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A Chinese court sentenced the scientist who created the world’s first “gene-edited” babies to three years in prison...for illegally practising medicine and violating research regulations...He Jiankui...said he had used gene-editing technology known as CRISPR-Cas9 to change the genes of twin girls to protect them from getting infected with the AIDS virus in the future...The backlash in China and globally about the ethics of his research and work was fast and widespread...“They have crossed the bottom line of ethics in scientific research and medical ethics.”...READ MORE

Artificial intelligence has become a crucial part of our technological infrastructure and the brain underlying many consumer devices....This progress has sparked the use of AI in drug discovery and development...Artificial intelligence can improve efficiency and outcomes in drug development across therapeutic areas...Misapplication of these technologies, however, can have unintended harmful consequences. To see how a good idea can turn bad, just look at what’s happened with social media...The FDA has already issued several proposals around the regulation of AI products, and it now has an opportunity to build on these efforts. The Center for Devices and Radiological Health has reviewed and cleared a number of devices that use AI. The center has also released a proposed framework, “Artificial Intelligence and Machine Learning in Software as a Medical Device.” These proposals, though, don’t necessarily apply to AI-based tools used as part of the drug development process. As a result, biopharmaceutical and technology companies aren’t sure how these tools fit into current regulatory frameworks..READ MORE

FDA released two guidance documents relating to the regulation of various digital health software devices...The first is a draft guidance outlining categories of clinical decision support products that would or would not require direct regulatory oversight from the agency. This is an update to a CDS draft guidance released in 2017, with the noteworthy addition of a risk-based categorization approach for determining enforcement over these tools...The second is a final guidance that brings several existing medical software policies from the agency into accordance with provisions outlined in 2016’s 21st Century Cures Act. In particular, the document describes certain types of software products that will no longer fall within the agency’s definition of a medical device...READ MORE

New system could free bench chemists from time-consuming tasks, may help inspire new molecules...Guided by artificial intelligence and powered by a robotic platform, a system developed by MIT researchers moves a step closer to automating the production of small molecules that could be used in medicine, solar energy, and polymer chemistry…The researchers tested the full system by creating 15 different medicinal small molecules of different synthesis complexity, with processes taking anywhere between two hours for the simplest creations to about 68 hours for manufacturing multiple compounds…The team synthesized a variety of compounds: aspirin and the antibiotic secnidazole in back-to-back processes; the painkiller lidocaine and the antianxiety drug diazepam in back-to-back processes using a common feedstock of reagents; the blood thinner warfarin and the Parkinson’s disease drug safinamide, to show how the software could design compounds with similar molecular components but differing 3-D structures; and a family of five ACE inhibitor drugs and a family of four nonsteroidal anti-inflammatory drugs...READ MORE

Pharmacists have taken their rightful place in the delivery of health care, engaging with patients and making a noticeable improvement in their patients’ health outcomes. As the clinical role of pharmacists has grown, so too has the imperative to fill an ever-increasing number of prescriptions in a day. As a result, pharmacy technology and automation companies are stepping up to the plate to ensure that pharmacists can juggle their role successfully...READ MORE

• Speeding up Dispensing
• Rethinking Processes
• Software and Workflow

In hopes of coming up with an alternative to those injections, MIT engineers, working with scientists from Novo Nordisk, have designed a new drug capsule that can carry insulin or other protein drugs and protect them from the harsh environment of the gastrointestinal tract. When the capsule reaches the small intestine, it breaks down to reveal dissolvable microneedles that attach to the intestinal wall and release drug for uptake into the bloodstream...“We are really pleased with the latest results of the new oral delivery device our lab members have developed with our collaborators, and we look forward to hopefully seeing it help people with diabetes and others in the future,”...READ MORE

New technology, enabling consumers to read packaging labels written in any language, will become the norm for the pharmaceutical industry within 12 months...A prototype video, shown on the Third Aurora website, demonstrates the solution with a prototype package being translated from English to Spanish, German, Russian, and Japanese...Behind the scenes, two technologies are at work. According to Chaffey, “Artificial intelligence reads and interprets the content and augmented reality projects the new text back onto the label.”...READ MORE

Amazon is jumping into the medication adherence space with a new feature that lets users link up their pharmacy prescription information and, in turn, get reminders about when to take their pills and order refills...The latest feature was born out of a collaboration between the online retail giant and Omnicell, a tech-enabled medication management company. Initially the feature will be rolled out to Giant Eagle Pharmacy customers...this feature will be using “multiple layers of verification” to protect user information, including voice recognition and passcodes...Voice technology is coming onto the healthcare scene in recent years...“Voice has proven to be beneficial for a variety of use cases because it removes barriers, and simplifies daily tasks,”... “We believe this new Alexa feature will help simplify the way people manage their medication by removing the need to continuously think about what medications they’ve taken that day or what they need to take...READ MORE

Amazon is going places with its free package pickup. The company has expanded its Counter pickup option to thousands of locations through its new store partners GNC, Stage Stores and Health Mart pharmacies...“For six years, my pharmacy team has served our community and made sure our patients get the care they need,” said Laura Temple, pharmacist and owner of Laura’s Health Mart Pharmacy in Azle, Texas. “Amazon Hub Counter has given my current patients a new, convenient way to pick up their Amazon packages, and it’s also brought in new neighbors who have then been introduced to the meaningful care at my pharmacy. I’m delighted to offer Counter in my local store.”...READ MORE

Walgreens is testing a new on-demand delivery service with Alphabet’s drone delivery service Wing, beginning next month...The pilot program will deliver food and beverage, over-the-counter medications and other items within minutes...Prescription deliveries will not be available...Walgreens will be the first retailer in the U.S. to test an on-demand drone delivery service...READ MORE