DUBLIN – The European Medicines Agency (EMA) has reiterated its support for Astrazeneca plc’s Vaxzervia COVID-19 vaccine, following an interim analysis of a data review, which the agency’s Committee on Human Medicinal Products (CHMP) has conducted over the past two weeks.
The CDC’s Advisory Committee on Immunization Practices again took up the matter of risk vs. benefit with the COVID-19 vaccine made by Johnson & Johnson, and proved significantly less skeptical at its second meeting. The FDA and CDC swiftly determined that the recommended pause should be lifted and use of the vaccine should resume.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Alivecor goes to ITC in patent scrum with Apple; Cordis carotid artery stent recalled; C-Rad snares court win for patent; Orthotics supplies subject of $65M in fraud.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, ADC, Biogen, BMS, Calliditas, Eisai, Gilead, Glaxosmithkline, Hua, Leo, Medicago, Merck, Protara, Roche, Shanghai Henlius, Shorla.
Nearly a full month ahead of the PDUFA date, ADC Therapeutics SA said Friday the FDA has granted accelerated approval for Zynlonta (loncastuximab tesirine), a CD19-targeted antibody-drug conjugate for the single-agent treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The approved indication includes the treatment of patients with diffuse large B-cell lymphoma not otherwise specified and those with DLBCL arising from low grade lymphoma and high grade B-cell lymphoma, which ADC's CEO Chris Martin said would be an important point of differentiation for the product.
TORONTO – Perimeter Medical Imaging Inc. has been awarded an FDA breakthrough device designation for a machine learning medical platform it said drives ultra-high-resolution, real-time imaging of breast cancer. Data collected from multiple pathology labs in Texas this past year were fed through the optical coherence tomography (OCT) imaging system which now is at the stage where its Imgassist artificial intelligence (AI)-based algorithms can be tested.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Ambu, Getinge, Impedimed, Nēsos, Novocure, Orthofix, Soundbite.
As of 2020, the NIH had identified 507 grant recipients who potentially had undisclosed conflicts of interest, with many of those conflicts involving affiliations with foreign governments that may expect the scientists to share or steal NIH-funded research.
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