FDA approves hybrid closed-loop insulin delivery app from CamDiab by Sean Whooley for DrugDelieveryBusiness.com, 24 May 2024.
CamDiab announced today that the FDA granted authorization for its CamAPS FX advanced adaptive closed-loop artificial pancreas app.
CamAPS FX, an Android app, received approval as an interoperable automated glycemic controller device (iAGC). It helps to manage glucose levels in people with type 1 diabetes, aged two and older, including during pregnancy. CamAPS FX already completed extensive clinical trial testing and holds a CE mark for use in Europe and the UK. It features integration capabilities with the Dexcom G6 and the FreeStyle Libre 3 — Abbott’s newest sensor — to work with the Ypsomed mylife YpsoPump. CamAPS FX is now available in Australia, Austria, Belgium, the Czech Republic, Germany, Finland, France, Ireland, the Netherlands, Norway, Poland, Spain, Sweden, Switzerland and the UK. CamDiab said it has more countries in the pipeline as well.
Roman Hovorka created CamAPS FX and developed it at the University of Cambridge. Hovorka now serves as a professor of metabolic technology at Cambridge’s Institute of Metabolic Science and Dept. of Pediatrics. He said the company set out to help people with type 1 diabetes and their families live better lives.
Additionally, the FDA authorized a closed-loop algorithm for an artificial pancreas system for use by people with Type 1 diabetes aged 2 years and older, including during pregnancy, according to a press release from Cambridge University. This is the first hybrid closed-loop algorithm cleared for use in the U.S. during pregnancy.
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FDA committee rejects recommending once-weekly insulin for approval in type 1 diabetes by Jill Rollet for Healio.com/endocrinology, 24 May 2024.
An FDA committee declined to recommend approval for a once-weekly insulin to improve glycemic control for adults with type 1 diabetes. The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted, 7-4, that the benefits of insulin icodec (Awiqli, Novo Nordisk) did not outweigh the risks for adults with type 1 diabetes. Insulin icodec is a once-weekly ultra-long-acting basal insulin analog being investigated for glycemic control among adults with type 1 and type 2 diabetes.
Some of the committee members who voted no said the data revealed that the risk for hypoglycemia outweighed minimal benefits for adults with type 1 diabetes. Novo Nordisk proposed mitigation strategies and label suggestions to address the hypoglycemia risk, but committee members said more data are needed on those strategies.
“The benefits of the therapy are clearly that once-weekly administration would be easier to do, but that’s likely to be offset by the increased treatment complexity,” Paul Beringer, PharmD, professor of clinical pharmacy at the Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences at the University of Southern California, who voted against the drug application, said during the hearing.
Read more: FDA committee rejects recommending once-weekly insulin for approval in type 1 diabetes
Ozempic Protects Kidneys, Boosts Survival in Diabetes Patients With CKD by Crystal Phend for MedPageToday.com, 24 May 2024.
For people with type 2 diabetes and chronic kidney disease, semaglutide (Ozempic) reduced the risk of major kidney events and death from cardiovascular causes, the phase III FLOW trial showed. Added to usual care, the GLP-1 receptor agonist reduced the primary composite endpoint — dialysis, kidney transplantation, an estimated glomerular filtration rate (eGFR) that falls at least 50% from baseline
Results were similar and statistically significant for both the kidney outcomes and cardiovascular mortality independently as well, according to findings published in the New England Journal of Medicine in conjunction with a presentation at the European Renal Association meeting in Stockholm. “These benefits reflect important clinical effects on kidney, cardiovascular, and survival outcomes among high-risk patients, particularly given the reassuring safety findings, and support a therapeutic role for semaglutide in this population,” the researchers concluded.
Read more: Ozempic Protects Kidneys, Boosts Survival in Diabetes Patients With CKD
GLP-1s not tied to higher risk for surgical complications for adults with diabetes by Michael Monostra for Healio.com/endocrinology, 22 May 2024.
Adults with diabetes who used a GLP-1 receptor agonist and underwent surgery requiring general anesthesia had similar odds for postsurgical complications as those receiving other oral diabetes medications, according to study data. The findings were published in Diabetes, Obesity and Metabolism.
“We know that when someone is taken off of diabetes medicine for surgery, they tend to have high blood sugar, and high blood sugar is associated with complications,” Klonoff told Healio. “Even as the anesthesiologists were embracing what they believed would be fewer perioperative and postoperative complications, they were also selecting a pathway that would lead to higher blood glucose levels at the time of surgery.”
Read more: GLP-1s not tied to higher risk for surgical complications for adults with diabetes
Medscape Physician Compensation Report 2024: Bigger Checks, Yet Doctors Still See an Underpaid Profession by Jon McKenna for MedScape.com, 23 May 2024.
2023 was another year of steady pay gains for US physicians. It was an unusual year in that inflation could undercut doctors’ contentment with their take-home pay. The narrowing of compensation gaps between men and women and among certain racial and ethnic groups was uneven last year. And many physicians continued to question whether a salary that dwarfed that of most Americans was enough to justify their stress and sacrifices.
On average, a US physician’s total compensation grew by about 3% last year. Pay rose by roughly 4% for an average primary care physician (PCP) and by around 3% for a doctor who practiced in one of 29+ medical specialties. Putting that overall 3% increase for doctors in perspective, it trailed the approximate 4% average hike for nonunionized US employees in 2023, reported by the Mercer consulting firm. The 2% Medicare reimbursement cut implemented last year hurt income for many physicians and medical employers.
“Since we came out of COVID, physicians have been back in the driver’s seat where job offers and contract negotiations are concerned,” said Jeff Decker, president of AMN Healthcare’s physician solutions division. However, many of those physicians are choosing to exercise that leverage for greater schedule flexibility rather than more money.
Meanwhile, the financial advantages enjoyed by specialists continued to gradually widen, as they earned about 44% more on average than a PCP, vs roughly 44% and 42%, respectively, in our 2023 and 2022 reports.
Read more: Medscape Physician Compensation Report 2024
Danish pharma giant Novo Nordisk’s office building is in danger of collapsing after a ‘massive fire’ broke out by Sanne Wass, Naomi Kresge and Bloomberg, 23 May 2024.
A Novo Nordisk A/S office building is in danger of collapsing after catching fire at the drugmaker’s headquarters complex in Denmark, less than a week after a fire incident involving one of its other Danish facilities. The Wednesday fire is now under control, though the building is “not able to be saved,” a Novo spokesperson said. The location isn’t used for production, Novo said. Shares of Novo fell as much as 2.7% before paring back. The stock is up 32% year-to-date.
Some 100 firefighters were on site Wednesday to battle the “massive fire”. The smoke from the fire isn’t toxic, and there are no injuries, according to Novo’s spokeswoman.
Think Like A Pancreas Episode 6: Is There a Conspiracy to Prevent a Cure for T1D? with Gary Scheiner, MS, CDCES and Aaron J. Kowalski, PhD, CEO of JDRF, 27 December 2023.
Host Gary Scheiner MS, CDCES, sits with Aaron J. Kowalski, Ph.D., CEO of JDRF to discuss the possible conspiracy to prevent a cure for T1D and the “There will be a cure in 5 years” that we have all heard. This no-holds-barred conversation hopes to educate, entertain, and, as always, share knowledge.
Listen now: Is There a Conspiracy to Prevent a Cure for T1D?
‘Air protein’ could soon become a key part of a healthy diet by Alex Hughes for ScienceFocus.com, 20 May 2024.
Solar Foods, who launched its product known as Solein back in 2021, is now upping the ante, officially unveiling its first factory. With this, Solar Foods hopes to make air protein the new norm, leaving meats, dairy, and other carbon-intensive options in the dust (or refined powder in this case). In essence, it is just like making a beer. Well, sort of: similar to your favorite lager, Solein relies on a gas fermentation process.
“Where beer uses sugar, wheat, and starch to convert the sugar material into alcohol, this is using gas as a feed which includes carbon dioxide – hence the term ‘air protein’,” said Dr. Ying Zhang, a molecular microbiologist and assistant professor at the University of Nottingham.
Solein uses a special type of microbe that can grow by feeding on carbon dioxide, nitrogen and hydrogen. Using renewable energy, it splits the water molecules found in air, providing hydrogen. The microbes are also fed a broth, including nitrogen, minerals, and other nutrients. Once the microbes multiply, they are separated from the liquid through centrifugation. What is left is then dried into a fine powder which is roughly 60 to 70 percent protein. This can then be used as a protein powder or turned into flakes, chunks or other shapes to mimic meats.
A product that is high in protein, vegan-friendly, and kind to the environment – it’s a miracle! Well, not exactly. There are a few key drawbacks stopping Solein from being the next big thing in food.
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- Firstly, Solein is still awaiting approval in most countries (including the UK and US), only achieving novel food regulatory approval in Singapore so far.
- Secondly, it’s the hydrogen. The fermentation process relies heavily on it, and it has a habit of going boom. “Hydrogen is essential in this process, but it is a difficult explosive gas to handle, especially at the scale they’re operating at with this factory. It’s possible to use safely, but it wouldn’t be easy on a mass scale,” says Zhang. In short, it’s incredibly dangerous to handle. Solar Foods claim that they are “serious” about hydrogen safety, using appropriate materials to store the gas. “Hydrogen management is our team’s responsibility, as well as a key skill and a strategic asset,” Pasi Vainikka, the CEO of Solar Foods explained to BBC Science Focus.
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Read more: ‘Air protein’ could soon become a key part of a healthy diet.
Fixing prior auth: 40-plus prior authorizations a week is way too many by Tanya Albert Henry for AMA-Assn.org, 29 April 2024.
The time-wasting, care-delaying, insurance company cost-control process known as prior authorization has gone from a rarely employed tool to discourage use of extremely pricey interventions to a form of utilization management that comes as naturally to payers as breathing does to the rest of us. Prior authorization is overused, and existing processes present significant administrative and clinical concerns. That is why fixing prior authorization is a critical component of the AMA Recovery Plan for America’s Physicians.
When it began decades ago, prior authorization was used sparingly as a way for insurers to determine if costly medical procedures or medications were needed. Today, prior authorization has deteriorated into a system that requires physicians to get the OK to prescribe even the most routine medications and procedures. It’s often even required for medications that a patient has been on for years to manage an illness
An AMA survey of 1,001 physicians found that:
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- On average, practices complete 45 prior authorization requests per physician, per week.
- Physicians and their staff spend an average of 14 hours—almost two business days—completing those requests each week.
- 35% of physicians have staff who work exclusively on prior authorizations.
- 88% of physicians describe the burden associated with prior authorization as “high” or “extremely high.”
- About 80% of physicians report that the number of prior authorizations required for prescription medications and medical services has risen over the last five years.
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Read more: Fixing prior auth: 40-plus prior authorizations a week is way too many
Pre authorization has a reason to exist. I may be in a minority but I see that reason. I think the bigger issue is the pay to play system that PBM’s utilize to list medications. Get rid of the pay to play system and we should have more medications listed in the formulary. Do that and lets then see where we are then limit Pre Auths.
Hey Novo has always been on shaky ground if you ask me. 🙂 I’m teasing.