Vertex cell therapy hit with FDA hold
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Today's Rundown

Featured Story

Most influential people in biopharma—the CEOs

With great pleasure, the Fierce Biotech and Fierce Pharma teams bring you our 2022 selections for the most influential people in biopharma. Starting today and for following three weeks, we’ll release five honorees each Monday and tell you their stories. We will shed light on why they are significant players in their respective fields and why their peers are paying close attention to their moves. 

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Top Stories

Unwelcome surprise for Vertex as FDA slaps hold on phase 1/2 diabetes cell therapy study

Vertex’s new diabetes cell therapy has brought many surprises: first, the rush of excitement that followed new data from a single patient last year. And now, an FDA clinical hold on a phase 1/2 trial.

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As Teladoc shares tumbled after dismal Q1 earnings, analysts question telehealth giant's growth strategy

Telehealth giant Teladoc warned of a weak sales outlook for 2022 and some analysts are now questioning the company's long-term growth prospects as it faces competitive headwinds.

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'The Top Line' podcast: Pharma advertising shifts gears and Novartis taps a surprising M&A czar, plus this week's headlines

This week The Top Line podcast discusses pharma's ad spending for 2021, an intriguing executive move at Novartis and more.

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FDA crowns Johnson & Johnson's Monarch surgical robot with urology nod

Auris Health has added another jewel to its crown. The Johnson & Johnson subsidiary earned a second FDA clearance for its Monarch surgery system, allowing the robot to be used in kidney stone removal procedures.

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Biogen takes another dip into Scribe gene therapy collab with another disease target

Biogen is double-dipping into a 2020 collaboration with Scribe Therapeutics, exercising its option for an additional neurological disease target in gene therapy using the biotech's CRISPR technology. 

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With FDA approval, Supernus' Qelbree is the first nonstimulant ADHD med for adults in 2 decades

Adults with ADHD have a new nonstimulant treatment option in Supernus' Qelbree, which earned FDA approval in the age group one year after its initial nod in children.

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Medtronic issues new warning after finding another defect in discontinued HeartWare pump

Nearly a full year after it was discontinued due to a spate of safety issues, the troubles with Medtronic’s HeartWare Ventricular Assist Device, or HVAD, rage on.

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Hello Heart notches $70M to scale up cardiovascular health app among employers

Hello Heart, a startup that helps people manage their heart health at home using their smartphones, is seeing a spike in demand among employers for digital cardiovascular solutions. The startup banked a $70 million financing round to help fuel its growth.

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Patient Square Capital invests $300M to support 'golden age of therapeutics' with Enavate Sciences

Healthcare investment firm Patient Square Capital sees a bright future in therapeutics—despite a bear market—cashing in $300 million to form portfolio company Enavate Sciences, which will work to support and grow a series of therapeutics companies.

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HHS: ACA coverage expands to record 35M people as more states expand Medicaid

A record-setting 35 million people have gained coverage via Affordable Care Act programs thanks in part to new legislation and flexibilities stemming from the pandemic.

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Guardant debuts first cancer screening blood test for catching colorectal tumors

The blood-testing company Guardant Health aims to offer a simpler option to people who may have missed their recommended appointments to be checked out for colorectal cancer—such as a colonoscopy—with the launch of its first cancer screening test.

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Paxlovid's post-exposure protection flop hardly spells the end for Pfizer's COVID franchise: analysts

Heavy is the head that wears the COVID-19 crown. Late last week, Pfizer revealed its antiviral Paxlovid fell short in a post-exposure protection trial. Still, in the pill’s quest to reach as many patients as possible, one setback doesn’t spell defeat.

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Cedars-Sinai AI catches pancreatic cancer in CT scans years in advance: study

The AI was trained to analyze CT images to look for certain changes in texture on the surface of the pancreas that are potentially linked to the molecular changes that occur while pancreatic cancer is developing.

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