BioSpace News Archive

News

Biora Therapeutics to Host Virtual KOL Event on NaviCap™ Targeted Oral Delivery Platform and Results from Phase 1 Clinical Trial of BT-600 on July 17, 2024

October 14, 2024

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8 min read

A scientist with pill bottles in front of FDA headquarters

Regulatory

FDA Action Alert: Amgen, Camurus, Iterum and Lexicon

The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT inhibitor for use alongside insulin in type 1 diabetes and chronic kidney disease.

October 14, 2024

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4 min read

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Tristan Manalac

Opioid health risk and medical crisis with a prescription painkiller addiction epidemic concept as a group of people running away from a dangerous falling bridge of pills as a medicine addict problem with 3D illustration elements.

FDA

5 Accelerated Approvals Gone Wrong

Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.

October 14, 2024

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7 min read

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Heather McKenzie

Set of two dart targets with arrow and dart. Vector color illustration.

Cancer

With Myriad Recent Approvals in Cancer, The Era of Bispecifics Is Here

As companies roll out data showing the power and improved safety profile of antibodies that target two antigens, analysts say the class could overtake monoclonal antibody Keytruda as the “immunotherapy backbone” of solid tumor treatment.

October 14, 2024

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6 min read

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Kate Goodwin

Press Releases

NMD Pharma to Present Data on its Skeletal Muscle Targeted Therapy for Rare Neuromuscular Diseases at the 2024 AANEM Annual Meeting

October 14, 2024

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4 min read

Press Releases

Press Release: Sanofi in discussions to sell a controlling stake in Opella