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Successfully navigate the complex worlds of compliance, legislation, policy regulation, and industry developments with the expertise of our worldwide network of expert analysts and journalists.
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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Pink Sheet gives you the power to go behind the regulatory and compliance headlines to understand the implications of worldwide industry developments on your business.
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With a network of journalists and analysts crisscrossing the globe, our industry experts and thought leaders track product progress from submission to approval. We also draw on the strength and expertise of the rest of the Pharma Intelligence family of analytical and market intelligence tools.
Analysis and opinion covers key topic areas such as:
Pink Sheet
By Michael Cipriano 16 Jan 2019
FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.
Topic FDA
Pink Sheet
By Ian Schofield 10 Jan 2019
New drug approvals in the EU were again dominated by oncology in 2018, although medicines for infectious diseases came a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some key new arrivals in the areas of multiple sclerosis, genetic disorders, metabolism and migraine.
Topic Drug approval Drug review
Pink Sheet
05 Dec 2018
A UK report on patient access to cancer drugs suggests that the European Medicines Agency could learn from the US Food and Drug Administration and best practice elsewhere in the world when it comes to taking a faster, more flexible approach to assessing evidence.
Topic Cancer
Pink Sheet
By Michael Cipriano 31 Oct 2018
If approved, ALKS 5461 would be first opioid-containing product to carry indication for depression; Alkermes CEO Pops tells Pink Sheet that agency's safety and efficacy concerns are surmountable because "all depression drugs have mixed results."
Pink Sheet
By Derrick Gingery 26 Oct 2018
President Trump touts CMS proposal that would peg Part B prices to an international index in the hopes of lowering US costs; industry calls it foreign price controls and warns it will hinder access.
Pink Sheet
By Michael McCaughan 18 Oct 2018
Treating mandatory wholesale acquisition cost disclosure in TV ads as a major drug pricing reform is close to ludicrous. But the broad approval of the action is an important sign of the continued public image cost of the ads to the drug companies.
Topic Drug approval Drug review
Pink Sheet
By Ian Schofield 18 Oct 2018
Companies wanting to compete in the newly off-patent adalimumab market in England have until Oct. 22 to submit their bids. They will need to offer “competitive prices” if they are to secure the highest share of sales to the national health service. At the same time, NHS trusts and clinical commissioning groups have been warned not to accept discounted interim offers from suppliers keen to get a foot in the door.
Pink Sheet
By Cathy Kelly 26 Sep 2018
Approach has been endorsed by Express Scripts as more workable solution than trying to cut list prices for drugs already on the market.
Pink Sheet
By Cathy Kelly 21 Sep 2018
Even though measure was blocked in Congress, it may still advance through regulation.
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
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21 Jan 2019
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18 Jan 2019
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18 Jan 2019
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