The FDA has given Sarepta Therapeutics the green light for its phase 2 Duchenne muscular dystrophy clinical trial after slapping the biotech with a clinical hold in June. The hold came after a grade 3 adverse event was reported in the midstage trial. Now, only a few months later, the agency has lifted the hold, and we'll discuss why there was a quick turnaround on the hold and what to expect next. 

To learn more about topics in this episode: 
Sarepta picks up momentum as FDA lifts hold on phase 2 DMD trial
As EU challenge intensifies, Illumina clocks a stateside win in FTC antitrust case over Grail buy
EU blocks Illumina's yearslong quest for Grail
Philips recalls 17M CPAP and BiPAP machine masks due to potential magnet interference
GSK helps SpringWorks double payday from boosted combo deal as it also reels $225M in new funding
BMS-backed Arsenal Bio pulls trigger on $220M series B, touting potential fleet of gene-edited cell therapies
Amylyx's ALS drug faces tough FDA scrutiny ahead of 2nd advisory panel meeting

The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

The FDA has given Sarepta Therapeutics the green light for its phase 2 Duchenne muscular dystrophy clinical trial after slapping the biotech with a clinical hold in June. The hold came after a grade 3 adverse event was reported in the midstage trial. Now, only a few months later, the agency has lifted the hold, and we'll discuss why there was a quick turnaround on the hold and what to expect next. 
To learn more about topics in this episode: 
<ul>
<li><a href="https://www.fiercebiotech.com/biotech/sarepta-picks-momentum-fda-lifts-hold-phase-2-dmd-trial">Sarepta picks up momentum as FDA lifts hold on phase 2 DMD trial</a> </li>
<li><a href="https://www.fiercebiotech.com/medtech/eu-challenge-intensifies-illumina-clocks-stateside-win-ftc-antitrust-case-over-grail-buy">As EU challenge intensifies, Illumina clocks a stateside win in FTC antitrust case over Grail buy</a> </li>
<li><a href="https://www.fiercebiotech.com/medtech/european-union-blocks-illuminas-years-long-quest-grail">EU blocks Illumina's yearslong quest for Grail</a> </li>
<li><a href="https://www.fiercebiotech.com/medtech/philips-recalls-17m-cpap-and-bipap-machine-masks-due-potential-magnet-interference">Philips recalls 17M CPAP and BiPAP machine masks due to potential magnet interference</a> </li>
<li><a href="https://www.fiercebiotech.com/biotech/springworks-enjoys-double-payday-expanded-gsk-combo-deal-225m-funding">GSK helps SpringWorks double payday from boosted combo deal as it also reels $225M in new funding</a> </li>
<li><a href="https://www.fiercebiotech.com/biotech/bms-backed-arsenal-bio-raises-220m-series-b-touting-potential-fleet-gene-edited-cell">BMS-backed Arsenal Bio pulls trigger on $220M series B, touting potential fleet of gene-edited cell therapies</a> </li>
<li><a href="https://www.fiercepharma.com/pharma/amylyxs-als-drug-application-shot-down-again-fda-advisory-committee">Amylyx's ALS drug faces tough FDA scrutiny ahead of 2nd advisory panel meeting</a></li>
</ul>
The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning. 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.&nbsp;

The Top Line

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We’ll analyze the week’s biggest business news—from mergers and marketing to drug R&D and device development. Available every Friday morning.

 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We&rsquo;ll analyze the week&rsquo;s biggest business news&mdash;from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.
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