- Dubai Health Authority deploys robots to disinfect facilities (healthcareitnews.com)
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
- Chinese executives get ‘pre-test’ injections in vaccine race (apnews.com)
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
- Lab that tested U.S. execution drug will no longer accept lethal injection samples (reuters.com)1st federal execution in nearly 2 decades carried out (reviewjournal.com)
DYNALABS, in St. Louis, Missouri, announced the new policy after Reuters published an investigation...that named some of the companies involved in a secret supply chain to make and test a drug ahead of the first federal executions in 17 years...DYNALABS, told Reuters they did not know the samples of the drug, pentobarbital, belonged to the Justice Department, nor that it was intended for executions...“It will be our policy going forward to require a statement from our client indicating their preparation will not be used for execution,” Michael Pruett and Russell Odegard, DYNALABS’ co-founders, said in a statement published on Friday on their website. “Clients that decline to make that declaration will not be allowed to submit their pentobarbital preparations to DYNALABS for testing.”...READ MORE
- Bayer hits Roundup settlement snag as judge ‘tentatively inclined’ to reject $1.25B deal (fiercepharma.com)
A U.S. judge, skeptical of how Bayer plans to resolve future Roundup claims, says he's "tentatively inclined" to reject that part of the $10 billion-plus settlement...Looks like Bayer’s Roundup litigation headache may not be over after all, even after the company committed nearly $11 billion to a settlement...U.S. District Judge Vince Chhabria...said in a court filing...that he’s ready to reject part of the deal centered on potential future claims that the popular Monsanto weedkiller causes cancer...“[T]he Court is skeptical of the propriety and fairness of the proposed settlement, and is tentatively inclined to deny the motion,” Chhabria wrote...READ MORE
- Biohaven hits social media jackpot with superceleb Khloe Kardashian as spokesperson for migraine med Nurtec ODT (fiercepharma.com)
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
- UK, US, Canada accuse Russia of hacking virus vaccine trials (apnews.com)
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
- USP launches new standards (chaindrugreview.com)Protecting patients from harmful impurities (usp.org)
USP has announced the release of six new Reference Standards to support manufacturers and regulators in analyzing and monitoring potentially harmful nitrosamine impurities in the drug supply chain...in 2018, nitrosamine impurities were found to be present in some angiotensin II receptor blockers used to treat high blood pressure and heart failure...exposure to this class of chemical compounds, nitrosamines have the potential to cause cancer. Nitrosamine impurities have since been found in ranitidine and metformin, leading to major recalls and efforts by regulators and industry worldwide to reduce or eliminate the presence of these impurities in the drug supply...READ MORE
- Johnson & Johnson to start human testing of COVID-19 vaccine next week (fiercepharma.com)
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
- Kansas City Ex-Pharmacist Robert Courtney Will Remain In Prison, Senator Hawley Says (kcur.org)
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
- Want to defeat COVID-19? Deliver a 70% effective vaccine—and get 70% of people to take it, FDA official says (fiercepharma.com)FDA Maps Expectations for COVID Vaccine Proposals (biopharminternational.com)Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry (fda.gov)
To eradicate SARS-CoV-2, the virus that causes COVID-19 illness, we'll need a vaccine that's 70% effective—and 70% of the population will need to receive it, an FDA vaccine official said...That's a higher bar than the FDA set last week. To pass muster at the agency, a COVID-19 vaccine will need to be at least 50% more effective than placebo, according to new FDA guidelines...But the agency felt a 50% efficacy requirement was a “reasonable place” and about comparable to a flu vaccine on a good year, said Peter Marks, director of the Center for Biologics Evaluation and Research...READ MORE