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…
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…
Clinical trials: stringent draft rules put onus of injuries, death on drugmakers
Pharmaceutical firms conducting clinical trials of drugs in India will no longer be able to escape responsibility in case of injury or death of participants. According to new draft rules for clinical trials and new drugs, if the sponsor fails…
Indian pharma cos get record 300 USFDA generic drug nods in 2017
Domestic pharmacompanies received more than 300 approvals in 2017 to launch generic drugs in the US, which is an all-time high. The clearances came despite regulatory pressure from the US Food and Drug Administration (FDA), and unprecedented warning letters issued…
Indian pharma majors are rushing to ‘Make in America’
US President Donald Trump’s ‘Make in America’ pledge may have spooked many, but Indian pharmaceutical companies are optimistic. Several Indian drugmakers that have large operations in the US are now pushing to acquire assets there by either investing in greenfield…
Google invests in UK vaccine pioneer Vaccitech
Google has invested £20 million ($27.1m) in a biotech firm spun out of Oxford University working on novel treatments which include a universal flu vaccine and a therapeutic cancer vaccine. The tech giant’s GV division (formerly known as Google Ventures)…
Spark and Pfizer’s gene therapy wows in haemophilia B
Gene therapy company Spark Therapeutics has published data showing its one-time treatment can almost entirely eliminate bleeds in patients with haemophilia B. The news confirms Spark as a frontrunner in the groundbreaking field, where it is poised to gain the…
