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Ology Bioservices, an Alachua, Fla.-based biologics contract development and manufacturing organization (CDMO), has been granted a contract worth up to $106.3 million from the U.S. Army to help out with COVID-19 vaccine and therapeutic production. Read More
The European Commission is ramping up its efforts to obtain COVID-19 vaccines for EU member states. The commission and AstraZeneca (AZ) signed a contract yesterday for the drugmaker to supply up to 400 million COVID-19 vaccine doses for the EU. Read More
Trials of drugs to treat cancer in the central nervous system (CNS) that has metastasized from solid tumors outside the CNS should examine whether the treatment controls the cancer at all disease sites, according to an FDA draft guidance released Wednesday. Read More
A new bill introduced by Sen. Gary Peters (D-Mich.) would give the FDA the authority to recall unsafe drug products, a power it currently does not have. Read More
The Department of Justice (DOJ) has charged a Teva Pharmaceuticals subsidiary with allegedly conspiring to rig prices for generic drugs, making it the seventh drugmaker to be indicted as part of an ongoing probe. Read More
Partner Therapeutics has enrolled the first patient in a phase 2 trial evaluating its inhaled Leukine (sargramostim) for hospitalized COVID-19 patients. Read More
Three ranking Democrats have asked a Virginia-based consulting firm to reveal details of its government contract for Operation Warp Speed’s chief adviser Moncef Slaoui, citing concerns that the contract allows the former pharma executive to skirt ethics rules and avoid disclosing potential conflicts of interest. Read More
Moderna’s coronavirus vaccine candidate was well-tolerated and worked well in elderly COVID-19 patients in a small, early-stage trial, the company said Wednesday, following promising results announced in July for younger patients. Read More