FDA, Covis release dueling documents over the fate of a drug for premature births; ‘Patchy efforts’ by major insulin makers mean access lags

Taking stock of the drug industry, from the lab to the medicine chest ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ 

Sponsored by        STAT+: FDA and Covis release dueling documents over the fate of a controversial drug for premature births By Ed Silverman Adobe Keeping Makena available would "unnecessarily expose patients to the risks associated with a drug that is not shown to be effective," FDA says Read More STAT+: 'Patchy efforts' by major insulin makers mean access lags in many poor countries By Ed Silverman Alissa Ambrose/STAT “The global inequity is so stark and... I think we need to do something about this,” said Jayasree Iyer of the Access to Medicines Foundation. Read More Sponsor content by Alexion Pharmaceuticals The accelerated approval pathway's impact speaks for itself Without FDA's accelerated approval pathway, nearly two-thirds of new medicines developed in the last 20 years would have failed to reach patients. More than 80% of these medicines treat rare conditions. And with FDA-approved treatments for only 5% of the estimated 7,000 to 10,000 rare diseases, pathways like accelerated approval are vital to encourage rare disease drug development in the biopharmaceutical industry. Read new findings on the impact of the accelerated approval pathway here. STAT+: Medicare tasks a senior adviser with staffing its new drug pricing division By Rachel Cohrs Graeme Sloan/Sipa USA Medicare has tasked a senior adviser with assembling a small army of bureaucrats to get its new drug price negotiation program up and running. Read More STAT+: Alzheimer's clinical trials have a recruitment problem. Telehealth platform Ro thinks it can help  By Mario Aguilar Evan Vucci/AP Alzheimer’s clinical trials have a recruitment problem. Telehealth platform Ro just struck an agreement with the NIA to try to help. Read More Opinion: The new law that could stealthily transform biomedical innovation By M. Gregg Bloche and Neel U. Sukhatme and John L. Marshall Adobe The Inflation Reduction Act ties Medicare's payment for treatments to how well they work. That could catalyze biomedical breakthroughs. Read More Thursday, October 6, 2022       1 Exchange Pl, Suite 201, Boston, MA 02109 ©2022, All Rights Reserved. I no longer wish to receive STAT emails Update Email Preferences | Contact Us | View In Browser