PharmaSens submits insulin patch pump for FDA approval

PharmaSens announced that it applied for FDA approval for its Niia Essential insulin patch pump system. FDA submission follows the pump’s recent ISO 13485 certification for the Switzerland-based company. This encompassed the entire process of design, development, manufacturing, and distribution of insulin infusion pumps and accessories.

Niia Essential, the first of three patch pumps from PharmaSens, features a patient-centric design aimed at enhancing ease of use. PharmaSens designed its basal-bolus patch pump to combine the ease of an insulin pen with the advantages of a sophisticated pump. It features a 3 mL reservoir, offering extended usage periods and access to reimbursed patch pump therapy. PharmaSens says the design positions Niia Essential as one of the most compact patch pumps on the market.  Niia Essential also incorporates a distinctive automatic needle insertion mechanism, safeguarding the 90° steel needle before each use. The design also aligns with the principles of cost-efficiency and sustainable product design for an environmentally friendly approach.

PharmaSens CEO Marcel Both expects a favorable review from the FDA, with the company gearing up for a market launch. He also said the company has ongoing trade sale partnership discussions to ensure successful market entry. A sale would also allow the company to advance its product pipeline, which includes a closed-loop system and an integrated CGM sensor and pump.

Read more: PharmaSens submits insulin patch pump for FDA approval

FDA authorizes Florida to import drugs from Canada by Jonathan Gardner and Ned Pagliarulo for, 5 January 2024.

For the first time, the Food and Drug Administration has authorized a U.S. state to import prescription drugs from Canada, granting Florida preliminary clearance to bulk purchase medicines from wholesalers there. Florida has estimated its importation plan could save state taxpayers $150 million annually once fully implemented. 

The decision is a major policy shift for the agency, which has long resisted drug importation efforts on grounds that it couldn’t ensure the safety and supply of medicines shipped from abroad. Supporters have argued that importing drugs from Canada, where medicines cost far less than in the U.S., could help rein in pharmaceutical costs.

However, it’s unclear whether that kind of effect would actually materialize. Canada has taken steps to prevent the distribution of drugs outside of the country if shortages would result. The country’s population is also far smaller than the U.S.’s, totaling about two times the population of Florida, potentially limiting the supply that would be available in any case. 

The FDA’s clearance also comes with requirements for Florida to submit detailed information on the drugs it proposes to import, as well as ensure they comply with FDA standards. Florida must handle relabeling the imported drugs in line with FDA-approved prescribing information.

Read more: FDA authorizes Florida to import drugs from Canada

Tissue-integrated sensitive glucose nanosensor uses inactive glucose oxidase enzyme for continuous monitoring by Wiley for, 2 January 2024.

A research team from the University of California, Berkeley, has now developed a battery-independent fluorescent nanosensor based on single-wall carbon nanotubes and an inactive form of the enzyme glucose oxidase (GOx).

Because the enzyme is not in its active form, the analyte is not consumed during the measurement, and continuous, reversible, and non-invasive bioimaging of glucose levels in body fluids and tissues is possible, the team reports in the journal Angewandte Chemie International Edition.  Blood glucose levels are typically measured using GOx-based electrochemical sensors. However, these sensors produce toxic hydrogen peroxide as a byproduct and require bulky electrical circuits and batteries, making it difficult to prepare implantable devices for continuous measurement.

Tiny SWCNTs, on the other hand, can be integrated into tissues and provide bioimaging information: when excited by light, SWCNTs produce a near-infrared fluorescence signal that travels through tissue and can be easily recorded using non-invasive bioimaging techniques.

Now, Markita P. Landry and her research team at the University of California, Berkeley have disproved the assumption that GOx-based sensors require active GOx for successful glucose sensing. Using sonication, they prepared GOx-loaded SWCNT sensors that reliably, selectively, and sensitively detected glucose, as demonstrated for glucose measurements in serum, plasma, and mouse brain slices.

Read more: Tissue-integrated sensitive glucose nanosenor uses inactive glucose oxidase enzyme

Extreme Heat and Hypoglycemia Risk in Older Insulin Users by Shrabasti Bhattacharya for, 2 January 2024. Summer’s coming (or has already come in your part of the world).  

New research shows: Older adults (aged ≥ 65 years) with diabetes who received insulin may have an increased risk for serious hypoglycemic events in extreme heat.

The thermoregulatory response is often compromised in older adults with diabetes, making them vulnerable to extreme heat. Researchers evaluated the association between ambient heat and risk for hypoglycemia in about 2 million and about 283,000 patients aged 65-100 years with diabetes from the United States and Taiwan, respectively, who received insulin.  “Our finding of elevated risk of hypoglycemia-related ED visits in older adults using insulin and exposed to extreme heat underscores the need for patients and providers to be aware and cautious that extreme heat may increase the risk of hypoglycemia,” the authors wrote.

Read more: Extreme Heat and Hypoglycemia Risk in Older Insulin Users

GlucoTrack eyes human trials for implantable blood glucose monitor by Phalguni Deswal for, 3 January 2024. 

New Jersey-based GlucoTrack has completed the first preclinical study with its implantable continuous glucose monitor (CBGM) and is preparing for first-in-human studies, with trial initiation expected this year. US-based GlucoTrack expects to start first-in-human studies with its implantable continuous glucose monitor this year.  

The implantable CBGM is placed subcutaneously and connected to a lead placed directly into a blood vessel. This allows for zero lag time when taking continuous blood glucose measurements. The company aims to develop the CGBM device with a long sensor life, which does not require additional wearable components and has a once-only calibration event.

The preclinical study assessed the implantation technique and device safety. The implant approach was based on commonly used cardiovascular implantable devices and the implantation procedure took approximately 20 minutes.  GlucoTrack’s CEO Paul Goode said: “The intravascular approach creates a system that is truly differentiated in the diabetes market. By measuring glucose in the blood, our system operates in a way that is comparable to what people expect with conventional fingerstick blood glucose monitoring. And we accomplish this continuously with long-term use, improved simplicity, and increased discretion.”

Read more: GlucoTrack eyes human trials for implantable blood glucose monitor

UPDATE: Apple Watch sales resume after latest twist in Masimo patent case by Susan Kelly for, 3 January 2024.

Masimo accused Apple of misappropriating its technology for measuring blood oxygen levels. The ITC agreed, ruling in October 2023 that Apple infringed two of the patient monitoring company’s patents. Masimo CEO and founder Joe Kiani, an engineer who co-invented the pulse oximetry technology, called the commission’s finding “a powerful message” that the world’s largest company is not above the law.

Apple appealed the ITC ruling in federal court but stopped selling the Series 9 and Ultra 2 watches just before Christmas 2023 in what it called a pre-emptive step to comply with the order.

The ITC’s decision became final on 26 December 2023, when U.S. Trade Representative Katherine Tai decided not to reverse the determination at the end of a 60-day review period.  However, the U.S. Court of Appeals for the Federal Circuit paused the ITC ban the next day. The court gave the commission until 10 January 2024 to oppose the motion and gave Apple until 15 January 2024 to reply.  In addition, an Apple attorney told the court that a U.S. customs office is scheduled to issue a decision on Jan. 12 on the company’s proposed redesign for its watches. 

BTIG analyst Marie Thibault said it is unclear how long it will take the court to rule on Apple’s motion for a stay of the ITC order after 15 January 2024. “It is also difficult for us to handicap how likely it is that the U.S. Customs and Border Protection will rule in Apple’s favor,” Thibault wrote in a 27 December 2023 note to clients.

Read more: Apple Watch sales resume after latest twist in Masimo patent case


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