BioSpace News Archive

Policy

FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types

, the U.S. Food and Drug Administration granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers.

September 29, 2023

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4 min read

New Analysis Highlights Importance of Adhering to Uninterrupted Full Course of Treatment with TEPEZZA® (teprotumumab-trbw) to Support Thyroid Eye Disease (TED) Patient Outcomes

Horizon Therapeutics plc (Nasdaq: HZNP) today announced new data showing that disrupting the recommended TEPEZZA treatment regimen by lengthening the amount of time between infusions can increase the need for a second course of treatment.

September 29, 2023

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9 min read

ARUP’s New Institute for Research and Innovation in Diagnostic and Precision Medicine™ Will Forge the Future of Laboratory Medicine

ARUP Laboratories today announced the formation of the new ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine™ (R&I Institute).

September 29, 2023

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5 min read

Business

Stephen Dilly Receives the 2023 Bloom Burton Award

Bloom Burton & Co. (“Bloom Burton”) is pleased to announce Stephen Dilly, former Chief Executive Officer of Sierra Oncology, as the recipient of the 2023 Bloom Burton Award.

September 29, 2023

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3 min read

Policy

FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies

The U.S. Food and Drug Administration is taking steps to help further accelerate the development of novel drug and biological products for rare diseases.

September 29, 2023

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5 min read

BioCapital

Incyte to Present Multiple Studies from Dermatology Portfolio at 2023 European Academy of Dermatology and Venereology (EADV) Congress

Incyte (Nasdaq:INCY) today announced multiple abstracts featuring new data from across its dermatology portfolio have been accepted for presentation at the upcoming European Academy of Dermatology and Venereology (EADV) Congress 2023 held October 11-14 in Berlin.

September 29, 2023

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6 min read

Policy

KVK-Tech, Inc. Issues Voluntary Nationwide Recall of one lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a precautionary measure due to a single foreign tablet found during the line clearance after the batch was packaged

KVK-Tech, Inc. is voluntarily recalling one lot of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed “K” above bisect “13" on one side and plain on the other side” to the consumer level.

September 29, 2023

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3 min read

FDA

FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA®

Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA.

September 29, 2023

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8 min read

BioMidwest

Oragenics Enters into Agreement with Lantern Bioworks for Replacement-Therapy Assets

Oragenics, Inc. and Lantern Bioworks announce a groundbreaking partnership, marked by the formalization of a materials transfer agreement.

September 29, 2023

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4 min read

Business

Children’s Hospital of Philadelphia Names New Chief of Adolescent Medicine

Children’s Hospital of Philadelphia has appointed Renata Arrington Sanders, MD, as Chief of the Craig Dalsimer Division of Adolescent Medicine, effective October 1, 2023.

September 29, 2023

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3 min read