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Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

Read The Fine Print: China's New Data Protection Plan Has Some Catches

China SDA's newest proposal gives six and 12 years' data protection for innovative new drugs and therapeutic biologics, respectively, but certain terms and conditions apply.

China Intellectual Property

India Flouting Own Patent Law By Giving IP Protection To Undeserving Drugs?

India is known for its strict patent legislation restricting which drugs can be given IP protection, but a new study suggests authorities in the country are actually being too lenient in awarding patents in a rush to grant new applications.

India Intellectual Property

New Rules Could Means IP Loss For Firms Doing R&D In China

Multinationals and M&A deals could be adversely affected by new measures in China that could delay or even block the export of intellectual property out of the country.

China Policy

Australia Makes 'Profoundly Important' Changes To Delivery Of Costly Medicines On PBS

The Australian government will test a new model next year that will reduce the upfront costs incurred by pharmacies on expensive medicines listed on the Pharmaceutical Benefits Scheme. The changes are expected to free up additional funds to invest in new and earlier PBS listings.
Reimbursement Australia

GMP Lapses At Biocon’s Indian Site – Jitters for Neulasta Biosimilar Plans?

Biocon’s facility in Bangalore, India, has failed to pass muster with the US FDA, raising questions on whether this could result in a pushback of commercialization timelines for partner Mylan’s biosimilar pegfilgrastim in the US. The European regulator has also not cleared the Bangalore site. 
Manufacturing FDA

Global Pharma Guidance Tracker – April 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.
International Europe
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Set Alert for Europe

Latest From Europe

UK MHRA To Boost Pharmacovigilance With More Focus On Office-Based Inspections

The UK medicines regulator is exploring how it can focus its pharmacovigilance inspections on areas of high-risk and reduce the number of days it spends on inspections. To this end, office-based inspections have emerged as a useful concept, and there are plans to use this approach more vigorously.
Compliance Safety

EU, US Regulators Examine Birth Defect Concerns For 'One Of The Safest' HIV Drugs

Four cases of birth defects associated with HIV drug dolutegravir have prompted the EU and US regulators to recommend discontinuing its use in women seeking to get pregnant until the issue is investigated further. The development comes as a surprise because dolutegravir is regarded as one of the safest and most potent drugs for HIV treatment.
Drug Safety Europe

Liver Damage Worries Lead To Further EU Restrictions On Richter’s Esmya

The European Medicines Agency’s pharmacovigilance committee has recommended more restrictions on the use of Richter’s Esmya because of concerns over the risk of serious liver damage.
Drug Safety Europe

EMA Tackles Tough Job Of Filling UK Void In Working Parties

The European Medicines Agency has started the difficult task of finding replacements for the UK chairs and members of its numerous working parties and groups who are having to vacate their position because of Brexit.

Brexit Regulation

Mid-June Launch For EMA’s Simplified Online Orphan Designation Filing System

The European Medicines Agency will encourage companies to submit their orphan designation applications through a new portal when it is launched on June 15. Applications through existing processes will be accepted until Sept. 15.
Europe Regulation

Brexit Could Make UK A 'Second-Tier State' For Innovative New Drugs, Business Committee Warns

A report from the UK House of Commons business committee on its inquiry into the impact of Brexit on the pharma sector has flagged up the multiple challenges facing companies and regulators.
Brexit Approvals
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United States

Set Alert for United States

Latest From United States

Right-To-Try Bill Heads To White House, Putting Firms In Driver's Seat

Proponent says companies ready to use new expanded access pathway that US FDA will have essentially no involvement in.
Legislation Clinical Trials

Insys' Sublingual Buprenorphine Spray Fails At US FDA Panel, But Some Members See Future In Limited Role

Main concerns involved the delayed onset to meaningful pain relief and the safety signal of hypoxia. 
Advisory Committees Neurology

FDA Busy Sorting OTC Monograph Ingredients Anticipating System Overhaul

FDA has yet to finalize about one-third of its OTC monographs and several hundred ingredients do not have a final GRASE determination. Sorting will help the agency determine which of the 800 active OTC monograph ingredients are designated as needing more information to establish GRASE under a faster system based on administrative orders.

Consumer Drug Approval Standards

Pharmas Join To Build Inflammation Biomarkers In Alzheimer's, Depression

Drug firms exploring link between inflammation and central nervous system disorders are now sharing resources through public/private Biomarkers Consortium project.
Clinical Trials Research & Development

Keytruda, Tecentriq Face Efficacy Questions In Urothelial Cancer

Monotherapy patients with tumors that have low PD-L1 expression experienced decrease survival in two confirmatory trials; however, the immune checkpoint inhibitors’ accelerated approvals are unlikely to be affected pending final results comparing use in combination with chemotherapy to chemo alone.

ImmunoOncology Clinical Trials

Impax Defeats FTC Pay-For-Delay Complaint, Helped By Status As Sole Marketer Of Generic Opana ER

FTC Chief Administrative Law Judge finds procompetitive benefit of Endo-Impax patent settlement agreement outweighs unjustified no-authorized generic provision.

Generic Drugs Legal Issues
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