Drug price restraints dropped as Biden prioritizes other measures was reported by Jonathan Bardner for BioPharmaDive.com, 29 October 2021. Industry opposition appears to have toppled another administration’s effort to lower prices. No matter what your political leanings, as someone living with Type 1 diabetes, this has to make you angry and confused.
Broad national drug pricing controls aren’t likely to be signed into law this year after President Joe Biden, facing congressional opposition, left them out a legislative negotiating framework for a package that includes health insurance, education and more support for household income.
The announcement Thursday likely ends all hope of enacting a law authorizing the federal government to negotiate, and potentially reduce, prescription drug prices. But smaller measures could still make it into the package, such as provisions that target Medicare payments for biologic drugs administered in healthcare facilities.
Medicare negotiation of drug prices has been a signature proposal for Biden’s allies among congressional Democrats. But the idea has been fiercely resisted by drugmakers, whose lobbying by Pharmaceutical Research and Manufacturers of America (PhRMA) has built enough opposition that it and other price restraints won’t be part of the social package.
Frustrated? You can participate with Diabetes Patient Advocacy Coalition (DPAC), co-founded and run by people with diabetes who understand that like diabetes, advocacy is a long-term process with no quick fixes. DPAC was formed because the patient voice was missing from important policy conversations in Congress and the states. They identify what matters most and help empower advocates to take action. Share your story to help keep policymakers’ attention on people with diabetes!
Restoring Immune System Balance Using the Power of Cell Therapy is the mission of Sonoma Bio, where they are leveraging the properties of regulatory T cells (Tregs) to create living cell therapies that restore the immune system back to its balanced, fully functioning state. This is serious and very significant science … and something we learn about!
The immune system is complex, touching every tissue type in the body. Immune cells must meet the challenge of distinguishing between “non-self” (such as viruses, bacteria and other pathogens) and “self” antigens. If they cannot make this distinction, the result is the onset of devastating autoimmune diseases like rheumatoid arthritis, Crohn’s disease, Type 1 diabetes and over 80 other syndromes. Despite significant advances in the development of therapies to treat these conditions, existing medicines are often short-lived, need to be chronically delivered and can be ineffective at treating the underlying causes of disease, leaving many patients to suffer in silence.
Cell and genetic engineering have already established a new pillar of medicine for the treatment of cancer. In harnessing the power of regulatory T cells (Tregs) – shown to have multiple therapeutic and tissue-reparative properties – we are engineering a new generation of cell therapies to have enhanced function and the ability to target specific tissues.
Tregs, circulating throughout every tissue type, act as sentinels that survey the body for unwanted immune attacks and rebalance the immune system. Our best-in-class Treg therapies possess multiple therapeutic effects, within a single medicine, helping overcome the complex and multifaceted nature of autoimmune and inflammatory disease.
Emerging research shows that enhanced Treg cells work directly at the site of inflammation for a durable, lasting response. We are developing Tregtherapies that have the potential to deliver long-lasting efficacy and can target tissues with high specificity. This is a paradigm-shifting approach that can transform treatments for autoimmune and inflammatory diseases.
Listen to the latest episode of TheSugarScience Podcast with Jeff Bluestone, PhD, CEO and President of Sonoma Biotherapeutics. He is one of the leading immunologists in the field of T-cell activation and immune tolerance research that has led to the development of multiple immunotherapies, including the first FDA-approved drug targeting T-cell co-stimulation to treat autoimmune disease and organ transplantation and the first CTLA-4 antagonist drugs approved for the treatment.
Read more: Sonoma BioTherapeutics
Here is a very far and fascinating extension into a new area of research that can clearly have an impact possibly on how the body senses glucose and manages the release of hormones, as well as regulates immune responses. As I said, way far out but possibly critical thinking … about INTEROCEPTION, the long-overlooked links between our brain and the heart, stomach and other organs. Sense of Self, Scripps Research Magazine, Fall 2021
This interior dialogue between your body and your nervous system, referred to by scientists as “interoception,” is fundamental to your conscious experience. It’s also essential to more under-the-radar processes that help your heart, lungs, stomach and other organs respond to your minute-to-minute needs without you having to make any conscious effort. Yet, vital as it is, scientists know very little about how interoception works.
“It’s really remarkable how little we know about these internal sensory systems compared to what we know about our external senses,” says Ardem Patapoutian, PhD, a neuroscience professor at Scripps Research and winner of the 2021 Nobel Prize in Physiology or Medicine. “We’re just now beginning to identify how these neurons gather information from our organs, to decipher the neural circuits that process that information before it goes to the brain, and to figure out what the brain does with that information.”
Our interoception systems help us stay balanced while we walk, keep our blood pressure and heart rate steady, play a key role in hunger and thirst, and appear to influence our moods and emotions. They are involved in many of the essential biological functions that are undermined by diseases affecting billions of people worldwide.
What happens to a neuron when you poke it? Determined to find an answer, they used a method of jabbing single cells with a tiny glass probe in a laboratory dish. This pressure forced the cells to fire off an electrical signal—the essential information currency of the nervous system. Then, one by one, using genetic manipulation technologies, the scientists removed different types of proteins, known as ion channels, from the neurons to find the sensor that responds to the applied mechanical force. It turns out the channels were involved in far more than the sense of touch. They have since been found in many internal organs, including the heart, lungs, blood vessels and lining of the stomach, to name a few.
Why would we have pressure sensors in our organs? As it turns out, many physiological functions involve mechanical forces that our brain and other parts of our nervous system must monitor and influence.
A record number of biotechs are going public was published by Ben Fidler for BioPharmaDive.com, 29 October 2021. Initial public offerings have fueled biotech’s boom. Keep track of them as they happen with this database.
Initial public offerings are the lifeblood of the biotech industry. Stock listings give young companies access to the vast amount of cash necessary to advance their drugs through clinical development, and their venture backers a crucial opportunity to earn a return and form new biotechs. At the start of the last decade, the IPO markets weren’t receptive to biotech companies. But by 2013, public investment was pouring into the industry, drawn by scientific advances and boosted by the newfound interest of a broader range of investors.
Ever since, biotechs and their backers have ridden a multi-year boom. Many young drugmakers, including those still years from human trials, have gone public at valuations never thought possible in the 2000s. Records have been made and broken, several times over. Last year, a new high water mark was set during the deadliest pandemic in a century.
Biopharma Dive is tracking these details in the database below, which will be updated regularly. U.S. biotech IPOs of $50 million or higher from the past 2018 and after are included. We will add stock offerings as they happen in the months and years ahead.
Read more and BOOKMARK: A record number of biotechs are going public
And this is just a great story of success … by a T1D!
How a bullied boy became a successful med-tech entrepreneur was written by Abigail Klein Leichman for Israel21c.org, 27 October 2021. ‘I want any teenager with problems to know that life doesn’t end with school,’ says Shilo Ben Zeev. ‘If you push your dream and don’t give up, you can do a lot.’
“I was fat and had lots of health problems. I didn’t have friends. My father didn’t believe in me. Altogether, I couldn’t really be a good student,” says Ben Zeev, who was raised in a religious family in Jerusalem. After high school, the army rejected Ben Zeev because of his weight. Determined to be a soldier, he went on a strict diet for seven months. But despite losing 40 kilos (88 pounds) and entering the armored corps – where he made his first real friends — his IDF service was cut short when they discovered he had Type 1 diabetes.
Nevertheless, through a lot of sweat equity and a knack for identifying golden opportunities and business partners, Ben Zeev became a serial med-tech entrepreneur. One of his cofounded companies, Emendo Biotherapeutics, was acquired in 2020 by Japanese pharmaceutical company AnGes for $300 million.
“I want any teenager with problems to know that life doesn’t end with school. I became an entrepreneur with no skills. If you push your dream and don’t give up, you can do a lot. There were years when I struggled to make a living, and I lost two toes to diabetes. But life is not about happiness, it’s about achievement. So keep fighting. At some point, it gets better.”
His physician, Prof. Itamar Raz, now head of the Israel National Council of Diabetes, spotted potential in Ben Zeev. “He saw that I knew how to get things done.” When Raz founded the D-Cure Fund in 2004 to advance diabetes research in Israel and abroad, he asked Ben Zeev to be its CEO.
His next venture was cofounding LabStyle Innovations. Its flagship product was MyDario, a compact glucose meter connected to mobile devices through a diabetes management app. “It was the first time an iPhone was used as a medical device,” says Ben Zeev, whose business model was to sell test strips for the glucometer. Although MyDario won awards for its revolutionary approach, ultimately what survived was the app rather than the device.
“Then I met Dr. David Baram and we founded three companies: MyBiotics, [a microbiome pharmaceutical company]; Smartzyme Biopharma, [a diagnostics and therapeutics company that builds advanced tools for protein engineering]; and Emendo Biotherapeutics, [which develops gene-editing tools for genetic disorders]. We sold Emendo last year in a deal orchestrated by David, and he remains its CEO.”