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A global network of over 20 analysts, industry experts and thought leaders track product progress from submission to approval. We’re also able to draw on the strength and expertise of the rest of the Pharma Intelligence family. Analysis and opinion covers key topic areas such as:

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Pink Sheet lets you go behind the regulatory and compliance headlines to understand the implications of developments on your business.

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Mylan, Amgen Biosimilars Sail Through Advisory Panels, May Diverge From There

By Derrick Gingery 17 Jul 2017

Mylan's Herceptin biosimilar faces questions on off-label use and manufacturing.

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Irish Health Minister Speaks About EMA Relocation, Drug Pricing, and Boosting Biosimilars

By Ian Schofield 17 Jul 2017

Dublin will “absolutely” meet the criteria for hosting the European Medicines Agency.

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Master Protocols Are Both Welcome And Inevitable – US FDA's Woodcock

By Bridget Silverman 12 Jul 2017

Center for Drug Evaluation and Research Director Janet Woodcock continues to promote innovation.

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Abuse-Deterrent Opioid Manufacturers Want FDA To Set Conversion Deadline

By Brenda Sandburg 08 Jul 2017

US agency denied group's 2013 citizen petition, but with more abuse-deterrent products on the market.

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Abuse-Deterrent Opioids: Rexista To Test New FDA Leadership's Approach

By Sue Sutter 06 Jul 2017

Intellipharmaceutics seeks oral, intranasal and intravenous abuse-deterrence claims for Rexista when it goes before an advisory committee July 26.

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Big REVEAL: Merck's Anacetrapib Surprises With Success, But What Next?

05 Jul 2017

The positive top-line results for Merck & Co's cardiovascular outcomes trial for its CETP inhibitor anacetrapib may not be enough to de-risk the class.

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Biosimilars In EU: From 'New Mess' To Beacon For Safety

By Michael Cipriano 30 Jun 2017

Regulators nor industry knew what to do when the biosimilars regulatory framework was first introduced.

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New Irish Generics Body Wants “Fundamental” Reform Of Medicines Procurement

By Ian Schofield 29 Jun 2017

Two generic industry associations have merged to form a single body that includes the largest generic companies in Ireland.

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Pfizer’s EPO Biosimilar Stalls In US On Hospira Compliance Woes

By Sue Sutter 26 Jun 2017

US FDA hands Pfizer its second complete response letter for its proposed biosimilar to Epogen/Procrit.

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Key Indian Panel Go-Ahead For Novartis’ Kisqali

By Anju Ghangurde 26 Jun 2017

Just months after the US FDA cleared Kisqali, Novartis appears on course to bring the breast cancer therapy to India after a key local expert panel.

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Orphan Biosimilars: Developers See Big Prospects In Small Markets; Soliris Is One Target

By Kate Rawson 21 Jun 2017

Using lessons learned from the first wave of biosimilar approvals – and citing high prices in the US .

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Taking Biosimilars Down A PEG: Why Copying Neulasta Isn’t So Easy

By Michael McCaughan 21 Jun 2017

Biosimilar sponsors are 0-3 so far in attempts to win US FDA approval for copies of Amgen’s pegfilgrastim.

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Neulasta Biosimilar From Coherus Needs Better Immunogenicity Assay After Stumble At US FDA

By Sue Sutter 14 Jun 2017

Despite facing one-year delay, Coherus is buoyed by FDA’s apparent support for its decision not to conduct clinical study in cancer patients.

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Taking Biosimilars Down A PEG: Why Copying Neulasta Isn’t So Easy

By Michael McCaughan 14 Jun 2017

Biosimilar sponsors are 0-3 so far in attempts to win US FDA approval for copies of Amgen’s pegfilgrastim (Neulasta).

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Orphan Biosimilar: Soliris Is One Target

14 Jun 2017

Using lessons learned from the first wave of biosimilar approvals – and citing high prices in the US – some developers are starting to 'think small' with biosimilars for rare disease markets. Alexion’s Soliris is a case in point.