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Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

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

Tagrisso Reimbursed In Korea, After Difficult Price Negotiations

Korea's National Health Insurance Service and AstraZeneca reach an agreement on reimbursement of Tagrisso, sharply reducing financial burdens of NSCLC patients in the country. Tough price negotiations between the two sides underlines the difficulties pricey innovative drugs face to get reimbursed in the country.

Reimbursement Market Access

How Biocon Site Prevented FDA 'OAI' Finding From Derailing Biosimilars

By carrying out certain corrective and preventive actions, a Biocon facility in Bangalore, India, averted an "official action indicated" finding US FDA officials had proposed in an establishment inspection report, one that could have potentially delayed approval of two Mylan biosimilars. Key issues at the site included visible particles in sterile injectable drug products as well as various aseptic processing practices.

Manufacturing Quality

China Approves Lundbeck Antidepressant In Year-End Dash

China FDA greenlights Lundbeck's Brintellix for severe depression, and more new drug approvals may be on the way. Physician education will be key for Brintellix, given relatively low number of psychiatrists in China.

Approvals Regulation

Australia, Canada, Switzerland, Singapore Test Simultaneous Authorizations For Generics

Generic drug makers are being invited to take part in a trial that could help them get their products approved simultaneously in Australia, Canada, Switzerland and Singapore.

Drug Review Australia

Singapore And Colombia Become ICH Member and Observer

Singapore’s Health Sciences Authority is now a member of the International Council for Harmonisation, while Colombia’s Invima is recognized as a regulatory observer. Local industries are expected to gain.

Colombia Singapore
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Europe

Set Alert for Europe

Latest From Europe

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

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

Lilly, Novartis, Jazz and Ionis Take New Products To EMA

Lilly’s migraine prevention therapy, galcanezumab, is among the nine new products that companies have submitted to the European Medicines Agency for evaluation in recent weeks.

Europe Approvals

Brexit Could Rob Industry Of Access To Markets Covered By 35 EU Free Trade Deals

A coalition of life sciences industry bodies has written a position paper outlining its concerns about Brexit in areas such as EU free trade deals, customs declarations and tariff barriers.

Brexit Trade

EMA To Establish Minimum Requirements For CAR-T Cell Registries

The European Medicines Agency is exploring the possibility of establishing minimum requirements for all CAR-T Cell registries in the EU to facilitate efficient data collection on such products in the post-authorization phase.

Post Market Regulation & Studies Regulation
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United States

Set Alert for United States

Latest From United States

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

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

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

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
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