As the U.S. FDA struggles to meet a massive court-ordered release of documents related to its approval of the Pfizer Inc.-Biontech SE COVID-19 vaccine, it could help itself by being more proactive in publicly releasing documents related to the approval and labeling of prescription drugs, according to a U.S. regulatory expert.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytokinetics, Mylan Laboratories, Novavax, RDIF, Revolo, Roche, TG, Tiziana, Viatris.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biomunex, Nanopass Technologies, Navidea, Varsity .
“The premise of our whole company is that we target molecular machines, but we don’t target the engine,” Adrian Schomburg told BioWorld. Instead, “we interfere with the throttle and other highly specific controls of these machines.” “We,” in this case, is Eisbach Bio GmbH, a German startup that is developing anticancer programs aimed at exploiting synthetic lethality by targeting helicases. Founded in 2019, the company has three programs, a recently announced collaboration with MD Anderson Cancer Center in oncology, and another program in COVID-19.
The CDC’s Advisory Committee on Immunization Practices (ACIP) has unanimously recommended the agency endorse administering Moderna Inc.'s COVID-19 vaccine, Spikevax (elasomeran), to adults. The vote was a strong echo of the FDA’s full approval of the vaccine for adults only a few days earlier, on Jan. 31. After hearing safety and efficacy data from Moderna and an internal analysis of that data from the CDC, ACIP recommended by a vote of 13-0 that the CDC endorse the vaccine’s use for people 18 years and older.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Antares, Biophytis, Catalyst, Eubiologics, Novavax, Pardes, Pharmazz, Syros, Timber.
Despite mandating earlier this year that private health insurance plans make over-the-counter COVID tests free to their subscribers, the U.S. CMS took until Feb. 3 to make the same benefit available to Medicare beneficiaries. The problem is that these tests will not be available to Medicare beneficiaries free of charge until “early spring,” the agency said, a point in time by which the latest surge of the pandemic is likely to have dissipated.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Jazz, Logicbio, Pfizer, Qsam, Samsung, Theseus.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amylyx, Glaxosmithkline, Johnson & Johnson, Merck, Mitsubishi Tanabe Pharma America, Pfizer, Qilu Regor, Regor, Ridgeback, Vir, Xbiotech.
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