Tag Archives: therapy

Treatments and best practices on when to prescribe hormone therapy and what medications to use have evolved in recent years. MStudioImages/E+/Getty Images hide caption toggle caption MStudioImages/E+/Getty Images When obstetrician JoAnn Pinkerton spoke on a Food and Drug Administration panel recently, she didn’t mince words. “Please stop harming women,” she said. Pinkerton argues that the FDA’s black box warning labels …

Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at drewqjoseph.45. European regulators on Friday said that a Duchenne muscular dystrophy gene therapy should not be approved, further imperiling the future of the treatment that is facing increasing scrutiny in the U.S. and globally.  The decision in Europe comes as Japan and …

Jennifer Hill Blair recognized the Cincinnati number on her buzzing phone and slipped out of the school meeting, excited to finally learn when her son Cayse would receive a therapy she believed would change his life. Blair, a second-grade teacher in southern Mississippi, and her husband had been fighting the state insurer since April, calling senators and representatives to lobby …

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54. This is the online version of Adam’s Biotech Scorecard, a …

Thomas Fuller | SOPA Images | Lightrocket | Getty Images Sarepta Therapeutics said on Monday that it will pause all shipments of its Elevidys gene therapy in the United States after a muscular dystrophy patient who received a different, experimental treatment died. U.S. regulators on Friday asked Sarepta Therapeutics to voluntarily halt shipments of its gene therapy. However, the company …

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54. Sarepta Therapeutics said Monday evening it will pause all shipments …

Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy  Fierce Biotech We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress  statnews.com Sarepta Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug  Yahoo Finance Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths  The New York Times …

Undruggable No More: AI Hits Disordered Proteins, Unlocks Therapy Targets  Genetic Engineering and Biotechnology News Undruggable ‘disordered’ proteins become druggable with new AI techniques from David Baker  statnews.com David Baker’s lab uses AI to help catch nature’s squirmiest proteins  Endpoints News UW scientists use AI to crack ‘undruggable’ proteins, opening door to new treatments  GeekWire New AI-assisted methods take aim at ‘undruggable’ proteins  C&EN Source …

WASHINGTON (AP) — Drugmaker Sarepta Therapeutics said late Friday it won’t comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the death of a third patient receiving one of its treatments for muscular dystrophy. The highly unusual move is a latest in a string of events that have hammered the …

Sarepta says it won’t comply with FDA request to stop shipping gene therapy Elevidys  Reuters Sarepta Refuses FDA Request to Stop Shipping Muscular Dystrophy Drug Elevidys  The New York Times Sarepta shares plunge 40% as future of its gene therapy appears at risk  CNBC Third death from a Sarepta gene therapy  biocentury.com We are mothers of Duchenne patients. Recent setbacks with Sarepta must not …