Drug Development
The hold, placed by the FDA on an early-stage clinical trial of an experimental BET inhibitor, stems from a recent observation of testicular toxicity in canines given the treatment.
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Disruptive conditions are typical in non-Western markets. The U.S. industry, thrown into a period of significant change as the Trump administration overhauls HHS and considers implementing tariffs, could learn a thing or two by looking overseas.
Like they say about the weather in Iceland, if you don’t like an action taken by the new administration, wait five minutes; it’ll probably change. The markets, it seems, don’t react kindly to that kind of policymaking.
AI is enabling the development of a next generation of drugs that can more precisely target cancer cells while sparing healthy tissues.
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Losing the FDA’s senior negotiators would slow the renewal of the user fee programs “considerably,” according to policy and regulatory expert Steven Grossman.
With tariffs pushing manufacturing home to the U.S., Pitchbook warns of reduced M&A activity and venture capital funding.
The French pharma giant has made multiple trips to the artificial intelligence well over the past few years, this time with Delaware-based Earendial Labs.
Eli Lilly’s shares shot up 11% pre-market on Thursday after orforglipron became the first small-molecule GLP-1 drug to ace a late-stage study in type 2 diabetes, eliciting significant reductions in body weight and improvements in glucose control.
Analysts at Leerink agreed with Sanofi that, despite falling short of statistical significance in the Phase II TIDE-Asthma trial, amlitelimab warrants further development in this indication.
Merck has not disclosed which of its peptide therapies it plans to develop oral formulations for.
According to analysts at BMO Capital Markets, non-obstructive hypertrophic cardiomyopathy would have meant a $1.3 billion label expansion opportunity for Camzyos.
In a Phase Ib trial, VERVE-102 showed it could lower bad cholesterol across doses, setting up an opt-in decision for Eli Lilly and a showdown with Novartis.
Pfizer’s discontinuation of danuglipron brings the company down to a single molecule in its obesity pipeline.
At the GenScript Biotech Global Forum 2025, industry leaders celebrated CAR T cell therapy achievements while discussing ongoing challenges in manufacturing, distribution, treatment center capacity, and global payment structures for cell and gene therapies.