Alzheimer’s drugs eyed as next big obesity-like opportunity
Investors seeking the next obesity-like market opportunity will be closely watching developments related to treatments for ...
FDA Approves Amgen Treatment For Pretreated Colorectal Cancer With Certain Mutation
The Food and Drug Administration approved Amgen Inc ‘s AMGN Lumakras (sotorasib) in combination with Vectibix (panitumumab) ...
MM&M5d
Rx Rundown: Johnson & Johnson, Eli Lilly, the FDA and more
N-Power Medicine, backed by Merck GHI, announced the acquisition of Syapse Holdings. Samsung Biologics and LigaChem extended their ADC services deal. Publicis Worldwide merged with Leo Burnett to form ...
FiercePharma5d
Government watchdog recommends tweaks to FDA accelerated approval program
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
MedPage Today5d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
Becker's Hospital Review6d
Watchdog flags flaws in FDA's fast-track drug approvals
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...
precisionmedicineonline6d
Biogen Says It's 'Doubling Down' on Alzheimer's Disease at JPM
Despite Leqembi's initial slow sales, the firm's CEO cited areas for the drug's growth and ambitions for an antisense ...
precisionmedicineonline6d
OIG Recommends Changes in FDA Accelerated Approval After Flagging Concerns With Aduhelm, Other Drugs
The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.
STAT6d
Pharmalittle: We’re reading about FTC criticizing PBMs, an NIH policy on access to medicines, and more
The FDC released a second highly critical report of PBMs, which may provide further impetus for legislative action to curb ...
BioSpace6d
Under Pressure to Deal, Biogen Executives Deflect Urgency at JPM25
While investors and analysts push for a deal, Biogen CEO Chris Viehbacher and Head of Development Priya Singhal refuse to ...
Sage Therapeutics: Biogen's Unsolicited Bid Is Best Step Forward For Shareholders
Sage Therapeutics' financials indicate a need for additional funding in 2025, risking dilution and further financial ...
kffhealthnews6d
After 2 Deaths, Philips Recalls Software That Mishandled Some EKG Readings
Another 109 people reported injuries after using the remote cardiac monitoring software, Modern Healthcare reported. Other pharmaceutical and tech news is on the FDA's drug approval system and a rapid ...