Looking back at two decades of CGM advances

FreeStyle Libre 2 from Abbott

Continuous glucose monitors (CGMs) have transformed how many people with diabetes manage blood sugar, but attempts to monitor blood glucose have a long history.

Attempts to manage glucose kicked off in earnest when researchers began measuring glucose in urine in the mid-1800s. Scientists’ ability to do so steadily improved over the years, but urine glucose testing wasn’t commercialized until 1908, establishing a foundation for diabetes care. 

Elkhart, Ind.-based Ames Company refined the process in 1945 with the introduction of Clinitest reagent tablets, which are still commercially available, albeit from Bayer (ETR: BAYN). The company would introduce the first blood glucose test strip in 1965. The Dextrostix-branded strips were intended for use in doctors’ offices. 

In the 1970s, Ames developed a device known as the Ames Reflectance Meter to measure reflected light from a Dextrostix strip. It was the first blood glucose mete…

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United Therapeutics launches Remunity pump for Remodulin

United Therapeutics (NSDQ:UTHR) announced today that it launched its Remunity pump for Remodulin in patients with pulmonary arterial hypertension (PAH).

Research Triangle Park, N.C.-based United Therapeutics’ Remunity pump initially received FDA clearance in May 2019 for patient filling, adding another 510(k) clearance in February 2020 to enable cassettes to be prefilled with Remodulin by contracted specialty pharmacies in an effort to increase convenience for patients, according to a news release.

The Remunity pump for Remodulin injection is indicated for the continuous subcutaneous delivery of Remodulin in adults greater than 22 years of age.

Remunity’s cassettes contain enough drug for up to three days and arrive from the specialty pharmacy prefilled to eliminate the need for a patient to mix or fill. The water-resistant, small device is programmed using a wireless remote to increase safety and simplicity of use.

“We are excit…

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Surmodics rises on mixed-bag Q1

Surmodics (NSDQ:SRDX) shares ticked up today on first-quarter results that were mixed compared to the consensus forecast.

The Eden Prairie, Minn.-based company posted losses of $274,000, or -2¢ per share, on sales of $22.3 million for the three months ended Dec. 31, 2020, for a bottom-line slide into the red on a sales decline of -1.4%.

Adjusted to exclude one-time items, earnings per share were 2¢, 11¢ ahead of Wall Street, where analysts were looking for sales of $22.4 million.

The company reached a major milestone in the quarter when 12-month data from its Transcend clinical trial showed that its SurVeil drug-coated balloon is non-inferior to Medtronic’s In.Pact Admiral.

“The entire Surmodics team is wholeheartedly pleased with the results of our Transcend clinical trial, which demonstrates comparable safety and effectiveness of our SurVeil drug-coated balloon using a substantially lower drug dose than the comparative product,” Surmodics presid…

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Phillips-Medisize, Subcuject team on wearable osmotic bolus injector

Phillips-Medisize announced today that it is collaborating with Subcuject to bring a wearable bolus injector to market.

Hudson, Wis.-based Phillips-Medisize, a Molex company, said in a news release that the on-body delivery system technology that is based on osmosis is now available for the next stage of drug-specific wearable injector solution after Subcuject filed for intellectual property of the concept.

The wearable osmotic bolus injector is designed as a low-cost, patient-friendly, pre-filled wearable injector for single use. It uses osmosis to generate the force to complete a full injection cycle and requires no additional electronics or batteries.

Phillips-Medisize and Subcuject said they are exploring the opportunity to meet the demand for larger-volume drug delivery, allowing patients to self-administer certain medications almost anywhere instead of relying upon healthcare professionals to do so in a clinical setting.

“We are very p…

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Dyve Biosciences appoints Camilla V. Simpson to its board

Clinical-stage biotechnology company Dyve Biosciences announced this week that Camilla V. Simpson joined its board of directors.

Simpson possesses over 25 years of experience in the biotech industry, currently serving as an independent member of the board of directors at Spruce Biosciences and as a member of the scientific advisory board at Aristea Therapeutics, according to a news release.

She also holds the role of president of Rare Strategic and acts as a strategic advisor to early-stage biotech companies working in a number of indications across various modalities.

Simpson has also held previous roles including senior VP & head of product portfolio development at BioMarin Pharmaceutical and, before that, she was the VP of global regulatory strategy for early development and business development at Shire Pharmaceuticals.

“I am very pleased to join Dyve’s board of directors to support its efforts to develop new therapeutics utilizing innovat…

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Why COVID-19 could drive a surge in diabetes 

Why COVID-19 could drive a surge in diabetes

Diabetes was already an epidemic before the novel coronavirus struck. But some researchers now suspect that COVID-19 can trigger the condition. Approximately 14% of patients with severe COVID-19 develop the disease, according to a meta-analysis recently published in the journal Diabetes, Obesity and Metabolism.

To arrive at that thesis, the researchers analyzed eight studies. Half of those came from China, while two came from Italy and two from the U.S.  

Researchers are uncertain why COVID-19 could cause diabetes, but they have linked infections to damage to several organs, including the lungs, heart, kidneys and brain. Some scientists are now investigating whether the disease can damage the pancreas. 

The study is not the first to stipulate a link between COVID-19 and diabetes. Indeed, researchers have suspected a range of viruses can trigger type 1 diabetes. Diabetes Research and Clinical Practice and the N…

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Catalent to acquire Acorda’s manufacturing and packaging operations

Catalent (NYSE:CTLT) has entered into a definitive agreement to purchase a dry-powder inhaler (DPI) capsule manufacturing and packaging facility from Acorda Therapeutics (NSDQ:ACOR).

The acquisition will enable Catalent to establish a center of excellence for spray-dried dispersion for DPI capsule manufacturing. The transaction will also expand Catalent’s existing U.S.-based commercial-scale capabilities in metered-dose inhalers and nasal inhalation technologies. 

To get the whole story, check out our sister site Pharmaceutical Processing World. 

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How CGMs can inspire lifestyle changes

G6 from Dexcom

As an early adopter of fitness trackers such as the FitBit, I’ve long appreciated the power of health data. But my recent experience with a continuous glucose monitor (CGM) has done far more to inspire me to look after my health — even as a nondiabetic.

I had heard about the potential of such technology before from the cardiologist Dr. Eric Topol, who serves on the board of Dexcom (NASDAQ:DXCM), and the entrepreneur Tim Ferriss, who has discussed using the technology as a non-diabetic to optimize weight loss and muscle gain.

But I have only recently had the chance to evaluate CGM as part of Dexcom’s “Hello Dexcom” sample program that enables patients to try out the company’s G6 CGM at no cost. The goal of the program is to increase awareness among healthcare providers and consumers.

The G6 device,  pictured above, provides blood glucose readings every 5 minutes for 10 days via a smartphone app or dedicated receiver.

Brian Buntz


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Surmodics’ DCB shown non-inferior to Medtronic’s In.Pact Admiral

Surmodics (NSDQ:SRDX) announced data showing that its SurVeil drug-coated balloon is non-inferior to Medtronic’s In.Pact Admiral.

Eden Prairie, Minn.-based Surmodics’ 12-month data from the Transcend clinical trial, presented at the Leipzig Interventional Course 2021 virtual event, revealed primary results that found the SurVeil DCB is non-inferior to In.Pact Admiral in both safety and efficacy while delivering a “substantially lower” drug dose, according to a news release.

Transcend is a global, multi-center, randomized, controlled clinical trial with 1:1 randomization to SurVeil or In.Pact Admiral in patients with symptomatic femoropopliteal artery disease. Both DCBs use coatings with paclitaxel — a controversial drug that could cause a higher risk for death — although In.Pact Admiral has a 75% higher drug load of paclitaxel than SurVeil, Surmodics said.

The primary efficacy endpoint for the trial was primary patency — defined a…

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How continuous glucose monitors have transformed the diabetes landscape

Dexcom G6 sensor and applicator [Image from Dexcom]Continuous glucose monitors (CGMs) are among the most potent diabetes management tools to emerge in recent decades.

FDA approved the first professional CGM in 1999, and the technology has evolved swiftly since then. Current models beam data via Bluetooth to smartphones (plus the Apple Watch) and the cloud, enabling patients to explore their blood glucose readings in an app or via downloadable PDFs.

“Decades ago, we were still checking urine sugars,” said Dr. Egils Bogdanovics, a Connecticut-based endocrinologist. “In the early 1980s, fingerstick blood glucose monitors came out. That was a big deal — a revolution in diabetes,” Bogdanovics recalled.

But the fingerstick blood glucose monitor provides more of a snapshot than a moving picture. “About 15 years ago, professional continuous glucose monitoring was introduced. Initially, it was just endocrinologists [who used it], and we used it in what we called …

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Biden’s COVID-19 response will make manufacturers busy

(Image courtesy of Biden for President)

Manufacturers of vaccine supplies and personal protective equipment can expect more work as the new Biden administration rolls out its plans to combat the COVID-19 pandemic.

In one of his first official acts as president, Joe Biden announced a plan to “fully use” the Defense Production Act to ramp up production of testing supplies, masks, face shields and other PPE, with an eye toward boosting American manufacturing to reduce reliance on other countries. The president also announced his intention to invest $25 billion in a vaccine manufacturing and distribution plan that will provide vaccines to all Americans, free of charge.

Get the full story on our sister site, Medical Design & Outsourcing.

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Mylan must face EpiPen racketeering lawsuit

A federal judge in Minnesota has decided that Mylan must face a lawsuit accusing it of paying bribes and kickbacks to pharmacy benefit managers and of conspiring to fix prices on its EpiPen device.

Drug wholesalers Rochester Drug CoOperative and Dakota Drug filed separate but similar lawsuits in March 2020 and June 2020, respectively, claiming that Mylan paid bribes and kickbacks to a group of pharmacy benefit managers (PBMs) —referred to collectively as CVS Caremark, Express Scripts, and OptumRx — to ensure that Mylan could raise the price of its EpiPen auto-injector with impunity while also keeping a monopoly share of the market. The cases were consolidated in August.

Mylan and the PBM defendants filed separate motions to dismiss for failure to state a claim. The PBMs also argued that Rochester Drug and Dakota Drug have not alleged plausible racketeering claims, that the claims are time-barred, and that the claims against the PBMs’ corporate parents should be…

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