BioSpace News Archive

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  Immunology and inflammation

  Lupus Reveal Gives Investors a Peek at Biogen’s ‘Underappreciated’ Pipeline

  With two late-stage programs set to read out in the next 48 months, Biogen is translating its wealth of experience in multiple sclerosis to lupus—developing a pipeline BMO Capital Markets analysts called “thoughtful.”

  September 9, 2025

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  4 min read

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  Heather McKenzie
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  Manufacturing

  As Ori Wins Designation, FDA’s Advanced Manufacturing Program Nears Proof Point

  Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.

  September 9, 2025

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  5 min read

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  Nick Paul Taylor
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  Allergies

  Regeneron’s Antibodies Block Cat and Birch Allergies With ‘Robust Activity’

  Regeneron’s antibody duos significantly lowered eye itching and redness, as well as pin prick reactivity, in people with cat and birch allergies. Still, BMO Capital Markets expressed uncertainty about the assets’ “commercial potential in a highly generic market.”

  September 9, 2025

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  2 min read

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  Tristan Manalac
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  Lung cancer

  BMS, BioNTech Post Geographically Consistent Mid-Stage PD-L1/VEGF Data in SCLC

  Truist Securities called pumitamig’s data on Monday “very reassuring,” given the consistency between its performance in Chinese and global patient populations.

  September 9, 2025

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  2 min read

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  Tristan Manalac
• 

  Complete response letters

  FDA Turns Away Ultra-Rare Disease Therapy

  After receiving a complete response letter for its pyruvate dehydrogenase complex deficiency candidate, Saol Therapeutics anticipates it will need “several years” and “significant financial resources” to address the FDA’s concerns.

  September 9, 2025

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  2 min read

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  Tristan Manalac
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  Mergers & acquisitions

  Novartis Deals in Cardio Again, Dropping $1.4B To Acquire Tourmaline

  Novartis has been investing heavily in its cardiovascular pipeline this year, forging partnerships with Flagship startup ProFound Therapeutics and China’s Argo Biopharmaceutical, among others.

  September 9, 2025

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  2 min read

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  Tristan Manalac
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  Mergers & Acquisitions

  Novartis’ Busy BD Team Keeps 2025 Bolt-On Deal Promises

  Executives at Novartis have not been shy about a desire to buy more companies, with cardiovascular a big focus. In total, the Swiss pharma has put $17.23 billion on the line in M&A and licensing deals this year.

  September 9, 2025

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  2 min read

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  Annalee Armstrong
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  Government

  Second MAHA Report Emphasizes Chronic Disease, Tilts at Vaccine Reform

  In a livestreamed meeting Tuesday afternoon, Health Secretary Robert F. Kennedy Jr. drew a dark portrait of the state of America’s health while addressing the MAHA Commission’s most recent report, which includes plans to research potential links between vaccines and rising rates of chronic disease.

  September 9, 2025

   · 

  3 min read

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  Heather McKenzie
• Press Releases

  PhotonPharma Inc. Receives U.S. Patent for Innovative Cancer Immunotherapy

  September 9, 2025

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  3 min read
• Press Releases

  AMGEN AND KYOWA KIRIN ANNOUNCE TOP-LINE RESULTS FROM ROCATINLIMAB PHASE 3 ASCEND LONG-TERM EXTENSION STUDY IN ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

  September 9, 2025

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  15 min read