BioSpace News Archive

Finding the right balance in business. Art collage.

Regulatory

Summit’s Potential Keytruda Rival Gets November FDA Decision Date

The FDA is currently reviewing Summit’s PD-1/VEGF bispecific as part of a chemotherapy combo for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer.

January 30, 2026

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1 min read

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Tristan Manalac

Obesity

AstraZeneca’s China Trip Yields CSPC Obesity Deal Worth $1.2B Upfront

The pact, which could see AstraZeneca ultimately put out $18.5 billion in milestones and sales-based payments, is centered on SYH2082, a long-acting dual agonist of the GLP-1 and GIP receptors.

January 30, 2026

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2 min read

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Tristan Manalac

Cancer

FDA’s Multiple Myeloma Guidance Highlights Decade of Success

New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better treatments.

January 30, 2026

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4 min read

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Dan Samorodnitsky

UFO looking like White house abducting a man. Conspiracy theory, paranoia afunny concept.Vector illustration.

Rare diseases

Despite Wide Support for Rare Disease, Voucher Program Caught Up in Senate’s ICE Fight

The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.

January 30, 2026

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3 min read

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Annalee Armstrong

President Donald Trump signs S.1852, The GENIUS Act, Friday, July 18, 2025, in the East Room of the White House. (Official White House Photo by Daniel Torok)

Drug pricing

TrumpRx Delayed Amid Potential Anti-Kickback Concerns

In a Cabinet meeting, Health Secretary Robert F. Kennedy Jr. said the website could go live “probably in the next 10 days,” but an exact launch date remains unclear.

January 30, 2026

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2 min read

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Tristan Manalac

Pictured: A syringe broken in half with long hallway in background/Nicole Bean for BioSpace

Vaccines

Sanofi Moves Away From mRNA Flu Vaccine as CEO Projects Confidence

Despite Sanofi CEO Paul Hudson’s confidence in vaccines, the French pharma has cut at least one mRNA flu shot program.

January 30, 2026

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2 min read

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Tristan Manalac

Deals

Moderna Teams With Recordati on Rare Disease mRNA Therapy for up to $160M

Moderna will continue to lead clinical development and manufacturing of the asset, while Recordati will handle commercialization of mRNA-3927, which is under development for the rare metabolic disorder propionic acidemia.

January 30, 2026

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1 min read

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Annalee Armstrong

Press Releases

Elevar Therapeutics Names Dong-Gun Kim CEO as It Focuses on Post-NDA Commercialization Strategy

January 30, 2026

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2 min read

Press Releases

The Lancet Publishes TRICORDER Study: Real-World Evaluation Shows Increased Detection When Eko AI-Enabled Stethoscopes Are Used in Primary Care