BioSpace News Archive

Joey Mattingly, PharmD, MBA, PhD, is an associate professor and vice chair of research in the Department of Pharmacotherapy at The University of Utah College of Pharmacy.

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Drug Development

How Data Secrecy Is Stalling Progress in Cell and Gene Therapy

Amid a season of regulatory and scientific advances, experts reveal a culture of data hoarding among cell and gene therapy developers that is reinforcing fragmentation, stalling innovation and delaying access to treatments.

July 21, 2025

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7 min read

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Ana Mulero

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Complete response letters

Lack of US Data Stymie Roche’s Earlier-Stage Lymphoma Push for Columvi

Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for DLBCL in a U.S. population, according to the FDA.

July 21, 2025

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2 min read

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Tristan Manalac

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Duchenne muscular dystrophy

Sarepta Stands Ground Against HHS Request To Stop Elevidys Shipments

In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The designation, granted last month, was the first of its kind to be announced publicly.

July 21, 2025

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2 min read

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Tristan Manalac

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Adcomms

Otsuka, Lundbeck Fail To Sway Adcomm on Rexulti Combo for PTSD

Otsuka and Lundbeck’s data are insufficient to establish significant efficacy of Rexulti plus sertraline in PTSD, according to the FDA’s outside experts.

July 21, 2025

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2 min read

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Tristan Manalac

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Regulatory

FDA’s CDER Gets New Chief in Biopharma Veteran George Tidmarsh

Tidmarsh, an adjunct professor at Stanford’s medical school, brings decades of industry experience to the table. Serving as director of the Center for Drug Evaluation and Research will be his first government position.

July 21, 2025

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2 min read

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Dan Samorodnitsky

Manufacturing

Biogen Commits $2B To Expand US Drug Production Amid Tariff Talk

The biotech is planning to expand antisense oligonucleotide capabilities and infrastructure on campuses that already produce drugs such as the ALS therapy Qalsody.

July 21, 2025

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2 min read

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Nick Paul Taylor

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Vaccines

After Moderna Pulled Its Shot, Combination Flu/COVID Vaccines Hang in Limbo

Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based combination shot that targets both influenza and COVID-19. Now, the entire vaccine sector is sizing up a new regulatory world, companies’ next steps uncertain.

July 21, 2025

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7 min read

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Dan Samorodnitsky

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Immunology and inflammation

Roche Flunks Phase III Trial in COPD, Falling Further Behind Dupixent

The path to market for Roche’s astegolimab became more uncertain after the investigational antibody failed to significantly lower disease exacerbation rates versus placebo in patients with chronic obstructive pulmonary disease.

July 21, 2025

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2 min read

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Tristan Manalac

Press Releases

Cloudbreak Pharma Inc. Announces Positive Phase 2 Results for CBT-004 in Patients with Vascularized Pinguecula

July 21, 2025

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5 min read