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Europe

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Collaboration Makes The (Real) World Go Round: Global Efforts Strive To Anchor RWE With Real-World Data Standards And Practices

Can the decentralized global healthcare ecosystem to turn real-world evidence from a buzzword to a useful approach to fit-for-purpose evidence generation?

Real-World Evidence Drug Approval Standards

UK To Use Vaccine Taskforce Model For ‘Cutting-Edge’ R&D Funding Program

The latest initiative under the UK’s Life Sciences Vision is intended to fund the development of innovative treatments while saving the National Health Service “millions of pounds.”

Europe United Kingdom

EU Finalizes Option To Omit Expiry Date On Inner Labeling Of Investigational Drugs

Revised labeling requirements for unauthorized investigational and auxiliary medicinal products under the EU Clinical Trial Regulation have been published in the Official Journal.

Europe Clinical Trials

Roche Wants EU Pharma Legislative Revision To ‘Dare Something New’

New, more flexible regulatory approaches will be needed to deal with the integrated therapies coming through company pipelines, and the European Medicines Agency should play a “key orchestrating role” in smoothing the way, says Sabine Atzor, Roche’s head of EU regulatory policies.

Europe Legislation

EMA Launches First RWE Studies Under Big Data Project

The European Medicines Agency has partnered with eight institutions having access to real-world healthcare data to enable its DARWIN EU project to deliver real-world evidence to the EU medicines regulatory network when needed.

Europe Real-World Evidence

UK HTA Body To Conduct More Appraisals, And Faster, Through Proportionate Approach

Faced with the rise in its workload, the UK’s health technology assessment body NICE is exploring ways of tailoring its approach to appraisals according to the type of product under consideration.

Europe United Kingdom

EU Refines Simultaneous Scientific Advice Pilot With Focus On Clinical Trials

Improvements have been made to the second phase of an EU pilot that allows drug sponsors to obtain simultaneous scientific advice from two member states.

Europe Clinical Trials

Results Imminent From Sweden’s Pilot Of Novel Antibiotic Reimbursement Model

If successful, a new Swedish model for reimbursing antibiotics that involves guaranteed minimum annual revenues for companies, could be tested on other kinds of products.

Reimbursement Europe

New EMA Innovation Group To Provide Point Of Entry For Developers & Contribute To Regulatory Assessments

The European Medicines Agency’s newly established Quality Innovation Expert Group will focus on innovative pharmaceutical manufacturing approaches, starting with continuous manufacturing for biologicals and end-to-end processes, and decentralized manufacturing.

Innovation Manufacturing

EMA, PIC/S To Update 11-Year-Old GMP Guide On Computerized Systems

The European Medicines Agency and the international association of pharmaceutical inspectorates, PIC/S, say they need to make extensive changes to their guide on using computerized systems when manufacturing medicines.

Europe International

EMA Consults On Need For New Guide To Enable Confirmatory Platform Trials

The European Medicines Agency believes that a scientific guideline on clinical trials incorporating a platform design is needed because such studies are expected to play an increasingly important role in future marketing authorization applications.

Europe Clinical Trials

EMA Tackles How To Substantiate New Active Substance Claims For Biologics & ATMPS

The European Medicines Agency is seeking feedback on its position on assessing whether biological substances and advanced therapy medicinal products qualify for NAS status.

Europe Regulation
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