FDA opens doors to OTC hearing aids
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Today's Rundown

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HLTH21: Where Walmart is focusing its health efforts in the next 5 to 10 years

Walmart's health leads outline the retailer's omnichannel opportunity and the hurdles it will need to clear to become a healthcare staple for consumers.

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Top Stories

WHO plots multibillion-dollar campaign to buy COVID-19 antivirals for $10 per course: Reuters

Almost immediately after Merck & Co. reported impressive data for its COVID-19 pill, questions about pricing and access started swirling. It turns out officials at the World Health Organization are already working through those issues with a multibillion-dollar international effort.

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Atea and Roche's COVID-19 antiviral flunks phase 2, prompting switch that will delay pivotal data

Atea Pharmaceuticals and Roche have suffered a big blow to their bid to bring an oral antiviral for COVID-19 to market. A phase 2 trial of the candidate missed its primary endpoint, prompting Atea and Roche to consider changes that will delay data from a pivotal study by around one year. 

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FDA opens doors to over-the-counter hearing aids

A newly proposed rule would establish a new category of hearing aids that can be sold over-the-counter online or in stores, without the need for medical exams or appointments with a specialist.

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HLTH21: DeSalvo says baking health into all Google's efforts opens the door to 'billions' of healthy consumers

Shuffling the Google Health team across its various projects represents a chance to reach more consumers than ever before, the tech giant's chief health officer said at HLTH 2021.

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Lupin recalls blood pressure tablets on cancer-causing contamination concerns

Lupin Pharmaceuticals issued a voluntary recall of blood pressure medications following tests on API batches that indicated possible contamination with cancer-causing elements.

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Not for sale: Intellia isn't interested in a buyout, but CEO Leonard has an eye out for complementary tech

When Moderna’s CEO Stephane Bancel said he wanted to buy into gene editing, the chatter over the potential target flared to a roar. So you know we had to ask when we had Intellia CEO John Leonard on the line.

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Intrivo launches at-home COVID test that returns results in 10 minutes via AI-powered app

There’s an app for just about everything these days—including, now, to generate the results of an at-home COVID-19 test.

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HLTH21: UnitedHealthcare, Optum collaborate on new virtual-first plan design

UnitedHealthcare has unveiled a new virtual-first plan design called NavigateNOW, which was developed in collaboration with its sister company, Optum.

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Failed cancer immunotherapies cost Medicare hundreds of millions. How should FDA revamp accelerated approvals?

A recent FDA review of past conditional go-aheads for cancer immunotherapies has led to several withdrawals. Health policy and economics researchers see the campaign as another opportunity to push for a revamp of the agency’s accelerated approval pathway.

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Injured tumor cells activate immuno-oncology drugs to combat breast cancer and melanoma in mice

Scientists at the MIT Center for Precision Cancer Medicine developed a method for removing tumor cells, treating them with chemotherapy and then combining them with checkpoint-inhibiting drugs to stimulate an immune attack against cancer. In mouse models of melanoma and breast cancer, the technique eliminated 40% of tumors, they reported.

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Castle Biosciences taps into Cernostics' GI cancer test franchise with $80M deal

Cernostics' AI-driven biopsy test evaluates patients with Barrett’s esophagus and predicts their chances of developing potentially fatal cancer.

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Entasis' antibiotic bests last resort treatment on path to become new weapon against drug-resistant bacteria

A new antibiotic by Entasis Therapeutics has bested an existing therapy against a pathogen deemed by the CDC to be an urgent threat during a phase 3 clinical trial.

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D&D Pharma snags $51M ahead of Korean IPO for Alzheimer's, Parkinson's

D&D Pharmatech raised $51 million in a series C to bankroll mid-stage studies in Alzheimer's and Parkinson's. The financing will also fund other assets across the company's five subsidiaries and sets it up for an initial public offering in Korea in the first quarter of 2022.

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