article thumbnail

Biogen is in deep trouble and may not survive

World of DTC Marketing

SUMMARY: The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug. Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.

article thumbnail

Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). 2019; 380(14):1347-1358. 2019; 16(9):1297-1299. 2023; 44(3):1384-1392.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Acorai receives Breakthrough Device Designation for their Non-Invasive Intracardiac Pressure Monitor

Legacy MEDSearch

Acorai has ethics approval in 5 countries, including the U.S., Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. The full analysis of this study is currently being prepared for publication. NCT05835024] Subscribe here for updates about this trial’s progress and other Acorai news.

article thumbnail

Clinical trials and pregnancy: regulators weigh in

Clarivate

Drug developers often face a Catch-22 regarding clinical trials and pregnancy. How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

article thumbnail

Cancer: Progress but a long way to go

World of DTC Marketing

The mortality rate from lung cancer has dropped in recent decades—by 56% in men from 1990 to 2019 and by 32% in women from 2002 to 2019. Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease. sustaining life)?