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Our team of global contributors helps you to anticipate challenges, minimize risks and maximize opportunities. Pink Sheet is the biopharma industry’s go-to source for business-critical insights and policy and regulatory intelligence.
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Analysis and opinion covers key topic areas such as:
Pink Sheet
By Maureen Kenny 12 Sep 2018
Clusters of excellence, competition as well as co-operation, Brexit, and aiming high. Danish Medicines Agency head Thomas Senderovitz talks national agencies and engagement in an interview with the Pink Sheet.
Pink Sheet
By Maureen Kenny 12 Sep 2018
Thomas Senderovitz will chair the management group of the EU Heads of Medicines Agencies for at least the next two years. The Danish regulator tells the Pink Sheet of his big plans for the network.
Pink Sheet
By Maureen Kenny 12 Sep 2018
The European Medicines Agency and drug regulators throughout the EU are having to invest huge amounts of time and effort in dealing with the fall-out from Brexit - and it hasn't even happened yet. Plans for working together on bigger issues agreed on a few years ago will likely have to change, senior regulator Thomas Senderovitz tells the Pink Sheet.
Topic Brexit Business strategies
Pink Sheet
By Maureen Kenny 12 Sep 2018
Changing mindsets, technologies outpacing regulatory frameworks, intense international collaboration, and the future of the randomized controlled clinical trial. Big data is forcing us to think big, senior European regulator Thomas Senderovitz tells the Pink Sheet.
Topic Brexit Business strategies
Pink Sheet
By Neena Brizmohun 06 Sep 2018
A new deal between Novartis and England’s National Health Service is one of the fastest funding approvals in the 70-year history of the NHS.
Topic Cancer
Pink Sheet
By Nielsen Hobbs 30 Aug 2018
"At least four" guidances will replace it, Commissioner Gottlieb notes in frank update which states "I don’t want to look back ten years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of this crisis."
Topic FDA
Pink Sheet
By Michael McCaughan 23 Aug 2018
HHS’ “First 100 Days” take on the drug pricing “Blueprint” is a novel use of a tried-and-true milestone for presidential action. But it is probably more enlightening to look at what has happened in the 1,000 days since drug pricing became the overwhelming focus of political attention.
Topic us-election
Pink Sheet
22 Aug 2018
Are you prepared for Brexit and what it could mean for your business? In a few short months, the interim period will end and the UK will depart from the European Union, leaving uncertainty in its wake. How can you prepare for this unprecedented event? Informa Pharma Intelligence has prepared an article pack covering Brexit and the topics discussed at the recent Drug Information Association (DIA) Europe meeting, and it is now available to you – for free.
Topic Policy and regulation
Pink Sheet
By Ian Schofield 22 Aug 2018
Gedeon Richter’s uterine fibroid drug, Esmya (ulipristal acetate), is expected to be the subject of a safety recommendation by the EMA’s pharmacovigilance committee this week.
Pink Sheet
By Sue Sutter 22 Aug 2018
Accrual difficulties force changes that nullify Special Protocol Assessment; ongoing, randomized FOCUS trial in patients with ocular melanoma that has metastasized to liver will become single-arm study and target enrollment will be reduced by 66%.
Pink Sheet
By Derrick Gingery 22 Aug 2018
Reviewer expertise may be better leveraged in more focused roles, but basic tenets of rare disease program should not fundamentally change as part of proposed Office of New Drugs reorganization.
Topic FDA
Pink Sheet
By Francesca Bruce 22 Aug 2018
PRIMA, the new service the National Institute for Health and Care Excellence offers to review economic models, must not be affected by confidentiality and conflict of interest issues, warns UK the pharmaceutical industry group, ABPI.
Topic Business strategies
Pink Sheet
By Derrick Gingery 22 Aug 2018
Sarepta will face a US FDA staff with which it does not have a controversial history, the Center for Biologics Evaluation and Research, likely avoiding the reviewers that evaluated its Duchenne muscular dystrophy treatment Exondys 51.
Topic Diseases
Pink Sheet
By Bowman Cox 22 Aug 2018
When firms are developing highly anticipated gene therapies, it’s important to establish GMP-controlled manufacturing processes earlier in development, as Sarepta discovered when US FDA placed a clinical hold on a promising Duchenne muscular dystrophy gene therapy.
Topic FDA
Pink Sheet
By Cathy Kelly 22 Aug 2018
Regulations allow manufacturers to request that drug production and marketing costs and price contracting information provided to the state be kept confidential.
Topic Drug approval
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