Tandem Mobi, World’s Smallest Durable Insulin Delivery System, Receives FDA Clearance

 Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced U.S. Food and Drug Administration (FDA) clearance for the Tandem Mobi insulin pump for people with diabetes age 6 and up, expanding the company’s portfolio of products. The Tandem Mobi is fully controllable from a mobile app and is the world’s smallest durable automated insulin delivery system.1

"Testing the limits of pump miniaturization, Tandem Mobi joins the t:slim X2 pump in our family of insulin delivery solutions bringing new options in wearability, the flexibility to disconnect, and full phone control," said John Sheridan, president and chief executive officer. "Through this expansion, we are delivering on our commitment to bring greater choice, along with the proven benefits of Tandem’s technology, to more people living with diabetes."

Key Tandem Mobi System Features:

The Tandem Mobi features a 200-unit insulin cartridge and an on-pump button that provides an alternative option to phone control for bolusing insulin. Additional features include:

• Multiple Wear Options – Less than half the size of the t:slim X2 pump, Tandem Mobi can fit in a coin pocket, be clipped to clothing, or worn on-body with an adhesive sleeve (sold separately).

• Detachable Infusion Sets – Compatible with all existing Tandem-branded infusion sets manufactured by the Convatec Group, including a new five-inch tubing option made just for Tandem Mobi. Infusion sets allow users to temporarily disconnect from their pump for convenience and provide the flexibility of more than 30 mix-and-match infusion site and tubing length combinations.

• AID Compatibility – Designed for use as part of an automated insulin delivery (AID) system, the Tandem Mobi features Control-IQ technology.

• Mobile App Control – Full iOS mobile control through a user’s compatible iPhone

• Modern Technology – Inductive charging and capable of wireless remote software updates via a compatible smartphone

https://finance.yahoo.com/news/tandem-mobi-world-smallest-durable-130000270.html

Most patients using weight-loss drugs like Wegovy stop within a year

 Only about one-third of patients prescribed a popular weight-loss drug like Novo Nordisk’s Wegovy were still taking it a year later, while total healthcare costs for the group rose sharply, according to an analysis of U.S. pharmacy claims shared with Reuters.

The annual cost of overall care for patients prior to taking Wegovy or a similar drug was $12,371, on average, according to the analysis. The full-year cost after starting the medication jumped by 59% to $19,657, on average.

The costs for a similar control group of patients not taking the drugs decreased by 4% over the same period. The mean age of patients included in the analysis was 47 and 81% were female.

Medicines such as Wegovy can cost more than $1,000 per month, and any improvement in health and subsequent reduction in medical costs is not likely to occur quickly.

"This analysis points to the fact that there can be a lot of spending on people that are not likely to reap any long-term health benefits," said Khrysta Baig, a health policy researcher at Vanderbilt University who reviewed the findings for Reuters.

"We need to better target who has access to them if we want to realize their full potential," she said of the obesity treatments.

Novo Nordisk did not comment on the analysis, but said in a statement that "obesity requires long-term management" and "broadening coverage is key to ensure that those who need (therapy) can access and afford their medicines."

Shares of the Danish drugmaker fell 2.3% on Tuesday.

The analysis by Prime Therapeutics, a pharmacy benefits manager (PBM), reviewed pharmacy and medical claims data for 4,255 people with commercial health plans. They had all received new prescriptions of the drugs from a class known as GLP-1 agonists between January and December 2021, and had a diagnosis of obesity, prediabetes or a body mass index of 30 or higher.

GLP-1 drugs, originally developed to help control blood sugar in patients with type 2 diabetes, also suppress appetite and promote a feeling of fullness.

https://news.yahoo.com/exclusive-most-patients-using-weight-100228827.html

CareDx’s AlloSure Lung dd-cfDNA Testing Service Receives Medicare Coverage

 CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that CareDx’s AlloSure® Lung donor-derived cell-free DNA (dd-cfDNA) molecular testing service has received Medicare coverage.

The MolDX technology assessment program has determined that AlloSure Lung will be covered under the existing Medicare Local Coverage Determination for Molecular Testing for Solid Organ Allograft Rejection for use in the surveillance setting in lung transplant patients, effective May 9, 2023.

https://finance.yahoo.com/news/caredx-allosure-lung-dd-cfdna-110000459.html

ADC pauses enrolment in mid-stage trial for cancer therapy

 ADC Therapeutics said on Tuesday it had paused enrollment of new patients in a mid-stage study evaluating its drug Zynlonta along with rituximab for treating a type of blood cancer over safety concerns.

https://finance.yahoo.com/news/adc-therapeutics-pauses-enrolment-mid-111707401.html

Cingulate: Positive Top-Line Results from Phase 3 Adult Efficacy and Safety Trial in ADHD

 Results Indicative that CTx-1301 Provides Entire Active-Day Efficacy with Optimal Onset and Duration

 Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced positive top-line results from its Phase 3 adult trial of its lead candidate, CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity disorder (ADHD), upon approval from the U.S. Food and Drug Administration (FDA).

Ann Childress, M.D., President, Center for Psychiatry and Behavior Medicine, Inc., and lead investigator in the Phase 3 CTx-1301-022 study who conducted the primary efficacy evaluations, AISRS and PERMP, stated, “From my observation the changes in the Adult ADHD Investigator Symptom Rating Scale (AISRS; a scale that measures aspects of ADHD in adults) demonstrated a positive effect in subjects that received CTx-1301 versus subjects that received placebo. I was also impressed with the overall improvement (change from baseline) of PERMP scores in subjects who were randomized to CTx-1301 compared to placebo. Although a secondary endpoint, the established CGI scale for severity of illness demonstrated clinical improvement in severity of illness. Overall, this in combination with the favorable safety profile, bodes well for future Phase 3 studies.”

The Phase 3 CTx-1301-022 study (NCT05631626), which assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom setting, demonstrated a meaningful trend in improving ADHD symptoms with a rapid onset of action and entire active-day duration. After a 5-week dose optimization period, subjects were either randomized to their optimized dose of CTx-1301 or placebo. Subjects who were randomized to their optimized dose of CTx-1301 showed improvements on the Permanent Product Measure of Performance (PERMP) (effect size 0.88 to 2.6; with an average of 1.79) compared to subjects randomized to placebo.

https://finance.yahoo.com/news/cingulate-announces-positive-top-line-120000574.html

Freeline starts Gaucher study, Parkinson's research

 FLT201 is a highly differentiated AAV gene therapy candidate that delivers a longer-acting engineered variant of GCase, the enzyme missing in people with Gaucher disease

Company expects to report initial clinical data for FLT201 in third quarter of 2023

Parkinson’s disease program leverages same longer-acting GCase enzyme as FLT201, with aim of developing a gene therapy for genetically defined patient subset with GBA1 mutations

 Freeline Therapeutics Holdings plc (Nasdaq: FRLN) today announced that the first patient has been dosed in the Phase 1/2 GALILEO-1 clinical trial evaluating FLT201, its adeno-associated virus (AAV) gene therapy candidate, in Gaucher disease type 1. Gaucher disease is a debilitating genetic disorder in which a deficiency of the GCase enzyme leads to a buildup of fatty substances in the organs, causing symptoms including enlarged spleen and liver, low blood counts, bone pain and reduced lung function.

“We believe that FLT201 has life-changing potential for people with the most common type of Gaucher disease,” said Pamela Foulds, M.D., Chief Medical Officer at Freeline. “Existing therapies do not sufficiently penetrate deeper tissues, and enzyme levels wane in between infusions, giving harmful substrates the opportunity to build back up in all disease-affected organs. FLT201 is a highly differentiated gene therapy candidate for Gaucher disease type 1 that delivers a longer-acting, rationally engineered enzyme. Preclinically, FLT201 has been shown to produce sustained levels of enzyme and penetrate deeper tissues, including bone and lung, giving us reason to believe it has the opportunity to stop disease progression and improve outcomes with a one-time treatment.”

“The dosing of the first patient in the GALILEO-1 trial of FLT201 marks an important step forward for the Gaucher community,” said Dr. Ozlem Goker-Alpan, founder and CEO of the Lysosomal and Rare Disorder Research and Treatment Center (LDRTC) and an investigator in GALILEO-1. “There is a clear need for better treatment options. Existing therapies come with a heavy lifelong treatment burden, and many patients continue to experience serious symptoms. FLT201 represents a promising approach for addressing the underlying cause of Gaucher disease with a one-time gene therapy, potentially providing a more effective and less burdensome option for patients. I look forward to further evaluating FLT201 in this clinical trial.”

https://finance.yahoo.com/news/freeline-announces-first-patient-dosed-113000832.html

Biodexa Completes Enrolment and Treatment in Phase 1 in Treatment of Child Gliomas

 Biodexa Ltd (a wholly owned subsidiary of Biodexa Pharmaceuticals PLC, Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of products aimed at primary and metastatic cancers of the brain, is pleased to announce completion of enrolment and treatment of nine paediatric patients into the ongoing investigator-sponsored Phase I study of MTX-110 in newly diagnosed DMGs (NCT 04264143).

All of the  patients (age range 4-17 years) were enrolled at the Columbia University Irving Medical Centre and received radiation therapy as per the institution’s standard of care. Each patient subsequently underwent surgery with implantation of an intratumoral catheter and a programmable subcutaneous pump and 8 out of 9 have received two infusions of MTX110 via convection-enhanced delivery (CED) separated by a period of 1 week. Concentrations of 30, 60 or 90 µM were delivered with no intra-patient dose escalation.

No dose limiting toxicities related to the study drug have been reported in the study.

Full study results are expected to be made public around the 1st quarter of 2024.

https://finance.yahoo.com/news/completion-enrolment-treatment-phase-1-120000719.html