// 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. Read Full Article on Biopharma Dive >>
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. Read Full Article on Biopharma Reporter >>
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). Getting in now on Johnson & Johnson or Arrowhead Pharmaceuticals could get investors in early before hype builds around the event and additional data arrives concerning a potential blockbuster treatment for hepatitis B virus (HBV). Read Full Article on Seeking Alpha >>
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. Read Full Article on Fierce Pharma >>
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. The market research report also provides what are related to the market size market growth rate revenue market share and consumption of the leading market players, strengths, weaknesses, business strategies, important trends, and opportunities in the market. Read Full Article on Digital Journal >>

// 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. Read Full Article on PharmaExec.com >>
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. Full Article on Healthcare IT News >>
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. Smart devices can also act as virtual assistants or nurses, using AI to set reminders, manage prescriptions, monitor behavior, and even order groceries. Read Full Article on Healthcare Weekly >>
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. Health IT vendor Ventech Solutions has published a white paper designed to provide guidance to health tech startups and healthcare organizations on steps they can take to ensure the security of a healthcare data infrastructure to support tech development and reduce the cybersecurity threat to their businesses. Read Full Article on MedCity News >>
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. Read Full Article on HealthTech Insider >>
Tandem Diabetes Care delivers 1 million insulin boluses using t:connect mobile app
August 18, 2022 / Mobile Apps / Diabetes / Tandem – Tandem Diabetes Care (Nasdaq:TNDM) announced today that its users have delivered more than 1 million insulin boluses using its app. Users of the t:connect app feature on their mobile devices have reached the 1 million insulin bolus milestone with the t:slim X2 insulin pump within the first month following its commercial release. Read Full Article on Drug Delivery Business News >>

// 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. Read Full Article on Forbes >>
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. Alcon will add the commercial products netarsudil and latanoprost ophthalmic solution (Rocklatan) 0.02%/0.005% and netarsudil ophthalmic solution (Rhopressa) 0.02%, as well as AR-15512, a Phase 3 product candidate for dry eye disease, alond with a pipeline of several clinical and preclinical ophthalmic pharmaceutical product candidates. Read Full Article on Contract Pharma >>
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. The extension included participation from new premier healthcare investors Cowen Healthcare Investments, MRL Ventures Fund, the therapeutics-focused corporate venture fund of Merck & Co., Inc., ArrowMark Partners, Mirae Asset Venture Investment, Timefolio Capital (formerly known as NS Investment), Pappas Capital, and other undisclosed participants. All existing investors MPM Capital, Vida Ventures, EcoR1 Capital, Octagon Capital, TCG Crossover, Bristol Myers Squibb, and Novartis participated in the financing. Read Full Article on Biospace >>
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. Read Full Article on Fierce Healthcare >>
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. Read Full Article on Fierce Pharma >>

// 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. Read on Berkshire Hospital Review >>
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. They also call on the agency to publish in advance the questions it will ask advisory committees to consider and to standardize some of the questions related to approval or authorization of products. Finally, the researchers ask FDA to commit to publicly explaining its reasoning when rejecting the advice of an advisory committee. Read on Regulatory Focus >>
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. In June, the company presented data supporting the use of Omnipod 5 in young children, with the platform significantly improving time in range and reducing HbA1c in children aged 2 through 5.9 years old with type 1 diabetes over 12 months of use. Read on Drug Delivery Business >>
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. The listings run the gamut from physician posts and consumer safety roles to those for program analysts, statisticians and regulatory counsel. Read on Fierce Pharma >>
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. A number of specific adaptations could strengthen current regulatory oversight while promoting ongoing innovation. Read on Nature.com >>

// 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. Read Full Article on Taylor & Francis >>
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.” Read Full Article on Genetic Engineering & Biotechnology News >>
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. Because galantamine can cause gastrointestinal adverse events including nausea, vomiting and decreased appetite, Alpha Cognition sees a market for a prodrug formulation that remains inert as it passes through the stomach. Read Full Article on Fierce Pharma >>
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. Now, an application for the SERD has been validated by the European Medicines Agency for patients with second-line and third-line ER+/HER2- advanced or metastatic breast cancer. The validation means that the agency is kicking off its formal review. Read Full Article on Fierce Biotech >>
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.
The study was primarily funded by three philanthropic foundations: Parsemus Foundation, Rainwater Charitable Foundation, and Fast Grants. Read Full Article on World Pharma News >>

// Politics

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. Read Full Article on Axios >>
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. Read Full Article on Los Angeles Times >>
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. Read Full Article on AARP >>
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. Read Full Article on MedCity News >>