Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
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...
UK Study Shows COVID-19 Vaccines Reduce Risk of Long COVID
A UK study has shown that the risk of developing long COVID, as well as severe illness caused by COVID-19, is greatly reduced in a person who is fully vaccinated. Published by the Lancet Infectious Diseases Journal, the study indicates that those who have received...
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