Lilly sells emergency diabetes drug for $500M by Jonathan Gardner for BioPharmaDive.com, 24 April 2023.
Eli Lilly will sell its emergency diabetes treatment Baqsimi to Amphastar Pharmaceuticals for $500 million upfront, the company said, divesting a drug launched four years ago that had $139 million in sales last year.
Baqsimi is an intranasal version of glucagon, a hormone that raises blood sugar levels, and is used to rescue people with diabetes who have a severe hypoglycemia episode after injecting insulin. Amphastar specializes in injectable, inhalable, and intranasal drugs, and markets an injectable glucagon as a hypoglycemia rescue medicine.
Per deal terms, Lilly is also due $125 million one year after closing and could earn up to $450 million in sales-based milestones. The companies expect the deal to close in the second or third quarter of the year.
Read more: Lilly sells emergency diabetes drug for $500M
JDRF to fund insulin cell implantation solution for diabetes patients by Robert Barrie for MedicalDevice-Network.com, 27 April 2023.
Humacyte is teaming up with the JDRF (Juvenile Diabetes Foundation) to focus on the development of a biovascular pancreas. Although transplantation of pancreatic islets is an effective form of treatment, the technique is difficult due to insufficient oxygen levels in the vein transporters and can lead to cell death.
A biovascular pancreas removes this hurdle by acting as a ‘carrier’ for the cells and providing a vascular scaffold to supply oxygen to the islets. Whilst promising, the biovascular pancreas is not approved by the US Food and Drug Administration (FDA). JDRF will provide Humacyte with funding to advance the development and research of the technique.
Humacyte is using its investigational tissue-engineered blood vessel – Human Acellular Vessel (HAV) – to help the biovascular pancreas deliver cells. The HAV technology is in late-stage clinical trials targeting other vascular applications such as vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. Humacyte’s HAV technology, combined with insulin-producing islets, may constitute a groundbreaking development in the treatment of T1D in the future.
Read more: JDRF to fund insulin cell implantation solution for diabetes patients
Dexcom reports ‘growing momentum’ behind G7 launch in first quarter by Nick Paul Taylor for MedTechDive.com, 28 April 2023.
Dexcom, a leading maker of diabetes devices, reported “growing momentum” behind the rollout of its G7 continuous glucose monitor (CGM) system in the first quarter. Progress in the weeks after Dexcom launched the device in February helped the company add more users than in any other quarter in its history.
“Nearly 1,000 health care providers have prescribed G7 who previously were not prescribing Dexcom CGM,” Dexcom CEO Kevin Sayer said on a conference call with investors. “We have advanced coverage more quickly than anticipated, and we expect G7 to be covered by all major [pharmacy benefit managers] by the end of the second quarter.”
Sayer added that Dexcom “already [has] more commercial pharmacy coverage established for G7 today than our competitor does for their sensor platform,” a reference to Abbott’s FreeStyle Libre device. Commercial durable medical equipment coverage for G7 is “on par with G6 levels,” Sayer said on the call.
Read more: Dexcom reports ‘growing momentum’ behind G7 launch in first quarter
Know Labs hopes to advance non-invasive glucose sensor with proof-of-concept test by Nick Paul Taylor for MedTechDive.com, 25 April 2023.
Bio-RFID uses spectroscopy to identify organic and inorganic materials and analytes. Applied to clinical diagnostics, Know Labs thinks the technology can support the development of a pocket-sized sensor that non-invasively measures blood glucose and offers an alternative to finger pricks and CGM patches. The company has a market cap of $46.7 million and less than one year of cash.
To validate Bio-RFID, Know Labs worked with Mayo Clinic — which has a financial interest in the company — to apply its technology to three solutions. The collaborators shared Bio-RFID signatures of isopropyl alcohol, together with the 1% to 5% water solutions. “What we are describing here is truly ground-breaking. This novel application of the Bio-RFID technology to accurately detect and quantify specific molecules in liquid provides strong support for non-invasive monitoring of physiologically and medically relevant analytes in the human body,” Dr. James Anderson, chief medical officer at Know Labs, said in a statement.
Read more: Know Labs hopes to advance non-invasive glucose sensor with proof-of-concept test
Medtronic Diabetes unit fully resolves FDA warning letter by Sean Whooley for MassDevice.com, 25 April 2023.
Medtronic announced that the FDA lifted the warning letter related to its Diabetes business unit headquarters. In December 2021, the FDA issued a warning letter to Medtronic’s Northridge, California, Diabetes headquarters. The letter centered around the inadequacy of specific medical device quality system requirements at the Northridge facility. It scrutinized the areas of risk assessment, corrective and preventive action, and complaint handling. The letter also related to device recalls and the reporting of adverse events.
Medtronic said today that the resolution follows ongoing remediation from the company. It took proactive actions to continue to strengthen its quality systems, according to a news release. All regulatory restrictions associated with the letter are resolved, the company said.
Read more: Medtronic Diabetes unit fully resolves FDA warning letter
Omnipod GO Receives FDA Clearance for People with Type 2 Diabetes by Patrick Campbell for HCPLive.com, 25 April 2023.
The US Food and Drug Administration (FDA) has approved clearance of the Omnipod GO, and announced on April 25, 2023, clearance of the Omnipod GO, which is indicated for use as an insulin delivery device for people with type 2 diabetes aged 18 or older who typically take daily injections. This marks a first-of-its-kind indication for a basal-only insulin pod and Insulet plans to commercialize the Omnipod GO in the US beginning in 2024.
Billed as a standalone, wearable, insulin delivery system capable of a fixed rate of continuous rapid-acting insulin for 72 hours, the Omnipod GO has been cleared for use with multiple U-100 insulins, including Novolog, Fiasco, Humalog, Admelog, and Lyumjev. Tubeless and waterproof, the Omnipod GO also offers 8 different programmed daily rates, ranging from 10-40 units per day, and has the ability to operate without the need for a handheld device to control the pod.
According to Insulet, the Omnipod GO was developed with the specific intent of serving people with type 2 diabetes earlier in their treatment journey. The company notes, if an Omnipod GO user were to become insulin-intensive, transitioning to another Omnipod product would become easier. The release also points out customers may start Omnipod GO in their physician’s office and will be able to access ongoing supplies through their pharmacy benefit.
Read more: Omnipod GO Receives FDA Clearance for People with Type 2 Diabetes
Doctors More Neurotic, Less Open Than Patients by Michael DePeau-Wilson for MedPageToday.com, 24 April 2023.
Doctors may be more neurotic than both patients and the general population, according to two nationally representative Australian surveys. When it comes to the “Big Five” personality traits, doctors were also significantly more agreeable, conscientious, and extroverted than both the general population and patients, according to Mehdi Ammi, PhD, health economist of Carleton University, in Ottawa, Canada, and the University of Queensland, in Australia, and coauthors. However, they were significantly less “open” than patients only, the researchers reported in BMJ Open.
“The most surprising [finding] is that the doctors were much more neurotic than the other groups,” Ammi told MedPage Today. “They also have a slightly more external locus of control, meaning they think outcomes of their action depend more on external factors. We would have expected them to be less neurotic or externally controlled, or at least not different.”
“We can only speculate about this, but we suspect this might be coming from their jobs being more demanding and stressful than the other groups,” Ammi wrote. He said his group’s findings could help physicians become more prepared for treating certain patients, especially those individuals who differ in personality traits notably from themselves.
“Future research should focus on neuroticism among doctors in comparison to other population groups and the role it plays in medical practice,” the authors wrote.
What do you think about this finding???
Read more: Doctors More Neurotic, Less Open Than Patients
Diabetes standards of care, 2023 by Riva Greenberg for DiabetesStories.com, 24 April 2023.
“I think endocrinologist and Professor, Anne Peters, is a warrior out there fighting the good fight as she has all her career. Her credentials and advocacy are beyond impressive. Here, she gives an update to the Diabetes Standards of Care. What strikes me is how oriented we are to solve everything with medicine. For instance in the Netherlands, and I happen to know this because it is the husband’s home country, depression is first treated with walks in nature and music. Interesting.”
“If you have type 2 diabetes you’re likely on anywhere between six and ten pills, there’s barely a mention of psychosocial support, and the lower targets and plethora of medicines that form the standards make me wonder, “Who is truly benefitting?” I don’t have the answer, but this video begs the question – for me.” THANKS, Riva!
That is some news about Baqsimi. I think that is a big upside business. I am shocked they sold it. I am delighted that MedT finally resolved that letter. It seems to me that they had to get that off the books. It will no doubt mean that they will be more open going forward.