| 04.04.22 | 10 ways COVID-19 rocked biotech; Novartis' Tsai is out, replaced with familiar face

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Today's Rundown

10 ways COVID-19 rocked biotech—plus an honorable mention for omicron Novartis says bye to Tsai as restructuring triggers the return of a familiar face Legend Biotech CSO abruptly leaves Johnson & Johnson's CAR-T partner he co-founded Sponsored: Precision Recruitment at Scale: Rapid ID of High-Risk Participants FDA puts Curis' leukemia trial on partial hold after patient death spurs review of muscle breakdown Big Pharma-backed $1B AMR Action Fund picks 1st antimicrobial biotech investments ACC: Ionis-AstraZeneca antisense drug reduces troublesome cholesterol in phase 2b ACC: Bristol Myers drug helps patients avoid heart procedure amid FDA countdown In major shake-up, Novartis combines pharma and oncology units, leaving 3 top execs without jobs ACC: Massive Chinese smartwatch study screens millions for signs of afib ACC: Philips to bring its 'calming' MRI ambience to the cath lab AMA, MGMA call for HHS to hold off on $100M in provider relief clawbacks Alnylam's Onpattro follow-on delayed thanks to manufacturing holdup at FDA

Featured Story

10 ways COVID-19 rocked biotech—plus an honorable mention for omicron

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.

This week's sponsor is H1

Novartis says bye to Tsai as restructuring triggers the return of a familiar face

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.

Legend Biotech CSO abruptly leaves Johnson & Johnson's CAR-T partner he co-founded

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.

The list of biotechs under clinical hold keeps getting longer. Curis is the latest company to join the list, with the FDA slapping a partial hold on a phase 1/2a leukemia study while it gathers information about the death of a patient.

Big Pharma-backed $1B AMR Action Fund picks 1st antimicrobial biotech investments

By Annalee Armstrong

The AMR Action Fund, backed by Big Pharmas such as Pfizer, Eli Lilly, Bayer and more, has selected the first beneficiaries of its $1 billion fund to address drug-resistant bacterial infections: Adaptive Phage Therapeutics and Venatorx Pharmaceuticals.

ACC: Ionis-AstraZeneca antisense drug reduces troublesome cholesterol in phase 2b

By Max Bayer

Ionis Pharmaceutical, in need of a win after a high profile pipeline flop last week, has found that its AstraZeneca-partnered cholesterol med lowered levels of the troublesome substance in patients during a mid-stage trial.

ACC: Bristol Myers drug helps patients avoid heart procedure amid FDA countdown

By Annalee Armstrong

Bristol Myers Squibb is presenting data this weekend that shows its targeted heart drug mavacamten helped reduce the risk of needing septal reduction therapy.

In major shake-up, Novartis combines pharma and oncology units, leaving 3 top execs without jobs

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.

ACC: Massive Chinese smartwatch study screens millions for signs of afib

By Conor Hale

Using Huawei devices equipped with the same light-based sensors found on Apple Watches, Fitbits and more, researchers found a free app could track a person’s pulse and issue an alert when it falls out of sync.

ACC: Philips to bring its 'calming' MRI ambience to the cath lab

By Conor Hale

Undergoing a medical procedure is always a stressful prospect for a patient—so much so that, at times, their anxieties are simply considered unavoidable. But Philips is looking to make the entire experience just a little less scary.

AMA, MGMA call for HHS to hold off on $100M in provider relief clawbacks

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.

Alnylam's Onpattro follow-on delayed thanks to manufacturing holdup at FDA

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.

This week's sponsor is Thermo Fisher Scientific.

Resources

Whitepaper: Oncology Market Outlook: Key Trends to Watch

Sponsored by: Blue Matter, strategic consultants in the life sciences

What’s in store for the oncology market in 2022 and beyond? This paper looks at 5 trends driving the market.

Whitepaper: Uncovering the hidden value of quality in chemical supply

eBook: Leveraging Clinical Data for Study Success

Sponsored by: Medidata, a Dassault Systèmes company

The landscape of clinical trials has been permanently changed. Today's trials require sponsors to modernize their use of technology and data to adapt. This eBook provides an overview of how sponsors can empower trials with real-time performance data to improve study integrity, reduce risks, optimize patient safety, and increase trial success rates.