BioSpace News Archive

Business

InspireMD Announces Strategic Agreement with Jacobs Institute to Execute Early Feasibility Study of CGuard EPS for the Treatment of Acute Stroke Patients with Tandem Lesions

InspireMD Announces Strategic Agreement with Jacobs Institute to Execute Early Feasibility Study of CGuard EPS for the Treatment of Acute Stroke Patients with Tandem Lesions.

November 27, 2023
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6 min read
Drug Development

Neumora Therapeutics Announces NMRA-266 IND Clearance and Initiation of Phase 1 Clinical Study

Neumora Therapeutics, Inc. today announced the initiation of a Phase 1 single ascending dose / multiple ascending dose study evaluating NMRA-266 in healthy adult participants.

November 27, 2023
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6 min read
FDA

Genelux Corporation Receives FDA Fast Track Designation for Olvi-Vec in Platinum Resistant/Refractory Ovarian Cancer

Genelux Corporation today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for the development program of Olvi-Vec (olvimulogene nanivacirepvec) for the treatment of patients with platinum resistant/refractory ovarian cancer.

November 27, 2023
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3 min read
FDA

RedHill Biopharma Announces FDA Grant of 5-Year U.S. Market Exclusivity for Talicia® with IP Protection Running to 2034

RedHill Biopharma Ltd. (NASDAQ: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, announced that the U.S. FDA (U.S. Food and Drug Administration) has granted five years’ market exclusivity for Talicia.

November 27, 2023
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12 min read
Business

Bayer Commits to Veeva Vault CRM and Veeva OpenData Globally

Veeva Systems (NYSE: VEEV) today announced that Bayer will be among the first top 20 biopharmas to move to Veeva Vault CRM worldwide, while also standardizing global customer data with Veeva OpenData.

November 27, 2023
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3 min read
BioMidwest

Abeona Therapeutics Announces FDA Accepts and Grants Priority Review for Pz-cel Biologics License Application (BLA)

Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel).

November 27, 2023
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5 min read
Biotech Bay

Alterity Therapeutics Announces Presentation of Novel Biomarker Data for Evaluation of Multiple System Atrophy

Alterity Therapeutics today announced a poster presentation from the Company’s Biomarkers of progression in Multiple System Atrophy (bioMUSE) Natural History Study at the recent 34th International Symposium on the Autonomic Nervous System (AAS).

November 27, 2023
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7 min read
FDA

AWAK Technologies Announces FDA Breakthrough Device Designation for their Artificial Intelligence Enabled Kidney Disease Prediction Tool

AWAK Technologies today announced that its kidney disease progression prediction (KDPP) Artificial Intelligence (AI) model for CKD patient care has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).

November 27, 2023
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4 min read
Biotech Beach

Halozyme to Present at Upcoming Investor Conferences - November 27, 2023

Halozyme Therapeutics, Inc. (NASDAQ: HALO) (“Halozyme”) today announced that members of the senior leadership team are scheduled to present and host investor meetings at the following investor conferences.

November 27, 2023
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2 min read
Pharm Country

Seelos Therapeutics Announces the Selection of SLS-002 (intranasal racemic ketamine) for Inclusion in the U.S. Department of Defense’s Adaptive Platform Trial to Evaluate Potential Treatments for Post-Traumatic Stress Disorder (PTSD)

Seelos Therapeutics, Inc. today announced that SLS-002 (intranasal racemic ketamine) has been selected for inclusion in an adaptive platform trial to evaluate treatments for post-traumatic stress disorder (PTSD) in active-duty service members and veterans.

November 27, 2023
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8 min read