A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.
A congressional investigation into COVID-19 vaccine manufacturing failures at Emergent Biosolutions Inc. unveiled more troubling issues at the company’s Bayview facility in Baltimore, which had been awarded a lucrative U.S. government contract to produce vaccines for Johnson & Johnson.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Elpiscience, Logicbio, Resverlogix, Selection, Teva, Therapeutics Solutions.
The U.S. FDA reported it is evaluating the potential for exposure to some chemicals associated with the use of several models of hemodialysis machines made by Fresenius Medical Care Inc., of Waltham, Mass., including units that are no longer in production.
Cvrx Inc. secured U.S. FDA approval for magnetic resonance-conditional labeling for its Barostim system, a neuromodulator that improves symptoms of patients with heart failure. With the latest approval, patients with the implanted system can have magnetic resonance imaging (MRI) at 1.5T under the specified conditions.
The U.S. FDA’s efficacy bar for COVID-19 vaccines for the youngest children may be lower than the 50% required for the adult vaccines, according to Peter Marks, director of the agency’s Center for Biologics Evaluation and Research.<
In a draft guidance released May 9, the U.S. FDA described the benefit-risk principles it uses when conducting quality-related assessments of chemistry, manufacturing and controls (CMC) information submitted as part of a new drug application, biologics license application or supplement.
Even though at least two different U.S. district courts have ruled that the 340B enforcement letters the Department of Health and Human Services’ (HHS) Health Resources and Services Administration has sent to biopharma companies violate the Administrative Procedures Act, the agency continues to send the letters, along with threats of civil money penalties, to companies that place restrictions on the 340B discounts to contract pharmacies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cvrx, Lucira Health, Philips.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Johnson & Johnson, Myovant, Pfizer.
RSS
