BioSpace News Archive

FDA

Krystal Gets First FDA Approval for Redosable Gene Therapy, Rare Skin Disease

The topical treatment Vyjuvek got the FDA’s greenlight, making it the first redosable gene therapy and the first therapeutic for the rare skin disease dystrophic epidermolysis bullosa.

May 22, 2023
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2 min read
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Tristan Manalac
FDA

AbbVie, Genmab Score FDA Nod for DLBCL as Blood Cancer Space Heats Up

With Friday’s approval, Epkinly edges out Roche’s bi-specific antibody glofitamab, which is also being proposed for diffuse large B-cell lymphoma.

May 22, 2023
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2 min read
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Tristan Manalac
Drug Development

Phase III Results Prime Dupixent as First Potential Biologic Approval for COPD

Sanofi and Regeneron reported positive results for the anti-inflammatory drug in a chronic obstructive pulmonary disease trial. The companies hope to see approval before a 2024 read-out of a second trial.

May 22, 2023
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2 min read
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Kate Goodwin
Drug Development

Ironwood to Pay $1B to Acquire VectivBio, Late-Stage Digestive Therapy

Data from a Phase III trial of apraglutide for a type of short bowel syndrome with intestinal failure is expected by the end of the year. It is also in a Phase II study for acute graft-versus-host disease.

May 22, 2023
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2 min read
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Jef Akst
Drug Development

Hepion Claims Phase II NASH Victory Following Intercept’s Adcomm Defeat

The 61-patient study met the primary endpoint of improved physiologic liver function and secondary endpoints, which included established non-alcoholic steatohepatitis biomarkers, Hepion reported Monday.

May 22, 2023
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3 min read
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Heather McKenzie
Business

Nanox Announces First Quarter of 2023 Financial Results and Provides Business Update

NANO-X IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging technology company, today announced results for the first quarter ended March 31, 2023 and provided a business update.

May 22, 2023
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26 min read
Biotech Bay

Ansa Biotechnologies Announces First Shipments of Complex Clonal DNA Sequences to Customers in its Early Access Program

Ansa Biotechnologies, Inc will present more information regarding these milestones at the SynBioBeta conference on Wednesday, May 24, 2023, at 11:46 a.m. PT.

May 22, 2023
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3 min read
Biotech Beach

Aethlon Medical Receives Ethics Board Approval to Add Second Site to its Ongoing Clinical Trial of its Hemopurifier® to Treat Severe COVID-19 in India

Aethlon Medical, Inc. announced that it has received Ethics Review Board approval from the Maulana Azad Medical College, for a second site for its ongoing clinical trial of Aethlon’s Hemopurifier® to treat severe COVID-19 in India.

May 22, 2023
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4 min read
Lone Star Bio

bioAffinity Technologies Presents Research Findings at CYTO 2023

bioAffinity Technologies, Inc. today will present the poster “Development of porphyrin-stained polystyrene compensation beads for use on an automated analysis platform” at CYTO 2023 , the annual Congress for the International Society for the Advancement of Cytometry (ISAC), in Montréal, Québec, Canada.

May 22, 2023
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3 min read
Business

Panbela Announces Clinical Trial with Moffitt Cancer Center for Phase I/II Program in STK11 Mutant Non-Small Cell Lung Cancer

Panbela Therapeutics, Inc. today announced it has entered into a clinical trial agreement with Moffitt Cancer Center for a Phase I/II program in STK11 mutant non-small cell lung cancer (NSCLC).

May 22, 2023
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7 min read