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It is estimated that those 20 million Americans may suffer from peripheral arterial disease, a condition where a person’s arms or legs do not receive enough blood to keep up with what is needed. Severe cases of this disease can lead to strokes and heart attacks or a condition called critical limb ischemia, which can have an extremely high mortality rate if the limb is not amputated. When this disease affects the lower legs, the standard of care is balloon angioplasty, which may be helpful but not sustainable.
On Monday the FDA approved a new treatment developed by Abbott for patients with this condition below the knee: a dissolvable stent that opens the artery to deliver a drug, everolimus, which helps prevent the plaques that cause the disease from developing. In a clinical studythis system, called Espirit BTKshowed significantly greater efficacy than balloon angioplasty and was over 30% more likely to prevent the need for amputation compared to this standard of care. Additionally, because the stent can be reabsorbed into the body, it is easier for doctors to re-deliver the treatment if necessary.
“This was the first trial to show that there is a treatment that can outperform what is being offered to patients,” said Jennifer Jones-McMeans, Abbot’s vice president of global clinical affairs. Forbes. “It leaves so many opportunities for patients and doctors to have a new tool to fight this disease.”
This biotech startup aims to speed up drug testing on animals
When developing new treatments for diseases, biotech researchers are often limited by two time-consuming steps: first, they screen thousands of drug candidates in test tubes, and second, they take the best candidates and test them on lots of animals to make sure they’re safe and effective. Combined, these steps can be slow and expensive.
A startup called Gordian Biotechnology has debuted a technology that could make this process better for both animals and humans: a new animal testing platform that allows multiple gene therapies to be tested simultaneously with a single animal. Instead of gene therapy being administered to the animal and affecting an entire area of its body, Gordian’s innovation enables him to test a drug inside a single cell. This means that a mouse could potentially support the evaluation of hundreds of potential new gene therapies in a way that is faster and affects fewer animals with less risk of harming 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 & Deal Updates
Pain on the back: The FDA cleared Medtronic’s Inceptiv Spinal Cord Stimulator for Chronic Pain Treatment. What’s different about Medtronic’s new system is that it can detect the patient’s body position and adjust the amount of electrical stimulation accordingly, improving quality of life. “This is a new generation of devices that makes life much easier for patients,” said David Carr, vice president of pain interventions. Forbes.
Next Gen Biologics: Enlaza Therapeutics, which is developing a new class of biologics that can chemically attach to drug targets for better precision, announced that it has increased a $100 million Series A; led by JP Morgan.
Gene editing: Regeneron announced that it is entered into a research collaboration with Jennifer Doudna who founded the CRISPR company Mammoth Biosciences to develop new gene editing therapies. As part of the deal, Regeneron will provide an upfront payment of $100 million ($95 million of which is an equity investment) and is eligible for up to $370 million in milestone payments per target, plus royalties.
Autoimmune disorders: Bristol Myers Squibb has entered into a research agreement with Repertoire for vaccine development for three different autoimmune diseases. Repertory is getting a $65 million advance, and the overall 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 illness, lifted up a $15 million Series A funding round led by Quiet Capital. Amae’s first Los Angeles clinic has reduced ER readmissions, increased medication adherence and has an 80% patient retention rate, according to the company.
Walmart to close health clinics in latest blow to retail health care
Walmart is closing its in-person clinics and virtual care business, saying it doesn’t see a viable business model in primary care. It’s the latest blow to the retail health clinic model, with the retail giant saying it will close 51 Walmart Health Centers in five states and Walmart Health Virtual Care, which is the retailer’s telehealth business. The centers will close in the next 30 to 90 days.
Read more here.
Other health news
The US Preventive Services Task Force said breast cancer screenings it should start at age 40—a decade earlier than previous recommendations.
by Pfizer The 44% drop in earnings still topped estimates as the stock rebounded from decade lows.
The Federal Trade Commissionn is challenging hundreds of allegedly “useless” drug patent listings, including Novo Nordisk’s, which the federal agency says is delaying cheaper generic options.
Novo Nordisk’s Wegovy is back in stock in the US after months of limited supplies, according to an update on the FDA’s website, although shortages are expected to continue.
South Dakota could vote on legalization abortion This year.
CVS Health reported a profit of $1.1 billion in the first quarter – nearly half of last year – due to higher costs for treating seniors in Medicare Advantage plans.
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What else are we reading?
Promising technique could make blood types mutually compatible (The Economist)
Biggest Venture Funding Class in Q1 Was Not AI (Inc)
Pasteurization inactivates H5N1 bird flu in milk, new FDA and academic studies confirm (STAT News)