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Read our takes on the biggest stories happening in the industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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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.”
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.
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.
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.”
Perhaps the most interesting of the pile of FDA rejection letters was for Lykos Therapeutics’ MDMA therapy. Letters sent to Stealth BioTherapeutics, Regeneron and more were also released as the agency also promised future CRLs “promptly after they are issued to sponsors.”
The new additions would bring ACIP membership to 14 total. Several of the proposed members have taken part in anti-vaccine activity or made anti-vaccine statements.
Generous severance packages, getting out of toxic workplaces and finding a better job with better pay are a few reasons respondents to a recent BioSpace survey felt that being laid off was for the best.
As more and more groups call for the health secretary’s removal from office, senators will question Kennedy on his recent moves, including the controversial firing of CDC Director Susan Monarez.
In this episode presented by Taconic Biosciences, BioSpace’s head of insights Lori Ellis discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment with Mike Garrett, CEO.
The reprioritization effort will help AC Immune extend its cash runway through the third quarter of 2027.