Author: Peter

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development...under the umbrella of the International Coalition of Medicines Regulatory Authorities...Emphasis was placed upon the requirement for Phase III clinical trials...should include those with underlying medical conditions so that relevant data can be generated. Additionally...clinical studies should be designed with stringent success criteria to ensure there is convincing demonstration of efficacy...READ MORE

Centers for Disease Control and Prevention Director Dr. Robert Redfield says the controversial new process, which calls on hospitals to send capacity and utilization data to HHS, was made with CDC support...The Trump administration has directed hospitals to stop reporting COVID-19 data to the Centers for Disease Control and Prevention's National Healthcare Safety Network...Instead, starting Wednesday, they have been told to send capacity and utilization information – including patient numbers, remdesivir inventory and bed and ventilator usage rates – to the U.S. Department of Health and Human Services through the new HHS Protect system...HHS Protect has been aggregating data since April, with much of that information coming from the CDC...During the pandemic it became clear that we needed a central way to make data visible to first responders...READ MORE

Several biopharma players are racing to deliver COVID-19 vaccines, and now Johnson & Johnson is revving up its plans for late-stage trials earlier than originally expected—and it's aiming far above the FDA's 50% efficacy bar for approval...Johnson & Johnson chief scientific officer Paul Stoffels said the company has seen “strong” preclinical data, and it's now ready to kick off human testing...A phase 1/2a study in more than 1,000 adults ages 18 to 55 will start by enrolling in Belgium next week and open to U.S. participants the week after...READ MORE

Robert Courtney, the former Kansas City pharmacist whose dilution of cancer medications led to the premature deaths of hundreds and possibly thousands of patients, will not be released from prison early...The decision to keep Courtney in prison would mark a reversal by the Bureau of Prisons to release him to a halfway house today and then to home confinement in Trimble, Missouri, because of the COVID-19 pandemic...Courtney was sentenced to 30 years in prison after he pleaded guilty in 2002 to various crimes associated with his drug dilution scheme...READ MORE

CVS Pharmacy has issued a face covering policy at all locations for customers...Since the pandemic began, we’ve done everything we can to keep people safe and healthy. This includes requiring that store employees wear face coverings and encouraging our customers to do so as well. In any community with state or local laws mandating the use of face coverings, we’ve made that very clear through signage and other reminders...With the recent spike in COVID-19 infections, we’re joining others in taking the next step and requiring all customers to wear face coverings when entering any of our stores throughout the country effective Monday, July 20...READ MORE

The Dubai Health Authority has introduced eight “smart” robots to sterilise its government-run hospitals and clinics...The robots – created by...UVD Robots – are part of the emirate’s drive to use smart technology, where possible, in the disinfection process in order for it to be “thorough, efficient and less time-consuming”...“[The] UVD Robot is used as part of the regular cleaning cycle, and aims at preventing and reducing the spread of infectious diseases, vira [SIC], bacteria, and other types of harmful organic microorganisms in the environment by breaking down their DNA-structure...READ MORE

In the global race to make a coronavirus vaccine, a state-owned Chinese company is boasting that its employees, including top executives, received experimental shots even before the government approved testing in people...“Giving a helping hand in forging the sword of victory,” reads an online post from SinoPharm with pictures of company leaders it says helped “pre-test” its vaccine...Whether it’s viewed as heroic sacrifice or a violation of international ethical norms, the claim underscores the enormous stakes as China competes with U.S. and British companies to be the first with a vaccine to help end the pandemic — a feat that would be both a scientific and political triumph...READ MORE

A highly anticipated clinical trial for a potential COVID-19 vaccine managed in part by the American drug company Moderna has resulted in some adverse effects in more than half of the trial's participants, with one test group reporting "severe" symptoms...The trial, which is also being sponsored by the National Institute of Allergy and Infectious Diseases...The vaccine "induced anti–SARS-CoV-2 immune responses in all participants," the research team reported...in the New England Journal of Medicine. Researchers said that "no trial-limiting safety concerns were identified." Yet a majority of participants still reported at least one side effect..."Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site," the report states. Fever, joint pain and nausea were also reported...READ MORE

Khloe Kardashian’s pain—or rather, her relief from pain—may be Biohaven’s gain...The social media and reality TV super star, who has more than 100 million followers, suffers from debilitating migraines dating back to the sixth grade. A few months ago, though, she tried Nurtec ODT (dissolvable CGRP inhibitor ) and found pain relief she hadn’t had before...Kardashian is now the paid spokesperson in Biohaven’s just-launched “Take Back Today” campaign...READ MORE

Britain, the United States and Canada accused Russian hackers on Thursday of trying to steal information from researchers seeking a coronavirus vaccine, warning scientists and pharmaceutical companies to be alert for suspicious activity...Intelligence agencies in the three nations alleged that the hacking group APT29, also known as Cozy Bear and said to be part of the Russian intelligence services, is attacking academic and pharmaceutical research institutions involved in COVID-19 vaccine development...“It is completely unacceptable that the Russian Intelligence Services are targeting those working to combat the coronavirus pandemic,″ British Foreign Secretary Dominic Raab said in a statement, accusing Moscow of pursuing “selfish interests with reckless behavior.”...READ MORE