Results for 'PD-1'
Browse oncology articles matching PD-1 — expert analysis, clinical perspectives, and industry updates from across drug development and care delivery. Use the tabs above for podcasts, press releases, partners, and people for the same search.
Nidal Al-Huniti, Yan Feng, Jingyu (Jerry) Yu, Zheng Lu, Mario Nagase, Diansong Zhou, Jennifer Sheng
Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
tumor growth, drug developement, drug approval, TGD, MIDD, PDUFA
Model-informed drug development (MIDD) has advanced rapidly in recent years, especially in oncology. The Prescription Drug User Fee Act (PDUFA) VI includes commitments to enhance MIDD. Tumor growth dynamic (TGD) modeling is a key MIDD approach used to accelerate drug development, support new dru…
Jun 26th • 18 mins read
Jingjing Yu, Isabelle Ragueneau-Majlessi
In Vitro-to-In Vivo Extrapolation of Transporter Inhibition Data for Drugs Approved by the US Food and Drug Administration in 2018
In Vitro-to-In Vivo, Transporter Inhibition Data, Drug Approval, FDA, 2018
The analysis focuses on inhibition transporter data from New Drug Applications approved by the FDA in 2018, involving 42 drugs. Key points include: In vitro-to-in vivo predictions were available for nine recommended transporters. 29 parent drugs and 16 metabolites inhibited at least one transpor…
Jan 25th • 12 mins read
Natansh D. Modi, BPharm; Ahmad Y. Abuhelwa, PhD; Ross A. McKinnon, PhD
Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration
IPD sharing, clinical trial transparency, FDA anticancer approvals, oncology trials, data accessibility, pharmaceutical industry
The study examines the eligibility for individual participant data (IPD) sharing from clinical trials that supported the FDA approval of anticancer medicines over the past 10 years. Of the 304 trials analyzed, 136 (45%) were eligible for IPD sharing, while 168 (55%) were not. IPD sharing rates v…
Jul 28th • 20 mins read
Shun-Long Ou, Jing Luo, Hua Wei, Xiao-Li, Qian Jiang
Value assessment of PD-1/PD-L1 inhibitors in the treatment of esophageal and gastrointestinal cancers
PD-1/PD-L1 inhibitors, ESMO-MCBS, ASCO-VF, value, cost
Only a few treatment regimens showed clinical value in EC and CRC using ASCO-VF and ESMO-MCBS frameworks. Nivolumab met valuable threshold in resectable locally advanced EC/GEJC. 14 positive therapeutic regimens assessed; 11 negative regimens showed no improvement in QoL and were below the …
Apr 21st • 13 mins read
Shen Lin, Yaping Huang, Liangliang Dong, Meiyue Li, Yahong Wang, Dian Gu, Wei Wu, Dongni Nian, Shaohong Luo, Xiaoting Huang, Xiongwei Xu and Xiuhua Weng
The correlation between the costs and clinical benefits of PD-1/PD-L1 inhibitors in malignant tumors: An evaluation based on ASCO and ESMO frameworks
PD-1/PD-L1 inhibitors, malignant tumors, ASCO, ESMO, Immune Checkpoint Inhibitors, Gastrointestinal Cancers
Cancer drug innovation has significantly accelerated in the 21st century, with novel drug approvals and expenditures increasing notably. Assessment frameworks ASCO-VF and ESMO-MCBS were used to evaluate the clinical benefit of PD-1/PD-L1 inhibitors, finding that nearly half of the trials met "mea…
Feb 23rd • 9 mins read
A. Haslam, M.S. Kim, V. Prasad
Updated estimates of eligibility for and response to genome-targeted oncology drugs among US cancer patients, 2006-2020
genome-targeted therapy, eligibility, response
Recent studies have been conducted to update the estimates of eligibility and response rates to genome-targeted therapies among US cancer patients, reflecting data up to 2020. The number of FDA-approved drugs targeting genetic indications has increased significantly since prior assessments. …
Apr 20th • 7 mins read
Paul G. Kluetz, Patricia Keegan, George D. Demetri, Katherine Thornton, Joohee Sul, Janice Kim, Harvey Katzen, Laurie Beth Burke, R. Donald Harvey, Elleni Alebachew, Sundeep Agrawal, Abhilasha Nair, Martha Donoghue
FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs
FDA labeling format, PLR format, oncology drugs, FDA
The FDA conducts independent reviews of scientific data to ensure the safety and efficacy of investigational drug products. FDA-approved product labeling is a highly trusted source of information for approved drug use. FDA approval is only the beginning of a drug's lifecycle, with ongoing c…
Feb 15th • 13 mins read
G. Pentheroudakis
Recent eUpdates to the ESMO Clinical Practice Guidelines on hepatocellular carcinoma, cancer of the pancreas, soft tissue and visceral sarcomas, cancer of the prostate and gastric cancer
ESMO, hepatocellular carcinoma, gastric cancer, prostate cancer
The following ESMO Clinical Practice Guidelines have been recently updated with new treatment recommendations for the ESMO Clinical Practice Guidelines on Hepatocellular Carcinoma, Cancer of the Pancreas, Soft Tissue and Visceral Sarcomas, Cancer of the Prostate and Gastric Cancer.
Jun 6th • 2 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
Managing Emotions After Being Downsized
The biggest challenge a person faces after being downsized is the wide range of emotions that follow. Over the past 15 years, I’ve observed many individuals deal with this unfortunate circumstance, and I wanted to share what I’ve seen others do to cope. I genuinely hope this helps you or someon…
Oct 21st • 5 mins read
Michael Pietrack
How to Know When to Make a Job Change
In career conversations, one of the most common questions I hear is: “How do I know if it’s time to move on from my company?” The real decision often comes down to a mix of factors that influence job satisfaction and long-term career growth. That’s why I use the CLAMPS framework. CLAMPS …
Aug 26th • 5 mins read
Forbes Books Press Release Official
New Book Unites Oncology’s Brightest Minds To Innovate Cancer Cures
Voices of Oncology, Cancer cures, Oncology Voice Network, Kirk V. Shepard, Ramin Farhood, Forbes Books, Cancer treatment innovation, Oncology collaboration, Patient engagement in oncology, Precision medicine cancer
Voices of Oncology: Fostering a Collaborative Community of Experts to Accelerate Cancer Cures is a book by Kirk V. Shepard, M.D., and Ramin Farhood, PharmD, M.B.A., featuring insights from 33 contributors in the oncology field. It is available on platforms like Amazon and Barne…
Sep 9th • 5 mins read
Tom Caravela
Mastering the First Impression
first impression, job interviews, professional communication, resume tips, LinkedIn profile
Why is a first impression so important? Mainly because it could also be your last, and only, impression on someone. Oftentimes, job seekers can fail at conveying a positive first impression, and they will unfortunately never get another chance to show who they truly are. This is an area that I feel …
Jan 29th • 2 mins read
Tom Caravela
Job Search Checklist for Aspiring Medical Science Liaisons
Medical Science Liaison, MSL role, MSL career tips, Pharmaceutical industry jobs, Break into MSL career
Tips to Help Break into Your First MSL Role The Medical Science Liaison (MSL) role, has become one of the most sought-after career paths in the Pharmaceutical and Biotech industry. What does it take to land a role as a Medical Science Liaison? As an MSL Recruiter, this is a question that I am…
May 17th • 2 mins read
Tom Caravela
Resume Writing and Editing Tips for Pharma Professionals
Pharmaceutical recruiter, Resume writing tips, Professional CV, LinkedIn profile optimization, Job application keywords
As a Professional Pharmaceutical Recruiter, I read and evaluate resumes (as well as CVs), every day. While I am not a professional resume writer, I have a very strong understanding of what a good resume or CV looks like and what should be included. More importantly, I keep track of what is most effe…
Aug 8th • 1 min read
Tom Caravela
Promotability: How to Land Your Next Promotion
professional visibility, career advancement, promotion tips, career progression, networking strategies, mentorship benefits, resume upgrades, servant leadership, problem-solving skills, personal branding
“Promotability” may be defined as one’s suitability for being promoted. Is it your goal to obtain a promotion this year? If so, how suitable or promotable are you for that next step? Job-seekers and professionals often ask me what steps are necessary for advancement. I have broken …
May 5th • 10 mins read
iNIZIO
Transforming oncology: Five frontiers driving progress in cancer care
From biomarker-driven breakthroughs to AI-powered early detection and a renewed commitment to equity and patient centricity, the past 12 months have seen major strides across cancer research, treatment, and communication. At Inizio, we’ve had a front-row seat to this transformation, supporting…
May 16th • 5 mins read
Fei Liang, Sheng Zhang, Qin Wang, Wenfeng Li
Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration
Randomized trials, Clinical benefits, Immune checkpoint inhibitors, Cancer, Food and drug administration agency
The study evaluates the clinical benefits of immune checkpoint inhibitors using the ESMO-MCBS and ASCO VF scales. 18 indications for these inhibitors were approved based on RCTs conducted between 2011 and 2018. All indications meet the ESMO-MCBS 1.1 threshold for meaningful bene…
Aug 31st • 16 mins read