Top-line trial data unveiled by Janssen at the 2018 American Academy of Dermatology (AAD) Annual Meeting over the weekend indicate that the benefit of Tremfya in patients with severe plaque psoriasis is maintained in the long-term. The company said that…
Groundbreaking lung cancer approval a big boost for AZ’s Imfinzi
AstraZeneca’s immunotherapy Imfinzi has gained US approval in an important new earlier treatment setting for lung cancer patients. The company announced on Friday that the FDA had approved the drug’s use in patients with unresectable Stage III non-small cell lung…
Clinical trials: collaboration is the secret to successful outsourcing
Bringing new products to market in the era of outsourced clinical trials is reliant on the ability of sponsors and CROs to work together. The increasing globalisation of R&D has led to a rise in clinical outsourcing, as pharmaceutical companies…
Four digital trends in global clinical trials
Could ‘digital health’ be the next worldwide phenomenon? As advanced technology continues to evolve for health information purposes, it’s important to understand what digital health is and how its adoption is likely to impact end users. Digital health encompasses a…
Contract Delays and Legal Negotiations Become a Growing Concern in Global Site Selection
The largest pain points in global clinical site selection no longer focus just around randomization times and patient recruitment, but have broadened to include slow contract turnaround and legal negotiations. Total spending on study startups totals over $2.7 billion, and…
FDA Clarifies Stance on Clinical Trial Reimbursements for Patient Travel, Lodging
The FDA has updated its guidance to institutional review boards and clinical investigators clearly allowing reimbursements to patients in clinical trials for lodging and travel. While paying subjects for participation in clinical research may raise difficult questions that should be…
Indian pharma firms renew focus; Dr Reddy’s, Cipla eye $100-bn China market
Dr Reddy’s Laboratories (DRL) is expanding its presence in China, the world’s second-largest pharmaceutical market, where other drug manufacturers such as Cipla and Lupin are exploring opportunities.The more than $100-billion China market is dominated by local drug manufacturers and multinationals…
FDA approves smartwatch for epilepsy monitoring
A new smart watch which uses machine learning to monitor for the most dangerous kinds of epileptic seizures has been approved by the FDA. Cambridge, Massachusetts based Empatica is the company behind the new technology, which it says is the…
KEY CHANGES IN NEW DRAFT RULES FOR CLINICAL TRIALS IN INDIA
CDSCO has published the new draft Clinical Trial Rules 2018 in Feb 2018 after consultation with the Drugs Technical Advisory Board. This draft Rules shall be taken into consideration on or after the expiry of a period of forty five…
World Preview 2017, Outlook to 2022
Highlights Biologics to contribute 52%of the Top 100 product sales by 2022; Roche leads market Roche gains the top spot of the pipeline value creation ranking proving its leadership ambitions beyond oncology. AstraZeneca and AbbVie complete the podium NovoNordisk’s portfolio…
