BioSpace News Archive

Drug Development

GSK’s RSV Vaccine Wins Adcomm Backing One Day after Pfizer

Wednesday, the FDA’s VRBPAC agreed that GSK’s respiratory syncytial virus vaccine candidate is safe and effective in older adults.

March 1, 2023
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2 min read
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Tristan Manalac
Drug Development

FDA Rejects Cytokinetics’ Heart Failure Drug, Requests Another Trial

Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a decision announced Tuesday evening.

March 1, 2023
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2 min read
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Tristan Manalac
Business

Novavax Warns Investors it May Not be Able to Continue Operations

Novavax expressed doubts about its ability to continue operations beyond this year in its Q4 and full year 2022 financial report issued Tuesday.

March 1, 2023
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2 min read
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Hayleigh Evans and Heather McKenzie
Drug Development

Keytruda Offsets Back-to-Back Flops with Phase III NSCLC Win

Phase III KEYNOTE-671 study data showed Merck’s Keytruda improved event-free survival, one of the trial’s primary endpoints, in patients with stage II, IIIA or IIIB non-small cell lung cancer.

March 1, 2023
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2 min read
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Tristan Manalac
Drug Development

Chroma Scores $135M for Epigenetic Editing Approach

Backed by Google Ventures, ARCH Venture Partners and more, Chroma Medicine announced the closing of a $135 million Series B financing Wednesday.

March 1, 2023
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2 min read
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Kate Goodwin
Drug Development

Sequana Medical announces positive results from CHIHUAHUA, Phase 1 clinical trial of second-generation DSR product for congestive heart failure

Sequana Medical NV announces positive results from its Phase 1 single-center, single-arm, single-dose trial with its second-generation DSR product.

March 1, 2023
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7 min read
Drug Development

Poxel Announces Publication in Kidney International of PXL770 Preclinical Results in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

POXEL SA announced the publication of preclinical results in autosomal dominant polycystic kidney disease for PXL770, a novel, first-in-class direct adenosine monophosphate-activated protein kinase activator.

March 1, 2023
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4 min read
Drug Development

GE HealthCare Announces Completion of Phase I Subject Recruitment in Early Clinical Development Program for a First-of-its-Kind Macrocyclic Manganese-Based MRI Contrast Agent

GE HealthCare has announced, at the European Congress of Radiology in Vienna, Austria, the completion of Phase I subject recruitment in its early clinical development program for a first-of-its-kind manganese-based macrocyclic magnetic resonance imaging contrast agent.

March 1, 2023
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4 min read
Business

Immunovia appoints Karl Stone as new chief operating officer to develop R&D and operations

Immunovia, the diagnostics company that has launched the world’s first blood-based test dedicated to the early detection of pancreatic cancer, announced the appointment of Karl Stone as Chief Operating Officer effective 1 March, 2023.

March 1, 2023
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3 min read
BioNxt Signs Clinical Study Agreement and Commences Manufacture of Clinical Samples for Study of Transdermal Rotigotine Patch for Parkinson’s Disease

BioNxt Solutions Inc. is pleased to report that it has executed an agreement to carry out its comparative drug absorption study for the Company’s transdermal Rotigotine patch for the treatment of Parkinson’s disease.

March 1, 2023
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4 min read