In major shake-up, Novartis combines pharma and oncology units, leaving 3 top execs without jobs 10 ways COVID-19 rocked biotech—plus an honorable mention for omicron Anthem, Biogen, Eli Lilly and Pfizer develop digital endpoint toolkit to guide drug reimbursement decisions Abbott picks up the pace with FDA approval of removable, long-lasting leadless pacemaker Legend Biotech CSO abruptly leaves Johnson & Johnson's CAR-T partner he co-founded ACC: Bayer's Kerendia cuts cardio and kidney complications, and high-risk patients benefit most ACC: Medtronic touts 3-year data from its renal denervation system for high blood pressure Obesity may alter inflammation on a molecular level, throwing current treatments into question CHS' new CEO Tim Hingtgen boosted pay to $9.5M in 2021 Ascensia Diabetes Care launches Eversense's 6-month CGM system in the US AMA, MGMA call for HHS to hold off on $100M in provider relief clawbacks State-based ACA exchanges make backup plans in case Congress fails to act on enhanced ACA subsidies Alnylam's Onpattro follow-on delayed thanks to manufacturing holdup at FDA Novartis says bye to Tsai as restructuring triggers the return of a familiar face Dexcom plots U.K. rollout of pared-down diabetes monitoring system Featured Story | By Angus Liu Novartis CEO Vas Narasimhan is giving the Swiss pharma a huge makeover ahead of a possible spinoff of generics unit Sandoz, pushing out three C-level executives and preparing for layoffs. read more |
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Top Stories 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more 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. read more | 