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Today's Rundown

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Excision's CRISPR gene editing therapy for HIV is heading into human testing after FDA clearance

A CRISPR-Cas9 gene editing technology that has shown promise in clearing HIV from mice is headed into human testing. Excision BioTherapeutics will usher the CRISPR-based therapy EBT-101 into clinical trials after the FDA cleared an investigational new drug application.

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Humana rumored to be eyeing Centene takeover, again: report

Rumors are swirling, again, that Humana is interested in buying Medicaid managed-care company Centene. The speculation is based on chatter that a Humana private jet was spotted near Centene's headquarters in St. Louis, StreetInsider reported Friday.

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COVID-19 tracker: Key FDA panel votes down Pfizer's booster application; Biden admin to buy millions more Pfizer jabs

A key FDA advisory panel has voted against the full approval need for a third dose of Pfizer-BioNTech's COVID-19 vaccine for the broad population of those 16 and over, although the debate is still ongoing over certain high-risk groups through an emergency use authorization. The Biden administration is planning on buying hundreds of millions of extra Pfizer jabs to donate to other countries, the Washington Post reports. Plus more.

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Medtronic buys implanted infusion pump tech to develop new Type 1 diabetes therapy

Medtronic and the Mann Foundation will work together to further develop the technology into a new type of implantable insulin pump.

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Gilead's slumping COVID-19 drug takes another hit with study showing no real benefit

Gilead's Veklury was an immediate blockbuster upon its approval for COVID-19 patients last year. But evidence has mounted that the drug is not as effective as once thought. This week, a study from Europe published in The Lancet shows that Veklury has no real benefit for COVID patients.

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Lead exposure continues to be a 'silent epidemic' for kids. These 3 states have the most affected areas

Harnessing de-identified data on 5.6 million children from Epic, researchers discovered that elevated blood lead levels continue to be a serious health issue for children in the Midwest and Northeast. Clinicians say the study shows the promise of population-level health data, which can reveal trends and crises that drive action to improve public health. 

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With new facility and leadership, CDMO Genezen is stepping up to the big leagues

As a young baseball player, moving from Cave Spring High School to Virginia Tech University was a challenge for Ray Kaczmarek. Now, as the new CEO at Genezen, he is helping usher in a new era for the Indianapolis-based manufacturer, which is making a significant leap from a small networking firm to a full-fledged cell and gene therapy CDMO.

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New insights into bats' immunity could point to therapeutic approaches for fighting COVID-19

Knowing that bats can ward off many coronaviruses better than humans can, researchers at Monash University reviewed studies of the animal's immune responses to SARS-CoV-2, the virus behind COVID-19. Their findings could lead to new strategies for fighting the disease, such as reducing inflammasome signaling, they suggested.

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FTC warns health apps must notify users about data breaches or face fines

The FTC has warned apps and connected devices that collect personal health information, such as glucose levels or fertility data, are required to notify consumers if their data are breached or shared with third parties without their permission.

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Fierce Pharma Asia—Takeda's lung cancer nod; 4th death in Astellas' gene therapy trial; Everest's mRNA play

Takeda snagged an FDA nod for a niche lung cancer med to challenge Johnson & Johnson's bispecific antibody. The FDA slapped another clinical hold on Astellas' gene therapy trial after a patient death. China's Everest Medicines bought its way into the mRNA sector. And more.

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Chutes & Ladders—AltruBio snags new CMO with resume at Sublimity, Ardea, Amgen and Abbott

After pivoting to immunology, AltruBio picked up a new chief medical officer from Sublimity Therapeutics who also held director-level roles at Ardea and Amgen. Rusty Williams is back from Prime time, this time leading Walking Fish Therapeutics as CEO. And ViaCyte filled its vacant chief scientific officer role with an academic.

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