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Featured Stories


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 Research and Development Strategies

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 Regulation

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 Drug Approval Standards

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 Drug Safety
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FDA Performance Tracker

Keeping Track: A Diverse Array Of Approvals, A CRL For Evolus' Botox Competitor, And Coherus Refiles Neulasta Biosimilar

The latest drug development news and highlights from our US FDA Performance Tracker.
Drug Review Regulation United States

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

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 Neurology

Latest From Regulation

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

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

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

Latest From Policy

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

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

US Drug Pricing Reform: No More Medicare 'Gravy Train,' Azar Tells Pharma

HHS secretary urges serious proposals from biopharma on enhancing price negotiation in Medicare Parts D and B, promising action from the Administration whether the industry cooperates or not.

Pricing Debate Medicare

Clinical / R&D Explore this Topic

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Latest From 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

Takeda/Shire Merger: Five Things To Worry About

From 'breakthrough' designations to manufacturing hiccups, numerous review and development challenges await the combined entity.

Drug Review Research & Development

Galectin Plans To Head Into NASH Pivotal Studies Without Biopsy-Evaluated Endpoint

Company is moving its galectin-3 inhibitor into Phase III in non-alcoholic steatohepatitis patients with cirrhosis – a very advanced disease setting – and also to validate endpoints that don’t require liver biopsy.

Clinical Trials Liver & Hepatic

Commercial Explore this Topic

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Latest From Commercial

You Work In The Pharmaceutical Industry; Here's Why You Should Care About The Novartis Payments

There's a lot of finger-pointing in the industry when it comes to why pharma has a bad reputation. Maybe it's time everyone who works in pharmaceuticals takes responsibility for it.

Legal Issues Policy

Sarepta Will Challenge Expected No From EMA On Exondys 51

Sarepta is expecting the European Medicines Agency to recommend against EU approval of its Duchenne muscular dystrophy treatment eteplirsen. Persuading the agency to change its mind during the appeal will be an uphill task for the company.

Drug Review Business Strategies

Rebates And Discounts Have A Big Impact On US Drug Prices, IQVIA Report Shows

A new US drug spending report from IQVIA parses out how rebates impact drug spending and explores affordability for patients. The data show drug makers offset about 28% of drug spending and provide some support to industry's arguments on drug pricing. 

Pricing Strategies Pricing Debate

Manufacturing Explore this Topic

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Latest From Manufacturing

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

New PIC/S Guide Offers Framework For Voluntary Reliance On Foreign GMP Inspections

A new guideline has been adopted by PIC/S, the group representing international pharmaceutical inspectorates, to help regulators assess whether GMP compliance at foreign sites has been established by the hosting competent authority, without the need for an on-site visit.
Manufacturing 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

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Listerine Sensitivity Tops J&J Innovation Pipeline In '18

Johnson & Johnson will launch a Listerine mouthwash incorporating a class II device to address tooth sensitivity, Chief Technology Officer John Ghaim said during J&J’s Medical Devices & Consumer Analyst Day May 16. The company plans to launch 150 new products globally in 2018, which should help the company achieve sales ahead of the consumer health category.

 

Dental Oral Consumer

Smaller OTC Loperamide Packages Wait As Retailers Limit Purchase Amounts

Commissioner Scott Gottlieb updates US FDA's initiative to prevent potentially fatal abuse of OTC loperamide, noting that online and conventional retailers are limiting product purchases while the agency continues evaluating the appropriate number of doses per package.

Consumer Drug Safety

No GRASE For Ibuprofen, No Future In OTC Internal Analgesic Monograph

Nonprescription products containing ibuprofen can now only be marketed in the US through NDAs. No companies took advantage of a proposed ibuprofen addition to the the internal analgesic, antipyretic and antirheumatic OTC monograph, issued in 2002.

Consumer Inflammation
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