A criminal investigation was reportedly launched by the FDA into a herpes vaccine trial carried out by the late microbiologist William Halford, who injected participants with his experimental and unapproved herpes simplex virus vaccine in Illinois hotel rooms and on a Caribbean island without following essential safety protocols. Kaiser Health News reported that the FDA was investigating the research, although the agency has not commented, and the government of the Caribbean nation of St. Christopher and Nevis said it did not authorize the trial and is investigating.
A recall was issued by OC Raw Dog for its Freeze Dried Sardines because the FDA found that the sardines exceeded the agency's size restriction guideline for uneviscerated fish, making them a potential risk for Clostridium botulinum contamination. Also recalled were company's fish and produce Meaty Rox, Doggie Sliders and Doggie Dozen Patty Bag in various weights because they were found to be contaminated with Listeria monocytogenes.
A scientist working in a secure laboratory in Hungary was accidentally exposed to the Ebola virus last week, and the World Health Organization said it had coordinated the shipment of an experimental vaccine and drugs for use as therapies. The patient had exhibited no symptoms and was placed in isolation at a Budapest hospital.
The FDA approved Helsinn's intravenous formulation of Akynzeo, or fosnetupitant and palonosetron, in combination with dexamethasone to prevent acute and delayed nausea and vomiting in patients undergoing initial or repeat courses of highly emetogenic cancer chemotherapy. Akynzeo was previously approved as 300mg/0.5mg strength hard gel capsules.
The FDA granted orphan drug status to NeuroVive Pharmaceutical for KL1333, which is being developed as a treatment for patients with inherited mitochondrial respiratory chain diseases.
Two presentations by French researchers made recently at the International Liver Congress 2018 confirmed the safety and efficacy of treating hepatitis C patients with genotypes 1b and 4 with minimal fibrosis using an eight-week regimen of Merck's Zepatier, or elbasvir/grazoprevir. The first study showed a 98% sustained virologic response rate in treatment-naive patients with HCV genotype 1b, while preliminary results from the second study indicated that the same eight-week regimen was beneficial in treatment-naive patients with HCV genotype 4.
Australia's Therapeutic Goods Administration granted Celltrion approval to market its Truxima, a biosimilar version of Biogen ad Roche Holding's Rituxan. The drug was approved to treat patients with rheumatoid arthritis and non-Hodgkin lymphoma.
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended against the use of AB Science's masitinib to treat patients with amyotrophic lateral sclerosis because the data provided was not reliable enough to support a registration. The agency also said the relevance of the distinction between patients with normal progression -- who demonstrated an improvement in the primary endpoint -- and those patients with rapid progression was not recognized by the drug company.
Real-world data from a study in JACC: Cardiovascular Interventions showed the use of Neovasc's Reducer balloon-expandable stent for narrowing coronary sinus in patients with refractory angina who could not have further revascularization demonstrated significant improvements in quality of life, angina symptoms and exercise tolerance at four months. At one-year follow-up, benefits were sustained without reports of cardiac deaths, although one patient had recurrent angina and evidence of coronary disease progression, according to the 50-patient study.
Angel Medical Systems secured premarket approval from the FDA for its AngelMed Guardian system, an implantable cardiac monitor indicated for use in patients who experienced acute coronary syndrome events and continue to face a high risk for recurrent events. The system identifies heart attacks and other acute coronary syndrome events, providing patients with alerts using an external alarm device.
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