BioSpace News Archive

FDA

Merck’s Keytruda Snags Fifth NSCLC Nod

The FDA approved Merck’s Keytruda for the treatment of stage IB, II or IIIA non-small cell lung cancer after resection or platinum-based chemotherapy.

January 27, 2023
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2 min read
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Tristan Manalac
Policy

Market Skeptical Following Sen. Warren’s Antitrust Allegations

Sen. Elizabeth Warren (D-MA) voiced concerns to the FTC regarding the prospective acquisitions of Horizon Pharmaceuticals and Opiant Pharmaceuticals by Amgen and Indivior.

January 27, 2023
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3 min read
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Rosemary Scott
Business

Celularity Warns of Potential Layoffs in Strategic Review

Celularity announced Thursday it was conducting a strategic review and warned its workforce to brace for potential layoffs.

January 27, 2023
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1 min read
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Hayley Shasteen
Drug Development

XyloCor Advances Cardiovascular Gene Therapy Space with Positive Angina Results

XyloCor Therapeutics reported positive topline results Thursday from Phase II of the Phase I/II trial of its gene therapy for refractory angina.

January 27, 2023
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2 min read
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Heather McKenzie
Genetown

Ipsen Receives CHMP Negative Opinion for Palovarotene as a Treatment for Fibrodysplasia Ossificans Progressiva in E.U.

Ipsen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended not to grant marketing authorization for investigational palovarotene as a treatment for the ultra-rare bone disease, fibrodysplasia ossificans progressiva.

January 27, 2023
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10 min read
Genetown

Oxurion Provides Further Details Concerning the Second Amendment to Negma Funding Program

Oxurion NV has entered into an amendment of its mandatory convertible bonds issuance and subscription agreement with the Negma Group on January 25, 2023.

January 27, 2023
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2 min read
Business

Samsung Biologics Reports Fourth Quarter & Fiscal Year 2022 Financial Results

Samsung Biologics, the world’s leading contract development and manufacturing organization, announced strong financial results for the fourth quarter and record-high earnings for the fiscal year 2022.

January 27, 2023
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4 min read
Pharm Country

Bristol Myers Squibb Announces Positive CHMP Opinion for Once-Daily Sotyktu (deucravacitinib) as a Treatment for Adults With Moderate-to-Severe Plaque Psoriasis

Bristol Myers Squibb Announces Positive CHMP Opinion for Once-Daily Sotyktu (deucravacitinib) as a Treatment for Adults With Moderate-to-Severe Plaque Psoriasis,

January 27, 2023
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15 min read
Pharm Country

Dr. Reddy’s Laboratories announces the launch of Difluprednate Ophthalmic Emulsion 0.05% in the U.S. Market

Dr. Reddy’s Laboratories Ltd. today announced the launch of Dr. Reddy’s Difluprednate Ophthalmic Emulsion 0.05%, a therapeutic generic equivalent to Durezol® (Difluprednate Ophthalmic Emulsion 0.05%) in the U.S. market, following the approval by the U.S. Food and Drug Administration (USFDA).

January 27, 2023
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3 min read
Business

Arbutus Announces Resignation of Board Member

Arbutus Biopharma Corporation today announced that Tram Tran, MD has notified the Company of her intention to resign from the Company’s Board of Directors, effective February 26, 2023.

January 27, 2023
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5 min read