BioSpace News Archive

Dennis Sponer serves as fractional general counsel and advisor to several healthcare companies and VC firms through his consultancy, SRX Advisors.

Poznan, Poland - 5 October 2024: GSK -Glaxosmithkline headquarters office building in Poznan.

Immunology and inflammation

GSK Wins COPD Expansion for Nucala After FDA Delay

The approval tees GSK up to challenge Sanofi and Regeneron, which in September 2024 won the first biologic approval for COPD for their blockbuster antibody Dupixent.

May 23, 2025

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1 min read

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Tristan Manalac

Robert F Kennedy Jr speaking at the White House

Government

Court Halts HHS’ Reduction and Layoff Plans, Arguing a Lack of Authority

In an opinion issued late Thursday night, U.S. District Judge Susan Illston wrote that the president and department agency heads do not have the authority to reorganize the government without Congress’ input.

May 23, 2025

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2 min read

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Dan Samorodnitsky

Syringe resting on top of a vaccine vial, with more vaccine bottles in the background

Vaccines

FDA Vaccine Advisors Agree on COVID-19 Vaccine as New Framework Looms as ‘Elephant in the Room’

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

May 23, 2025

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2 min read

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Tristan Manalac

Government

Changes to IRA Pill Penalty Conspicuously Absent as Congress Narrowly Passes Trump’s Tax Bill

The “One Big Beautiful Bill Act” includes negotiation exemptions for orphan drugs approved to treat more than one rare disease and has implications for PBMs. Also on Thursday, the White House released its MAHA report with a mission to “make our children healthy again.”

May 23, 2025

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2 min read

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Tristan Manalac

A contemporary artistic collage featuring a hand holding a trophy. The concept of victory and achievement.

Cancer

Merus’ Bispecific Shows ‘Best in Disease’ Profile in Head-and-Neck Cancer Ahead of ASCO

Analysts were effusive about Merus’ new HNSCC data, writing that petosemtamab could “become the standard of care” in the first-line setting for this indication.

May 23, 2025

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2 min read

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Tristan Manalac

USA Flag formed by COVID-19 vaccine and blood test vials, 2019 pandemic United States of America, concept patriotic fighting coronavirus response, 3d illustration

FDA

‘Make American Healthy Again’ Report Takes Aim at Pharma Lobbying, GLP-1s and Vaccines

The report takes from HHS Secretary Robert F. Kennedy Jr’s playbook, calling out rising autism rates, the vaccine schedule and over medication of children as reasons for chronic diseases.

May 23, 2025

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4 min read

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Annalee Armstrong

Press Releases

Tevogen to Update on Robust Portfolio Assets, Business Expansion, Partnerships, Limited Tradable Float, High Insider Ownership and Strong Investor Confidence Ahead of June 23 Annual Meeting

May 23, 2025

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4 min read

Press Releases

Arcutis’ ZORYVE® (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older