Genematrix NeoPlex HPV 29 Detection Gains European CE-IVD
Genematrix, known for their real-time PCR based molecular diagnostics, have announced that NeoPlex HPV29 Detection has gained European Medical Device Certification (CE-IVD). Designed to simultaneously diagnose 29 genotypes of human papillomavirus (HPV - a key...
Medtronic Hugo Robotic Surgery System Granted European CE Mark
A global leader in medical technology, Medtronic, has been granted CE (Conformité Européenne) Mark for the Hugo™ robotic surgery (RAS) system, giving the green light for sales of the system in Europe. The approval has been given for urologic and gynecologic procedures...
Healthcare AI Technology: Beyond Mental Health and Diabetes
For those following our series on AI in communications, or for anyone closely watching developments in the life sciences, it won’t come as news that technology is one of the most promising new tools for solving challenges in health care and developing new treatments....
FDA Approves ChemoCentryx Drug for Rare Autoimmune Disease
ChemoCentryx has received US FDA (Food and Drug Administration) approval for their drug, avacopan, to treat the rare, fatal autoimmune disease, antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV). The oral drug, brand name Tavneos, will help those...
Finland, Sweden & Denmark Limit Moderna COVID-19 Vaccine
Following the release of a Nordic study, Finland joins Sweden and Denmark in pausing the distribution of the Moderna COVID-19 vaccine for young adult males (under 30) after reports of a rare cardiovascular side effect. The unpublished study will be sent to the...
J&J Submits Booster Emergency Use Authorization to FDA
Johnson & Johnson (J&J) has submitted its data to the US FDA (Food and Drug Administration) for emergency use authorization for its booster shot of the J&J COVID-19 vaccination. The submission is based on the Phase 3 ENSEMBLE 2 study that shows that a...
Acute Lymphoblastic Leukemia (ALL): First Approved CAR T-Cell
The US FDA (Food and Drug Administration) has approved the first-ever chimeric antigen receptor (CAR) T-cell therapy, brexucabtagene autoleucel (TECARTUS, Kite, a Gilead Company) for adults with relapsed or refractory acute lymphoblastic leukemia (ALL). The approval...
Merck COVID-19 Pill Gives Hope in Preventing COVID-19 Deaths
Experimental antiviral COVID-19 treatment pill, molnupiravir, developed by Merck & Co Inc and partner Ridgeback Biotherapeutics LP, presents promising results in halving the chances of dying or being hospitalized from COVID-19. If authorized, the pill would be the...
Diabetes: 20+ Year Study Shows Abnormal Nighttime BP Risky
Longitudinal study funded by the University of Pisa. Chiriacò and McLaughlin shows that adults with diabetes who experience abnormal blood pressure (PB) patterns overnight which either do not drop as expected (nondipping) or, increase at night (reverse dipping) are at...
FDA Releases Electronic 510(k) Submissions Draft Guidance
The US FDA (Food and Drug Administration) announced that it has released a draft guidance for sponsors using an electronic template for premarket notification 510(k) submissions. According to the drafted guidance, the FDA explained that it plans to accept the...
CE Mark Approval for Medtronic Radial Artery Portfolio
Global leader in medical technology, Medtronic, has been granted CE Mark approval for its radial artery access portfolio, comprising of their Rist 079 Radial Access Guide Catheter and Rist Radial Access Selective Catheter. Characterized by its ability to access the...
GSK’s COVID-19 Antibody Treatment Approved in Japan
GSK's (GlaxoSmithKline) and Vir Biotechnology's antibody treatment for COVID-19, Sotrovimab has been approved in Japan, Health Minister Norihisa Tamura announced this week. Aiming to treat mild to moderate coronavirus cases, GSK's antibody treatment does not require...
Early Parkinson’s Disease Can be detected by Apple Watches and iPhones
Apple Devices can identify individuals with early, untreated Parkinson’s disease (PD), according to recent research. Data from the 12-month WATCH-PD study, which included 132 individuals (82 with PD and 50 controls), highlighted the differences in a finger-tapping...
Pfizer-BioNTech Booster Gains FDA Limited Authorization
Pfizer-BioNTech has been granted FDA (Food and Drug Administration) authorization for its booster shot for people aged 65 and older, as well as individuals at high risk for severe disease and those working in patient-facing healthcare, six months are their second...
Vaccines Europe Calls for Vaccine-specific HTA and Committee
Vaccines Europe has called for an EU-wide committee to implement vaccine-specific clinical health technology assessment (HTA) methodologies in a recent position paper. The paper highlights the broader need for the European Commission (EC) to employ a set of common HTA...
Cervical Cancer: Seagen & Genmab Granted FDA Accelerated Approval
The US FDA (Food and Drug Administration) has granted Seagen and Genmab accelerated approval for TIVDAK (tisotumab vedotin-tftv) to treat adult patients with recurring or metastatic cervical cancer who have previously received disease progression or chemotherapy....
Moderna Shot Higher Effectiveness than Pfizer & JJ, CDC Says
A Centers for Disease Control and Protection (CDC) US-based study has found that the Moderna vaccine is more effective than Pfizer & JJ vaccines at preventing hospitalizations due to COVID-19. The agency’s Morbidity and Mortality Weekly Report states that, the...
MS: EMA Committee Supports Diroximel Fumarate Approval
European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has announced their approval of diroximel fumarate (Vumerity, Biogen Inc) for adults diagnosed with relapsing-remitting multiple sclerosis (MS). Although Diroximel fumarate is...
Dr. Vladimir Misik Interview: What Clinical Trial Market Will Remain Competitive?
CSOFT Health Sciences sat down with Dr. Vladimir Misik, board member of leading European CRO, SanaClis, as well as Partner and Founder of LongTaal, and Partner and Co-founder of VIARES Academy, in our newest podcast episode of Coffee & Conversations to evaluate...
FDA, EMA Launch PSA Pilot for Complex, Hybrid Generic Drugs
The US FDA (Food & Drug Administration) and the EMA (European Medicines Agency) have launched a joint pilot designed to give parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines (as they’re referred to in the EU). The aim of...