FDA drug review times are up, and the number of approvals are down, with a wary investment community taking note and adding a new element to their earnings projections. The lack of a permanent FDA commissioner, understaffing, and the recent recalls/withdrawals of approved drugs are among the factors that may be leading to a slowdown. But whatever the significance of any shift in approval patterns over the last year or two, there are longer-term regulatory causes of concern for the drug industry--some attributable to the agency, but others stemming from the industry itself. With novel drugs taking up an increasing proportion of drug company pipelines, the FDA's staffing problems are compounded by having to evaluate therapies for which there are no reference points. The agency, having learned the hard way that it's extremely difficult to manage risk once a drug hits the market, will be particularly careful before passing on groundbreaking medications. And that tendency towards caution is only likely to become stronger as consumers become a powerful force in affecting prescribing patterns.
By Jeffrey Dvorin
"Biotech Burned by Bad News FDA," "FDA Goes Hostile," "FDA Slows down Approvals, Industry Concerned," "Wall Street has a Headache...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on In Vivo for daily insights
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.
The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.
BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.
Metsera CEO Whit Bernard applies an unconventional leadership philosophy to develop next-generation obesity therapeutics, including monthly GLP-1 injections and oral peptides.