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BioWorld - Thursday, September 28, 2023
Home » Topics » Regulatory

Regulatory
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TGA de-lists STAR ankle device due to high rates of device fracture

Sep. 13, 2023
By Mark McCarty
No Comments
Australia’s Therapeutic Goods Administration (TGA) posted a Sept. 6 hazard alert for the Scandinavian Total Ankle Replacement (STAR) device by DJO Global, a subsidiary of Wilmington, Del.-based Enovis Corp. TGA said the polyethylene insert used to eliminate friction between the device’s moving parts has demonstrated a higher-than-expected fracture rate, and that the device has been delisted from the Australian Register of Therapeutic Goods (ARTg).
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Updated COVID-19 vaccines likely to hit US market in day or two

Sep. 12, 2023
By Mari Serebrov
No Comments
Instead of the bivalent COVID-19 vaccines comprising both the original and omicron BA.4/BA.5 SARS-CoV-2 strains that have been in use in the U.S. since April, the CDC’s Advisory Committee for Immunization Practices voted 13-1 Sept. 12 to recommend the universal use of updated monovalent XBB-containing COVID-19 vaccines as authorized or approved by the FDA.
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Regulatory actions for Sept. 12, 2023

Sep. 12, 2023
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquestive, Bicycle, Biolinerx, Biosyngen, Day One, Tango, Verona.
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Regulatory actions for Sept. 12, 2023

Sep. 12, 2023
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Limflow, Stryker Surgical, Zeta Surgical.
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Colonoscopy illustration showing endoscope, polyps in colon

Limaca receives FDA clearance for Precision biopsy device

Sep. 12, 2023
By Shani Alexander
No Comments
Limaca Medical Ltd. received U.S. FDA 510(k) clearance for its Precision for gastrointestinal (GI) endoscopic ultrasound (EUS) biopsy device which the company said allows for faster, more efficient and safer collection of tumor tissue samples. The approval follows the receipt of breakthrough device designation, and the deployment of the device into the U.S. market should lead to more efficient and effective diagnosis of GI cancers.
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Pipet, test tubes, chemical structure
Cancer

Eikon Therapeutics advances preclinical pipeline

Sep. 12, 2023
No Comments
Eikon Therapeutics Inc. has received IND clearance from the FDA to initiate phase I studies with IMP-1734, a highly selective poly(ADP-ribose) polymerase 1 (PARP-1) inhibitor developed in partnership with Impact Therapeutics Inc.
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Mast cell
Cancer

Hoth seeks pre-IND meeting with FDA for HT-KIT

Sep. 12, 2023
No Comments
Hoth Therapeutics Inc. has submitted a request for a pre-IND meeting to the FDA to discuss the...
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Rx pricing clause: One-off or HHS policy?

Sep. 11, 2023
By Mari Serebrov
No Comments
If the modification to Regeneron Pharmaceuticals Inc.’s $326 million contract with the U.S. Biomedical Advanced Research and Development Authority is anything to go by, pricing clauses could once again become a common feature in biopharma contracts involving government R&D funding.
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Aphexda

Biolinerx’s stem cell mobilizer approved for MM patients

Sep. 11, 2023
By Lee Landenberger
No Comments
With the U.S. FDA’s approval of Biolinerx Ltd.’s stem cell mobilization agent Aphexda (motixafortide) for treating multiple myeloma (MM) patients, the company is prepping for a launch in the next two or three weeks.
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Regulatory actions for Sept. 11, 2023

Sep. 11, 2023
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acticor, Citius, Janssen, Eli Lilly, Mendus.
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