BioSpace News Archive

Hand turns dice and changes the expression 'know the rules'. to 'follow the rules'.

Insights

New UK/EU Rules and AI Adoption Define CRO Priorities for 2026

With new UK clinical trial rules landing in 2026, the EU Biotech Act on the horizon and China and Australia gaining ground, CROs are zeroing in on study timelines, AI/ML and data privacy as the industry’s next pressure points.

December 3, 2025

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4 min read

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Jennifer C. Smith-Parker

surreal book concept pages flying out of book

Editorial

Pazdur’s Sudden Exit Leaves Just Three Veterans in FDA’s Senior Ranks

Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.

December 3, 2025

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4 min read

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Jef Akst

Business

Top 5 VC Raises by Women-Founded Biopharmas

Venture capital flow to women-founded companies has stabilized in the post-pandemic environment. BioSpace looks back at five companies that have nabbed the most over the past two decades.

December 3, 2025

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6 min read

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Annalee Armstrong

Tariff Trade Disaster and drowning with economic tariffs and market crash anxiety with government taxation or duties imposed on imports and exports on imported or exported goods as Protectionism.

Opinion

Even Early Stage Biotechs Can’t Ignore Tariffs

Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.

December 3, 2025

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4 min read

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Josh Medow

Podcast

Prasad’s Leaked FDA Memo, Alzheimer’s Ups and Downs, Next-Gen Obesity Drugs

Experts unpack the implications of CBER Director Vinay Prasad’s claim that COVID vaccines have caused 10+ child deaths; the 2025 Clinical Trials on Alzheimer’s Disease conference continues following two disappointing readouts; and Novo Nordisk’s amycretin yields promising weight loss results.

December 3, 2025

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1 min read

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Heather McKenzie

FDA signage at its headquarters in Maryland

Regulatory

FDA Moves to Cut Back on Testing Antibodies on Primates

For certain monospecific antibodies, three-month toxicology studies plus other supportive evidence will suffice, eliminating the need for six-month testing.

December 3, 2025

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2 min read

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Tristan Manalac

Mental health, illness ,brain development ,medical treatment concept, messy lines of thinks in human head , vector illustration

Neuroscience

Harmony’s Dravet Drug Halves Monthly Seizures in Late-Stage Study

The Phase III, open-label extension study suggests EPX-100 has a “positive” risk/benefit profile for the treatment of Dravet syndrome, analysts at H.C. Wainwright & Co. said Tuesday.

December 3, 2025

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2 min read

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Tristan Manalac

Pictured: Bristol Myers Squibb office in California

Alzheimer’s disease

BMS Delays Cobenfy Alzheimer’s Psychosis Data After ‘Irregularities’ in Phase III Study

Analysts had noted “unease” from investors regarding the state of the Phase III ADEPT-2 trial, with BMS at one point telling Leerink Partners that the reopening of enrollment would be a “significant development.”

December 3, 2025

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2 min read

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Tristan Manalac

Aircrafts landing and taking off at airport by night - vector illustration

Venture capital

Lilly, Novo GLP-1 Pricing Plans Clear Runway for Future Competitors

While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.

December 3, 2025

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2 min read

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Annalee Armstrong

Duchenne muscular dystrophy

Capricor Heads Back to FDA With Pivotal Results for DMD Cardiomyopathy Therapy

Six months after receiving a surprise rejection due to what the FDA called “lack of substantial evidence of effectiveness,” Capricor’s cell therapy deramiocel showed significant benefits in upper-limb function and slowed decline in cardiac function in a Phase III trial.

December 3, 2025

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3 min read

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Heather McKenzie