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Featured Stories


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 Reimbursement

EMA Panel Finalises Safety Probe Into Richter’s Fibroid Drug Esmya

Gedeon Richter’s uterine fibroid drug, Esmya (ulipristal acetate), is expected to be the subject of a safety recommendation by the EMA’s pharmacovigilance committee this week.

Drug Safety Europe Advisory Committees

New Group To Resolve 'International Divergence' Posed By EU ATMP Guide

Pharmaceutical inspectorates around the world are trying to address the divergences between Europe’s good manufacturing practice guideline on gene therapy and tissue-engineered products and the international GMP guideline for such products.

REMS Abuse Website: Celgene, Actelion Top List Of Suspected 'Gamers'

Other sponsors could be using tactics other than REMS abuse to game the system, US FDA Commissioner Scott Gottlieb says.

Generic Drugs Risk Management Regulation
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FDA Performance Tracker

Keeping Track: A CRL For Tlando, An Accelerated Approval For AndexXa, And A Burst Of Supplemental Approvals

The latest US drug development news and highlights from our Performance Tracker.

Drug Review Regulation United States

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

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 FDA

Latest From Regulation

House Appropriators Warn US FDA: Stop Working On Electronic Labeling Rule

Congress is 'very concerned' about potential final rule that would move to electronic labeling in lieu of paper distribution with prescriptions.
FDA Legislation

Lutathera Clinical Development Timeline

Chronicle of the development and US FDA review of Advanced Accelerator Applications' lutetium Lu 177 dotatate for gastroenteropancreatic neuroendocrine tumors.


Drug Review Profile Drug Review

Lutathera Reviewers

US FDA staff who participated in the review and approval of AAA's treatment for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.


Drug Review Profile Drug Review

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

Part B Drug Competitive Bidding Program Revival: Vendor Request Coming Soon

Distributors, specialty pharmacies and PBMs are in a better position now to act as vendors then they were a decade ago, when Medicare unsuccessfully tried to implement a Medicare Part B prescription drug competitive acquisition program, HHS Secretary Azar points out.

Pricing Debate Medicare

Pharma’s Blame-The-Middleman Strategy Pays Off – For Now

Success of drug industry’s campaign to highlight role of 'middlemen' in the supply chain was never more clear than during President Trump’s Rose Garden drug pricing event. But what happens now that the attention is turned squarely back on manufacturers?

Pricing Debate Pharmacy Benefit Management

Clinical / R&D Explore this Topic

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Latest From 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

Why Four In Five Applications For PRIME Still Fail Two Years On: EMA Clarifies Expectations

The European Medicines Agency’s priority medicines scheme, PRIME, attracts a lot of applications, but most of them fail. The agency has explained why and has updated it guidance documents for applicants.

Market Access Europe

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

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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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