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Results for 'legal'

The Four Employment Agreement Questions Every Pharma Executive Must Ask
Partner Avatar Michael Pietrack
The Four Employment Agreement Questions Every Pharma Executive Must Ask

opinion, career advice, leaderhsip, legal

Clarity on employment terms is essential to protect careers. In this column, Kaye/Bassman’s Michael Pietrack speaks to employment attorney Howard Matalon, JD, partner at OlenderFeldman, on how to evaluate the fine print of an employment agreement.

Dec 18th • 6 mins read

Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years
OVN Avatar Emmanuelle Jacqueta, Ghania Kerouani-Lafayeb, Francoise Grudeb, Sergio Goncalvesb, Annie Lorenced, Florence Turcryb, Liora Brunelb, Laetitia Belgodereb, Adrien Monardc, Gaëlle Guyaderb, Lotfi Boudalib, Nicolas Albin
Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years

Innovation, Expanded access, Early drug access, Cancer, FDA, EMA

Cancer incidence is increasing globally, and while medical innovation significantly impacts patient survival, the drug development process is lengthy, often exceeding 10 years for marketing authorization (MA). France has implemented the ATU (Temporary Authorization for Use) program to facil…

Apr 7th • 12 mins read

How do cancer clinicians perceive real-world data and the evidence derived therefrom? Findings from an international survey of the European Organisation for Research and Treatment of Cancer
OVN Avatar Robbe Saesen, Georgios Kantidakis, Ann Marinus, Denis Lacombe, Isabelle Huys
How do cancer clinicians perceive real-world data and the evidence derived therefrom? Findings from an international survey of the European Organisation for Research and Treatment of Cancer

real-world evidence, real-world data, oncology, cancer, survey, clinicians, randomized controlled trials, Europe

Real-world evidence (RWE) is increasingly being used in the development and decision-making processes for anticancer therapies, but clinician views on its use are unclear. A survey conducted between May and July 2021 involved 557 clinicians from 30 countries and 13 cancer domains. Most clinician…

Aug 1st • 45 mins read

Opportunities and challenges in biosimilar uptake in oncology
OVN Avatar Carina Dolan, PharmD, BCOP
Opportunities and challenges in biosimilar uptake in oncology

Trastuzumab, Rituximab, biosimiliar agents, emerging agents, cetuximab, bevacizumab, clinical trials, biosimiliars

The U.S. has 10 approved biosimilars, including 3 for oncology, with many more in development, potentially increasing access to expensive biologics. Acceptance by healthcare providers and patients requires extensive education, resolving concerns about immunogenicity, and ensuring interchangeability.…

Jun 26th • 7 mins read

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