News

InnovationRx: Sarepta Blinks In Showdown With FDA
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
Fierce Pharma3h
Roche halts Elevidys distribution in some countries, following Sarepta's lead in US
Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...
Fierce Biotech4h
With $550M on the line, Arrowhead reassures investors about pact with troubled Sarepta
Arrowhead Pharmaceuticals has moved to reassure Wall Street about its deal with Sarepta Therapeutics, telling investors that ...
STAT4h
Pharmalittle: We’re reading about Sarepta’s ‘arduous’ path ahead, pharma’s reliance on China, and more
Sarepta faces an “arduous and treacherous path” to try to get its Duchenne muscular dystrophy therapy Elevidys back onto the ...
Arrowhead Pharma Shares Rise After Statement on Sarepta Deal
Shares of Cambridge, Mass.-based Sarepta have fallen by more than 90% in the last year amid safety concerns about its Elevidys, a gene therapy that treats Duchenne muscular dystrophy, following ...
KFF Health News5h
Humana Plans Outpatient Prior Authorization Requirement Cuts
In line with its aim to provide decisions within one business day on at least 95% of prior authorizations by next year, Humana will cut a third of its prior authorization requirements. It will also ...
Roche stops shipping Sarepta gene therapy in some countries outside US
The Swiss company, which markets Elevidys abroad, said it believes the benefit-risk balance to treatment remains positive in Duchenne patients who can still walk, however.
Roche pauses Sarepta gene therapy shipments outside the U.S.
Sarepta Therapeutics (SRPT) stock is back in focus as Roche (RHHBF) pauses global shipments of its Elevidys gene therapy ...
BioSpace6h
Following Sarepta’s Lead, Roche Suspends Elevidys Shipments to Some Ex-US Countries
Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and ...
BioSpace7h
Sarepta’s Wild Week, CDER’s New Leader, FDA Rejections, Manufacturing Billions
Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug ...
STAT9h
Roche halts some shipments of Sarepta’s Duchenne gene therapy outside U.S.
Roche is following its partner Sarepta and halting shipments of the Duchenne gene therapy Elevidys in some countries, amid ...
Roche Pauses Contested Gene Therapy’s Shipments Outside US
Roche Holding AG paused some shipments of the controversial gene therapy Elevidys following a similar action by the embattled ...