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Latest News & Analysis

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for a pediatric use authorization, But it turned down a multiple myeloma product, and a sea squirt-based MS drug was withdrawn from the review process.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

First Biosimilar Neulasta In Final Stages Of EMA Review Process

A biosimilar version of Amgen’s Neulasta has yet to be approved in the EU but one such product is in the later stages of review at the European Medicines Agency.

Biosimilars Advisory Committees

‘Outstanding Issues’ Clarified For Nine Products Nearing EU Review End – Including Neulasta Biosimilar

Ammtek, Pfizer, Portola and Roche are among the companies that will shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are nearing the end of the review pathway. Questions are also in store for the sponsor of a biosimilar version of filgrastim.

Europe Approvals

Generic Labeling Rule Dies In Latest Reg Agenda, But Electronic Labeling Is Reborn

US FDA also indicated plans to update definition of biologic product and propose a one-page Patient Medication Information in the latest Unified Agenda.

Regulation FDA

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

FDA Pilot Finds That Advance Records Yield More Inspection Findings

When FDA piloted the use of Section 706 authority to obtain records in advance of inspection, the US agency found the results included more inspection findings but not quicker inspections.

Compliance Manufacturing

FDA Investigators Want Top Management Involved In Manufacturing Inspections

FDA’s expectation is that the most responsible individual at manufacturing sites be involved in inspections. The agency is increasingly talking about its “responsible corporate official” or Park Doctrine powers to hold top officials responsible for manufacturing issues and problems.

US States Manufacturing
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