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Regulatory
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Regulatory actions for April 17, 2020

April 17, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cirrusdx, Curative, Vent Multiplexor.
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Seattle Genetics wins FDA nod for Tukysa in breast cancer

April 17, 2020
By Randy Osborne
As expected – and well ahead of the Aug. 20 PDUFA date – Bothell, Wash-based Seattle Genetics Inc. (Seagen) won FDA clearance for the oral small-molecule breast cancer therapy tucatinib, a tyrosine kinase inhibitor branded Tukysa.
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Regulatory actions for April 17, 2020

April 17, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chi-Med, Everest, Redhill, Seattle Genetics.
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4-16-Synapse-Transaeris.png

Synapse gains EUA from FDA to stimulate the diaphragm of ventilated patients

April 16, 2020
By Stacy Lawrence
Case Western Reserve University spinout Synapse Biomedical Inc. has received emergency use authorization from the U.S. FDA for its Transaeris diaphragm pacing system (DPS) device to prevent and treat ventilator-induced diaphragm dysfunction (VIDD).
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Regulatory front for April 16, 2020

April 16, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Logan Labs.
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Regulatory actions for April 16, 2020

April 16, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Viveve.
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U.S. Securities and Exchange Commission

SEC clamping down on companies’ COVID-19 claims

April 16, 2020
By Mari Serebrov
Public drug and device companies may want to think twice before eagerly jumping on the COVID-19 bandwagon with announcements overselling their efforts to develop or repurpose products to treat patients infected with the coronavirus.
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Kolon Tissuegene’s Invossa gets second chance as FDA removes clinical hold

April 16, 2020
By Gina Lee
HONG KONG – South Korean biopharmaceutical company Kolon Tissuegene Inc. got a new lease on life as the U.S. FDA lifted the hold on the phase III trial for its lead candidate, Invossa-K (Invossa), for the treatment of osteoarthritis.
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Regulatory front for April 16, 2020

April 16, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Amneal.
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Regulatory actions for April 16, 2020

April 16, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alphamab, Ascendis, Autolus, Eagle, Emmaus, Index, Mayne, Mithra, Provention, Regeneron, Tetra, Tissuetech, Zai.
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