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Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said the agency’s new risk-based COVID-19 vaccine framework contradicts the current administration’s push for transparency and gold-standard science.
Given today’s available local talent pool, biopharma companies are less likely to turn toward international job candidates, according to a talent acquisition expert. Findings from two recent BioSpace LinkedIn polls underscore the issue.
Writing in JAMA, four former government officials warn that the Trump administration’s involvement in delaying the approval of Novavax’s COVID-19 vaccine could indicate a politicization of the drug approval processes that could ‘imperil public health.’
Are long R&D cycles, overwhelming literature reviews, or patent bottlenecks slowing your path to innovation? In the fast-evolving life science landscape, AI is no longer a luxury, it’s a necessity.
The newly appointed members of the CDC’s influential vaccine committee meet Wednesday and Thursday under an unusually rapid timeline, with unexpected topics on the agenda.
Tapping into the hidden job market can be challenging but is important in today’s employer-driven market. Three talent acquisition experts share tips for accessing hard-to-find roles.
Eli Lilly’s tirzepatide is expected to be worth $62 billion annually by 2030, according to Evaluate. That valuation would be three times larger than what AbbVie’s blockbuster Humira ever achieved.
Gilead is betting up to $750 million on Kymera’s anti-CDK2 molecular glue for solid tumors, while Sanofi elected to move forward with another protein degrader from the biotech, designed to target immune-mediated diseases.
The FDA is assessing the need for “further regulatory action” on Sarepta’s Duchenne muscular dystrophy gene therapy in the aftermath of two patient deaths, though the regulator has not yet specified what action this could be.
Mike Davis previously worked as clinical team leader at the FDA’s Division of Psychiatry before serving as chief medical officer for Usona Institute, a research organization advancing psychedelic science.
Despite Nektar’s share price shooting up as much as 175% on Tuesday, William Blair maintained that “there is an absence of clear differentiation” for rezpegaldesleukin in the atopic dermatitis space.
Robert F. Kennedy Jr. testified in front of largely combative congresspeople on vaccine policy, his MAHA report and more; the mass leadership exodus at the FDA continues as CDER and CBER shed key staff; Kennedy’s revamped CDC vaccine advisors convene for their first meeting; Novo and Lilly present new data at the American Diabetes Association’s annual meeting; and BioSpace recaps BIO2025.
PRESS RELEASES
Shareholders Must Recast Their Votes to be Counted
Integration into McKesson’s Medical-Surgical Solutions marketplace serving a nationwide customer base
Phase I results provide platform-level validation supporting AdJane’s broader development programs in pandemic preparedness, respiratory infectious diseases and antimicrobial resistance
International experts from leading universities, global biopharmaceutical companies, and investment organizations will convene in Riyadh, Saudi Arabia, September 14–16, 2026, for the fourth edition of RGMBS.
Leinfelden, Germany. Recent infectious disease events—from hantavirus outbreaks and meningitis cases to recurring disease outbreaks in livestock farming—highlight the need for flexibly scalable vaccine manufacturing processes. To address this challenge, Stuttgart-based technology company KyooBe Tech has developed a platform designed to accelerate vaccine production. This technology is now also available to external users for studies at the Fraunhofer Institute for Cell Therapy and Immunology (IZI).
AmesNet’s Task-Conditioned Learning architecture outperforms FDA, MIT, Tencent, and the University of Sydney models in both sensitivity and balanced accuracy on out-of-domain chemical data on a public dataset; AmesNet is built on top of ChemPrint, the core and proprietary deep-learning engine of the GALILEO platform that powers the company’s drug pipeline.