By Annalee Armstrong
COVID-19 is shifting to an endemic disease, and life is getting back to whatever this new normal will be. But for biotech, the pandemic made for Earth-shattering disruptions that will have a long-lasting impact on drug development timelines—and bottom lines.
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By Heather Landi
To prepare for the first drug labels and approvals based on data from digital endpoints, the nonprofit Digital Medicine Society partnered with Anthem and major pharmaceutical companies to develop a toolkit to support reimbursement for new drugs developed using digital endpoints.
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By Andrea Park
Though FDA approval for Abbott’s first leadless pacemaker comes several years after competitor Medtronic achieved the feat, the devicemaker is already upping the tempo.
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By Angus Liu
The co-founder of Johnson & Johnson’s partner in freshly FDA-approved CAR-T therapy Carvykti has stepped down unexpectedly as chief scientific officer. In a revelation that suggests an internal power struggle, the former R&D chief told Fierce Biotech he hasn't settled on his next gig.
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By Kevin Dunleavy
At the American College of Cardiology conference Monday in Washington, D.C., Bayer presented the latest findings on its diabetic kidney cancer drug Kerendia, discovered by pooling two trials. The company believes the findings will help guide it to more uses for Kerendia.
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By Conor Hale
Medtronic continues to build up clinical data for its kidney nerve ablation procedure for treating stubborn high blood pressure. A randomized clinical study has shown significant and sustained reductions after three years.
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By Max Bayer
In a quest to understand why some obese people don’t react to treatment for inflammation, a team of California scientists says it may have uncovered the first glimmer of an answer. The new study was published last week in Nature by researchers from the Gladstone Institute, UCSF and the Salk Institute for Biological Studies.
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By Dave Muoio
CHS CEO Tim Hingtgen’s $9.5 million take-home is a slight increase over the $9.1 million 2020 salary of Wayne Smith, who had served in the top role since 1997 and transitioned to the executive chairman position last year.
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By Conor Hale
After more than a yearlong wait at the FDA due to the COVID-19 pandemic, Senseonics’ six-month CGM system is finally headed to users with diabetes.
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By Heather Landi
The American Medical Association and other prominent medical groups are urging the Biden administration to give providers more time to report on COVID-19 pandemic assistance before the government takes back some of the funding.
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By Robert King
State-based ACA exchanges are eyeing backup plans and changes to their outreach efforts in case Congress doesn't act fast to extend boosted subsidies that go away in 2023.
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By Fraiser Kansteiner
The U.S. FDA has slapped a three-month delay on its review of Alnylam's RNA interference hopeful vutrisiran after the company tapped a new production facility to support the drug’s launch.
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By Nick Paul Taylor
Novartis is ringing the changes. With a restructuring prompting Chief Medical Officer John Tsai to decide to leave, the Swiss Big Pharma has rehired Shreeram Aradhye to lead the global drug development team.
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By Andrea Park
Not every diabetes patient needs all the bells and whistles of Dexcom's next-generation G7 CGM system. Enter: the pared-down, less-expensive Dexcom One.
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