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The European Medicines Agency (EMA) is reportedly conducting an audit that could conclude this month of the Serum Institute of India (SII), the largest vaccine manufacturer in the world, as the EU faces delays to AstraZeneca (AZ)/Oxford’s COVID-19 vaccine shipments. Read More
The U.S. has begun vaccinations with Johnson & Johnson’s (J&J) single-dose vaccine following the FDA’s authorization over the weekend but confronting a small initial rollout the drugmaker is accelerating dose production and working with multiple manufacturers in the U.S. and at sites in Europe, India and South Africa to meet its supply commitments. Read More
From March to October 2020, during the height of the COVID-19 pandemic, the FDA conducted just 52 domestic on-site pharmaceutical inspections and all but halted foreign inspections ― moves that have worried some regulatory experts. Read More
AstraZeneca’s and Amgen’s biologic drug tezepelumab reduced the rate of asthma attacks by 56 percent among patients with severe and uncontrolled forms of the condition, according to their just-released phase 3 trial results. Read More
New treatments for cancer, hereditary angioedema and spinal muscular atrophy may be available to European patients soon, as the European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA/CHMP) recommended that the agency approve six new drugs, including two biosimilars and one generic, at its four-day meeting last week. Read More
A single dose of the Pfizer/BioNTech vaccine significantly lowers asymtopmatic SARS-CoV-2 infections, which means it also reduces the risk of transmission from asymtopmatic individuals, a new UK study has shown. Read More
The Biden administration has secured 100,000 doses of Eli Lilly’s combination monoclonal antibody (mAB) treatment to be delivered through March 31, with an option to buy an additional 1.1 million doses through November of this year. But will hospitals and outpatient centers even use them? Read More
In a 219-212 vote along party lines on Saturday, the House of Representatives passed the massive $1.9 trillion COVID-19 relief bill that includes $500 million in extra funding for the FDA and the elimination of Medicaid drug pricing rebate caps starting in 2023. Read More
The FDA granted an Emergency Use Authorization (EUA) for a third COVID-19 vaccine Saturday, clearing Johnson & Johnson’s (J&J) single shot following unanimous support from its vaccines advisory panel. Read More