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Merck KGaA will pay Switzerland-based Debiopharm up to $1.08 billion (€900 million) for the global rights to Xevinapant, an investigational head and neck cancer treatment. Read More
CorMedix has received a Complete Response Letter (CRL) from the FDA regarding a New Drug Application (NDA) for its catheter-lock solution, DefenCath (taurolidine/heparin). Read More
Because of the way expensive, single-dose drugs are priced and paid for in the U.S., extra doses in discarded vials can’t be used to recoup costs, according to a congressionally mandated report from the National Academies of Sciences, Engineering, and Medicine. Read More
Medicare Part B may be unintentionally creating perverse incentives for hospitals to use certain drugs based on what the program reimburses for them, rather than medical necessity, a new Government Accountability Office (GAO) report finds. Read More
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