Author name: Leonardo Arias

Amid an unprecedented turnover in leadership at the FDA and mass layoffs of staff, communication has crumbled and uncertainty runs rampant, leaving small and medium biopharma companies without a clear path forward for their therapies.

Rick Doblin, the founder of the Multidisciplinary Association for Psychedelic Studies, which founded Lykos, bemoaned a “moving of the goal posts” in Lykos’ rejection but looked for positives in the newly released complete response letter.

Roughly 150,000 individual and group MA members will be affected by the plan exits, as will some 400,000 Part D enrollees.

Robert F. Kennedy Jr. repeated a series of anti-vaccine talking points during his appearance in front of the Senate finance committee on Thursday, as Democratic and Republican senators alike hammered the Health Secretary on recent COVID-19 vaccine restrictions and his views on Operation Warp Speed.

The company reported a 100% surgical success rate, beating the pre-specified 85% performance goal to meet the trial’s primary effectiveness endpoint.

The company, which helps medtech companies with AI compliance, has raised more than $55 million to date.

In coordination with the United States President’s Emergency Plan for AIDS Relief, Gilead will make its twice-yearly HIV prophylactic Yeztugo available to resource-limited countries “at no profit.”

Hengrui Pharmaceuticals has been busy this year, signing a nearly $2 billion cardio contract with Merck in March and a 12-asset agreement with GSK in July worth up to $12 billion.

Despite hitting its efficacy targets in the Phase III COAST-1 study, Sanofi’s amlitelimab remains “meaningfully inferior” to Dupixent, according to analysts at Leerink Partners.

Ousted CDC Director Susan Monarez claimed in an op-ed published in the Wall Street Journal Thursday that she was fired for refusing to rubber-stamp COVID-19 recommendations to be made by an advisory panel that has expressed “antivaccine rhetoric.”