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
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

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

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
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
Business

Kelyniam Global Releases Q1 Financials, Announces Licensing Agreement with Bioplate for Osteopore Products

Kelyniam Global, a leading maker of custom cranial implants, announced results for its quarter ended March 31, 2023.

May 22, 2023
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3 min read
Thousand Oaks Biologics and GeneQuantum Healthcare Signed A Strategic Partnership Agreement for ADC Drug Development

Thousand Oaks Biologics Inc. and GeneQuantum Healthcare Co., Ltd. are pleased to announce that they have formed a strategic partnership focusing on the CMC development of ADC products with a core conjugation technology for more stable drug candidates.

May 22, 2023
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3 min read
Lifespin Announces the Launch of its First Commercial Product in Regulated Healthcare

Lifespin GmbH, a start-up medical diagnostics company with offices in Regensburg and Boston, announced that it has launched Lifespin™ Amino Acid Profiler - its first commercial product for use in the regulated diagnostics field.

May 22, 2023
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3 min read
Business

Angle PLC Announces Board Change - Appointment of New Chairman

ANGLE plc, a world-leading liquid biopsy company announces that Garth Selvey has informed the Board of his intention to retire and leave ANGLE at the publication of the 2023 Interims in September.

May 22, 2023
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6 min read
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