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BioWorld, Regulatory
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EU flag, syringe, capsules

CHMP rejects Sarepta’s Elevidys, changes mind on Lilly’s Kisunla

July 25, 2025
By Nuala Moran
No Comments
After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be approving the Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec). Re-examination of the file led to a happier outcome for another drug that has attracted considerable controversy, Eli Lilly and Co. Inc.’s Kisunla (donanemab) for treating the early stages of Alzheimer’s disease.
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Skin irritation on hands

US FDA approves first hand eczema treatment: Leo Pharma’s Anzupgo

July 24, 2025
By Karen Carey
No Comments
Becoming the first approved treatment for chronic hand eczema in the U.S., Leo Pharma A/S’s Anzupgo (delgocitinib) received FDA clearance for an indication that affects 10% of adults worldwide. The cream, dosed at 20 mg/g and applied topically, will treat moderate to severe cases in those not responsive to, or unable to take, topical corticosteroids.
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PTAB to return to pre-pandemic hearing practice

July 23, 2025
No Comments
Five years after the COVID-19 pandemic virtually locked down the U.S. government and society in general, the Patent Trial and Appeal Board (PTAB) is shedding the last vestiges of those days.
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Ridding US vaccines of thimerosal prioritized over RSV prep

July 23, 2025
By Mari Serebrov
No Comments
It’s not surprising that, of all the recommendations the U.S. CDC’s vaccine advisory board made at its June meeting, the first one Health and Human Services Secretary Robert Kennedy signed off on would essentially remove thimerosal from influenza vaccines in the U.S. What is surprising is the time it took for him to do so, given his long-held position on the preservative used in multidose vials and his insistence that a thimerosal presentation and vote be added to the agenda.
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AI-generated image of man sleeping

Apnimed loses no sleep over new phase III apnea results

July 23, 2025
By Lee Landenberger
No Comments
Apnimed Inc.’s lead oral therapy for obstructive sleep apnea has delivered a second round of positive phase III data, bringing a potential U.S. FDA filing closer. Top-line results taken from the second pivotal late-stage study show AD-109 (aroxybutynin 2.5mg/atomoxetine 75 mg) hit its primary endpoint with clinically meaningful and statistically significant drops in airway obstruction at 26 weeks.
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Sarepta yields to FDA request, pauses Elevidys shipments

July 22, 2025
No Comments
In an about-face, Sarepta Therapeutics Inc. said it would “voluntarily and temporarily” pause all shipments of Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) in the U.S. The move comes only a few days after the firm publicly declined a U.S. FDA request to halt shipping of the therapy in the wake of a third patient death, this one linked to a gene therapy using the same adeno-associated virus (AAV) vector as Elevidys.
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Replimune says it didn’t see this CRL coming

July 22, 2025
By Lee Landenberger
No Comments
There are a raft of problems the U.S. FDA wants resolved before Replimune Group Inc.’s BLA for RP-1 (vusolimogene oderparepvec) with nivolumab to treat advanced melanoma goes any further, all of which the company said are a surprise.
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Makary chooses new CDER director from industry ranks

July 21, 2025
By Mari Serebrov
No Comments
Despite Health and Human Services Secretary Robert Kennedy’s oft-repeated vow to rid the FDA of industry influence, FDA Commissioner Marty Makary announced George Tidmarsh, an industry veteran, will be the next director of the agency’s Center for Drug Evaluation and Research (CDER).
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Sarepta confronts FDA, won’t stop Elevidys shipments

July 21, 2025
By Lee Landenberger
No Comments
Sarepta Therapeutics Inc. is declining a U.S. FDA request to voluntarily halt shipping its gene therapy, Elevidys (delandistrogene moxeparvovec), in the U.S. On July 18, Sarepta said had it received “an informal request” from the FDA to stop the shipments following a third patient’s death, tied to the gene therapy SRP-9004, which uses the same vector as Elevidys.
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June FDA approvals jump, led by three new NMEs

July 18, 2025
By Amanda Lanier
No Comments

The U.S. FDA approved 22 drugs in June, tying with March for the highest number of approvals and a jump from 15 approvals in May. The FDA approved 107 drugs in the first half (H1) of 2025, making it the third-highest total for this period in BioWorld’s records, trailing 118 approvals in 2024 and 108 in 2020.


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