In the news this week, reports urge pharmaceutical companies to exploit the benefits of synthetic data in clinical trials. In other news, FDA fears over the safety of tanezumab compromises approval for the Pfizer/Lilly pain drug, and the COSMIC database promises great advancements in better matching treatment to patients’ cancer profiles.

FDA FEARS OVER SAFETY OF PFIZER/LILLY PAIN DRUG – Approval for tanezumab painkiller injection continues to be disputed with fear over the drug’s safety profile. This is not the first-time issues have been raised, with development suspended in 2012 due to issues with joint destruction. FDA reviewers are primarily focusing on the risk of Rapidly Progressive Osteoarthritis Rheumatology (RPOA) which has developed during trials with the pain drug. There is additional concern with mild nerve pain.

LATEST REPORTS REINFORCE BENEFITS OF SYNTHETIC DATA IN TRIALS – One of the main issues for clinical trials, especially in oncology, is the challenging and expensive recruitment process. According to a report by Accenture, synthetic data offers the opportunity to create a ‘synthetic patient profile’ as a virtual cohort. Using real-word evidence, synthetic data has the potential to accelerate progression of clinical trials by removing placebo effects. 

EXCITING DEVELOPMENTS IN PRECISION ONCOLOGY WITH COSMIC DATABASE – The launch of the Actionability tool for the COSMIC database allows clinicians and researchers to search over 37 million mutations across 1500 cancer types for the first time. Users can search for drugs that target specific mutations throughout the stages of drug development. With the addition of Actionability, clinicians can not only identify the mutations of a cancer, but how to precisely tailor the treatment for patients according to the genetic profile, from diagnosis through to therapy.

In other news:

R&D: 
Daiichi Sankyo digital partnership confirmed for Atrial Fibrillation research

CLINICAL:
Moderna initiates paediatric COVID-19 vaccine study

MANUFACTURING:
Vaccine rollout by J&J delivers only 22% of March target  

That’s all for now. See you next week!

Charlotte Di Salvo, Junior Medical Writer
Proventa International