Results for 'review'
H. K. van Halteren, J. Bennouna, B.Brasiuniene, A.J. Cunquero Tomas, A.M. Garcia Trinidad, A. Indini, G. Liposits, B. Pellegrino, L. Popovic, A.Tan, R.Vidra & M.Strijbos
Twelve ESMO Congress 2022 breakthroughs: practicing oncologists' perceptions and potential application on presented data
ESMO Congress 2022, review, methodology, implementation
Background: At the ESMO Congress 2022, numerous clinical trial outcomes were presented, highlighting the importance of structuring data to weigh treatment burden against benefits. Materials and Methods: A narrative non-systematic review of 12 selected oral presentations was conducted, focusing…
Jan 10th • 12 mins read
Stephanie Faucette, Santosh Wagh, Ashit Trivedi, Karthik Venkatakrishnan, Neeraj Gupta
Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development
clinical pharmacology, FDA reviews, PMR, PMC, molecular entitites, anticancer drug development
The article discusses optimizing oncology drug development, focusing on the impact of pharmacokinetic factors like food effects and drug interactions. It recommends early evaluation of these factors to enhance dosing accuracy and patient compliance. Advanced modeling and simulation are suggested to …
Mar 11th • 15 mins read
Aaron S. Long, BS; Audrey D. Zhang, MD; Caitlin E. Meyer, MLIS; Alexander C. Egilman, BS; Joseph S. Ross, MD, MHS; Joshua D. Wallach, PhD, MS
Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors: A Systematic Review
single-enantiomer racemic drug pairs, single-enantiomer, FDA, RCTs, generic drugs
Chiral Switching: A strategy where drug manufacturers develop a single-enantiomer formulation from a racemic one to extend market exclusivity, often without proving enhanced efficacy or safety. Objective: To evaluate randomized clinical trials (RCTs) comparing FDA-approved single-enantiomer drugs…
May 6th • 18 mins read
Charles L. Bennett , Sumimasa Nagai , Andrew C. Bennett , Shamia Hoque , Chadi Nabhan , Martin W. Schoen , William J. Hrushesky , Stefano Luminari , Paul Ray , Paul R. Yarnold , Bart Witherspoon , Josh Riente , Laura Bobolts , John Brusk , Rebecca Tombles
The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions
Epoetin, Biosimilars, Interchangeable, Substitution, Guidelines
Biosimilars are biologic drug products similar to reference drugs in various attributes, including safety and efficacy. Biosimilar epoetin was approved by the FDA in 2018 after previous non-approval letters in 2015 and 2017 despite positive reviews by the FDA's Oncologic Drugs Advisory Committee …
Mar 12th • 7 mins read
Vanessa Arciero, BS, Seanthel Delos Santos, Liza Koshy
Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review
ESMO, MCBS, FDA, ASCO-VF, EMA, QOL
Recent oncology therapies approved by the FDA and EMA often lack evidence of clinically meaningful improvements in quality of life (QOL). Only 40% of FDA-approved and 58% of EMA-approved oncology therapies had published QOL evidence. Clinically meaningful QOL improvements beyond minimal dif…
Feb 11th • 4 mins read
Jorge J. García, Luis E. Raez, Daniel Rosas
A narrative review of biosimilars: a continued journey from the scientific evidence to practice implementation
Biosimilars, interchangeability, extrapolation, immunogenicity
Biologic agents have significantly improved the management of serious health conditions over the last two decades, offering better treatment outcomes and quality of life compared to traditional chemotherapy. The cost of biologic drugs is high, leading to increased healthcare expenses. This mirror…
Aug 3rd • 10 mins read
Ruben Van Paemel, Roos Vlug, Katleen De Preter, Nadine Van Roy, Frank Speleman, Leen Willems, Tim Lammens, Geneviève Laureys, Gudrun Schleiermacher, Godelieve A. M. Tytgat, Kathy Astrahantseff, Hedwig Deubzer, Bram De Wilde
The pitfalls and promise of liquid biopsies for diagnosing and treating solid tumors in children: a review
Liquid biopsies, Pediatric solid tumors, Cell-free DNA profiling
Cell-free DNA profiling via blood samples is emerging as a non-invasive method for cancer genomic characterization. Liquid biopsies are set to be integrated into pediatric cancer clinical trials, offering benefits such as earlier therapy response monitoring and detection of residual disease.…
Jan 3rd • 10 mins read
G. Zarkavelis A.L. Amylidi C. Verbaanderd N.I. Cherny Y. Metaxas E.G.E. de Vries P. Zygoura T. Amaral K. Jordan M. Strijbos U. Dafni N. Latino M. Galotti F. Lordick R. Giuliani F. Pignatti G. Pentheroudakis
Off-label despite high-level evidence: a clinical practice review of commonly used off-patent cancer medicines
off-label, ESMO-MCBS, EMA, cancer, ESMO Clinical Practice Guidelines
Several 'old' cancer medicines remain off-label despite strong scientific evidence supporting their use in specific settings. Off-label prescriptions often carry administrative and legal burdens for physicians, affecting workflows and potentially patient access to safe and effective therapies. R…
Nov 14th • 21 mins read
Laurent Azoulay
Rationale, Strengths, and Limitations of Real-World Evidence in Oncology: A Canadian Review and Perspective
real-world evidence; RWE, real-world studies, RWS, oncology, real-world evidence, RWE, randomized controlled trial, RCT
Data obtained from real-world studies have an integral role in evidence-based medicine, serving as an essential source of safety information and a complement to efficacy data from RCTs. RWE is particularly useful for expanding the evidence base to encompass populations of patients who are not well r…
Apr 26th • 9 mins read
Bhakti Arondekar, Mei Sheng Duh, Rachel H. Bhak, Maral DerSarkissian, Lynn Huynh, Kelsey Wang, John Wojciehowski, Melody Wu, Bryon Wornson, Alexander Niyazov, George D. Demetri
Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application
RWE, Biologics License, FDA, BLA, suplements
The FDA emphasizes early engagement and transparent protocols in Real-World Evidence (RWE) studies. Aligning RWE populations with pivotal trial populations is crucial, often achieved through criteria matching and propensity score methodologies. Major critiques include differences in tumor asse…
Jan 1st • 12 mins read
Kyle A. Dymanus BS, Mohit Butaney MBBS, Diana E. Magee MD, MPH, MSc, Amanda E. Hird MD, MSc, Amy N. Luckenbaugh MD, Merry W. Ma MD, PhD, Mary E. Hall MD, Heather L. Huelster MD, Aaron A. Laviana MD, MBA, Nancy B. Davis MD, Martha K. Terris MD, Zachary Kla
Assessment of gender representation in clinical trials leading to FDA approval for oncology therapeutics between 2014 and 2019: A systematic review-based cohort study
clinical trials, drug approval, health care disparities, medical oncology, sexism
Gender representation in oncology clinical trials varies by cancer type, with women often underrepresented compared to national cancer incidence. Despite FDA guidelines from June 2015 requiring consideration of biological variables like sex in research designs, disparities persist. Women continu…
Jun 23rd • 8 mins read
Hagop M. Kantarjian MD, Ferran Prat PhD, JD, David P. Steensma MD, Razelle Kurzrock MD, David J. Stewart MD, Mikkael A. Sekeres MD, Joseph Leveque MD
Cancer research in the United States: A critical review of current status and proposal for alternative models
cancer research, research, NCI, Drug industry-driven research model, development in research, 2018 cancer model
Early research focused on tissue histology and animal models, with surgery and radiotherapy as primary treatments. 1950s: Introduction of cell lines (e.g., HeLa cells) and first anticancer drugs (antifolates, thiopurines), leading to the establishment of the Cancer Chemotherapy National Service C…
May 14th • 10 mins read
Jamie Riley
The Talent Inflection Point in Pharma and Biotech: A Challenge to Companies — and a Call to Candidates
hiring, talent demand, job market
As pipelines advance and execution accelerates, pharma and biotech hiring may shift again in 2026, reshaping talent demand.
Feb 4th • 7 mins read
Angus Liu
Large pharma companies reduced headcounts by more than 22K in 2025 as $300B patent cliff looms
headcount, reduction, revenue per employee
Large pharmaceutical companies, each with at least $20 billion in 2025 revenue, collectively reduced their workforces by more than 22,000 employees last year. Among the 17 largest pharma companies analyzed in a Fierce Pharma review of annual reports, only five logged a head count increase in 2025…
Mar 23rd • 10 mins read
Michael Pietrack
Leadership Lab: 4 Ways Biopharma Leaders Can Prepare for Media Interviews
Media coverage can help biopharma executives connect with, inform and inspire the public. In this column, Kaye/Bassman’s Michael Pietrack and three communications experts share how to make the most of these opportunities.
Aug 20th • 6 mins read
Michael Pietrack
Practical Advice for When You're Downsized. What Activities will Pay-off after a Lay-off?
Have you or someone you know recently been downsized, laid off, or RIF’d? If so, you’re going to want to watch and share this video. When one is downsized, there is a range of emotions. Some feel betrayed and carry hurt feelings, while others fight with the fear of uncertainty and the reality…
Sep 15th • 5 mins read
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
Tom Caravela
Where Did My Interview Go Wrong?
interview preparation tips, job interview mistakes, hiring manager feedback, candidate interview performance, professional recruiter advice
During the course of a lengthy and involved interview process, job seekers are often left wondering where they went wrong, or why things didn’t pan out positively in their favor – with a great job offer at the end and an exciting next chapter to look forward to in their professional care…
Apr 24th • 1 min read
Tom Caravela
12 Interview Techniques to Help Land Your Next Job
interview preparation, job interview tips, business etiquette, salary negotiation, follow-up after interview
Your next career move could very well be one interview away. Be sure to take every measure to prepare yourself and make the most of the opportunity. According to a recent Simply Hired survey of over 850 Managers, an overwhelming 89% said that “showing lack of preparation” will affect the…
May 12th • 1 min read