Tag Archives: drug

Ohio company gets greenlight from FDA to test Cuban drug for diabetic foot ulcers

Diabetes News
cleveland.com

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CLEVELAND, Ohio— Cleveland-based biotechnology company Discovery Therapeutics Caribe will soon be studying a treatment for diabetic ulcers that was developed in Cuba.

The drug, which helps close hard-to-heal wounds in diabetic patients, was developed two decades ago and is authorized for use in 26 countries around the world to heal large ulcers in the feet of patients with poor circulation due to diabetes.

After applying to the U.S. Food and Drug Administration in February of 2024, Discovery Therapeutics Caribe received the greenlight to proceed with a Phase III clinical trial which it hopes will establish the drug’s efficacy as a treatment for diabetic foot ulcers here in the United States.

The drug will be marketed commercially under the name Heberprot-P. It is what’s known as a recombinant human epidermal growth factor (rhEGF), a genetically engineered version of a naturally occurring substance in the human body. Genetically modified yeast are used to produce the growth factor from human DNA.

The company says other therapies currently available in the United States that use growth factors for treating diabetic foot ulcers are applied directly to the surface of wounds. However, Heberprot-P is an injection that delivers the active ingredient under the skin, past the chronic wound environment that can otherwise degrade the drug and reduce the effectiveness of the treatment.

Naturally occurring human epidermal growth factor plays a crucial role in the body’s healing process. It works by activating a receptor on the surface of cells that stimulates them to grow, migrate where they are needed, and differentiate into the different cell types in wound healing such as those that form the skin (keratinocytes), connective tissue (fibroblasts), and blood vessels (vascular endothelial cells).

Epidermal growth factor aids in guiding these cells to the wound site, helps them develop into mature cells, and promotes the formation of new blood vessels. Together, these actions accelerate the formation of new tissue and help wounds heal effectively.

There is a pressing need for treatments that can halt the progression of diabetic foot ulcers before amputation becomes the inevitable solution, explained Dr. David Armstrong, a podiatric surgeon at the University of Southern California who studies diabetic foot ulcers, in a statement from the company.

Nearly half of patients who undergo lower extremity amputation resulting from diabetic foot ulcers do not survive beyond five years.

Among U.S. veterans, the prognosis is even more grim. Roughly two-thirds of veterans die following a diabetic foot amputation. In fact, in the past two decades, nearly 800,000 U.S. veterans have died from diabetic foot ulcers and lower limb amputation, more than all the soldiers killed in U.S. wars since the beginning of World War I (623,982).

In addition, Black patients are nearly twice as likely to undergo lower limb amputation within a year of a diabetic foot ulcers diagnosis compared to their white counterparts.

“Historically, treatment options have been limited, but with the introduction of advanced therapies like intralesional rhEGF, which I have seen used electively abroad, we are hopeful … ,” Armstrong said. “This trial represents an exciting potential to shift the current paradigm and provide new hope for those who desperately need it.”

The company says they are hoping to conduct the clinical trial in the Cleveland area. Diabetes is the 8th largest cause of death in Ohio.

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Diabetes and weight loss drug Wegovy could also cut cardiovascular risk

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Diabetes and weight loss drug Wegovy could also cut cardiovascular risk – CBS News


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The maker of diabetes and weight loss medication Wegovy said a trial found that the drug can also cut the risk of cardiovascular disease by 20%.

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Glenmark gets USFDA nod to market generic diabetes drug

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Glenmark gets USFDA nod to market generic diabetes drug

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Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic diabetes drug in the American market.

The company has received final approval from the US Food & Drug Administration (US FDA) for Saxagliptin Tablets (2.5 mg and 5 mg), the generic version of AstraZeneca’s Onglyza1 tablets, the Mumbai-based drug maker said in a statement.

According to IQVIATM sales data, for the 12-month period ending June 2023, the Onglyza tablets (2.5 mg and 5 mg) achieved annual sales of around USD 100.7 million.

Glenmark said its current portfolio now consists of 184 products authorized for distribution in the US market and 49 abbreviated new drug applications (ANDAs) are pending approval with the US FDA.

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AstraZeneca beats estimates with strong cancer and diabetes drug sales

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Strong sales of drugs for cancer and diabetes helped AstraZeneca beat expectations in the second quarter, as the drugmaker expands its genomic medicine business with a $1bn deal to buy assets from Pfizer.

Pascal Soriot, AstraZeneca’s chief executive, said eight medicines delivered more than $1bn of revenue in the first half, with each area of the business, except Covid-19 therapies, growing by double digits year-on-year. 

Soriot added that the company is encouraged by positive data from its closely watched first late-stage trial of oncology drug datopotamab deruxtecan. 

“We look forward to sharing the data with the medical community at an upcoming medical congress and are proceeding to file the data with the US Food and Drug Administration,” he said.

Investors were disappointed when the company first published results from the trial earlier in July, sending the stock down almost 8 per cent. Analysts said shareholders were concerned that AstraZeneca did not say that the data showed the drug was “clinically meaningful”.

AstraZeneca also announced its plan to acquire Pfizer’s early-stage portfolio of gene therapies, in a deal worth up to $1bn, plus royalties on future sales.

The deal follows AstraZeneca’s entry into rare diseases with its $39bn acquisition of Alexion in 2020. Marc Dunoyer, chief executive for the Alexion rare disease business within AstraZeneca, said the deal was “another major step forward” in its ambition to become an industry leader in genomic medicine. 

The Anglo-Swedish drugmaker reported adjusted earnings per share of $2.15, up 38 per cent year-on-year, and higher than the consensus forecast of $1.98.

Sales were $11.2bn, up 17 per cent from the same period the year before, excluding medicines for Covid-19, and above the average analyst estimate of $11bn.

Farxiga, a drug for type 2 diabetes, chronic kidney disease and heart failure, became the company’s biggest seller for the first time in the quarter, with sales up 41 per cent at constant exchange rates, while sales of oncology drugs increased by 25 per cent.

The company’s executive vice-president Mene Pangalos plans to step down after a 14-year tenure that included playing a crucial role delivering the Oxford/AstraZeneca Covid-19 vaccine. Soriot said Pangalos had transformed AstraZeneca’s approach to research and development, delivering a more than fivefold improvement in productivity.

Alexion’s Sharon Barr will replace him, becoming responsible for drugs in cardiovascular, renal, metabolism, respiratory and immunology.

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Common diabetes drug may serve as novel Afib treatment –

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Close Up Of Pills Pouring Out Of A Prescription Medication Bottle; Image credit: Getty Images

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Close Up Of Pills Pouring Out Of A Prescription Medication Bottle; Image credit: Getty Images



The common diabetes drug metformin may be a treatment for atrial fibrillation (Afib), a new study has found. If approved, it would be the first new drug identified to treat this disease of the heart in a decade, according to Cleveland Clinic researchers.

Investigators discovered the drug’s potential in a larger study looking for drugs to repurpose. Genetic sequencing and advanced computation helped to determine that metformin targets 30 genes that are associated with Afib, the investigators wrote in Cell Reports Medicine.

Afib is the most common cause of irregular and rapid heart rhythms (arrhythmia). It can lead to blood clots in the heart and an increased risk of complications including stroke and heart failure.

Past treatments have been directed toward preventing the arrhythmia, with drugs that target the electrical system, including ion channels in the heart. Catheter ablation is also used to isolate the pulmonary veins where initiating beats of atrial fibrillation occur. But these approaches may be limited due to complications and limited success, the researchers noted. 

Advantage of a repurposed drug

Although a new indication for metformin would require testing, the fact that it is already federally approved for use will shave years off the testing time frame, the researchers said.

“We can cut off 10-plus years in the drug development pipeline. We already have the information there. We just have to test it in a very computationally efficient way, such as artificial intelligence technology,” Feixiong Cheng, PhD, said.

The study is connected to a $14.2 million grant from the National Institutes of Health to investigate new atrial fibrillation treatments using genomic data.

Related articles:

Seniors may suffer in silence with atypical Afib symptoms, study finds

Falls, disability in seniors with Afib tied to lower anticoagulant use

Newer blood thinners surpass warfarin for treating seniors with Afib and prior stroke

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