BioSpace News Archive

Business

Cell Therapy Startup Tr1X Emerges from Stealth with $75M Series A

The San Diego-based startup, specializing in allogeneic engineered Treg and CAR-Treg cell therapies, plans to be in Phase I clinical trials in multiple indications in 2024.

January 18, 2024
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2 min read
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Tyler Patchen
Deals

CDMO Bora Pharmaceuticals Buys Generics Manufacturer Upsher-Smith for $210M

Taiwanese contract development and manufacturing organization Bora will purchase Minnesota-based Upsher-Smith Laboratories, expanding operations into the U.S. for the first time.

January 18, 2024
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2 min read
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Tyler Patchen
Business

Bayer Rolls Out New Operating Model, Eliminates Managerial Staff

The sweeping changes are meant to “reduce hierarchies” and “accelerate decision-making” as Bayer weathers several business crises and continues to suffer from the fallout of its disastrous Monsanto acquisition.

January 18, 2024
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2 min read
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Tristan Manalac
Policy

Global Regulators Increase CAR T Scrutiny in Wake of FDA’s Investigation

Regulatory authorities worldwide are tightening their monitoring mechanisms and launching their own investigations after reports of secondary malignancies potentially linked to chimeric antigen receptor T cell therapies.

January 18, 2024
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5 min read
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Patience Asanga
Policy

Satsuma Fails to Secure FDA Approval for Nasal Powder Migraine Drug

The FDA’s Complete Response Letter identified problems with the drug candidate’s chemistry, manufacturing and controls, parent company Shin Nippon Biomedical Laboratories announced Thursday.

January 18, 2024
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2 min read
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Tristan Manalac
Policy

FDA’s Marks Advocates for Flexibility in Rare Disease Gene Therapy Trials

CBER Director Peter Marks recently spoke in favor of single-arm trials in certain situations, but clinicians and ethicists say there are several variables to consider.

January 18, 2024
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6 min read
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Heather McKenzie
AbbVie’s Humira Maintains Market Dominance Amid Biosimilar Launches: Report

Despite offering discounts that reach as high as 85%, Humira biosimilars are finding it difficult to take market share away from the AbbVie blockbuster, according to a new report from Samsung Bioepis.

January 18, 2024
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3 min read
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Tristan Manalac
Drug Development

Novartis Ends Phase III Peanut Allergy Trial in Another Flop for Potential Xolair Successor

The Swiss pharma’s Phase III trial of ligelizumab in patients with peanut allergies has been terminated, according to a ClinicalTrials.gov update on Tuesday.

January 18, 2024
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1 min read
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Kate Goodwin
Deals

CG Oncology Sets IPO Target, Looks to Raise Up to $209M

The bladder cancer-focused biotech is looking to be one of the first companies out of the gate with an initial public offering in 2024.

January 18, 2024
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2 min read
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Tyler Patchen
Policy

argenx Announces Approval of VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Japan for Generalized Myasthenia Gravis

argenx SE announced that Japan’s Ministry of Health, Labour and Welfare approved VYVDURA® injection for subcutaneous use for the treatment of adult patients with generalized myasthenia gravis, who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies.

January 18, 2024
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3 min read