// Biotech and Pharma Therapeutics
Magnetic pills deliver insulin to refill implanted reservoir
August 24, 2021 / Diabetes / Implantable Drug Delivery / Implantable Pump / Insulin
It is now more than 40 years since the first diabetic received an implantable insulin pump. Yet, the concept never took off, with Medtronic pulling the plug on R&D back in 2007. Now, a group of Italian researchers is trying to revitalize the approach with an implant refilled using magnetic capsules.
With new results, J&J’s $1B gamble on a targeted inflammation drug faces long odds
August 24, 2021 / J&J / Inflammation Drug / Theravance
Izencitinib is a JAK inhibitor, a type of drug that blocks an enzyme involved in inflammation. The drug class is well-established, having already produced multiple approved treatments for autoimmune diseases.
August 29, 2021 / Medicare / Drug Pricing
For an increasingly important set of drugs, Medicare has been driving up prices. It knows how to do better.
Regeneron’s phase 2 trial of high-dose aflibercept in wet age-related macular degeneration meets primary endpoint
August 25, 2021 / Regeneron / Bayer
Regeneron Pharmaceuticals, Inc. announced that an ongoing phase 2 proof-of-concept trial evaluating an investigational 8 mg dose of aflibercept met its primary safety endpoint, with no new safety signals observed compared to the currently-approved 2 mg dose of Eylea (aflibercept) injection in patients with wet age-related macular degeneration (wet AMD).
// 4th Industrial Revolution
Zip codes have become a better predictor of health outcomes than genetic codes. Technology may be ready to fix that.
August 24, 2021 / AI / Genetic Codes / Diabetes / Clinical Data
A hospital EHR system can tell the full story of a patient’s care, and we’ve built advanced tools to make sense of it all: clinical decision-making aids, population health segmentation tools, and automated billing and coding assistants.
Treatable tumor models grown in the lab
August 20, 2021 / 3D Models / Brain Tumors / Cancer
Researchers in Israel are printing 3D models of brain tumors and connective tissues with synthetic blood vessels through which blood as well as anti-cancer agents can flow.
5 ways AI stands to advance the state of burn care
August 25, 2021 / AI / Machine Learning
The team concentrated on research testing the use of AI and machine learning specifically in burn care, breaking out such utilization aspects as clinical applications, algorithms, outcomes and validation methods.
HIMSSCast: Are digital therapeutics the future of mental health?
August 20, 2021 / Digital Therapeutics / Mental Health
For a long time, the standard of care in mental and behavioral health has been some combination of pharmaceuticals and talk therapy. But with FDA-cleared, rigorously vetted digital health apps, there’s a new piece of the puzzle, and it has the potential to combine the advantages of therapy with the scalability of drugs.
AWS on AI, machine learning, interoperability improving patient outcomes
August 23, 2021 / AI / Machine Learning / Patient / Amazon
As the country moves toward value-based care, artificial intelligence and machine learning – paired with data interoperability – have the potential to improve patient outcomes while driving operational efficiency to lower the overall cost of care.
// Business & Markets
August 24, 2021 / AllStripes / Patients / Medical Data
The round was led by current investor Lux Capital, with participation from AZZ Venture Partners, Spark Capital, Medidata Solutions, McKesson Ventures and Maveron. Angel investors include Arif Nathoo, CEO of Komodo Health, and Leila Zegna, director of the Kabuki Syndrome Foundation.
August 25, 2021 / Digital Health / Calibrate / Better Therapeutics / MedArrive / FDA
Calibrate plans to use the capital to expand its telehealth platform and build its enterprise business with glucagon-like peptide 1 (GLP-1) hormones, including Novo Nordisk’s Wegovy, which was recently approved by the FDA for chronic weight management.
August 26, 2021 / Clinical Trial Data / Gene Therapy / Rare Diseases / Alexion
Alexion picked up ALXN1840 in its $855 million takeover of Wilson Therapeutics as part of a push by CEO Ludwig Hantson, Ph.D., to rebuild the pipeline after earlier R&D missteps left the company unprepared for a forecasted downturn in sales of Soliris. After buying the asset, Alexion began a phase 3 clinical trial designed to show superiority over standard of care in Wilson disease and support blockbuster sales.
Better Therapeutics secures $50M debt facility for digital diabetes treatment tech
August 25, 2021 / Better Therapeutics / Diabetes / New Tech
The debt facility provides up to $150 million in total financing when combined with the proceeds from going public through a $113 million merger with SPAC Mountain Crest Acquisition Corp II and a PIPE investment.
// Legal & Regulatory
Elizabeth Holmes will be on trial. But the evidence will expose a bigger collision between tech culture and health care
August 24, 2021 / Elizabeth Holmes / Healthcare / Theranos
When the long-awaited trial of former Theranos CEO Elizabeth Holmes opens at the end of this month, expect a showdown between defense attorneys and federal prosecutors who have accused her of perpetrating one of the biggest corporate frauds in recent U.S. history.
Sesen, still reeling from FDA rejection, pulls filing for EU approval of cancer drug
August 26, 2021 / Bladder Cancer / Drug Safety / EMEA Application / European Medicines Agency
The rapid unraveling of Sesen Bio goes on. Two weeks ago, the biotech was on the cusp of winning FDA approval for cancer drug Vicineum and working its way toward authorization in Europe. Now, with the FDA rejecting Vicineum days before a media report of misconduct, Sesen has pulled its filing to the European Medicines Agency (EMA).
August 25, 2021 / FDA / Deceptive Drugs
August 26, 2021 / FDA / Evolut FX TAVR
Medtronic announced US Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut FX TAVR system. Designed to enhance ease-of-use and provide greater precision and control throughout the procedure, the Evolut FX system maintains the industry-leading hemodynamic (blood flow) and durability benefits of the Evolut platform, while bringing product and procedure innovation for patients with symptomatic severe aortic stenosis.
// Research & Development
Scientists harness human protein to deliver molecular medicines to cells
August 19, 2021 / Scientists / Molecular Medicines / MIT
Researchers from MIT, the McGovern Institute for Brain Research at MIT, the Howard Hughes Medical Institute, and the Broad Institute of MIT and Harvard have developed a new way to deliver molecular therapies to cells. The system, called SEND, can be programmed to encapsulate and deliver different RNA cargoes.
Medical Cannabis: The next innovation in oncology?
August 25, 2021 / Cannabis / Oncology
The market for medical cannabis has been growing steadily over the last decade, but it may be on the cusp of a breakthrough in oncology. Kat Jenkins takes a look at some of the cutting-edge cannabis research underway, speaking to those working at the forefront of the field to explore this evolving cancer treatment of the future
Sunflower pollen may be the answer to high-quality 3D printing ink
August 26, 2021 / Sunflower Pollen / 3D Printing
A team at Nanyang Technological University (NTU), Singapore, have used sunflower pollen to produce three-dimensional (3D) printing ink material that can be used to fabricate parts useful for tissue engineering, toxicity testing and drug delivery.
Tiny Neural Sensors for Brain Computer Interfaces
August 24, 2021 / New Tech / Brain Computer Interfaces / Neural Sensors
Brain-computer interfaces hold enormous promise as life-changing technologies for people with a variety of conditions. However, the technique is still in its infancy, and designing sensors that can effectively and safely monitor brain activity is a work in progress. Part of the issue is the complexity of the brain, and capturing this using a single sensor or affixing enough sensors in place is difficult.
High Cholesterol Fuels Cancer Metastasis by Fostering Resistance to a Form of Cell Death
August 25, 2021 / High Cholesterol / Metastasis / Cancer
Chronically high cholesterol levels are associated with increased risk of breast cancer, and with worse outcomes in most cancers, but the link hasn’t been fully understood. Studies in cancer cells and in mice by a Duke Cancer Institute-led team have now identified a mechanism that underpins how breast cancer cells use cholesterol to develop tolerance to stress, making them invulnerable as they migrate from the original tumor site.
August 25, 2021 / Accountable Care / Medicare Shared Savings Program / Value-Based / American Hospital Association
As Congress starts drafting a massive $3.5 trillion infrastructure package, a collection of provider groups is making a case for value-based care legislation to be included.
1 In 3 Americans Had Covid By The End Of 2020, Models Estimate – That’s Four Times The Official Count
August 26, 2021 / Covid-19
Around one third of Americans had been infected with Covid-19 by the end of 2020, according to new research published in the journal Nature Thursday, suggesting a much wider spread of the coronavirus than what official testing detected and highlighting the early failures of the U.S. testing program.
August 19, 2021 / FDA / Biden / Janet Woodcock
President Joe Biden’s administration has ruled out nominating Janet Woodcock as permanent head of the Food and Drug Administration, people familiar with the matter say, as the search continues for a leader during a crucial period for full approval of coronavirus vaccines.