Noel Alaka named vice president of life sciences at COTA

Makary: Level of evidence is an artificial and dogmatic construct

Speaking at an FDA Roundtable on Cell and Gene Therapy, FDA Commissioner Marty Makary questioned the construct of “levels of evidence” as artificial and dogmatic, saying that n-of-1 “stories” can drive regulatory decisions.xxx:more“I think we can learn a lot from individual experiences,” Makary said at the roundtable discussion June 5. “We tend to talk in the lexicon of clinical medicine about Level 1, 2, and 3 evidence, and it’s become this sort of dogma that ‘we

RWE and phase I data support the role of Orserdu for ER+, HER2- advanced or metastatic breast cancer

The Menarini Group and Stemline Therapeutics will present new and expanded data on Orserdu at the upcoming 2024 San Antonio Breast Cancer Symposium, held from Dec. 10-13. The company will bring real-world progression-free survival results of Orserdu in adult patients with ER+/HER2-, advanced or metastatic breast cancer. Additionally, the company will present updated efficacy results of elacestrant plus abemaciclib, along with a pooled safety analysis from phase Ib/2 of both the ELECTRA and ELEVATE trials.

December 06, 2024

Vol.50 No.45

In Brief

COTA, Panalgo collaborate to enhance AI & RWD-enabled cancer care

COTA joined Panalgo’s Partner Network to make their hematologic oncology data available via Panalgo’s Instant Health Data Analytics platform.

September 13, 2024

Vol.50 No.34

Clinical

RWE study pinpoints gaps in mental health care utilization among parents of children with cancer

Unquestionably, a child’s cancer diagnosis weighs heavily on the parents’ minds. But now, an analysis of nearly 30,000 U.S. families has quantified how often parents of children with cancer use mental health services.

May 17, 2024

Vol.50 No.20

By McKenzie Prillaman

Drugs & Targets

COTA and Sanofi collaborate to accelerate cancer trials using real-world data and AI

COTA, a leader in real-world data and analytics for oncology, is entering a collaboration with Sanofi to use RWD and artificial intelligence to increase the speed of oncology trials, including for multiple myeloma.

April 19, 2024

Vol.50 No.16

Clinical Roundup

Non-classical mutations present in 20-30% of all patients with EGFR-mutated NSCLC, analysis shows

Non-classical mutations are present in 20-30% of all patients with epidermal growth factor receptor-mutated non-small cell lung cancer, according to an analysis of real-world evidence presented by Black Diamond Therapeutics, Inc. at the American Association of Cancer Research annual meeting.

April 12, 2024

Vol.50 No.15

Noel Alaka named vice president of life sciences at COTA

YOU MAY BE INTERESTED IN

Makary: Level of evidence is an artificial and dogmatic construct

RWE and phase I data support the role of Orserdu for ER+, HER2- advanced or metastatic breast cancer

COTA, Panalgo collaborate to enhance AI & RWD-enabled cancer care

RWE study pinpoints gaps in mental health care utilization among parents of children with cancer

COTA and Sanofi collaborate to accelerate cancer trials using real-world data and AI

Non-classical mutations present in 20-30% of all patients with EGFR-mutated NSCLC, analysis shows

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