BioSpace News Archive

Mechanical weight scale, body mass control concept : Bathroom scale on pale blue wood background. Analog scale operated with spring that pressure is calibrated to translate tension into a mass readout.

Obesity

Metsera Touts ‘Powerful’ Weight Loss Results—Again

Months after posting weight loss of 7.5% at 36 days for patients taking MET-097i, Metsera releases mid-stage results of just over 11% average body weight reduction at 12 weeks, with no plateau and a promising safety profile.

January 7, 2025

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2 min read

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Tristan Manalac

Group Of Employees Being Fired By Their Company.

Layoffs

CytomX to Cut 40% of Staff as It Updates Pipeline Priorities

CytomX’s workforce cuts could leave the biotech with fewer than 75 employees as it focuses resources on its wholly owned clinical-stage programs, most notably an antibody-drug conjugate for advanced metastatic colorectal cancer.

January 7, 2025

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1 min read

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Angela Gabriel

Double exposure of abstract virtual creative light bulb hologram with human brain on Chinese flag and blue sky background, idea and brainstorming concept

China

Big Pharma Rushes to China for Deal Prospecting Despite Regulatory Uncertainty

China is adapting its Life Sciences policy to bolster innovation and data transparency. Big Pharma is taking note.

January 7, 2025

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6 min read

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Annalee Armstrong

FDA signage at its headquarters in Maryland

Artificial intelligence

FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement

The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information regarding models’ development and maintenance.

January 7, 2025

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2 min read

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Tristan Manalac

ALS

Denali Suffers Another ALS Fail With Phase II/III Flop

Denali’s failure on Monday continues biopharma’s losing streak against amyotrophic lateral sclerosis. PTC Therapeutics and Amylyx have seen similarly disappointing results.

January 7, 2025

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2 min read

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Tristan Manalac

NextGen

BioSpace’s NextGen Class of 2025 Leans Into Biopharma’s Hottest Trends

From ADCs and radiopharmaceuticals to cell and gene therapies, eager young startups are betting on advances in biopharma’s most competitive therapeutic spaces—and attracting dollars from Big Pharma.

January 7, 2025

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5 min read

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Heather McKenzie

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FDA

When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance

Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for confirmatory trials for therapies seeking the shortened path to market.

January 7, 2025

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3 min read

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Heather McKenzie

Press Releases

Orca Bio to Present at the 43rd Annual J.P. Morgan Healthcare Conference

January 7, 2025

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1 min read

Press Releases

LivaNova Appoints Natalia Kozmina as Chief Human Resources Officer