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.
Shares of Heron Therapeutics Inc. sank 27% in morning trading, after the San Diego-based firm disclosed a second complete response letter (CRL) for HTX-011 in postoperative pain. The CRL, received from the FDA on June 26, the anticipated PDUFA date, stated the agency was unable to approve the NDA in its present form and called for additional nonclinical information.