BioSpace News Archive

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

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
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
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

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
Americhem Expands Medical Grade Materials Compounding Facility to Meet Increasing European Demand

Americhem, Inc, a global industry leader in innovative polymer compounding, announced it has completed the expansion of their manufacturing facility in Denmark, which includes a clean compounding facility dedicated to medical grade materials.

May 22, 2023
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2 min read
Genetown

PharmEnable Closes $7.5M Financing led by MP Healthcare to Develop Next Generation of Small Molecule Drugs to Treat Cancer and Neurological Diseases

PharmEnable, a drug discovery company focused on chemical novelty, diversity and complexity, announces it has closed a Pre-Series A investment round of $7.5M to develop the next generation of small molecule drugs against disease areas of high clinical need.

May 22, 2023
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6 min read
Business

WuXi Biologics Receives 2023 ISPE Facility of the Year Award for Operations

WuXi Biologics, a leading global Contract Research, Development, and Manufacturing Organization, announced that the International Society for Pharmaceutical Engineering has awarded the company a 2023 Facility of the Year Award in the Operations category.

May 22, 2023
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3 min read
BioForest

NanoString to Host Conference Call on Monday, May 22, 2023, to Provide Comments on Decision of the Regional Court of Munich

NanoString Technologies, Inc., a leading provider of life science tools for discovery and translational research, announced that the Company will host a conference call on Monday, May 22, 2023, at 4:30pm ET to provide an update on the recent Decision of the Regional Court of Munich.

May 22, 2023
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2 min read
Drug Development

AiViva Biopharma Initiates Phase 1 Clinical Trial of AIV007 for Age-Related Macular Degeneration and Diabetic Macular Edema

AiViva Biopharma Inc., a clinical-stage biotechnology company, announced that it has begun a Phase 1 trial and completed dosing the first cohort of patients diagnosed with wet age-related macular degeneration, and/or diabetic macular edema.

May 22, 2023
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2 min read