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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 Europe

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 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 Intellectual Property

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 United States
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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

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 Research & Development

Latest From 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

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

Latest From Policy

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

Amgen’s Challenge Over Sensipar Pediatric Exclusivity Moves To US Appeals Court

Amgen asserts FDA improperly tied pediatric exclusivity denial to lack of meaningful labeling resulting from the studies; justices question whether Amgen's data were adequate to support exclusivity but also agency's public silence on how it decides when a sponsor has 'fairly responded' to a written request.

Legal Issues Intellectual Property

CAR-T Therapy In Medicare: National Coverage Policy Could Come In 2019

Medicare begins analysis process for CAR-T cancer therapies in response to a request from UnitedHealthcare for a national coverage policy.
Medicare Cancer

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

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

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

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

Industry Consortium Developing Best Practices For Meeting Proposed EU GMP PUPSIT Requirement

The pharmaceutical industry is grappling with the fact that, despite their concerns of additional risk, pre-use, post-sterilization integrity testing (PUPSIT) may remain an expectation in the EU's Annex 1. A consortium has been established to help companies address filtration related risks that PUPSIT is designed to mitigate and to develop a best practice guide on PUPSIT to help manufacturers comply with the EU's Annex 1.
Manufacturing Quality

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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