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Latest News & Analysis

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

Pharmaceutical Industry Not 'Reaping the Benefits' Of Quality Risk Management Tools, Expert Says

Despite the benefits in improving product quality and reducing product defects, the pharmaceutical industry is still struggling to incorporate ICH Q9 quality risk management principles into quality operations, and even more dispiriting, there is still lingering uncertainty on what constitutes quality risk management.

Manufacturing Quality

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

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

African Countries Adopt Treaty To Set Up New Medicines Agency

African health ministers have agreed on a treaty to set up a new pan-African agency to coordinate regional drug regulatory harmonization initiatives and pool limited regulatory expertise.

Regulation Middle East and Africa

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

Insys May Need Convenience Argument To Save Sublingual Buprenorphine Spray

US FDA advisory committee will hear agency's concerns with Buvaya's effectiveness, safety, and abuse potential. 
Advisory Committees Neurology

DTC And The Art Of Selling An Establishment Pricing Plan To A Populist President

The most surprising proposal coming out the Rose Garden drug pricing event was a call for disclosure of prices in DTC ads. As a policy idea, it may be a dud – but that doesn’t mean it isn’t a critical element of the plan.

Advertising, Marketing & Sales Pricing Debate

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
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