By Andrea Park
Owlet is no longer selling its Smart Sock vital sign monitors for babies and toddlers after the FDA informed the company that the devices had been improperly brought to market.
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By Heather Landi
Early in 2020, there was a massive pandemic-induced nosedive in merger and acquisitions deals in healthcare. But the industry rapidly rebounded, and the pace accelerated in 2021. In this report, we’ll take you through some companies that could be in the M&A crosshairs during 2022, such as digital pharmacies and health systems.
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By Ben Adams
GlaxoSmithKline has seen a host of vaccine research staffers exit the Big Pharma over the past year, but it’s hoping a big name can get its vaccine business back on track.
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By Fraiser Kansteiner
A U.S. appeals court has declined to resurrect a key patent on Biogen’s once-stalwart multiple sclerosis med Tecfidera, according to court documents filed Tuesday. It’s the latest spot of trouble for the struggling blockbuster, which succumbed to its first generic competitor last summer.
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By Kevin Dunleavy
A devastating trial flop for its gastrointestinal cancer drug Qinlock has prompted Deciphera to undergo a transformation. The biopharma will cut 140 jobs, reducing its headcount by 35%. Deciphera also will abandon its development of Qinlock and ovarian cancer candidate, rebastinib.
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By Angus Liu
After the FDA slapped an updated safety warning on marketed oral JAK inhibitors for inflammatory diseases, market watchers have started worrying about other candidates in the pipeline. Bristol Myers Squibb now has a date to learn how the agency views its novel medicine deucravacitinib, with blockbuster sales at stake.
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By Conor Hale
The portable MRI machine maker Hyperfine obtained a new clearance from the FDA, adding deep-learning algorithms that can boost the quality of images taken by its scanner-on-wheels.
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By Arlene Weintraub
NYU researchers have developed a drug that prevent a protein called rage from triggering inflammatory signals in diabetes. The drug reduced the risk of heart attack and sped up the healing of diabetic wounds in mouse models of diabetes.
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By Annalee Armstrong
Fierce Biotech profiles three women breaking barriers in Alzheimer's disease R&D at leading pharmaceutical companies. Today, Eli Lilly's donanemab launch leader Brandy Matthews.
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By Paige Minemyer
UnitedHealth will host its annual investor conference Tuesday morning, and the healthcare giant updated its outlook for 2021 ahead of the meeting.
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By Dave Muoio
The preliminary injunction is an early win for the 22 rural and red states that have filed challenges against CMS' COVID-19 vaccine requirement for healthcare workers.
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By Annalee Armstrong
The FDA still hasn't found what its looking for in TG Therapeutics’ application for the leukemia and lymphoma combo treatment nicknamed U2, and so the therapy will be examined at an advisory committee meeting.
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By Conor Hale
The former Fierce 15 winner announced that the first healthy volunteer in an Australian study has received a limited, intravenous dose of the company’s ISM001-055, a small-molecule inhibitor aimed at the chronic lung disease.
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