BioCentury | Jan 20, 2021
Politics, Policy & Law

Biden’s science team & early cancer detection: a BioCentury podcast

...she made while head of FDA’s CDER, including her intervention in the review of Exondys 51 eteplirsen...
BioCentury | Jan 16, 2021
Politics, Policy & Law

Woodcock’s appointment as acting FDA commissioner could be audition for permanent position

...as much turmoil among agency review staff as Woodcock’s intervention in the review of Exondys 51 eteplirsen...
...overruled a decision by Office of Drug Evaluation I Director Ellis Unger to reject the Exondys 51...
...director of CDER Woodcock had the last word.   While Califf wrote in 2016 that the Exondys 51...
BioCentury | Jan 14, 2021
Politics, Policy & Law

Calls to make Woodcock permanent FDA commissioner

...as much turmoil among agency review staff as Woodcock’s intervention in the review of Exondys 51 eteplirsen...
...overruled a decision by Office of Drug Evaluation I Director Ellis Unger to reject the Exondys 51...
...and Research (CDER) Woodcock had the last word.   While Califf wrote in 2016 that the Exondys 51...
BioCentury | Nov 21, 2020
Product Development

Could an approval of Biogen’s Alzheimer’s therapy still be an option?

...in to grant accelerated approval to Exondys 51 eteplirsen...
BioCentury | Nov 20, 2020
Deals

After three-target Lilly deal, Precision BioSciences hunting for more partnerships

...since then.Sarepta Therapeutics Inc. (NASDAQ:SRPT) has the only two innovative, FDA-approved drugs for DMD: Exondys 51 eteplirsen and...
BioCentury | Nov 14, 2020
Politics, Policy & Law

Candidates for next FDA commissioner

...a controversy over the review of Exondys 51 eteplirsen...
BioCentury | Oct 23, 2020
Finance

Sarepta joins investor trio in Aavanti’s $107M series A round to develop gene therapy for Friedreich’s ataxia

...patient advocacy group GoFAR and the Muscular Dystrophy Association Venture Philanthropy Fund.Best known for Exondys 51 eteplirsen...
BioCentury | Aug 28, 2020
Product Development

Aug. 27 Quick Takes: Priority Review for casimersen in DMD, tepotinib in NSCLC; plus asciminib meets in CML and a farewell to digital pioneer Proteus

...the application. About 8% of DMD patients are exon 45-amenable; Sarepta’s marketed exon-skipping therapies Exondys 51 eteplirsen...
BioCentury | Jan 25, 2020
Product Development

A milestone year for Roche’s CNS gambit could kick off its plan for the decade

...the gene therapy and gained an option outside the U.S. to Sarepta’s DMD drugs Exondys 51 eteplirsen...
BioCentury | Jan 23, 2020
Company News

Disparities in FDA decisions on Sarepta DMD therapy raise questions about integrity of review process

...of whom pointed to the agency’s controversial 2016 approval of Sarepta’s first DMD drug, Exondys 51 eteplirsen...
...“to a level that is reasonably likely to predict clinical benefit” (see “FDA Approves Sarepta’s Eteplirsen...
...fell $4.66 to $118.33 Wednesday. Elizabeth S. Eaton, Staff Writer Exondys 51 (Brand), AVI-4658 (Compound #), eteplirsen (Generic), Exondys 51...
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