News

Lawmakers press FDA to target knockoff weight-loss drug
Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...
Targeted Oncology16h
Drug Approval Hurdles: Funding & Regulation Slow Life-Saving Cures
Unpredictable FDA and funding woes delay crucial drug approvals, depriving thousands of patients access to vital treatments ...
Hims & Hers drops as U.S. lawmakers target copycat weight loss drugs
Hims & Hers (NYSE:HIMS) stock slips as U.S. lawmakers seek FDA action against copycat versions of weight loss drugs from Novo ...
How to find out if weight loss drugs are covered by your insurance, and what to do if they're not
GoodRx reports that insurance coverage for GLP-1 medications varies. It's more likely when prescribed for FDA-approved uses ...
Applied Clinical Trials Online20h
FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors
Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.
Fierce Pharma20h
Doctored data, protest from trial observers: Lawsuit points to alleged misconduct at Amgen-bought biotech
On Nov. 26, 2019, ChemoCentryx issued a press release announcing that the Advocate trial met both of its primary endpoints, saying Tavneos showed noninferiority of disease remission at 26 weeks and ...
PharmExec21h
Replimune CRL Fallout: How Biopharma Leaders Should Manage a New Layer of FDA Uncertainty
A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...
PharmTech23h
CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success
Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...