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Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

Key Indian Panel Go-Ahead For Novartis’ Kisqali

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 recommended the product for marketing in the country, though the filing route through a local Sandoz company has raised some questions.

India Approvals

EU, US & Japan Tackle Difficulties With Randomized Trials Involving Multi-Drug Resistant Bacteria

The European Medicines Agency has given the Pink Sheet more detail on its recent agreement with its counterparts in the US and Japan to align certain clinical data requirement to stimulate the development of new treatments to fight antimicrobial resistance.

Clinical Trials Japan

Consumer Health Weekly Trademark Review June 6, 2017

Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled from the Official Gazette of the U.S. Patent and Trademark Office.

Consumer Trademarks

Top Indian Official Hints At Drug Price Regulation To Curb ‘Profiteering’

A top Indian pharmaceutical department official says the government is determined to press ahead with its push for the prescription of more ‘no-name’ generic drugs in the face of a perception of profiteering by the pharma industry.

India Policy

AMR Threat Prompts EU, US And Japan To Join Forces To Align Data Requirements For New Drug Developers

EU, US and Japanese regulatory agencies will provide advice to developers of antibiotics that is consistent with the agreements they have reached on aligning their data requirements.

Infectious Diseases Clinical Development & Trials

Innovation The Big Winner As China Joins ICH

Patients, international companies, and innovation-driven firms are set to gain the most from China’s dramatic move to join the ICH process, says one regulatory affairs veteran.

Regulatory Clinical Trial Regulation
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Set Alert for Europe

Latest From Europe

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

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

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

Support For Continued EU Co-operation On Health Technology Assessment Is ‘Overwhelming’

Support is strong for continuing EU co-ordination on health technology assessment, according to a report on the responses to a consultation on the topic. An impact assessment on what will follow the EUnetHTA Joint Action 3 will come in late 2017.

BioPharmaceutical Europe

Criteria Out For EMA’s Future Home; Bid Procedure About To Be Approved

The procedure allowing EU member states to bid to host the European Medicines Agency when it leaves the UK is to be formally endorsed by a meeting of heads of state on June 22. The criteria countries will have to meet have been publicly announced at a press conference following a meeting of EU ministers.

Brexit Regulation

NICE Turns Attention To Roche's Perjeta After Finally Passing Kadcyla For Breast Cancer

After okaying Roche's advanced breast cancer therapy Kadcyla after four years of deliberation, the UK's HTA body NICE will now decide how to respond to the Swiss group's proffered patient access scheme for Perjeta.

Health Technology Assessment Cancer
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United States

Set Alert for United States

Latest From United States

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

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

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

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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