Featured Articles
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Tackling The Pharmacovigilance Crunch At The Local Level
12/19/2024
Local market pharmacovigilance (PV) requirements can be daunting to manage successfully. Experts at PharmaLex provide best practices for managing PV across local affiliates.
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Antibodies 2025: Venerable & Naked Or Complex & Multi-Specific?
12/19/2024
Antibodies are the biotherapeutic bulwark, the steadfast stalwart in not just oncology, but infectious and chronic inflammatory diseases as well. We consulted with a variety of antibody developers for insight into the challenges and opportunities antibody modalities face in the coming year and beyond.
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A Father's Perspective On The Rare Pediatric Disease PRV Program
12/17/2024
The FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) program is set to expire on December 20, 2024, if the U.S. Senate doesn't act. Stuart Siedman explains why the program is so important.
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A Realistic Look At What RFK Jr. Could Mean For FDA
12/17/2024
“Make America Healthy Again” is coming to Washington. Jennifer D. Newberger and Jeffrey N. Gibbs at Hyman, Phelps, & McNamara, discuss the implications of RFK Jr.’s nomination to lead HHS.
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Inside Interius' Global Regulatory Strategy
12/13/2024
Interius BioTherapeutics' lentiviral gene therapy INT2104, which creates CAR T and CAR NK cells in vivo, headed to clinical trials in Australia where the company dosed a first patient with a B-cell malignancy. CEO Phil Johnson, M.D. gave us a look inside the company's global regulatory strategy.
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The Bond Factor: Connecting For Success In Life Sciences
12/13/2024
Sanofi’s chief learning officer Wanda Shoer explains the importance of self-awareness about of your own core skills, talents, and values in becoming more adaptable and successful.
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Optimism For Life Sciences Growth Amid Policy Shifts In 2025
12/11/2024
EY's Arda Ural provides an assessment of the current life sciences business environment, and reasons for optimism about 2025 despite the uncertainty that comes with a new administration in the U.S.
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Leading Through Biotech's Perfect Storm: Lessons From The Front Lines
12/9/2024
Memo Therapeutics CEO Erik van den Berg reflects on the strategies and skills needed to build company resilience and navigate successfully through challenging external circumstances.
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Four Ways For Legal Departments To Create Financial Efficiency
12/6/2024
Life sciences legal departments can do more to improve financial efficiency across an organization. This article includes insights from an Ernst & Young survey of multinational corporations across the pharmaceutical, consumer health, and medical device industries.
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The Fork In The Road: Personal Decisions That Change Our Career Trajectory
12/4/2024
Novo Nordisk SVP Blandine Lacroix shares her career story and discusses the importance of prioritizing your own personal needs, and the personal needs of others, in navigating a professional career.