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BioWorld - Thursday, March 23, 2023
Home » Topics » Regulatory

Regulatory
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Regulatory actions for Aug. 11, 2020

Aug. 11, 2020
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Life Spine, Magventure, United Imaging.
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Regulatory front for Aug. 11, 2020

Aug. 11, 2020
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The latest global regulatory news, changes and updates affecting biopharma, including: Kodak, Moderna.
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Regulatory actions for Aug. 11, 2020

Aug. 11, 2020
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Gene Technologies, Arvelle, Atyr, Clearside, Equillium, Fennec, Kyorin, Mersana, Mesoblast, Neurogene, Protalix.
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Fingerprick blood test

TGA approves Atomo Diagnostics’ rapid COVID-19 antibody test

Aug. 10, 2020
By Tamra Sami
No Comments
PERTH, Australia – As the state of Victoria in Australia records its deadliest day since the COVID-19 pandemic began, reporting 17 deaths and 394 new cases, Atomo Diagnostics Ltd.’s new COVID-19 antibody test could ease pressure on health care systems.
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Medicare puzzle

MITA, surgeons pushing back against Medicare physician fee draft for 2021

Aug. 10, 2020
By Mark McCarty
No Comments
The annual publication of the draft Medicare physician fee schedule (MPFS) is an event, but this year’s draft has drawn substantial criticism from across the board, despite the promise of more coverage of telehealth. The Medical Imaging & Technology Association (MITA) and a coalition of surgeons have blasted the draft as a hazard to patient access to both evaluation and management (E/M) services and surgical procedures, both of which present substantial headwinds for the medical device industry.
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Cancer cell and DNA

FDA gives thumbs up to first liquid biopsy NGS CDx test

Aug. 10, 2020
By Liz Hollis
No Comments
The U.S. FDA revealed good news for Guardant Health Inc. Specifically, the agency has given a thumbs up for Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm. The Redwood City, Calif.-based company noted that this marked the first approval to combine next-generation sequencing (NGS) and liquid biopsy in one diagnostic test to guide treatment decisions. The assay previously was granted a breakthrough device designation.
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FDA approved metal stamp

FDA approves Trevena’s Olinvyk for clinical controlled settings

Aug. 10, 2020
By Lee Landenberger
No Comments
Knocked back by a complete response letter (CRL) in late 2018, Trevena Inc. dusted itself off, resubmitted its NDA for oliceridine and found satisfaction as the FDA has approved the opioid agonist.
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Eagle draws CRL for new Ryanodex indication: heat stroke

Aug. 10, 2020
By Michael Fitzhugh
No Comments
Nearly three years after an FDA rejection of Eagle Pharmaceuticals Inc.'s initial effort to add exertional heat stroke (EHS) to the list of approved indications for Ryanodex (dantrolene sodium), its efforts have again been met with a complete response letter. The calcium channel modulator is already approved for the treatment of malignant hyperthermia (MH), but Eagle said it has decided to drop further pursuit of EHS.
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U.S. Capitol building

Domestic Rx, device supply chain a tall order

Aug. 10, 2020
By Mari Serebrov
No Comments
“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines.
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Regulatory front for Aug. 10, 2020

Aug. 10, 2020
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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Covidien, Medtronic, MITA.
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