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Home » Topics » Regulatory

Regulatory
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Aion Biosystems itempshield

Aion heats up with clearance for continuous temperature monitor

Aug. 30, 2023
By Annette Boyle
Aion Biosystems Inc. may be operating at a fever pitch right now, with FDA 510(k) clearance in hand for the company’s Itempshield device, which provides continuous measurement of body temperature. The company is targeting use of the quarter-sized device for patients with cancer and individuals in long-term care.
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Regulatory actions for Aug. 30, 2023

Aug. 30, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aion Biosystems, Bionicm.
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Regulatory actions for Aug. 30, 2023

Aug. 30, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Bloomsbury Genetic Therapies, BMS, Eagle, Faron, Genentech, Halozyme, Hutchmed, Janssen, Laurent, Merck, Tscan, Valneva, Xortx.
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Litigation continues over COVID-19 mRNA vaccines

Aug. 29, 2023
Biontech SE and Pfizer Inc. filed a petition with the U.S. Patent Trial and Appeal Board for an inter partes review against Moderna Inc., the latest move in an ongoing patent battle over the mRNA technology used to develop COVID-19 vaccines.
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With a new approval, BMS’s Reblozyl expands anemia treatment

Aug. 29, 2023
By Lee Landenberger
The U.S. FDA has awarded Bristol Myers Squibb Co. (BMS) with its third approval for treating anemia with Reblozyl (luspatercept-aamt). Specifically, the approval is for treating anemia without previous erythropoiesis stimulating agent use in adults with very low- to intermediate-risk myelodysplastic syndromes who may require regular red blood cell transfusions.
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Pills spilling out of bottle onto money

Let the games begin: CMS rolls out price negotiation list

Aug. 29, 2023
By Randy Osborne
The list of 10 part D Medicare drugs listed by the Centers for Medicare & Medicaid Services (CMS) as eligible for negotiation raised some eyebrows on Wall Street, but proved mostly in accord with what the industry expected. Under the Inflation Reduction Act, Medicare can for the first time bargain with drug companies. The back-and-forth begins this year, carrying into next year, and the agreed-upon prices will take effect in 2026.
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Regulatory actions for Aug. 29, 2023

Aug. 29, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ICU Medical.
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India map on technology concept background

India takes steps to separate device and drug regulations

Aug. 29, 2023
By Alfred Romann
India is taking steps to separate how it regulates medical devices and pharmaceuticals, as it works to reduce its dependency on imports of devices and turn itself into a global hub for med-tech innovation and manufacturing.
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Regulatory actions for Aug. 29, 2023

Aug. 29, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Harbour, Tourmaline.
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Cancer cell, dropper, test tubes
Immuno-oncology

Tscan’s PRAME-targeting TCR T-cell product cleared to enter clinic

Aug. 29, 2023
Tscan Therapeutics Inc. has received FDA clearance of its IND application for TSC-203-A0201, a T-cell receptor (TCR)-engineered T-cell therapy (TCR-T) targeting preferentially expressed antigen in melanoma (PRAME). PRAME is expressed in melanoma and other solid tumors, including head and neck cancers and non-small-cell lung cancers. TSC-203-A0201 is specific for patients with HLA type A*02:01.
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