// Biotech and Pharma Therapeutics
Magnetic Pills Deliver Insulin To Refill Implanted Reservoir
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.
www.fiercepharma.com
Pharma’s Reputation Drops Again. Could It Foreshadow A Return To The Bottom?
Pharma's reputation continues to slide, now down to 53% of consumers who still hold a positive view. The decline began after a February high of 62% approval, down to 60% in May and then 56% in June—and now down three more percentage points, according to The Harris Poll.
www.fiercepharma.com
With New Results, J&J’s $1B Gamble On A Targeted Inflammation Drug Faces Long Odds
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.
www.biopharmadive.com
That $56,000 Drug? Blame Medicare.
For an increasingly important set of drugs, Medicare has been driving up prices. It knows how to do better.
www.nytimes.com
Regeneron’s Phase 2 Trial Of High-Dose Aflibercept In Wet Age-Related Macular Degeneration Meets Primary Endpoint
Regeneron’s phase 2 trial of high-dose aflibercept in wet age-related macular degeneration meets primary endpoint. 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).
pharmabiz.com
// 4th Industrial Revolution
Zip Codes Have Become A Better Predictor Of Health Outcomes Than Genetic Codes. Technology May Be Ready To Fix That.
Consider this scenario. Two 60-year old women live 10 miles apart in the Washington DC area. They’ve both been prescribed beta-blockers for high blood pressure, both have family histories of Type 2 diabetes, and have missed their last few annual check-ups. What should their care plans look like? Should they be different?
medcitynews.com
Treatable Tumor Models Grown In The Lab
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. In this way the replicas can preview a given tumor’s reaction to specific therapies and combinations thereof.
aiin.healthcare
5 Ways AI Stands To Advance The State Of Burn Care
AI has “remarkable potential” to improve diagnostic accuracy, care efficiency and workflow optimization in the surgical subspecialty of burn care. So conclude researchers in the U.K who systematically selected and analyzed 46 relevant studies published in English.
aiin.healthcare
Himsscast: Are Digital Therapeutics The Future Of 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.
www.mobihealthnews.com
AWS On AI, Machine Learning, Interoperability Improving Patient Outcomes
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. By enabling interoperability securely and supporting healthcare providers with predictive machine learning models and insights afforded by genomic research, clinicians will be able to seamlessly forecast clinical events – such as strokes, cancer or heart attacks – and intervene early with personalized care and access to curated information to support a superior patient experience.
www.healthcareitnews.com
// Business & Markets
Allstripes Lands $50M For Tool That Helps Patients Share Medical Data
AllStripes, a platform that helps patients share their medical data for research on rare diseases, announced it had raised $50 million in Series B financing. 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.
www.mobihealthnews.com
Calibrate Scores $100M Following Company’s One Year Anniversary And More Digital Health Fundings
Calibrate, a virtual program for losing weight, announced Wednesday it has raised $100 million in Series B funding. The round was led by new investors Founders Fund and Tiger Global, with participation from Optum Ventures and existing investors Forerunner Ventures, Threshold Ventures and Redesign Health. 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.
www.mobihealthnews.com
Astrazeneca’s $39B Alexion Buyout Bears Fruit, Yielding Late-Phase Win For Potential Blockbuster Rare Disease Drug
The chances of AstraZeneca’s $39 billion bet on Alexion paying off just ticked up a notch. ALXN1840, a drug Alexion has hailed as a potential blockbuster, has hit the primary endpoint in a phase 3 rare disease trial, clearing the path for a regulatory filing.
www.fiercebiotech.com
Better Therapeutics Secures $50M Debt Facility For Digital Diabetes Treatment Tech
Better Therapeutics announced today that it secured a loan debt facility worth up to $50 million from Hercules Capital.
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.
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.
www.drugdeliverybusiness.com
Vertex Pharma, Arbor Enter New Collaboration To Develop Novel Ex Vivo Engineered Cell Therapies
The new agreement between Arbor and Vertex builds upon the companies’ first partnership established in 2018. Under this new partnership, Vertex will receive rights to use Arbor’s technology to research and develop ex vivo engineered cell therapies towards Vertex’s goal of generating fully differentiated, insulin-producing hypoimmune islet cells for the treatment of type 1 diabetes, for next-generation approaches in sickle cell disease and beta thalassemia, and for the treatment of other diseases.
pharmabiz.com
// Legal & Regulatory
Elizabeth Holmes Will Be On Trial. But The Evidence Will Expose A Bigger Collision Between Tech Culture And Health Care
The trial of Elizabeth Holmes will spotlight the collision between Silicon Valley culture and the more cautious cadence of health care. 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.
www.statnews.com
Sesen, Still Reeling From FDA Rejection, Pulls Filing For EU Approval Of Cancer Drug
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).
www.fiercebiotech.com
FDA Finds Public Easily Misled by Deceptive Drug Ads
The FDA’s Office of Prescription Drug Promotion (OPDP) has found through its own original research that it’s disturbingly easy to fool consumers and even doctors with false or deceptive drug advertising.“
www.fdanews.com
US FDA Approves Medtronic’s Evolut FX TAVR System To Treat Symptomatic Severe Aortic Stenosis
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.
pharmabiz.com
The FDA’s Culture: Should Safety Dominate All Practices?
The FDA wrote that their regulations “do not prescribe any particular type of trial design” and “nothing…requires that drugs undergo testing in distinct phases”. The FDA said: “in addition to flexibility in designing clinical trials, FDA has various other programs to expedite development and review of new drugs including…metastatic cancer”.
thehealthcareblog.com
// Research & Development
Scientists Harness Human Protein To Deliver Molecular Medicines To Cells
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. SEND harnesses natural proteins in the body that form virus-like particles and bind RNA, and it may provoke less of an immune response than other delivery approaches.
www.sciencedaily.com
Medical Cannabis: The Next Innovation In 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.
www.pharmafile.com
Sunflower Pollen May Be The Answer To High-Quality 3D Printing Ink
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.
www.europeanpharmaceuticalreview.com
Tiny Neural Sensors for Brain Computer Interfaces | Medgadget
Researchers at Brown University have developed wireless micro-implants that can function as a network of neural sensors and stimulators in the brain. The research team has dubbed their creation “neurograins,” which are intended to be implanted in the brain in large numbers. When inside, they can transmit data to an external communication hub, in the form of a patch attached to the scalp. The researchers hope that the neurograins will be able to record brain activity from a large number of neurons in the brain, allowing for advanced functionality when using brain-computer interfaces.
www.medgadget.com
High Cholesterol Fuels Cancer Metastasis by Fostering Resistance to a Form of Cell Death
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.
www.genengnews.com
// Politics
Providers Push Congress To Include Value-Based Care Bill In $3.5T Infrastructure Package
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.
www.fiercehealthcare.com
/https%3A%2F%2Fspecials-images.forbesimg.com%2Fimageserve%2F61279632d2b43eccb52f2911%2F0x0.jpg%3FcropX1%3D0%26cropX2%3D5000%26cropY1%3D212%26cropY2%3D3024)
1 In 3 Americans Had Covid By The End Of 2020, Models Estimate—That’s Four Times The Official Count
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.
www.forbes.com
Acting FDA Chief Janet Woodcock Ruled Out as Biden Nominee
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. Woodcock, who has served as acting commissioner since Biden took office, has faced firm opposition on Capitol Hill for the job from lawmakers including Democratic Senator Joe Manchin, a key swing vote in the evenly divided chamber who criticized the agency over the controversial accelerated approval this year of an Alzheimer’s drug
www.bloomberg.com
