Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzamend, Ananda, Biontech, Cytokinetics, Gilead, Huyabio, Incannex, Janssen, Nouscom, Pfizer, Sorrento, Teva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acuitas, Gilead, Homology, In8bio, Itolerance, Janssen, Kadimastem, Keros, Kyowa Kirin, Lassen, Luca, Metagenomi, Model, Neubase, Precision, Senti, Swanbio, Tonix, Vectory, Verastem.
The pandemic exponentially amplified the move to more patient-driven health care with at-home monitoring, wearable medical devices and telemedicine. Testing has arguably seen the greatest shift, led by emergency use authorizations (EUA) for dozens of rapid tests for SARS-CoV-2. Laboratory Corp. of American Holdings Inc. (Labcorp) stands to benefit even more from the trend with an EUA for an over-the-counter multiplex respiratory virus test and the launch of an at-home collection kit for testing hemoglobin A1c (HbA1c) this week.
While children younger than 5 in the U.S. still have no vaccine protection against COVID-19, those 5 and older may be able to get a third jab. The FDA authorized, May 17, the use of a single booster dose of the Pfizer Inc.-Biontech SE vaccine for kids 5 through 11 years of age who completed the primary two-dose series at least five months earlier.
An unknown U.K. biotech, RQ Biotechnology Ltd., has emerged from stealth mode with a $157 million licensing deal with Astrazeneca plc for its monoclonal antibodies, aimed at protecting vulnerable and immunosuppressed people against SARS-CoV-2.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exactech, Jointmedica, Labcorp.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Atamyo, Eli Lilly, Faron, Galera, Gedeon, Inmagene, Junshi, Mitsubishi, Point, Scpharmaceuticals, Sifi, Travere, Valneva, Zenas.
Among the policies the U.S. FDA’s device center leveraged for testing during the COVID-19 pandemic was the long-standing enforcement discretion lever, which drew less attention than the agency’s use of emergency use authorizations (EUAs). Nonetheless, the Government Accountability Office (GAO) urged the FDA to develop a formal policy for the use of enforcement discretion for pandemic-related tests, including some metrics for when that discretion would come to an end.
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