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Today's Rundown

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A return to the top: Former FDA Commissioner Califf reportedly Biden's pick for Woodcock's role

Robert Califf led the FDA in the last year of former President Barack Obama's second term in the White House. Now, he's reportedly President Joe Biden's nominee to fill the spot Janet Woodcock has held on an interim basis for nine months.

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Top Stories

Sanofi tries to quiet naysayers with follow-up data on MS drug at heart of $3.7B Principia buyout

Sanofi’s $3.7 billion acquisition of Principia Biopharma has been taking barbs from all sides, so perhaps some long-term follow-up data on the multiple sclerosis candidate at the heart of the deal will quiet the criticism.

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Mayo Clinic, Kaiser Permanente recruit 11 health system partners for new hospital-at-home advocacy coalition

Geisinger Health, Johns Hopkins Medicine, UNC Health and others under the Advanced Care at Home Coalition banner will petition the government to extend in-home care flexibilities and test a new CMMI model.

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Bristol Myers Squibb is nixing BeiGene's Abraxane deal in China amid manufacturing woes. Is their cancer rivalry really to blame?

A partnership between Bristol Myers Squibb and BeiGene on the chemotherapy Abraxane in China has quickly deteriorated since a manufacturing-related marketing hold last March. Now, the U.S. pharma is scrapping the deal—much to the Chinese partner’s disagreement.

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UnitedHealth expects Change Healthcare acquisition to close next year

Chief Operating Officer Dirk McMahon said on the company's earnings call that the regulatory process is proceeding apace.

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Cue Health snags the rebound, reupping NBA COVID testing contract for another season

For the third NBA season in a row, Cue Health is hoping to lead the league in assists as its go-to COVID-19 testing company.

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After 15 years helping lead early cancer research at Genentech, Malek jumps ship to run Novartis' NIBR oncology unit

The Novartis Institutes for BioMedical Research's oncology department has poached Genentech’s Shiva Malek, Ph.D., to help lead its cancer research.

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Merck bags imperfect immunotherapy first with Keytruda cervical cancer approval

Merck & Co. is adding yet another immuno-oncology first under Keytruda’s belt. But the breadth of the win comes out less than ideal. The latest FDA go-ahead makes Keytruda the first PD-1/L1 inhibitor for first-line cervical cancer treatment but only for those whose tumors express the PD-L1 biomarker.

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Headspace, Ginger finalize merger to form $3B mental health company

Less than two months after the deal was announced, Headspace and Ginger have closed their merger, creating a $3 billion mental health company. Headspace Health aims to provide employees a full range of mental health services, from coaching, therapy and psychiatric care to meditation.

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Decentralized clinical trials skyrocketed during pandemic, but patient experience mixed bag: survey

About 87% of CRO and sponsors use decentralized/hybrid trials or plan to within 12 months compared to 28% before the pandemic, according to a new survey by Veeva. Yet, 56% of the clinical R&D leaders said the digital trials improved convenience or retention for patients.

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Exscientia AI study spots which blood cancer therapies work and which don't

Using AI in personalized medicine could boost treatment success in patients with aggressive blood cancers, an Exscientia study found. The method follows a basic idea: Take a test to see whether a drug will work before it’s given. But AI allows clinicians to trial a whopping 139 different treatments in each patient—no risk required.

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Industry vets launch Tentarix with $50M to develop antibody-based cancer-killing treatments

Industry vets from Eli Lilly, Amgen, Regeneron and more are ready for their next venture: launching biotech Tentarix Biotherapeutics with a $50 million series A fundraising to advance the field of multifunctional biotherapeutics.

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Laborie expands GI profile with purchase of Pelvalon and its female fecal incontinence device

For its fourth acquisition in as many years, Laborie Medical Technologies has opted to build out its gastroenterology offerings, snapping up Pelvalon and its patient-controlled device for women experiencing fecal incontinence.

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Protein that manipulates gene expression inside the cell nucleus could inspire new RSV drugs, vaccines

In respiratory syncytial virus (RSV), the NS1 protein sneaks into the cell's nucleus and binds to the parts responsible for gene expression, undermining the body's ability to fight off the disease. The new findings from researchers at Washington University in St. Louis could light the path for new treatments and maybe even vaccines for the common virus.

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