BioSpace News Archive

Shawna Williams

Shawna Williams is a contract editor at BioSpace. She can be reached at shawna.williams@biospace.com or on LinkedIn. Learn more about her work at shawnawilliams.com.
FDA

Tris Pharma Gets FDA Approval for Non-Stimulant ADHD Medication

Tris Pharma on Wednesday secured the FDA’s green light for Onyda XR, the first liquid non-stimulant nighttime treatment for attention deficit hyperactivity disorder in pediatric patients.

May 30, 2024
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1 min read
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Tristan Manalac
FDA

FDA Action Alert: Lykos, GSK, BMS and More

In the next two weeks, the FDA is scheduled to decide on four drug applications and hold two highly anticipated advisory committee meetings.

May 30, 2024
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6 min read
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Tristan Manalac
Drug Development

Biohaven’s Phase I Data for Lead Protein Degrader Disappoints Investors

Despite Biohaven’s bispecific protein degrader cutting autoantibody IgG levels by up to 37% in an early-stage study, investors saw it as “below the high bar” of 60%, according to William Blair analysts.

May 30, 2024
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2 min read
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Tristan Manalac
Business

BioNTech Secures $145M to Boost mRNA Vaccine Capabilities in Africa

As BioNTech struggles to establish its footing in a post-pandemic world, the biotech has secured $145 million from the Coalition for Epidemic Preparedness Innovations to expand its mRNA operations in Rwanda.

May 30, 2024
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2 min read
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Tristan Manalac
Drug Development

BridgeBio Builds on Positive Phase III Data for Acoramidis in ATTR-CM

Additional analyses from BridgeBio Pharma’s late-stage study show the oral drug candidate improved clinical outcomes in transthyretin amyloid cardiomyopathy patients.

May 30, 2024
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2 min read
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Tristan Manalac
Drug Development

Opinion: GenAI Is Not a One-Size-Fits-All Solution for Regulatory Operations

Tempting as it may be to turn to full automation to meet burdensome requirements, the potential for hallucination and other issues means biopharma companies must proceed with caution.

May 30, 2024
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6 min read
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Mike King
Drug Development

Immunovant Shifts Focus to Other FcRn Inhibitor, Gives Rival Vyvgart Breathing Room

The Roivant spinout is shifting its attention away from batoclimab to anti-FcRn candidate IMVT-1402, which will target autoimmune disorders, while allowing argenx’s Myasthenia Gravis drug Vyvgart to maintain its lead position for now.

May 30, 2024
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2 min read
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Tyler Patchen
Drug Development

ASCO24 Preview: A Look at Some of the Cancer Meeting’s Hottest Abstracts

The American Society of Clinical Oncology annual meeting kicks off today in Chicago, with highly anticipated presentations that include reports on a bispecific antibody, an ADC and a BCMA-targeted CAR-T cell therapy.

May 30, 2024
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3 min read
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Mollie Barnes
BioMidwest

Neogen® to Participate in the 44th Annual William Blair Growth Stock Conference

Neogen announced today that the Company will participate in the 44th Annual William Blair Growth Stock Conference in Chicago, Illinois, on Tuesday, June 4, 2024.

May 30, 2024
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1 min read