BioSpace News Archive

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ALS

New Wave of ALS Therapies Signals Renaissance After Incremental Regression

After a demoralizing period punctuated by the withdrawal of one of the few marketed therapies for ALS, investment in new biotechs, state-backed collaborative initiatives and buzz at BIO2025 suggest a new day in drug development for one of medicine’s most intractable diseases.

September 2, 2025

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6 min read

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Heather McKenzie

Set Test tube and flask Equation solution Astronomical observatory Radiation warning document Planet earth radiation and icon. Vector.

Radiopharmaceuticals

FDA’s New Radiopharma Guidance a Greenlight for an Accelerating Space

With a flurry of recent Big Pharma investment in radiopharmaceutical therapeutics, the FDA issued draft guidance last month in a move former FDA Commissioner Stephen Hahn sees as the regulator “trying to get ahead on a new set of therapy that they see becoming very important for cancer.”

September 2, 2025

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5 min read

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Dan Samorodnitsky

3d rendering of a plastic jar with medical pills on a hand truck on blue background. Medicine and health. Bottles and containers. Healthcare industry.

Manufacturing

Trump’s Push To Shore Up Pharma Supply Chain With US API Welcomed but Questioned

While trade groups hail the executive order as a national health security opportunity, analysts warn that production costs could go up in the near term.

September 2, 2025

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4 min read

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Nick Paul Taylor

Silver Spring, MD, USA 11/10/2020: Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medications, vaccines and food additives for human use.

Regulatory

Rare Diseases Secure Four FDA Firsts in August

Aside from the rare disease market, Novo Nordisk also scored a key regulatory win last month for its blockbuster GLP-1 drug Wegovy, which can now be used to treat patients with metabolic dysfunction-associated steatohepatitis.

September 2, 2025

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6 min read

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Tristan Manalac

Sep 17, 2020 Fremont / CA / USA - Novo Nordisk headquarters in Silicon Valley; Novo Nordisk A/S is a Danish multinational pharmaceutical company

Cardiovascular disease

Novo’s Wegovy Cuts Cardio Risk by 57% Versus Tirzepatide

Novo Nordisk’s Wegovy has been on a winning streak as of late, with a metabolic dysfunction-associated steatohepatitis approval last month and prime position in the oral obesity race.

September 2, 2025

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2 min read

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Tristan Manalac

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Approvals

Biogen, Eisai Win FDA Nod for Subcutaneous Maintenance Leqembi

While the approval of Leqembi Iqlik bodes well for Biogen and Eisai’s planned application for a subcutaneous induction regimen next year, its financial impact remains “uncertain,” as potentially higher revenues from the injection could be offset by steeper costs of production, according to Jefferies.

September 2, 2025

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2 min read

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Tristan Manalac

2D illustration of the gut with microorganisms

Inflammatory bowel disease

Roche Makes Preclinical IBD Play in $420M+ OMass Pact

The OMass partnership will boost Roche’s strategy in inflammatory bowel diseases, currently led by afimkibart, an anti-TL1A therapy the pharma obtained from its $7.1 billion acquisition of Telavant in 2023.

September 2, 2025

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2 min read

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Tristan Manalac

Illustration showing a handshake, signaling cooperation, goodwill

Deals

Arrowhead Nabs up to $2B Novartis Commitment for siRNA Parkinson’s Program

Novartis is licensing ARO-SNCA, a preclinical siRNA therapy for synucleinopathies, a group of neurodegenerative disorders including Parkinson’s disease.

September 2, 2025

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1 min read

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Annalee Armstrong

Exeternal view of the Servier's headquarters in France

Cancer

Servier Commits up to $530M Into Eye Cancer Deal With IDEAYA

The French giant is gaining access to darovasertib, a small molecule protein kinase C inhibitor already in Phase II/III trials, with rights for the whole world besides the U.S.

September 2, 2025

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2 min read

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Dan Samorodnitsky

Building a rocket. Halftone hands assemble a rocket shaped puzzle. Concept of a startup, new business. Hasty rocket launch. Innovation, teamwork, development of ideas and technologies

Deals

Vertex, Enlaza Declare War on Autoimmune Disease in Potential $2B+ Pact

Vertex Pharmaceuticals commits $45 million upfront to leverage Enlaza Therapeutics’ War-Lock platform to create drug conjugates and T cell engagers for autoimmune diseases and gentler conditioning for sickle cell/beta thalassemia gene-editing therapy Casgevy.

September 2, 2025

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2 min read

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Heather McKenzie