BioSpace News Archive

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People

Lykos CEO to Resign After FDA Rejection of MDMA Therapy, Layoffs

Amy Emerson is stepping down on the heels of the FDA last month rejecting Lykos Therapeutics’ MDMA-based therapy for post-traumatic stress disorder and the company laying off three-quarters of its staff.

September 6, 2024

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2 min read

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Tristan Manalac

Pharmacy benefit managers

Cigna Continues Biosimilar Push, Targets J&J’s Stelara With No Out-of-Pocket Cost

Thursday’s announcement comes after the insurance giant last week said it would remove AbbVie’s Humira from its major formularies starting in 2025, replacing the blockbuster with more affordable biosimilars.

September 6, 2024

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2 min read

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Tristan Manalac

Neuron colorful watercolor vector illustration

Editorial

Roche and Sanofi MS Trials Show Potential, Challenges of Oral BTK Inhibitors

Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies.

September 6, 2024

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3 min read

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Greg Slabodkin

Pictured: FDA signage at its office in Washington, DC

Approvals

Travere Wins Full FDA Approval for IgAN Treatment Filspari

With the regulator’s traditional green light in IgA nephropathy, Filspari is up against Novartis’ Fabhalta—which won accelerated approval last month—and Calliditas’ Tarpeyo, which was approved in December 2023.

September 6, 2024

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2 min read

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Tristan Manalac

Immunology and inflammation

GSK Builds Nucala’s COPD Case With Phase III Win

If approved in chronic obstructive pulmonary disease, Nucala will compete with Verona’s Ohtuvayre and—pending a potential approval later this month—Sanofi and Regeneron’s blockbuster Dupixent.

September 6, 2024

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2 min read

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Tristan Manalac

Astellas Life Sciences Center in Cambridge, Mass.

Business

Astellas Pharma Opens Cambridge Life Sciences Center Featuring Incubator Space

Astellas Pharma’s new life sciences center houses its first U.S.-based SakuLab, an incubator space for external partners, as well as its engineered small molecules unit.

September 6, 2024

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1 min read

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Angela Gabriel

Business

Aptose Announces Results from Special Meeting of Shareholders

September 6, 2024

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2 min read

Press Releases

Sciwind Biosciences Announces Oral Presentations at the European Association for the Study of Diabetes 60th Annual Meeting (EASD 2024)