprising,” adding that investors were not calling for his departure.

Facing pressure around the world to withdraw the rare kidney disease drug Tavneos, Amgen has launched a robust defense with real-world evidence to support the product’s benefit-risk profile.

Sanofi had hoped the acquisition of Kymab would fill a major hole that will be left as autoimmune juggernaut Dupixent heads toward a patent cliff. Now, another therapy has failed to meet expectations.