BioSpace News Archive

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• 

  Business

  Genentech Shutters Cancer Immunology Group Amid Wider R&D Reprioritization

  The unit’s closure comes as Genentech’s parent Roche rethinks its cancer business, an effort that has included the discontinuation of three early-stage candidates and a T-cell partnership with Adaptimmune.

  August 19, 2024

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  2 min read

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  Tristan Manalac
• 

  FDA

  FDA Lifts Partial Hold on BioNTech, MediLink’s ADC Cancer Trial

  In June, the regulator placed a partial clinical hold on a Phase I trial of the companies’ antibody-drug conjugate after three patient deaths were reported.

  August 19, 2024

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  2 min read

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  Tyler Patchen
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  Gene Therapy

  Gene Therapies Break Through Against Genetic Hearing Loss in Children

  Regeneron, Akouos and Mass Eye and Ear are testing therapies that can reverse genetic protein deficiency to restore hearing, with promising early results.

  August 19, 2024

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  5 min read

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  Jill Drachenberg
• 

  Psychedelics

  FDA’s Lykos Rejection Delays—But Doesn’t Stop—Psychedelic Therapies

  Psychedelic drug developers are undeterred by the FDA’s Complete Response Letter for the company’s MDMA therapy for PTSD, and experts expect Lykos will ultimately obtain approval.

  August 19, 2024

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  5 min read

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  Heather McKenzie
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  Infectious disease

  Bavarian Nordic Accelerates Mpox Vaccine Production to Respond to Global Emergency

  The Danish company on Saturday announced plans to increase production of its vaccine Jynneos on the heels of the World Health Organization last week declaring mpox a global health emergency.

  August 19, 2024

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  2 min read

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  Tristan Manalac
• 

  Drug Development

  ATTR-CM Space Heats Up as RNA Therapies Show Promise

  The entry of new players and new approaches into the ATTR-CM space could help bring down the cost of treatment, experts say.

  August 19, 2024

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  5 min read

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  Aayushi Pratap
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  Leadership

  Leadership Lab: 5 Steps for Building Your Personal Brand

  By building and nurturing a strong personal brand, you can benefit in multiple ways, including enhancing your credibility, attracting opportunities and inspiring investor confidence.

  August 19, 2024

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  5 min read

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  Michael Pietrack
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  Infectious disease

  Mid-Stage Study Finds Only Mpox Drug Ineffective Against Current Outbreak

  SIGA Technologies’ TPOXX did not outperform placebo at resolving lesions in patients with clade I mpox, the new strain that has spread through parts of Africa and is reaching beyond the continent.

  August 19, 2024

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  2 min read

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  Tristan Manalac
• 

  Regulatory

  Liquidia Misses Full Approval for Pulmonary Hypertension Drug as Competitor Retains Market Exclusivity

  The FDA on Monday only granted Liquidia’s Yutrepia tentative approval, keeping it off the U.S. market until after rival United Therapeutics’ exclusivity expires in May 2025.

  August 19, 2024

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  2 min read

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  Tristan Manalac
• Business

  Stryker to participate in the 2024 Wells Fargo Healthcare Conference

  August 19, 2024

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  1 min read