BioSpace News Archive

A scientist with pill bottles in front of FDA headquarters

Regulatory

FDA Action Alert: Argenx, AstraZeneca/Daiichi Sankyo, Biogen/Eisai and Cingulate

The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for Alzheimer’s disease.

May 4, 2026

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4 min read

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Tristan Manalac

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Obesity

Obesity ends oncology’s long reign as top contributor to biopharma pipeline value

In its latest biopharma pipeline report, Deloitte warned that the growing importance of a small pool of potential mega-blockbusters raises the risk of “significant value destruction from a single program failure.”

May 4, 2026

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2 min read

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Nick Paul Taylor

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Mergers & acquisitions

UCB captures Candid in $2.2B autoimmune deal as pharma’s M&A train chugs along

Candid Therapeutics follows closely behind Neurona Therapeutics, which UCB acquired in mid-April in a potential $1.15 billion deal.

May 4, 2026

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2 min read

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Tristan Manalac

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Approvals

FDA clears Pfizer, Arvinas’ novel breast cancer therapy despite mixed data

Veppanu, the first PROTAC therapy approved by the FDA, improved progression free survival by 43% versus AstraZeneca’s Faslodex but showed no such significant benefit in the intention-to-treat analysis.

May 4, 2026

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2 min read

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Tristan Manalac

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Lung cancer

Summit shares descend as PD-1/VEGF asset misses early survival mark

Summit Therapeutics planned an early interim progression-free survival readout for HARMONi-3 in the hope of enabling earlier regulatory engagement—but the early analysis delivered disappointment for the company and shareholders.

May 4, 2026

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2 min read

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Tristan Manalac

Adcomms

First FDA ODAC meeting without Pazdur highlights conceptual challenges with trial

The advisory committee meeting—the FDA’s first drug-related adcomm in nine months—could have been a “more conceptual discussion” about the design of AstraZeneca’s Phase 3 trial of camizestrant in HER2-negative advanced breast cancer, former cancer regulator Harpreet Singh told BioSpace.

May 4, 2026

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9 min read

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Tristan Manalac

pharmaceutical industry, medicine pills are filling in the bottle on production line machine conveyor at the medical factory. selective focus.

Manufacturing

PCI adds US sterile fill/finish capabilities through $1B global expansion drive

Amid disruption to the outsourced fill/finish market, PCI is investing $100 million to more than double the capacity to fill ready-to-use prefilled syringes and cartridges at its San Diego campus.

May 4, 2026

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2 min read

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Nick Paul Taylor

Layoffs

Passage cuts 75% of workforce after FDA trial design request

Passage Bio, which has been working toward a registrational trial for a drug candidate whose indications include frontotemporal dementia, is exploring strategic alternatives in addition to cutting staff.

May 4, 2026

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1 min read

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Angela Gabriel

Opinion

Gene therapy’s evidence problem—lessons from recent FDA decisions

Comprehending the spate of recent rejections in the cell and gene therapy space may require looking no further than early-stage clinical trials of candidates from REGENXBIO, Excision BioTherapeutics and Intellia Therapeutics.

May 4, 2026

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6 min read

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Jenna DiRito

Press Releases

Agendia to Present New FLEX Study Data at ASBrS 2026 Confirming the Consistent Performance of MammaPrint + BluePrint Across Diverse Racial Groups in Genomically Basal-Type Breast Cancer

May 4, 2026

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4 min read