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Latest News & Analysis

FDA Getting Reg Slashing Directive In Trump Executive Order

Draft order wants "comprehensive review" to find regulations that that "unnecessarily increases expenses" for patients, researchers, and manufacturers.

Pricing Debate Generic Drugs

Trump Exec Order On Drug Costs: Seeking To Balance Access, Innovation

Draft version of order signals a focus on insurance benefit design, accelerating drug approvals and de-regulation.

Pricing Debate Market Access

Best Of BIO: Policy & Regulatory Updates From BIO 2017

Antibiotic incentives, vaccine strategies, drug pricing, patent updates and more hot topics from the Biotechnology Innovation Organization's recent annual conference.

ImmunoOncology Market Access

EFPIA Calls For Interim Accords To Ease Brexit Impact

As the first day of Brexit talks highlighted how lengthy and complex the negotiations over the UK’s departure are going to be, Europe’s drug makers are pushing for transitional measures to be in place to keep disruption to regulation and health care to a minimum.

Europe Brexit

Perrigo Predicts Upturn On OTC Private Label Breadth, Depth And Bandwidth

Perrigo counts on its OTC private label dominance to thwart new store brand entries and give it a leg-up in e-commerce sales, which are growing at 50% year-to-year. Private label is "a distinctly different business than the national brand space," says consumer health executive Jeffrey Needham.

Consumer Prescription To Otc Switch

FDA's NDA And BLA Approvals: Cotempla XR-ODT, Baxdela, Mydayis, Rituxan Hycela, Haegarda

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

EU Postpones Decision On EMA’s New Home To November

The decision on where the European Medicines Agency should be located after the UK leaves the EU has been postponed to November. The European Council has published details of the bidding process countries must follow if they want to host the EMA.

Brexit Europe

Canada Aims To Implement eCTD v4 By 2022

Canada joins other international regulators in announcing plans to implement the next major revision of the electronic common technical document format (eCTD v4). A roadmap has been issued to help pharmaceutical companies prepare and plan for this change.

Regulation Drug Approval Standards

Majority Of British Public And GPs Don’t Trust Drug Industry, UK Review Confirms

The Association of the British Pharmaceutical Industry is to discuss the recommendations from a report requested by the Chief Medical Officer for England that has found that most UK adults and general practitioners do not trust pharma.

Drug Review United Kingdom

Was PD-L1 Test To Blame For Failure Of Bristol's Opdivo In '026 Trial?

NEJM editorial suggests that differences in PD-L1 testing may explain why Bristol's Opdivo failed in first-line lung cancer trial whereas Merck's Keytruda succeeded, but some analysts aren't so sure.

ImmunoOncology Clinical Trials

White House Mulls Proposal To Pause FDA's Quality Metrics Initiative

Trump administration briefing materials show that the pharmaceutical industry's complaints about FDA's quality metrics initiative are getting high-level attention.

Quality Manufacturing
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