Regulatory
Protocol design optimization and timely engagement of regulators are the crux of optimized, patient-centric clinical trials.
Even after the runaway success of mRNA vaccines against COVID-19, the pathway to approval for upcoming would-be mRNA therapeutics has yet to be laid out.
The regulator lifted a clinical hold on Verve Therapeutics’ CRISPR-based therapy clearing its Investigational New Drug application and plans to evaluate VERVE-101 in a Phase I heterozygous familial hypercholesterolemia trial.
A Discussion with IQVIA’s Michelle Gyzen Sr. Director, Regulatory Affairs and Drug Development Solutions
While Merck lost out to Pfizer earlier this year in snapping up Seagen, this week the company closed a deal worth a potential $22 billion with Daiichi Sankyo—further evidence of the industry’s insatiable appetite for ADC technology.
Despite increasing antitrust scrutiny across the biopharma industry, the European Commission on Thursday said it found no competitive issues with Pfizer’s buyout of the antibody-drug conjugate company.
The trial, which is the first late-stage study of an in vivo CRISPR treatment in the U.S., will start by the end of 2023. Intellia’s NTLA-2001 is a treatment candidate for transthyretin amyloidosis cardiomyopathy.
After the FDA released draft guidance on increasing diversity in clinical trials, companies have been left to figure out the details. Here’s what experts say is working.
Months after a denial of its rare eye cancer injection, Aldeyra Therapeutics is bracing for another potential rejection by the regulator, this time for its investigational dry eye disease treatment.
The regulator approved the combination of Pfizer’s Braftovi and Mektovi for the treatment of metastatic non-small cell lung cancer in adult patients with a BRAF V600E mutation.
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