BioSpace News Archive

Drug Development

Otsuka’s Centanafadine Shows Promise in Phase III Pediatric ADHD Studies

The Japanese pharma’s attention deficit/hyperactivity disorder candidate has shown significant symptom improvements in children and adolescents in two late-stage studies.

October 30, 2023
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2 min read
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Tristan Manalac
FDA

Coherus, Junshi Get FDA Approval for First Chinese PD-1 and NPC Treatment

Loqtorzi is the first programmed death receptor-1 from China to be approved by the U.S. regulator, and the first for patients with recurrent or metastatic nasopharyngeal carcinoma across all lines of treatment.

October 30, 2023
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3 min read
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Matt Olszewski
Business

Confidence and Caution as AI Predicts Drug Safety

More and more companies are turning to artificial intelligence for drug safety prediction, but as with any new application of AI, experts urge caution.

October 30, 2023
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6 min read
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Vijay Shankar Balakrishnan
Policy

FDA Flags Off-Target Effects of Vertex, CRISPR’s Sickle Cell Therapy Ahead of Adcomm

In a briefing document for Tuesday’s advisory committee meeting, the FDA raised concerns about the potential off-target effects of Vertex Pharmaceuticals and CRISPR Therapeutics’ investigational gene edited therapy.

October 30, 2023
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2 min read
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Tristan Manalac
Business

Sobi publishes Q3 2023 report: Strong revenue and solid performance

Swedish Orphan Biovitrum AB announced its report for the third quarter 2023.

October 30, 2023
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3 min read
Policy

Integrum’s OPRA™ Implant System gets FDA approval for clinical study on below-knee amputations

The clinical study will be important for the future approval of the OPRA™ Implant System on the below-knee amputation level, which is the most frequent amputation level.

October 30, 2023
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1 min read
Merck KGaA, Darmstadt, Germany, Strengthens Oncology Pipeline Through Strategic Partnership with Hengrui for Next-Generation Selective PARP1 Inhibitor and Antibody-Drug Conjugate

Merck KGaA, Darmstadt, Germany, a leading science and technology company, announced a strategic collaboration with Jiangsu Hengrui Pharmaceuticals Co. Ltd.

October 30, 2023
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5 min read
A New Hope for Epidermolysis Bullosa (“butterfly children”) Thanks to Novel CRISPR-Cas3 Platform

Healiva SA and C4U Corporation are pleased to announce that they have entered into a strategic alliance agreement regarding the development of CRISPR-Cas3 derived therapeutic solutions for Epidermolysis Bullosa, also known as “butterfly children”.

October 30, 2023
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3 min read
Deals

United Therapeutics to Acquire Miromatrix Medical

United Therapeutics Corporation and Miromatrix Medical Inc. announced a definitive agreement for United Therapeutics to acquire Miromatrix.

October 30, 2023
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9 min read
Biotech Beach

MannKind Expands Patent Portfolio With New Clofazimine Formulation Patent

MannKind Corporation announced a new patent issued by the United States Patent and Trademark Office covering clofazimine inhalation suspension, which is under development for the potential treatment of nontuberculous mycobacterial lung disease.

October 30, 2023
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3 min read