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FDA Releases Electronic 510(k) Submissions Draft Guidance
The US FDA (Food and Drug Administration) announced that it has released a draft guidance for sponsors using an electronic template for premarket notification 510(k) submissions.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...
WHO-Backed African Hub to Replicate Moderna COVID-19 Vaccine
The World Health Organization (WHO) has announced that they plan on replicating Moderna’s COVID-19 vaccine to boost COVID-19 vaccination rates and production in Africa. Although efforts have yet to yield results, the plans will allow for more developing countries to...
FDA Accepts Axsome Therapeutics NDA for AXS-07
Biopharmaceutical company Axsome Therapeutics, known for developing innovative therapies for central nervous system (CNS) disorders, announced that the FDA (Food and Drug Administration) has accepted their New Drug Application (NDA) for AXS-07 for acute migraine...
BeiGene’s BLA for Tislelizumab Accepted for Review by FDA
The US FDA (Food and Drug Administration) has accepted for review BeiGene’s Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab to treat patients with reoccurring locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)...
MENA: BioCryst Partners with NewBridge Pharma to Market ORLADEYO
The Ministry of Health and Prevention (MOHAP) in the United Arab Emirates (UAE) has granted BioCryst Pharmaceuticals marketing authorization for their oral medication ORLADEYO® (berotralstat) to help prevent frequent hereditary angioedema (HAE) attacks in patients 12...
Soin Therapeutics receives FDA Orphan Drug Status Grant
The US FDA (Food and Drug Administration) has granted Ohio-based pharmaceutical company Soin Therapeutics orphan drug status for low dose naltrexone (LDN) for the treatment of complex regional pain syndrome (CRPS). Complex Regional Pain Syndrome is characterized by...
Novavax Begins Australian Influenza/COVID-19 Vaccine Trial
American biotech company Novavax announced that it will begin an early-staged trial for a combined influenza/COVID-19 vaccine. The trial will be conducted in Australia and will include 640 adults (between 50 and 70 years of age) and who have either been previously...
2% of Patients With IBD Will Develop PSC, Study Says
A new study has found that approximately 2% of patients with inflammatory bowel diseases (IBD) will develop primary sclerosing cholangitis (PSC), with more men developing the condition compared to women. The analysis, published in Gastroenterology, also states that...