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.
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.
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.
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.