JD Supra13h
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
federalnewsnetwork.com1d
FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
pharmaphorum2d
Aduhelm and an expensive failure to launch
From the beginning, the approval of its Aduhelm (aducanumab) treatment was met with controversy – over the interactions with the FDA, and the advisor committee’s vote against the treatment ...
The American Journal of Managed Care3d
FDA Approves New Maintenance Dosing for Lecanemab to Treat Early-Stage Alzheimer Disease
The FDA approves a new maintenance dosing regimen for lecanemab (Leqembi; Eisai) in patients with early-stage Alzheimer ...
pharmaphorum1d
And then there were three: another FDA adcomm member quits over Aduhelm
The FDA gave Aduhelm an accelerated approval, meaning that Biogen has to carry out a post-marketing trial to confirm that it is effective, but critics say results from that will be years away.
Wedbush Forecasts Biogen’s FY2024 Earnings (NASDAQ:BIIB)
Equities research analysts at Wedbush dropped their FY2024 EPS estimates for Biogen in a research report issued on Thursday, ...
Wedbush Weighs in on Biogen’s Q4 Earnings (NASDAQ:BIIB)
Stock analysts at Wedbush lowered their Q4 2024 earnings estimates for Biogen in a research report issued on Thursday, January 23rd. Wedbush analyst L. Chico now forecasts that the biotechnology ...
Boston College5d
Medicare and prescription drug costs
A Boston College Center for Retirement Research report looks at the financial implications for Medicare of Alzheimer's drug Aduhelm The recent controversy over Alzheimer’s treatment Aduhelm—criticized ...
WSAY1d
Fight Knee-Jerk: Robert F. Kennedy May Surprise You
When Robert F. Kennedy Jr. was fighting mercury contamination in fish, he was considered a champion of environmental health ...
Australian Broadcasting Corporation22h
South Australia
The state and federal governments today announced they will dedicate a combined $30 million to the Whyalla airport, in addition to $3.14 million from the federal government to kick start the long ...
The New York Times1d
World News
The new leadership of the country said the rebel coalition leader, Ahmed al-Shara, would serve as president during a transitional period. By Christina Goldbaum The parents of Elizabeth Rose ...
The Real News Network4d
The Real News Network
Christian Mobley of Jonesboro, Arkansas, says local police ruined his livelihood through constant harassment and ticketing, which eventually cost him his job. Use SecureDrop, an anonymity tool for ...