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Policy & Regulation

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Global Pharma Guidance Tracker – November 2017

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

International Australia India

EU Regulators Urge Pharma To Share Their Brexit Plans

Sponsors of medicines evaluated through the EU's decentralized procedure are being urged to share their plans regarding Brexit with national agencies as soon as possible to help with planning. The head of the Dutch Medicines Agency thinks that the human medicines sector can learn from the progress being made in the veterinary space on this front.

Brexit Regulation Europe
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Regulation

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Latest From Regulation

340B Penny Pricing, Civil Monetary Penalty Revisions On Deck In Proposed Rule

Proposed rule will revisit controversial provisions in the January 340B final rule to address manufacturer concerns about the US discount program.

Pricing Strategies Market Access

EU Approval In Sight For New ATMP, Products For XLH And Diabetes, And 2nd Biosimilar Herceptin

A new ATMP, two generics and a biosimilar got the thumbs up this week from the European Medicines Agency’s drug evaluation committee, the CHMP. The committee also recommended one product for conditional authorization and another for a pediatric use authorization, But it turned down a multiple myeloma product, and a sea squirt-based MS drug was withdrawn from the review process.

Europe Approvals

FDA Blocks Chinese Contract Manufacturer's OTC Topical Imports

FDA says in a warning letter that Hangzhou Facecare Cosmetics's response to inspectors' findings following a June inspection was inadequate and the firm's imports in September were ordered detained without physical examination at all US ports.

Dermatology Consumer

Argentina Rejects Key Sofosbuvir Patent Application

Argentina’s patent office, INPI, has rejected an application for a key patent relating to Gilead’s hepatitis C drug Sovaldi (sofosbuvir).

South America Argentina

FDA's NDA And BLA Approvals: Xepi, Admelog, Ixifi

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review
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Policy

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Latest From Policy

Biosimilar Sponsors Are Not Liable Under State Law For Declining Patent Dance

US Federal Circuit finds in Amgen v. Sandoz that the BPCIA preempts innovator companies from seeking penalties under state law against a biosimilar sponsor that does not engage in the 'patent dance.'

BioPharmaceutical Policy

Sanofi's Dengue Vaccine Gets WHO Backing In People Previously Infected

Label restriction, discussions with regulators should keep vaccine in use, Sanofi suggests; Philippines suspended its vaccination program after data showed product can worsen disease in those not previously exposed to infection.

BioPharmaceutical Policy

Mandatory Provider Training For Opioids Embraced By PhRMA

Trade association members also commit tens of millions of dollars to set up addiction prevention programs and create new health care tools.

Neurology Policy

Drug Pricing: US Senate Hearings Conclude With No Clear View On Legislation

Measures that would increase financial transparency and empower federal government to negotiate drug prices highlighted by National Academies representative who discussed recent report on drug affordability, but former Congressional Budget Office Director Holtz-Eakin warns Senate HELP Committee against taking measures that merely shift costs from one party to another.

Pricing Debate Pharmacy Benefit Management

PhRMA Sues To Block 'Unprecedented' California Price Reporting Law

Ban on WAC price increases violates Commerce Clause and reporting requirement violates First Amendment, PhRMA contends; complaint says state officials have not clarified whether law is retroactive.

BioPharmaceutical Policy

How To Make Collaborative HTA Work In Europe: A Guide From EUnetHTA

A new report from the European HTA network Collaboration on health technology assessments and joint work, such as relative effectiveness assessments, will better succeed if they fit with member state procedures, according to an analysis from the European Network for Health Technology Assessment.

BioPharmaceutical Comparative Effectiveness
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