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BioWorld - Monday, January 30, 2023
Home » Topics » Regulatory

Regulatory
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Regulatory actions for June 30, 2020

June 30, 2020
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerus, Ancora Heart, Corelink, Endra Life Sciences, Illuminoss Medical, Kardium, Livsmed, Qure.ai, Seegene.
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Pfizer challenges fairness of Medicare antitrust policy

June 30, 2020
By Mari Serebrov
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Citing the First Amendment, the Fifth Amendment and the logic of fair play, Pfizer Inc. is taking on a Health and Human Services’ (HHS) antitrust policy that prohibits drug companies from helping Medicare beneficiaries with hefty copays.
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Regulatory front for June 30, 2020

June 30, 2020
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The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory actions for June 30, 2020

June 30, 2020
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alterity, Ardelyx, Astrazeneca, Bioinvent, Mediwound, Merck, Nuvox, Oncopeptides, Oncternal, Osmotica, Prestige, Sparingvision, Synthetic Biologics, Vericel, Verrica.
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FDA approves Phesgo for HER2-positive breast cancer

June 30, 2020
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Vadadustat approved in Japan for the treatment of anemia due to CKD

June 30, 2020
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Onoact approved for additional indication of tachyarrhythmia associated with sepsis in Japan

June 30, 2020
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Enspryng approved in Japan for adults and children with NMOSD

June 30, 2020
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Product images of Acclaim models 9000 and 9200

FDA grants breakthrough status to Envoy Medical’s Acclaim cochlear implant

June 29, 2020
By Meg Bryant
No Comments
Envoy Medical Corp. got some early support for its Acclaim fully implantable cochlear implant, with a breakthrough device designation from the U.S. FDA. If approved, it would be the first cochlear implant to address hearing loss without the use of any external components.
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Regulatory front for June 29, 2020

June 29, 2020
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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ACLA, I-Fixit, MITA, Palmetto GBA.
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