- FBI warns ransomware assault threatens US health care system (apnews.com)
...the FBI and two federal agencies said they had credible information of “an increased and imminent cybercrime threat” to U.S. hospitals and health care providers. The alert said malicious groups are targeting the sector with attacks aiming for “data theft and disruption of healthcare services.”...It involves a particular strain of ransomware, which scrambles a target’s data into gibberish until they pay up. Previous such attacks on health care facilities have impeded care and, in one case in Germany, led to the death of a patient..Independent security experts say the ransomware, called Ryuk, has already impacted at least five U.S. hospitals this week and could potentially affect hundreds more. Four health care institutions have been reported hit by ransomware so far this week, three belonging to the St. Lawrence Health System in upstate New York and the Sky Lakes Medical Center in Klamath Falls, Oregon...READ MORE
- Early-stage nano-carrier uses miRNA to deploy cancer meds on contact with diseased cells (fiercepharma.com)
Cancer cells could play a key role in the delivery of tumor-fighting drugs, thanks to a new DNA transport system that keeps its therapeutic payload locked away until it comes into contact with diseased cells...Scientists at the Technical University of Munich and the KTH Royal Institute of Technology...say they’ve developed a synthetic DNA transport system for targeted delivery of cancer drugs...the team has created a nano-carrier using mucin, glycerol and synthetic DNA, which wraps up cancer drugs in a secure package that can only be unlocked by a certain RNA sequence unique to diseased cells...READ MORE
- FDA launches Digital Health Center of Excellence (medicaleconomics.com)Digital Health Center of Excellence (fda.gov)
The U.S. Food and Drug Administration has announced the launch of the Digital Health Center of Excellence within the Center for Devices and Radiological Health...the center will be an important step in furthering the agency’s goal of advancing digital health technology, including mobile health devices, software as a medical device, wearables used with medical devices, and technology used to study medical products...The FDA aims to continue building and formalizing the coordinating structure and operation of the center as part of an its effort to modernize policies and regulations, as well as providing efficient access to specialized expertise, knowledge, and tools in accelerated access to digital health technology...READ MORE
- Humana files suit against telehealth company QuivvyTech over millions in alleged false claims (fiercehealthcare.com)
Humana has filed suit against Florida-based telehealth company QuivvyTech, saying it was defrauded out of millions of dollars...filed in Southern Florida district court, QuivvyTech telemarketers would cold-call Humana members and ask them questions about common ailments. They would then wire that information to physicians who were in the scheme to secure prescriptions for pricey, unneeded creams...The physicians would prescribe these creams without ever speaking to the patient directly, according to the lawsuit. The prescriptions would then be wired to pharmacies that were also active participants in the scheme to be dispensed to members...One doctor, for instance, submitted 1,600 claims through the scheme to which Humana paid out more than $1.1 million, the insurer alleges in the suit...A New York pharmacy submitted 2,100 claims for one type of cream, for which Humana paid more than $2.5 million, the insurer alleges...READ MORE
- Germany, Digital Healthcare Act, healthcare apps (healthcareitnews.com)
Two healthcare apps available for prescription in Germany for first time...after the German federal government passed the Digital Healthcare Act, two health apps are now officially available for prescription...two apps have been approved, making it the first country to prescribe insured health apps...The first apps were unveiled last week after making it through the test procedure from the Federal Institute for Drugs and Medical Devices. They are the Kalmeda app, which aims to help with tinnitus, and Velibra, a therapy programme for anxiety disorders...READ MORE
- AI Identifies Sex-Specific Adverse Events With High Precision (drugtopics.com)
Researchers have developed an algorithm that is able to accurately predict sex differences in drug response through the implementation of pharmacogenomic data...The study...presented AwareDX, a resource that uses machine learning to understand sex-specific adverse drug effects with the potential for use in drug discovery, repositioning, and pharmacogenetic studies, as well as for further analyses of electronic health records and clinical trials, according to investigators...Women are twice as likely as men to develop adverse drug reactions to a drug, partly due to differences in pharmacokinetics and pharmacodynamics that induce increased drug bioavailability and sensitivity to medication and women [remain] severely underrepresented in clinical trials...READ MORE
- Customizable synthetic antibiotic outmaneuvers resistant bacteria (sciencedaily.com)
Antibiotic resistance is one of the world's most urgent public health threats...Researchers at UC San Francisco are tackling antibiotic resistance using a different approach: redesigning existing antibiotic molecules to evade a bacterium's resistance mechanisms. By devising a set of molecular LEGO pieces that can be altered and joined together to form larger molecules, the researchers have created what they hope is the first of many "rebuilds" of drugs that had been shelved due to antibiotic resistance..."The aim is to revive classes of drugs that haven't been able to achieve their full potential, especially those already shown to be safe in humans,"..."If we can do that, it eliminates the need to continually come up with new classes of drugs that can outdo resistant bacteria. Redesigning existing drugs could be a vital tool in this effort."...READ MORE
- Moderna won’t enforce COVID-19 vaccine patents during pandemic (fiercepharma.com)What Are mRNA Vaccines, and Could They Work Against COVID-19? (smithsonianmag.com)
Moderna, a biotech advancing one of the leading COVID-19 vaccine candidates, has faced questions for several months over its patents and intellectual property. Responding to investor questions, the company now says it won't enforce its vaccine patents against other companies during the pandemic...company President Stephen Hoge said Moderna is “quite studiously not asserting infringement.” Without naming names, the biotech says other COVID-19 vaccines in development might be using Moderna-patented technology...“We’re not interested in using that IP to decrease the number of vaccines available in a pandemic,”...Further, the company is open to licensing its technology after the pandemic. Moderna made the pledge in response to investor questions around its patents...READ MORE
- DOJ charges hundreds in connection with $6B in healthcare fraud in largest takedown ever (fiercehealthcare.com)
The Department of Justice charged 345 people across 51 federal districts in the largest healthcare fraud takedown in the agency's history...The DOJ said the charges were in connection with cases responsible for more than $6 billion in losses. Among those charged were more than 100 doctors, nurses and other medical professionals, according to the DOJ...The billions in false claims were submitted to both public and private insurers,...with more than $4.5 billion connected to telemedicine schemes...In addition, $845 million in fraud losses were linked to substance abuse treatment facilities known as "sober homes," and $806 million was connected to other types of healthcare fraud and illegal opioid distribution...READ MORE
- GoodRx files to go public, boasting track record of profitability (fiercehealthcare.com)How GoodRx Profits from Our Broken Pharmacy Pricing System (drugchannels.net)
Joining a recent spate of digital health companies hitting the public market, GoodRx filed its initial public offering...The startup, which helps consumers find deals on their prescription medications, is looking to raise up to $100 million in an IPO...Unlike many other digital health companies that have gone public, GoodRx has been profitable since 2016...The majority of the company's revenue, or 97%, comes from its prescription offering in which if collects fees from pharmacy benefit managers when consumers use a GoodRx code to fill a prescription...With the acquisition of telemedicine company HeyDoctor...GoodRx...now competes with other startups that combine virtual care and pharmacy services such as Hims, Hers, Ro and Nurx...GoodRx doesn’t sell medications; it instead directs consumers to the drugstore with the best prices and offers coupons...READ MORE