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Vibha Sharma

Senior Writer

London, UK
Vibha is a senior writer covering pharmaceutical and medtech regulatory developments across the globe. She plays a key role in tracking and writing about news of important regulatory issues affecting the sectors, and explaining their implications for industry. Vibha's fields of interest include the EU regulations on clinical trials, pharmacovigilance and pediatrics, on which she has written several exclusive articles from various industry conferences. She has also commissioned some pieces of expert analysis on major developments in the pharma and medtech regulatory arenas.

Latest From Vibha Sharma

EU Regulators May Check Redactions In CTIS Documents To Boost Trial Transparency

A new EU guideline addresses numerous questions raised by study sponsors on processes for protecting commercial and personal data while using the Clinical Trials Information System.

Europe Clinical Trials

EMA Says Yes To BMS’ Sotyktu But Turns Down Ipsen’s Sohonos

The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.

Europe Approvals

Sponsors Split Over Benefits Of EU Clinical Trials Regulation

A survey undertaken last year on the implementation of the EU Clinical Trials Regulation drew some positive feedback from study sponsors but also threw light on well-known concerns with the legislation. Some of the highlighted issues are being addressed on a priority basis.

Europe Clinical Trials

EMA Takes Steps To Improve Predictability Of Drug Submissions

The European Medicines Agency says it will become more systematic in seeking explanations from companies who delay or withdraw their planned marketing submissions and in chasing “no-shows.”

Europe Regulation

BMS’ Plaque Psoriasis Drug Deucravacitinib Among Six Hopefuls Awaiting EMA Verdict

A novel TYK2 inhibitor and a drug to treat an ultra-rare genetic disorder are among products up for a marketing authorization opinion this week from the European Medicines Agency’s human medicines committee, the CHMP.

Approvals Drug Review

EMA To Focus On Filings For Novel Drugs Under Restart Of Trial Transparency Policy

The European Medicines Agency is working on restarting its landmark policy on publishing clinical trial data, with the first phase expected to start this year.

Europe Clinical Trials
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