BioSpace News Archive

Policy

Opinion: Space Is the Next Frontier in Drug Discovery

Microgravity offers unique advantages when investigating cells and proteins, but collaboration and a strong ethical framework are needed to fully realize its benefits.

December 21, 2023
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7 min read
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Deepika Khedekar
FDA

Calliditas Therapeutics Nabs Full FDA Approval for IgAN Therapy Tarpeyo

The oral formulation of budesonide, marketed as Tarpeyo, is the only FDA-approved therapy that significantly reduces the loss of kidney function in immunoglobulin A nephropathy patients.

December 21, 2023
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2 min read
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Tristan Manalac
Policy

FDA Denies Accelerated Approval for Clene’s ALS Candidate

Clene disclosed Thursday the FDA has determined that biomarker Neurofilament Light Chain reduction in its Phase II programs “were insufficient to support accelerated approval at this time.”

December 21, 2023
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2 min read
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Kate Goodwin
Policy

Merck’s Chronic Cough Drug Fails to Secure FDA Approval for Second Time

The regulator’s Complete Response Letter on Wednesday said Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness.” The FDA also rejected the drug in 2022 due to a lack of efficacy evidence.

December 21, 2023
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2 min read
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Tristan Manalac
Drug Development

Sanofi Axes Lung Cancer ADC After Phase III Trial Failure

The company is ending its program evaluating antibody-drug conjugate tusamitamab ravtansine after a non-small cell lung cancer trial did not meet a primary endpoint.

December 21, 2023
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2 min read
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Tyler Patchen
Business

RetinalGeniX Technologies Inc. Appoints Anatoly Dritschilo, M.D. to the Company’s Medical Advisory Board

RetinalGeniX Technologies Inc., announced that Anatoly Dritschilo, M.D. has joined the Company’s Medical Advisory Board.

December 21, 2023
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5 min read
invIOs to attend JP Morgan Week in San Francisco in January 2024

invIOs GmbH, a privately held biotechnology company developing novel therapies for cancer, will be participating in JP Morgan week activities in San Francisco, January 8-11, 2024.

December 21, 2023
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1 min read
Genetown

BeiGene to Present at the 42nd Annual J.P. Morgan Healthcare Conference

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the Company will participate in the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8th, 2024 with a presentation at 1:30 pm PT.

December 21, 2023
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2 min read
Lone Star Bio

Orthofix Announces Publication of New Data Supporting Use of PEMF Stimulation in Lumbar Spine Fusion Procedures for Patients at Risk of Pseudarthrosis

Orthofix Medical Inc. (NASDAQ:OFIX) today announced the publication of new data from a prospective, multicenter study investigating Pulsed Electromagnetic Field (PEMF) stimulation as an adjunct therapy to lumbar spinal fusion procedures in patients at risk for pseudarthrosis.

December 21, 2023
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5 min read
Business

Exscientia Announces Expansion of its Current Collaboration with Sanofi to Include Existing Exscientia Programme

Exscientia plc announced that Sanofi is adding a new discovery stage programme identified and initially advanced by Exscientia into the current collaboration.

December 21, 2023
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3 min read