Moderna’s COVID-19 Vaccine Approved by Singapore
Singapore has become the first Asian country that has approved the Moderna COVID-19 vaccine as it begins its efforts in implementing its immunization program. The first shipment of Moderna’s vaccine is expected sometime around March. Currently, 175,000 of Singapore’s...
FDA Places Interim Process to Communicate Issues Found During Record Reviews
The U.S. Food and Drug Administration (FDA) has outlined an interim process for drug developers to relay any problems identified during record reviews instead of, or in advance of, preapproval inspections. Their responses will be taken into consideration before action...
Sputnik V Vaccine Efficacy Validated by Peer Review
Despite facing much public scrutiny for rushing the Sputnik V vaccine, the efficacy of Russia’s vaccine has been validated in a peer-reviewed study that was published in The Lancet. The Lancet published an interim analysis of Phase III data that Sputnik V has...
FDA Grants Approval for ADMA BioCenters Plasma Collection Facility
ADMA Biologics announced today (2/1) that the U.S. Food and Drug Administration (FDA) has granted approval for the ADMA BioCenters Plasma Collection Facility in Knoxville, Tennessee. Adam Grossman, President and Chief Executive Officer of ADMA, stated, “The approval...
EMA Approves AstraZeneca and University of Oxford COVID-19 Vaccine
The European Medicine’s Agency (EMA) announced today (1/29) it’s approval of the AstraZeneca and University of Oxford’s COVID-19 vaccine. The approval marks the third vaccine passed by the EMA. The vaccine is administered as two doses, with the second coming between 4...
FDA Places Mexican Hand Sanitizers on Import Alert
For the first time in history, the U.S. Food and Drug Administration (FDA) has placed a countrywide import alert for all hand sanitizers from Mexico due to concerns of methanol contamination. Hand sanitizers that are contaminated with methanol are known to result in a...
Japan’s PMDA Publishes Procedure for Conducting Remote Inspections
As an update to the previous release late last year, Japan’s regulatory body, the Pharmaceutical and Medical Device Agency (PMDA), has released its translated English version of the process for conducting remote compliance inspections for drugs and regenerative...
Australia’s Therapeutic Goods Administration Gives Provisional Approval for Pfizer’s COVID-19 Vaccine
Yesterday (1/25), Australia’s Therapeutic Good Administration (TGA) authorized Pfizer and BioNTech’s COVID-19 vaccine. The provisional approval is the first for COVID-19 vaccines in Australia’s market for individuals 16 years and older and is expected to be...
FDA Approves First Oral Medication for Lupus Nephritis
The U.S. Food and Drug Administration (FDA) announced on Friday (1/22) the first ever approval for Aurinia Pharmaceutical’s Lupkynis oral medication in combination with a background immunosuppressive therapy regimen for lupus nephritis (LN), serious chronic autoimmune...
Curelator and University of Calgary Study Finds a Lack of Association Between Migraines and Stress Levels
Curelator, a digital health company based in Cambridge, MA, released its findings for the largest international study that focused on the relationship between stress and migraines in the January issue of Headache, The Journal of Head and Face Pain in collaboration...
Australia’s TGA Takes First Steps in Approving Novavax COVID-19 Vaccine
Yesterday (1/20), Novavax received provisional determination from Australia’s Therapeutic Goods Administration for its COVID-19 vaccine, marking the first steps in gaining provisional approval. Australia’s provisional approval pathway allows for drug therapies (or...
The Importance of Quality Translation for the 2021 EU MDR Deadline
On May 26th 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) will be replaced and fully covered by the Medical Device Regulation (MDR). Since the original medical device directive’s...
Seneca Biopharma Announces Results for Treatment of Ischemic Stroke in Phase 2 Clinical Trial
Seneca Biopharma announced today (1/20) its preliminary top-line results for their Phase 2 ischemic stroke study. The trial, which took place in Beijing, China, focused on evaluating the relative safety of NSI-566, a neural stem cell therapy, in patients afflicted...
FDA Releases AI/ML Five-Part Action Plan for SaMD
The U.S. Food and Drug Administration (FDA) released its artificial intelligence/machine learning five-part action plan for software as a medical device (SaMD). The FDA announced in the plan its intention to create a tailored regulatory framework for SaMD, as well as...
EMA Issues Draft Guidance Parallel to Article 58 and Centralized Authorization Reviews
The European Medicines Agency (EMA) issued a draft guidance yesterday (1/14) for medicines intended to be used in low- to middle-income countries outside the European Union (EU). The Article 58 process calls for EMA’s Committee for Medicinal Products for Human Use...
Medtronic Announces First Enrollment of Adaptive Deep Brain Stimulation (aDBS) Trial for Parkinson’s Patients
Medtronic announced today (1/14) the launch of its clinical trial enrollment of the innovative Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD). The novel trial, which will take place across 12 research study sites in the US, Europe...
The European Commission Announces Acceptance of Remote Audits Amidst COVID-19
The European Commission (EC) announced this week that it will now be accepting remote audits during the pandemic for some European medical device and in vitro companies. The cleared pathway comes in time for upcoming deadlines in May 2021 and 2022 for the EU’s MDR...
EMA Grants Orphan Drug Designation for NeuroSense Therapeutic’s ALS Drug Therapy
The European Medical Association (EMA) granted NeuroSense Therapeutics, a clinical stage drug development company, orphan drug designation today (1/12) for PrimeC, a unique combination drug for treatment of Amyotrophic Lateral Sclerosis (ALS). The U.S. Food and Drug...
Abbott Laboratories Announces FDA 510(k) Clearance for Innovative Rapid Handheld Blood Test for Mild TBIs
Abbott Laboratories, a multinational health care and medical device company, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA), making history as the first ever handheld blood test for traumatic brain injuries (TBIs). The...
The FDA Tracks COVID-19 Mutations Impact on Diagnostic Performance
On Wednesday (1/6) the U.S. Food and Drug Administration (FDA) announced that it is tracking the COVID-19 testing diagnostics with SARS-CoV-2 test developers to determine the efficacy of the already-approved tests on their ability to detect new COVID-19 variants. The...