BioSpace News Archive

A scientist with pill bottles in front of FDA headquarters

Regulatory

FDA Action Alert: Sanofi/Regeneron, Merck, REGENXBIO and More

In what is shaping up to be a back-loaded month, the FDA is set to release a slew of regulatory decisions in February, including two that would expand the labels of blockbuster drugs.

February 2, 2026

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7 min read

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Tristan Manalac

China

Clinical Trials Are Increasingly Going Global—With China a Main Beneficiary

AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.

February 2, 2026

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8 min read

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Annalee Armstrong

Drug Pricing

Opinion: Pricing Transparency Is Coming to the Pharma Industry

Opening up about drug pricing decisions is not optional for biopharma anymore. For the sake of credibility, companies should embrace it.

February 2, 2026

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5 min read

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Joshua R. Mansbach

Pictured: Amgen's office in Tampa, Florida

Autoimmune disease

Amgen Ends Autoimmune Alliance With Kyowa Kirin Amid Safety, Efficacy Questions

A Phase III readout in September 2024 for rocatinlimab, on which Amgen and Kyowa Kirin were collaborating in atopic dermatitis, appeared underwhelming to analysts, with Jefferies noting that the data “came in at the lower end of efficacy and expectations.”

February 2, 2026

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2 min read

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Tristan Manalac

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS).

Manufacturing

FDA Launches PreCheck Program, Intended To Bring Manufacturers Home

The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the design of their facilities.

February 2, 2026

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2 min read

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Tristan Manalac

Sanofi's Distribution Center in Quebec, Canada

Rare disease

Sanofi Rare Disease Drug Scores a Hit and a Miss in Phase III Tests

Sanofi will take venglustat to regulators for Gaucher disease but an application for Fabry disease is less clear after the failure of a Phase III trial.

February 2, 2026

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1 min read

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Annalee Armstrong

Drug or medicine dose adjustment. Dose regulation and overdose. Titration of medicine dosage. Overmedication and prescribed dose. Drug rejection.

Complete response letters

FDA Warned Corcept of ‘Significant Review Issues’ for Rejected Drug in Early Meetings

Corcept’s relacorilant was rejected for hypercortisolism late last year—a decision which CEO Joseph Belanoff expressed surprise with at the time.

February 2, 2026

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1 min read

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Tristan Manalac

Welcome to Pennsylvania sign at the Pennsylvania/New York state line along Interstate 90.

Manufacturing

Eli Lilly Commits $3.5B To Build Injectable Obesity Drug Plant in PA

The facility, which is part of Lilly’s $50 billion reshoring drive, will make obesity drugs such as tirzepatide and retatrutide when it starts operations in 2031.

February 2, 2026

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2 min read

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Nick Paul Taylor

Creative concept of Left and right brain illustration with colorful on right side isolated on dark background

Psychedelics

Psychedelics Space at a ‘Tipping Point’ as Compass, Definium Gear Up To File for Approval

With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”

February 2, 2026

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7 min read

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Heather McKenzie

This 3D rendering encapsulates the concept of a winning strategy in business, emphasizing productivity, innovation, and the importance of female leadership. The imagery represents the synergy of teamwork, where diverse ideas and collaborative efforts drive success and growth. It highlights the critical role of women in leadership positions, showcasing their contributions to strategic planning and innovation. This visual serves as an inspiring representation of how inclusive leadership and innovative thinking can propel a business toward achieving its goals and maintaining a competitive edge in the market.

Wave To Work Alone on RNA Editor as AATD Picture Becomes Clearer

After GSK’s return of Wave Life Sciences’ WVE-006 as well as the mid-stage failure of Korro Bio’s candidate, the alpha-1 antitrypsin deficiency landscape is coming into focus, with Wave and Beam Therapeutics leading the way.

February 2, 2026

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3 min read

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Heather McKenzie