The U.S. FDA has granted breakthrough device designation to Cerus Endovascular Ltd. for its Contour neurovascular system for the treatment of intracranial aneurysms. The company is targeting the second or third quarter of this year for the start of its IDE clinical trial.
Governments across the globe are struggling to keep pace with the SARS-CoV-2 virus’s impact on public health, but the new variants are presenting their own challenges. The next task facing governments across the globe is to sequence the latest mutated variants of the virus and keep track of any further mutations, all while validating new and revamped existing tests, a task that is likely to prove difficult to meet for at least the next few months.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MITA announces new health care supplier standard; Laggardly patient record response costs provider $75k; New med-tech resource platform now includes logistics; Spectrascience the subject of speculation, SEC action; HC nudging along with regulatory modernization plan.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Access Vascular, Braincool, Brainq, Cerus Endovascular, Genscript, Limacorporate, Roche, Techmah Medical.
Regeneron Pharmaceuticals Inc.’s angiopoietin-like 3 (ANGPTL3)-targeting antibody, Evkeeza (evinacumab), won FDA approval for use in reducing LDL cholesterol in patients with homozygous familial hypercholesterolemia.
Limited manufacturing capacity, supply chain disruptions and a dearth of personnel with specialized skills are all challenges vaccine makers are facing as they race to produce contracted quotas of COVID-19 vaccines that were developed and authorized in record time.
LONDON – The EMA has requested all COVID-19 vaccine developers to investigate if their products offer protection against new variants of SARS-CoV-2 and to submit the relevant data.
The latest global regulatory news, changes and updates affecting biopharma, including: Fed Circuit agrees Amgen patents lack enablement; HC nudging along with regulatory modernization plan; EMA: No Sputnik application yet.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinuvel, Genmab, Moderna, Oryzon, Polaryx, Seagen.
Diagnostic manufacturers are turning their attention to antibodies for those who have been vaccinated for the SARS-CoV-2 virus, and the U.S. FDA’s Tim Stenzel had some advice about this on the Feb. 10 testing town hall. Stenzel advised that developers think of such tests in the same vein as a companion diagnostic (CDx) in that these antibody test will have to be separately validated for each vaccine that is included in the test’s labeled claims.
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