Real world data has been gaining credence among regulators for decisions on drug approval and label expansion given that randomized clinical trials take place in controlled environments in a well-defined population that might also not be truly representative of ethnic or gender diversity.
Real World Data Adoption About 10% Amid Challenges: Parexel Executive
Innovation Hub Set Up In India
While real world data is reliable, synchronization challenges limit its use, Sanjay Vyas, executive vice president and managing director Parexel India tells Scrip in a wide-ranging interview that touches on aspects from synthetic analytics to the interest among Indian companies in developing cell and gene therapies
More from R&D
• By
Aldeyra’s dry eye candidate reproxalap received a second FDA complete response letter, but the firm expressed confidence about refiling quickly based on two ongoing studies.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
• By
By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.
• By
Compass' bispecific antibody tovecimig hits primary efficacy endpoint in Phase II/III top-line data in advanced biliary tract cancer, and may have class side-effect advantages. But additional survival data may be needed to support US approval.
More from Scrip
• By
By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.
• By
Compass' bispecific antibody tovecimig hits primary efficacy endpoint in Phase II/III top-line data in advanced biliary tract cancer, and may have class side-effect advantages. But additional survival data may be needed to support US approval.
• By
AstraZeneca remains committed to investing in R&D and alliances in China, where Susan Galbraith, the UK major’s head of oncology R&D, sees innovation eventually reaching parity with the US and Europe.