AstraZeneca holds talks with Bristol Myers Squibb over $400bn tie-up www.ft.com/content/e902...
AstraZeneca holds talks with Bristol Myers Squibb over $400bn tie-up
Deal would create world’s fourth-largest drugmaker by market value
ft.com
Eslam Maher
@eslammaher.bsky.social
Biostatistician, oncology trials @imperialsandc.bsky.social https://scholar.google.co.uk/citations?user=ZbSK3WwAAAAJ
How will ongoing UK heatwaves affect food & water supplies? Pauline Scheelbeek tells BBC Verify: "The drought could have a direct knock-on effect on food supplies" with potential for "less British produce and at higher prices in our supermarkets." More 👉 www.bbc.co.uk/news/article...
UK heatwaves: Satellite images show how UK landscape has changed
BBC Verify's analysis indicates “vegetation stress” in many areas, which may affect wildlife and farming.
bbc.co.uk
A great milestone to patients, Novartis, and to radiopharmaceutical development with US FDA approving Lu-PSMA-617 www.novartis.com/news/media-r...
FDA approves Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC), advancing potential new standard of care across metastatic disease
novartis.com
Eslam Maher@eslammaher.bsky.social · 7d agoPSMA Therapy Grey Zones: Actinium, Lutetium, or Terbium for the Future of Radioligand therapy? www.sciencedirect.com/science/arti...
I have a renewed appreciation for the statistical software packages Jamovi and JASP. Use them! In terms of reproducibility, they can't be beat. Archiving the data, code, and output in a single file is a genius move. Achieving the same reproducibility in R is very hard work.
PSMA Therapy Grey Zones: Actinium, Lutetium, or Terbium for the Future of Radioligand therapy? www.sciencedirect.com/science/arti...
sciencedirect.com
New FDA Guidance: Cancer Clinical Trial Eligibility Criteria: Performance Status www.fda.gov/regulatory-i...
Cancer Clinical Trial Eligibility Criteria: Performance Status
Guidance for Industry, IRBs, and Clinical Investigators
fda.gov
Research Fellow post at LSHTM. Come and work with Njeru Njagi, Matteo Quartagno, Wende Clarence Safari, Aurélien Belot, Bernard Rachet and myself on extending multiple imputation methods, in particular for analyses of electronic health records in cancer. jobs.lshtm.ac.uk/vacancy.aspx...
Job Opportunity at LSHTM: Research Fellow in Statistics
The London School of Hygiene & Tropical Medicine (LSHTM) is one of the world’s leading public health universities. Our mission is to improve health and health equity in the UK and worldwide; working i...
jobs.lshtm.ac.uk
Could Excel be conscious? We surveyed more than Jan 1 1900 people to find out.
The philosophical opinions of neuroscientists: "While 64% of participants endorse reductive physicalism - the view that mental activity is fully reducible to brain function - only 17.5% reject free will." pubmed.ncbi.nlm.nih.gov/42455665/ n=2,657
FDA-OCE-ASA Oncology Educational Fellowship for biostatisticians community.amstat.org/fdaoceasaonc...
Home - FDAOCEASAOncologyEducationalFellowship
The site home page
community.amstat.org
Design, simulate, refine: simulation-guided clinical trials for accelerated drug development www.nature.com/articles/s41...
Design, simulate, refine: simulation-guided clinical trials for accelerated drug development - Nature Reviews Drug Discovery
Simulation-guided clinical trial design can enable identification of the optimal design to bring safe and effective therapies to patients as efficiently as possible, and it is particularly useful when...
nature.com
The DahShu IDSWG Oncology Working Group published this nice survey across the industry to understand challenges and current practices following Project Optimus in early-phase oncology trials link.springer.com/article/10.1...
Implementing Project Optimus in Oncology Dosage Optimization: Where are We Now? - Therapeutic Innovation & Regulatory Science
Determining the optimal dosage of oncology drugs is a critical component of drug development, as many anticancer agents are associated with high toxicity. With the emergence of targeted therapies and ...
link.springer.com
FDA's new draft guidance on "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products". The final version is set to replace the standards set in 1998! www.fda.gov/regulatory-i...
Demonstrating Substantial Evidence of Effectiveness for Drugs
Draft Guidance for Industry: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
fda.gov
This paper is worth it for table 1 alone. 👏 @sabinehoffmann11.bsky.social @boulesteixlaure.bsky.social et al onlinelibrary.wiley.com/doi/10.1002/...
When to Adjust for Multiple Testing: A Unifying Guiding Principle
Most original articles published in the medical literature report the results of multiple statistical tests. In a few simple cases, there is agreement on whether to adjust for the number of performed...
onlinelibrary.wiley.com
RIP Joseph Fraumeni, who co-discovered the Li-Fraumeni syndrome (later known to be driven by germline p53 mutations) by identifying and following up 4 families with increased chances of childhood cancers... dceg.cancer.gov/about/staff-...
Joseph F. Fraumeni, Jr., M.D., biographical sketch
Joseph F. Fraumeni, Jr., M.D., biographical sketch
dceg.cancer.gov
@imperialcollegeldn.bsky.social, @who.int and @easlnews.bsky.social have launched first WHO Collaborating Centre dedicated to #liver disease. @britishlivertrust.bsky.social #LiverDisease #SteatoticLiverDisease www.imperial.ac.uk/news/article...
Imperial, WHO and EASL launch first WHO Collaborating Centre dedicated to liver disease
Imperial, the World Health Organization (WHO) Regional Office for Europe, and the European Association for the Study of the Liver (EASL) have launche...
imperial.ac.uk
A new target trial emulation concludes that GLP-1 receptor agonist use is associated with less cancer risk in obese nondiabetic adults. Median follow up = 2 years, 13 cancers. 🤔 www.annalsofoncology.org/article/S092...
GLP-1 receptor agonist use and cancer risk in obese nondiabetic adults
Recent data show that glucagon-like peptide-1 receptor agonist (GLP-1RA) use is associated with decreased cancer incidence in diabetic and obese patients. However, there have been no studies exclusive...
annalsofoncology.org
“I don’t need [people] to think of me as courageous or inspirational – just someone who believed in science and, when faced with a terrible diagnosis, tried something bold and new,” he wrote. Also check his case study: www.nature.com/articles/s41... www.theguardian.com/science/2026...
Richard Scolyer, acclaimed melanoma researcher who tried experimental treatment on his own brain cancer – obituary
Pathologist and athlete who was Australian of the year in 2024 underwent a bold experimental treatment after devastating brain cancer diagnosis
theguardian.com
I am not at #ASCO26, but I have seen posters online of phase 1 trials using the 3+3 design. How sad?
I love how the RASolute 302 trial for daraxonrasib in metastatic pancreatic cancer, is a successful drug development story. I love reading success stories like this one.
My much more radical opinion is that all ethical approvals for human/animal biomedical research should be openly published, and all papers resulting from those studies should be easily linked to the approval. This one *really* freaks people out and I suspect we all know why.
Darren Dahly@statsepi.bsky.social · 2mo agoPresumably you already have an ethical approval in place for human-participant or animal research. Are people really wanting to argue that there shouldn't be a clear correspondence between the study that was approved and the study that is eventually published? A RR just adds transparency. 2 cents.
New video presentation on the FDA Bayesian guidance: www.fharrell.com/talk/bguide/ #StatsSky #Statistics #Bayes @fda.gov #pharma #rct #clinicaltrials
Implications of the Draft FDA Bayesian Guidance – Statistical Thinking
I was fortunate while on detail from Vanderbilt University to FDA CDER to be able to participate in numerous Bayesian committees and to provide input into the drafting of the new Bayesian guidance for...
fharrell.com
Check out this interactive map for all dose-finding trial designs: eppi.ioe.ac.uk/cms/Portals/... Associated paper: onlinelibrary.wiley.com/doi/full/10....
Designs and statistical methods for adaptive clinical dose-finding trials
eppi.ioe.ac.uk
New NIH policy demands advance approval of any foreign co-authors drugmonkey.wordpress.com/2026/05/22/n...
New NIH policy demands advance approval of any foreign co-authors
New reporting in Science from Jeffrey Brainard and Jocelyn Kaiser informs us of new policy that is apparently being communicated by POs in relationship to progress reports. The takeaway message is …
drugmonkey.wordpress.com
EMA CHMP recommended approval, interesting: www.astrazeneca.com/media-centre...
Camizestrant in combination with a CDK4/6 inhibitor recommended for approval in the EU by CHMP for 1st-line advanced ER-positive breast cancer
astrazeneca.com
Eslam Maher@eslammaher.bsky.social · 3mo agoFDA ODAC's comments (rejection, 6-3 voting) on AstraZeneca's application for Camizestrant (in combination with a CDK4/6 inhibitor) for advanced HR+ breast cancer when they show an ESR1-mutation on 1L prior to PD (SERENA-6; phase 3 trial) www.fda.gov/media/192156... (PDF)
BIOMEDE randomized phase 2 trial for testing targeted treatments in DIGG was stopped for futility. Why does nothing work for this nasty disease.... www.nature.com/articles/s41...
Targeted therapies plus radiotherapy for diffuse intrinsic pontine glioma: the randomized phase 2 BIOMEDE trial - Nature Medicine
In a biomarker-driven trial evaluating radiotherapy with erlotinib, everolimus or dasatinib in patients with newly diagnosed diffuse intrinsic pontine glioma, the primary endpoint of overall survival ...
nature.com