Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UK Cancer Drugs Fund Debuts To Muted Applause From Pharma, Charities

The re-launch of the controversial Cancer Drugs Fund in the UK has offered another point for debate about cancer drug pricing, budgetary pressures and the cost of innovation.

Cancer United Kingdom Reimbursement

No Thaw In Sight: German Bill Extends Price Freeze To 2022

Drug price freeze introduced in 2010 would remain to 2022, under draft legislation to revise AMNOG reimbursement system. It introduces some limits on the year of free pricing that companies enjoy after launch.

Market Access Germany Policy

Ocaliva In NASH Manageable With Indication-Based Pricing, ICER Roundtable Suggests

Indication-specific pricing could address 'tension' between initial pricing of Ocaliva for orphan condition and later use in large patient population, according to expert roundtable convened by Institute for Clinical and Economic Review.

Market Access Pricing Strategies Commercial

A Clinton Twist On Price Negotiation: Hillary’s Role With PEPFAR

Former President Bill Clinton's convention speech cites his wife's experience with driving down cost of HIV therapy supported by the AIDS relief program.

Legislation Policy Pricing & Regulation
Advertisement


FDA Performance Tracker
For more on the FDA Performance Tracker, click here.

Policy & Regulation

Set Alert for Policy & Regulation

Manufacturing Problems Aren't Rising, But It Was A Hot July

Lack of readiness derails eye drugs from Valeant and Ocular, which now must convince FDA they know what they are making; meanwhile, an expert shares how mistake-proofing processes can help.

Manufacturing United States BioPharmaceutical

Latest From Regulation

Keeping Track: FDA Approves Adlyxin, Accepts Brineura, Lowers Hurdle For Xadago

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

Performance Tracker Regulation

User Fees For FY 2017 Make Sponsors Happy, Manufacturers Sad

Several facility fees will increase next year as application fees drop.

Drug Review Analysis

FDA's ANDA Approvals

Generic drug approvals and tentative approvals in mid- and late July.

Approvals Regulation

Latest From Policy

"Crazy" European Orphan Drug Pricing System Has To End

Eurordis head Yann Le Cam outlines his vision for the future of orphan drug pricing in Europe.

Policy Pricing Reimbursement

GDUFA Negotiations Shift To 'Tiered' Fee Models

Finance subgroup talks about new structure for generic drug user fee program that could mean bigger firms would pay more.

Policy Legislation

ICER Eyes QALY Ratios, Budget Impacts In Methods Review

Institute for Clinical and Economic Review plans to unveil an updated drug value framework in early 2017.

Market Access Pricing Strategies

Clinical / R&D

Set Alert for Clinical / R&D

Latest From Research & Development

Keeping Track: FDA Approves Adlyxin, Accepts Brineura, Lowers Hurdle For Xadago

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

Performance Tracker Regulation

Tobira Says Secondary Endpoint In NASH Will Carry CVC Into Pivotal Study

The biotech argues that success in reducing fibrosis is more important than the failed primary endpoint measuring NAFLD activity score improvement – and also meets FDA's expectations – but the firm is taking a beating nonetheless.

Research & Development Drug Approval Standards

Japan Builds Asia Links Through New AMED Programs

In line with similar initiatives by Japan on other regulatory fronts, the country's Agency for Medical Research and Development is building up its partnerships and presence in Asia.

Asia Pacific Japan

Commercial

Set Alert for Commercial

Latest From Commercial

ICER Eyes QALY Ratios, Budget Impacts In Methods Review

Institute for Clinical and Economic Review plans to unveil an updated drug value framework in early 2017.

Market Access Pricing Strategies

Teva, Allergan Generics: FTC Worried About A Multitude Of Markets, Not A Behemoth

Record-setting divestment order driven by sheer number of products where firms competed, not size of company that would result from acquisition.

Commercial Antitrust Regulation

Off-Label Communication Principles From PhRMA, BIO Aim For Reg Changes

Manufacturer communications with providers and payers could include real-world evidence and pharmacoeconomic information, associations urge.

Formularies Policy

Manufacturing

Set Alert for Manufacturing

Latest From Manufacturing

UK MHRA Aims To Address "Fundamental Failures" In Data Integrity

The UK MHRA's revised guidance on maintaining the integrity of data throughout the chemical and pharmaceutical development lifecycle is intended to address various shortcomings identified by regulators during inspections.

Regulation BioPharmaceutical

GSK Faces 'Profoundly Difficult' Penicillin Challenge, FDA Warning Letter Says

Aging plant in Worthing, UK, must either dedicate building solely to penicillin or undergo wrenching decontamination before US distribution of non-penicillin products could resume.

Manufacturing BioPharmaceutical

WHO Pilots Pre-Submission GMP Inspections To Facilitate Prequalification Of Medicines

The WHO pilot will allow drug makers seeking prequalification for their medicinal products to work simultaneously on addressing GMP issues and preparing their dossiers for submission.

Regulation Africa

Consumer / OTC Drugs

Set Alert for Consumer / OTC Drugs

Latest From Consumer

Weekly Trademark Review July 26, 2016

OTC drug, personal care product and nutritional supplement trademark filings compiled by “The Tan Sheet” from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

Consumer Intellectual Property

North America Anchors Colgate As Currency Headwinds Continue Abroad

Innovation across categories helped make Colgate's North American business its star segment in the second quarter, rising 1.6% to $793m on strong oral care sales, while the firm’s international business remains impacted negatively by currency headwinds.

Asia Pacific Asia

Hyland’s Score Points Asking To Dismiss Class Action, But Loses Ruling

Hyland’s fails to convince a federal court to dismiss nationwide class claims alleging false advertising of its baby products, but the judge says the two women alleging the firm made false claims about its homeopathic formulas have a “high hurdle” to demonstrate a nationwide class action.

United States Consumer
UsernamePublicRestriction

Register