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FDA Approves Abbott’s Dissolvable Stents




FDA Approves Abbott's Dissolvable Stents

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IIt is estimated that as many as 20 million Americans may suffer from peripheral artery diseaseA condition in which a person’s arms or legs do not get enough blood to supply what they need. Severe cases of this disease can lead to strokes and heart attacks or a so-called condition critical ischemia of the limbs, which can have an extremely high mortality rate if the limb is not amputated. When this disease affects the lower legs, the standard treatment is balloon angioplasty, which can be helpful but is not durable.

On Monday, the FDA approved a new treatment developed by Abbot for patients with this condition under control: a dissolvable stent that opens the artery to deliver a drug, everolimus, that helps prevent the growth of plaques that cause the disease. In a clinical studythis system, called Espirit BTKshowed significantly greater efficacy than balloon angioplasty and was over 30% more likely to avoid the need for amputation compared to that standard of care. In addition, because the stent can be reabsorbed into the body, it is easier for doctors to re-perform the treatment if necessary.

“This was the first study to demonstrate that there was a therapy that can go beyond what is offered to patients,” said Jennifer Jones-McMeans, Abbott’s division director of global clinical affairs for vascular diseases. Forbes. “It offers so many opportunities for patients and doctors to have a new tool to fight this disease.”

This biotech startup aims to accelerate drug testing on animals

When developing new therapies for diseases, biotech researchers are often limited by two time-consuming steps: first, screening thousands of drug candidates in test tubes and second, taking the best candidates and testing them on multiple animals to make sure that it is safe. and effective. Combined, these steps can be slow and expensive.

A startup called Gordian Biotechnology has introduced a technology that could make this process better for both animals and people: a new animal screening platform that allows multiple gene therapies to be tested simultaneously using just one animal. Instead of the gene treatment being given to the animal and affecting an entire part of its body, Gordian’s innovation allows it to test a drug in a single cell. That means one mouse could potentially support the evaluation of hundreds of possible new gene therapies in a way that is faster and affects fewer animals with less risk of harm to them.

“We have a platform that allows us to essentially parallelize the most difficult part of the drug discovery process, the animal testing process,” Gordian CEO Francisco LePort told Forbes.

Read more here.

Pipeline and deal updates

Backache: The FDA approved Medtronic’s Inceptiv spinal cord stimulator for the treatment of chronic pain. What makes Medtronic’s new system different is that it can sense a patient’s body position and adjust the amount of electrical stimulation accordingly, improving quality of life. “This is a new generation of devices that will fundamentally make patients’ lives easier,” said David Carr, vice president of pain operations. Forbes.

Next generation biologics: Enlaza Therapeutics, which is developing a new class of biologics that can chemically bind to drug targets for improved precision, announced that it a $100 million Series A led by JPMorgan.

Gene editing: Regeneron has announced that this is the case entered into a research collaboration co-founded the CRISPR company Mammoth Biosciences with Jennifer Doudna to develop new gene editing therapies. As part of the deal, Regeneron will make an upfront payment of $100 million (of which $95 million is an equity investment) and will be eligible to receive up to $370 million in milestone payments per target, plus royalties.

Autoimmune diseases: Bristol Myers Squibb has entered into an agreement research agreement with Repertoire to develop vaccines for three different autoimmune diseases. Repertoire will receive an upfront payment of $65 million and the entire deal is potentially worth up to $1.8 billion in milestone payments plus royalties.

Mental health: Amae Health, a value-based healthcare startup treating serious mental health conditions, increased a $15 million Series A financing round led by Quiet Capital. Amae’s first clinic in Los Angeles has reduced emergency room readmissions, increased medication adherence and achieved an 80% patient retention rate, according to the company.

Walmart is closing health clinics in the latest blow to retail

Walmart is closing its in-person clinics and virtual care operations, saying it doesn’t see a sustainable business model in primary care. It’s the latest blow to the retail health clinic model, with the retail giant saying it will close its 51 Walmart Health centers in five states and Walmart Health Virtual Care, the retailer’s telehealth business. The centers will close in the next 30 to 90 days.

Read more here.

Other healthcare news

The American Preventive Services Task Force said this breast cancer screenings should start at age 40 – ten years earlier than previous recommendations.

Pfizer’s The 44% earnings decline still exceeds expectations as shares recover from decade lows.

The Federal Trade Commissionn is challenging hundreds of so-called “junk” pharmaceutical patent lists, including that of Novo Nordisk, which the federal agency says is delaying cheaper generic options.

Novo Nordisks According to an update on the FDA’s website, Wegovy is back in stock in the US after months of limited supplies, although shortages are expected to persist.

South Dakota could vote on legalization abortion this year.

CFS health reported a profit of $1.1 billion in the first quarter — nearly half of last year’s — due to higher costs for treating seniors in Medicare Advantage plans.

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What else we read

A promising technique could make blood groups mutually compatible (The Economist)

The largest venture capital class in the first quarter wasn’t AI (Inc)

Pasteurization Inactivates H5N1 Bird Flu in Milk, New FDA and Academic Studies Confirm (STAT News)