BioSpace News Archive

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  In partnership with GenScript

  Beyond the Breakthrough: Industry Leaders Address Key Hurdles Facing Cell and Gene Therapies

  At the GenScript Biotech Global Forum 2025, industry leaders celebrated CAR T cell therapy achievements while discussing ongoing challenges in manufacturing, distribution, treatment center capacity, and global payment structures for cell and gene therapies.

  April 14, 2025

   · 

  6 min read

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  BioSpace Insights
• 

  FDA

  FDA Action Alert: Regeneron, Sanofi and Abeona

  Lined up for the FDA in the coming weeks are a cell-based gene therapy for a rare skin disease and two product expansions for Regeneron, one with partner Sanofi.

  April 14, 2025

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  3 min read

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  Tristan Manalac
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  Mergers & acquisitions

  Theratechnologies in Talks with Anonymous Potential Buyer While Fielding Future Pak Buyout Offer

  Future Pak—whose acquisition offer was rejected by Vanda Pharmaceuticals last summer—is offering to buy Theratechnologies for an unsolicited $255 million. The Canadian biotech is under an exclusivity agreement with another yet-to-be-disclosed potential purchaser.

  April 14, 2025

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  2 min read

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  Tristan Manalac
• 

  Weight Loss

  Viking Rises as Pfizer’s Oral Obesity Med Falters

  Viking Therapeutics enjoyed a nice share rally on the news that rival Pfizer is discontinuing obesity candidate danuglipron. But the biotech has a long way to go to recover after six straight months of decline.

  April 14, 2025

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  3 min read

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  Annalee Armstrong
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  Gene editing

  Verve’s Base Editor ‘Numerically Beats’ Other Cholesterol-Lowering Drugs

  In a Phase Ib trial, VERVE-102 showed it could lower bad cholesterol across doses, setting up an opt-in decision for Eli Lilly and a showdown with Novartis.

  April 14, 2025

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  2 min read

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  Dan Samorodnitsky
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  FDA

  FDA After the Storm: Drug Review Delays and Increased Executive Oversight Expected

  After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with regulatory experts predicting delays in drug approvals and greater influence of political appointees.

  April 14, 2025

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  6 min read

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  Heather McKenzie
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  Government

  HHS Secretary Kennedy Accuses FDA Employees of Being Industry ‘Sock Puppet’

  Leerink analysts warned that Kennedy’s remarks to FDA staff would likely be a negative for the biotech industry.

  April 14, 2025

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Legal

  Vanda Sues FDA Again, This Time Over Off-Label Use of Hetlioz for Jet Lag

  Vanda is criticizing the FDA’s restrictions on information companies can provide regarding off-label use of approved medicines.

  April 14, 2025

   · 

  2 min read

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  Tristan Manalac
• 

  Weight loss

  Pfizer Drops Lead Obesity Asset After Liver Safety Concerns, Overall Review

  Pfizer’s discontinuation of danuglipron brings the company down to a single molecule in its obesity pipeline.

  April 14, 2025

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  2 min read

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  Tristan Manalac
• 

  Machine Learning

  Opinion: Smart Antibodies Will Transform Our Fight Against Solid Tumors

  AI is enabling the development of a next generation of drugs that can more precisely target cancer cells while sparing healthy tissues.

  April 14, 2025

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  4 min read

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  Gino Van Heeke