BioSpace News Archive

Business

AstraZeneca, Ionis Drop Hypercholesterolemia Candidate Despite Positive Mid-Stage Data

AstraZeneca has decided to drop the hypercholesterolemia candidate AZD8233 through to Phase III, despite meeting its Phase IIb primary efficacy endpoint, its partner Ionis announced Friday.

September 23, 2022
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2 min read
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Tristan Manalac
FDA

FDA Review: ClearPoint Neuro, Oncopeptides, Iterative Scopes and More

The U.S. FDA had a busy week with a range of drug approvals, advisory committee meetings and classification announcements.

September 23, 2022
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3 min read
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Mark Terry
Drug Development

Oncopeptides CEO: ODAC Meeting “Unexpectedly Contentious” in Cancer Drug Rejection

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-2 against Oncopeptides’ Pepaxto, a drug that has been on the market since 2021 for multiple myeloma under accelerated approval.

September 23, 2022
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4 min read
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Mark Terry
Policy

Patent Proceedings: Merck’s Favorable Result and Amgen’s Supreme Court Case

Merck announced positive results on its patent infringement case against Viatris, while Amgen faces political headwinds from the White House.

September 23, 2022
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3 min read
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Mark Terry
Drug Development

Cell Death Research could Hold Potential in Alzheimer’s Treatment

Recently published research into repairing nerve damage caused by injury may also pay off in treating some of the most vexing neurodegenerative diseases like Alzheimer’s.

September 23, 2022
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2 min read
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Paul Elias
Drug Development

Biogen Strives for Tofersen Approval in ALS Based on Neurofilament Biomarker

One-year data indicates Biogen’s tofersen for SOD1-ALS, slows the decline of the disease through the lowering of SOD1 protein and neurofilament levels.

September 23, 2022
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3 min read
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Alex Keown
Drug Development

Research Roundup: Regenerative Potential, Long COVID Insights, Immuno-Oncology and More

This week, researchers delivered insights and breakthroughs in regenerative medicine, Long COVID, immuno-oncology and inflammatory diseases.

September 23, 2022
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4 min read
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Katherine Davis
Policy

ODAC Hones in on Secura’s P13K Inhibitor in Next Vote

The FDA will meet Friday to discuss the future of Secura Bio’s Copiktra (duvelisib), which has been approved as a third-line treatment for relapsed or refractory CLL/SLL.

September 23, 2022
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3 min read
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Alex Keown
Drug Development

At Inflection Point, NovoCure Expands Glioblastoma Portfolio in US

NovoCure announced the launching of a U.S.-based arm to focus on and attempt to grow its glioblastoma (GBM) business and increase its patient population.

September 23, 2022
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2 min read
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Paul Elias
Drug Development

Innate Pharma Presents Data From Ongoing Phase 2 TELLOMAK Trial Demonstrating Clinical Activity of Lacutamab in Advanced Mycosis Fungoides

Regulatory News: Innate Pharma SA announced that lacutamab, an anti-KIR3DL2 antibody, demonstrated clinical responses in patients with mycosis fungoides, in the ongoing Phase 2 TELLOMAK clinical trial.

September 23, 2022
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8 min read