Results for 'EMA'
Browse oncology articles matching EMA — 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.
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
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
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
Tanja Cufer, Tudor E. Ciuleanu, Peter Berzinec, Gabriela Galffy, Marko Jakopovic, Jacek Jassem, Dragana Jovanovic, Zhasmina Mihaylova, Gyula Ostoros, Christiane Thallinger, Milada Zemanova, Christoph Zielinski
Access to Novel Drugs for Non-Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis
Health Outcomes and Economics of Cancer Care, Lung Cancer, NSCLC, EMA
Treatment for non-small cell lung cancer (NSCLC) has significantly improved with the introduction of targeted and immune-oncologic drugs. Despite rapid development and European Medicinal Agency (EMA) registration, these novel drugs are not easily accessible in Central and Eastern European (CEE) c…
Nov 24th • 10 mins read
Barbara Kiesewetter , Nathan I Cherny, Nicolas Boissel, Francesco Cerisoli, Urania Dafni, Elisabeth G E de Vries, Paolo Ghia, Nicola Gökbuget, Verónica González-Calle, Brian Huntly, Ulrich Jäger, Nicola Jane Latino, Jean-Yves Douillard, Luca Malcovati, Ma
EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies
ESMO, hematological malignancies, Clinical benefit scale, EHA
The ESMO-MCBS v1.1 has not been previously validated for haematological malignancies, but it is being explored to avoid duplication of efforts. A feasibility test was conducted using 80 studies related to various haematological malignancies such as acute and chronic leukaemia, lymphoma, myel…
Jan 20th • 20 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
Dr Leon Rozen
Clarity is not the same as legibility
You can say something clearly and still not be understood. Understood, in the sense that matters in a decision making forum: whether the reasoning behind the recommendation is accurately read. The recommendation is clear. The words are plain. But the reasoning that produced it remains opaque to the…
Jun 6th • 0 min read
Dr Leon Rozen
The signal they read is not the signal you sent
Four structural features. Four predictable distortions.
May 26th • 0 min read
Dr Leon Rozen
We know more than we can tell
The structural reason good reasoning doesn’t always carry weight
May 19th • 0 min read
Leon Rozen
The advice was good. It didn't matter.
Medical Strategy, Medical Leadership, Medical Affairs
There is a particular kind of professional frustration that doesn't have a clean name. It isn't failure — the work was sound. It isn't incompetence. The reasoning was careful, the constraints were weighed, the recommendation was defensible. It is something more specific: the experience of having d…
Apr 12th • 5 mins read
Jürgen Wiehn, Marian Duven
Why leadership teams become dependent on pressure and what it costs performance
leadership, career, performance
In many high-performing environments, pressure is not the exception. It becomes the operating baseline. Deadlines compress.Decisions stack.Communication tightens.Expectations increase. And over time, something subtle but important happens. Leadership teams begin to rely on pressure to function. …
Apr 13th • 5 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: 10 Ways Executives Can Stay Visible, Valuable Between Jobs
For biopharma executives who are between roles, navigating the transitionary time can be challenging. However, they can remain visible and valuable so they’re ready to seize their next big opportunity.
Oct 22nd • 5 mins read
Michael Pietrack
Leadership Lab: 5 Ways Biopharma Execs Can Restore Trust, Retain Talent After Layoffs
In the latest installment of his column, Kaye/Bassman’s Michael Pietrack shares five ways leaders can help their teams after a layoff, from acknowledging emotions to reestablishing culture.
Jun 25th • 4 mins read
Michael Pietrack
Leadership Lab: How To Spot When Employees Are About To Walk Away
Employees rarely leave companies for one reason alone. In this column, Kaye/Bassman’s Michael Pietrack shares a framework that helps leaders identify when their team members are thinking about heading for the exit—and how to address it.
Oct 22nd • 7 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
Resume Advice: Tattoos and Breadcrumbs
Okay, Pietrack has finally lost it! What do tattoos and breadcrumbs have to do with resume advice? If you did a web search seeking resume advice, you would get pages of information about resume construction to format to length. So much of how a resume should be constructed is subjective or based o…
Jul 14th • 5 mins read
Michael Pietrack
What Do Tennis and Job Interviewing Have in Common?
What do tennis and Job interviewing have in common? In a game of tennis, one person sends the ball over the net and the other person, sends it back, right? Well, when it comes to job interviewing, correspondence with the hiring manager is a lot like tennis. How? When you send the ball over the ne…
Apr 14th • 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
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