// Biotech and Pharma Therapeutics
Backed by $40M, a biotech startup targets cancer with help from the immune system
August 16, 2022 / Cancer / Biotech / Startups
M3T Biosciences is emerging from stealth with plans to develop therapies based on T cell receptors. 3T, which was initially formed in 2017, aims to harness the body’s immune system to fight cancer. It’s a goal shared by many other biotechs, but one that, for complex biological and scientific reasons, has proven challenging nonetheless. 3T believes it’s in a position to succeed, though, thanks to a suite of technologies it claims can help overcome two obstacles in immunotherapy development.
Novartis is spinning off its Sandoz business
August 25, 2022 / Sanofi / Amcenestrant / Cancer
The Swiss pharma giant wants to turn its biosimilar and generics division into a standalone company.
Johnson & Johnson And Arrowhead Pharmaceuticals Could Have Big News Coming
August 23, 2022 / J & J / Arrowhead Pharmaceuticals
Johnson & Johnson (NYSE:JNJ) is often a big contributor at large scientific conferences, which can often include the release of new data sets and future plans for parts of their pipeline. This year’s 2022 AASLD Liver Meeting in Washington D.C. from November 4-8 could be an exciting catalyst for the company as it could be in the position to release some exciting new liver candidate results that could be great for the company as well as partner companies such as Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR).
Global Blood Therapeutics’ tough negotiating led Pfizer to boost its buyout offer 3 times, filing shows
August 23, 2022 / Pfizer / Global Blood Therapeutics
Turns out, Pfizer didn’t proactively seek a Global Blood Therapeutics acquisition in the first place. The first contact with GBT was made by another company, which on May 26 asked to buy out the sickle cell disease (SCD) specialist for $55 per share, a new securities filing shows. In the months that followed, GBT pitted that first comer and Pfizer against each other, managing to push Pfizer to sweeten its offer several times before shaking hands on the $68.50-per-share price in their $5.4 billion deal.
RNA Therapeutics Market to reach Huge Growth and Tremendous Demand in Next Coming years by 2030 | Quark Pharmaceuticals Inc. (USA), Alnylam Pharmaceuticals Inc. (USA)
August 25, 2022 / RNA Therapeutics / Quark Pharmaceuticals / Alnylam Pharmaceuticals
Global RNA Therapeutics Market: research report covers market opportunities, competitive landscape as well as growth analysis and forecast during the projected time. Not only this but also the report aims to provide a global RNA Therapeutics market overview that consists of comprehensive market segmentation by type, geography as well as application. According to the market analyst during the forecast period, the RNA Therapeutics market is expected to witness huge growth.
// 4th Industrial Revolution
AI + Social Media: The Intersection of 2 Contemporary Inventions Takes Physician Engagement to the Next Level
August 24, 2022 / Artificial Intelligence / Social Media / HCPs
The two technologies are helping HCPs spread information and collect data in new ways. More industries are prioritizing social media as they recognize its significance for appealing to consumers. Healthcare and life sciences are no exception. For healthcare professionals (HCPs), social media is now a driving force for disseminating information, advocating for change, and connecting with patient communities and peers.
Where to invest increasing digital health dollars
August 24, 2022 / Digital Transformation / HIMSS22 / Digital Health
According to the HIMSS22 State of Healthcare Report, 80% of health system leaders plan to increase their investment levels in digital health over the next five years. The report also found 60% describe themselves as “stuck in the planning and pre-implementation phases” of digital transformation, either because they don’t have the necessary infrastructure or they lack the high-quality patient and other data required to achieve their goals.
How Smart Homes Are Revolutionizing Home Care
August 21, 2022 / Home Care / Smart Homes / Telehealth
Smart homes are advancing the future of personal healthcare – without patients ever leaving the front door. Healthcare is already amid great technological evolution, especially with the rise of telehealth. Smart home technologies will take that to a new level in the years ahead. From better air quality to at-home elder care, smart homes are already helping people live healthier lives. Smart home tech increases visibility so home occupants can adjust their habits and household for their own health needs and goals.
What healthcare startups need to know to create a secure environment for sensitive data
August 23, 2022 / Ransomware / Health IT / HIPAA / FISMA / HITRUST / NIST
Actions ranging from data theft to ransomware cost the healthcare industry over $9.2 million on average for every breach, according to data from IBM. Healthcare startups and healthcare organizations that use protected health information have to presume they are potential targets for cybersecurity attacks and data breaches and plan accordingly.
Smartphone App Measures Fall Risk for Seniors in Their Homes
August 15, 2022 / Mobile Apps / Elderly Care / Fall Prevention
Falls among older adults are common, costly, and, much too often, fatal. The CDC’s 2019 statistics on older adult falls include 3 million falls that required emergency department visits and $50 billion in annual medical costs, 75% paid by Medicare and Medicaid. Even more shocking, older adult falls resulted in 34,000 deaths in 2019, the most frequent cause of injury death. In 2021 Health Tech Insider wrote about OneStep, a digital physical therapy app.
// Business & Markets
Fair Square Medicare Just Raised Its Series A. Here’s How It And Other Digital Health Platforms Are Guiding Seniors Through The U.S. Healthcare Maze
August 25, 2022 / Fairsquare Medicare / Senior Care / US Healthcare
Daniel Petkevich is an American entrepreneur pursuing the American dream following his parent’s immigration from the old Soviet Union. But, while his entrepreneurial story could shape up to be the quintessential experience that every immigrant family hopes for, unfortunately for his parents, they are also getting the quintessential experience that comes with the U.S. healthcare system.
Alcon to Acquire Aerie Pharmaceuticals in $753M Deal
August 24, 2022 / Alcon / Aerie Pharmaceuticals Inc. / Merger
Alcon and Aerie Pharmaceuticals Inc. have entered into a definitive merger agreement through which Alcon will acquire Aerie in a transaction valued at approximately $753 million. The acquisition expands Alcon’s footprint in the ophthalmic pharmaceutical space and is expected to add broader R&D capabilities to its existing commercial efforts.
Aktis Oncology Raises $84 Million to Advance Novel Targeted Alpha Radiopharmaceuticals
August 25, 2022 / Cancer / Oncology / Investments
Aktis Oncology, a biotechnology company discovering and developing novel classes of targeted alpha radiopharmaceuticals to treat a broad range of solid tumors, today announced it has raised a Series A Extension financing of $84 million, bringing the total capital raised to date to $161 million.
Amazon Care is shutting down at the end of 2022. Here’s why
August 24, 2022 / Amazon Care / Virtual Urgent Care
Three years after it began piloting a primary care service for its employees that blended telehealth and in-person medical services, Amazon plans to cease operations of its Amazon Care service. Amazon announced Wednesday afternoon that it would end Amazon Care operations after December 31. In an email to Amazon Health Services employees, Neil Lindsay, senior vice president of Amazon Health Services, said Amazon Care wasn’t a sustainable, long-term solution for its enterprise customers.
Pharma’s new marketing mix brings closer collaboration with sales reps
August 24, 2022 / Marketing / Digital / Pharmaceutical Sales
While pharma experienced a massive shift to digital sales brought on by the COVID-19 pandemic moving forward, a marketing mix that includes in-person touch points remains integral to building strong relationships in the pharmaceutical marketing industry. That’s according to Dan Rizzo, Veeva Systems’ head of global business consulting, who explained in an interview that pharma needs to be shifting sales and marketing tactics in this new, so-called “blended environment,” which includes developing a new sales compensation model for the future.
// Legal & Regulatory
The promise and uncertainty of healthcare in the metaverse
August 24, 2022 / Metaverse / HIPAA
There have been more than 400 healthcare patents filed in the metaverse as people look to the virtual reality platform to improve the healthcare industry, yet the platform is still underdeveloped, Politico reported Aug. 24. According to IFI Claims, a Connecticut company that tracks intellectual property, IBM, Microsoft, Medtronic, Siemens and Chinese telehealth firm Ping An have filed for healthcare patents in the metaverse, but experts say the metaverse’s place in healthcare is still vague.
FDA’s adcomm process needs reform, researchers say
August 22, 2022 / FDA / Regulation
Reforms are needed to make the US Food and Drug Administration’s (FDA) advisory committee process more consistent and transparent, according to three researchers from the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital and Harvard Medical School. The researchers propose that FDA issue guidance spelling out how it decides whether to convene an advisory committee and committing to seeking advisory committee input for certain types of regulatory decisions, such as accelerated approvals.
FDA clears Insulet Omnipod 5 for children two years and older
August 22, 2022 / Insulet / Type 1 Diabetes / Omnipod 5
Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 for individuals aged two years and older with type 1 diabetes.
Acton, Massachusetts-based Insulet’s Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals six years of age and older.
FDA says it’s making recruitment strides, but problems with overseas inspections persist
August 22, 2022 / FDA / Inspections / Human Resources
Amid pandemic-fueled delays to the FDA’s manufacturing inspection work, staffing issues have emerged as another sticking point for the regulator. While the agency seems to have made good progress on hiring in the past 12 months—even picking up a few lessons courtesy of COVID-19—there’s still much work to be done, especially when it comes to agents overseas. As of Monday, the FDA had 56 open job postings on USAjobs.gov, a significant drop from the 416 vacancies the agency had listed on the website about a year ago.
Regulatory considerations to keep pace with innovation in digital health products
August 19, 2022 / Digital Health Products / Regulatory / Medical Devices
Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a useful structure, but the evolution of digital devices requires concomitant innovation in regulatory approaches to maximize the potential benefits of these emerging technologies.
// Research & Development
Estimating the impact of biosimilar entry on prices and expenditures in rheumatoid arthritis: a case study of targeted immune modulators
August 15, 2022 / Rheumatoid Arthritis / Targeted Immune Modulators (TIMs)
To model changes in prices, utilization, and expenditures of targeted immune modulators (TIMs) for rheumatoid arthritis, accounting for biosimilar entry. Biologics facing biosimilar competition may experience price decreases, potentially offering substantial savings to payers, patients, and society, although the magnitude of these estimates depends on biosimilar uptake.
CRISPR Engineers Stronger T Cells For Immunotherapy
August 25, 2022 / Gene Therapy / Cancer / T cells
Using CRISPR-based genome editing on T cells used in immunotherapy treatments, researchers have rendered the therapeutic cells more resilient. The discovery may help overcome a major factor limiting the success of these promising therapies in curbing both solid and liquid tumors. This work is published in Nature in the paper, “RASA2 ablation in T cells boosts antigen sensitivity and long-term function.”
Alpha Cognition’s delayed-release Alzheimer’s drug hits goal, teeing up approval filing
August 23, 2022 / Alzheimer’s / Study
Alpha Cognition has taken another step toward a filing for approval of its delayed-release treatment for Alzheimer’s disease, publishing top-line results from a study that compared the prospect to an incumbent product. The asset, ALPHA-1062, is a delayed-release prodrug formulation of galantamine, a reversible inhibitor of acetylcholinesterase that is used to treat the symptoms of Alzheimer’s.
As Sanofi’s SERD falls, Menarini’s advances with EU review
August 19, 2022 / Sanofi / Menarini / Breast Cancer
Just days ago, Sanofi sent its oral selective estrogen receptor degrader (SERD) for breast cancer to the trash can. But over in Italy, a biotech is plodding forward with its own candidate, with the EU beginning a regulatory review. The news for Menarini comes a few days after the FDA accepted elacestrant for priority review and placed a due date of Feb. 17, 2023, on the decision.
Metformin drastically reduces COVID hospitalization
August 19, 2022 / COVID-19 / Metformin / Diabetes
The widely available diabetes drug metformin reduced serious outcomes by more than half if started within 4 days of COVID symptoms in a large, randomized, double blind controlled trial, the University of Minnesota announced today. The results were published Aug. 18 in the New England Journal of Medicine.
New drug pricing law puts cancer drugs in the spotlight
August 24, 2022 / Medicare / Cancer
Democrats’ new drug pricing law will likely deliver a financial blow to one of the fastest-growing and most lucrative segments of the pharmaceutical industry: cancer drugs. Why it matters: The drug industry argues that the new law will keep oncology treatments from reaching some patients who need them. But experts say the current system lets companies profit from developing drugs that yield only incremental advances — and that cancer drugs will still be valuable enough for companies to pursue.
Everyone is thrilled that Medicare can finally negotiate drug prices. Prepare to be disappointed
August 19, 2022 / U.S. Senate / Medicare
Among the healthcare provisions of the Inflation Reduction Act just signed by President Biden, one shiny object stands out. It’s the provision allowing Medicare to negotiate pharmaceutical prices directly with drug companies for the first time. Journalists and some consumer advocates are over the moon about this provision, which has been on Democratic policymakers’ wish list for decades. The healthcare news site Stat called it a “crowning healthcare achievement” for Biden.
How Medicare Rx Price Negotiations Will Work
August 15, 2022 / Medicare / Drug Pricing
When Congress added a prescription drug benefit to Medicare nearly two decades ago, the bill explicitly prohibited the program from negotiating with pharmaceutical companies for the prices of the life-sustaining drugs that millions of enrollees take every day. AARP has made the argument for many years that with more than 50 million Americans getting their medications through Medicare, if the program was allowed to negotiate prices, the power of those numbers would yield a much better deal for Medicare beneficiaries and for taxpayers, who ultimately foot the bill for the lion’s share of the medication costs.
Government issues final rules to prevent surprise medical bills
August 24, 2022 / No Surprises Act / Texas Medical Association
People continue to get “surprise medical bills” for unknowingly being treated by providers outside of their health insurance network even after Congress passed a law banning this. On Friday, the Department of Labor, Department of the Treasury and Department of Health and Human Services took steps that is expected to prevent consumers from receiving them at all. It issued final rules concerning standards related to the arbitration process between providers and payers that is key to implementing the No Surprises Act.