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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
Many of the FDA’s decisions this quarter involve applications that have previously been delayed, declined or outright rejected, including one for an mRNA vaccine that became the center of controversy earlier this year.
AstraZeneca and CSPC Pharmaceutical Group have already inked two other agreements this year, including an obesity-focused deal in January and one focused on chronic diseases in June.
The mid-stage disappointment in Alzheimer’s disease delivers another blow to Neuphoria Therapeutics, which in November last year was forced to launch a strategic business review after a Phase 3 trial in social anxiety disorder failed.
The FDA approved the expansion of Casgevy, which had previously been greenlit for patients 12 and up, into a younger pediatric population under the agency’s Commissioner’s National Priority Voucher program.
Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you.
Looking for your next role in Philly? Here are eight companies currently hiring.
FDA’s draft guidance on the validation of non-animal methods (NAMs) is reshaping how nonclinical programs are designed and justified. This webinar explores how sponsors can apply NAMs to streamline development, improve human relevance, and support IND decision-making within a weight-of-evidence framework.
Ipsen is penning its second acquisition of the week, this time securing Memo Therapeutics and its midstage monoclonal antibody in a deal that could approach $800 million.
The approval of Tregzi—the first regulatory greenlight for Orca Bio—was based on a Phase 3 study in which patients on the therapy were twice as likely to survive without cancer relapse and without chronic GVHD compared with conventional allogeneic transplant.
Teams at facilities being developed by Eli Lilly, Regeneron and other companies will receive early technical guidance and additional perks from the FDA.
Despite the late-stage fail, Vistagen will nevertheless continue to push its drug candidate forward and meet with the FDA to align on a potential registrational path.
PRESS RELEASES
· Prof. Dr. med. Jürgen Braun joins the Scientific Advisory Board of MetrioPharm AG. · With more than 800 peer-reviewed publications and various prestigious awards, Prof. Braun is internationally recognized as a leading expert in the field of modern clinical and academic rheumatology.
Pharmaceutical service provider receives prestigious management award for the seventh year in a row · Family-owned company once again excels in all four key business areas · Site development and digitalization as strategic investment priorities · Focus on new sources for skilled workers and on lifelong learning
The upgraded platform offers a searchable database of over 300 risk-assessed HCPs, automated research scanning, and new flexible pricing options for mid-size drug developers.
New preprint by Jianghui Xiong, PhD, and the DeepoMe team introduces SteeraMed, a steerable biomedical world model for N-of-1 intervention reasoning across chronic diseases and aging