BioSpace News Archive

Amgen sign at its headquarters in Thousand Oaks, California, USA.

Approvals

Amgen Wins Expansion for Uplizna as First Drug for IgG4-Related Disease

In the Phase III MITIGATE trial, Uplizna cut IgG4-related disease flares by 87% versus placebo.

April 4, 2025

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2 min read

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Tristan Manalac

Creative photo poster picture collage collapsing dollar banknote arm holding cash money bankrupt decrease income funds loss.

Government

FDA Faces ‘Catastrophic Collapse’ as Massive Layoffs Endanger User Fee Program

The FDA derives just under half of its yearly funding from pharma user fees, which help support its operations and fund employee salaries. An analysis from AgencyIQ suggests that the agency is dangerously close to losing it all.

April 4, 2025

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3 min read

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Tristan Manalac

Accumulated problems, contradictions. Dead end, we need to go back. You cannot continue further. Complete impossibility to continue. Rejection of an idea. Hard sanctions. Fatal error.

Immunology and inflammation

Aldeyra Shares Crash as Dry Eye Drug Gets Second Rejection from FDA

The FDA has asked for another well-controlled trial to establish the efficacy of reproxalap in dry eye disease.

April 4, 2025

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2 min read

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Tristan Manalac

Duchenne muscular dystrophy

Committee Recommends EU Trials of Sarepta’s Elevidys Continue, Day After Holds

One day after the European Medicines Agency requested that three clinical trials of Elevidys be placed on hold after the death of a U.S. teenager, a data monitoring committee concluded that they should continue unchanged.

April 4, 2025

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2 min read

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Dan Samorodnitsky

Business bankruptcy assistance concept. businessman on a paper boat and rescues a drowning man vector

Gene therapy

Lilly Throws Sangamo a Lifeline With Pact Worth Potential $1.4B+

Sangamo, which has been having cash problems, will receive $18 million upfront in licensing fees for its AAV capsid that in preclinical studies has shown the ability to cross the blood-brain barrier.

April 4, 2025

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2 min read

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Tristan Manalac

Illustration of a group of businessmen white-collar workers dismissed

Layoffs

Spark Therapeutics Cuts 298 Employees as Part of Reorganization

Roche’s reorganization of Spark Therapeutics is coming more into focus, with nearly 300 employees being let go by the end of this year. Spark also trimmed its staff in 2024.

April 4, 2025

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1 min read

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Angela Gabriel

Huge leg kick throw upset businessman out of office. Giant foot fire dismiss unhappy man employee of work. Job dismissal concept. Flat vector illustration, cartoon character.

Editorial

FDA Gutted Under Trump, RFK Jr., With More Than Half of Senior Leadership Now Gone

While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers who have recently left the agency is unprecedented. The lack of communication, transparency and human decency is as well.

April 4, 2025

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7 min read

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Jef Akst

Press Releases

Intellia Therapeutics Announces First Patient Dosed in the MAGNITUDE-2 Phase 3 Study of Nexiguran Ziclumeran (nex-z), a One-Time Gene Editing-Based Treatment for Transthyretin (ATTR) Amyloidosis with Polyneuropathy

April 4, 2025

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7 min read

Press Releases

NeuroPace Announces Upcoming Oral Presentation of Data from the Long-Term Post-Approval Study of the RNS System at the 2025 AAN Annual Meeting