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Policy & Regulation

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From Rare To Real: Pharma Urged To Act As China Preps New Rare Conditions List

Chinese regulatory agency working around the clock in preparation to release another official list of rare diseases, and a push to launch more innovative orphan drugs is underway. But this time pharma firms need to be more proactive, noted an NMPA official.

China Rare Diseases Research and Development Strategies

Regulation

Set Alert for Regulation

Latest From Regulation

Long Hot Summer For Novel Drug Reviews Forecast At US FDA

Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.

Approvals Drug Review

Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza

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

US FDA Performance Tracker Approvals

Dutch Hospital Resumes Own Manufacture Of Leadiant’s Costly Drug

While the Dutch government negotiates an acceptable price for Leadiant Biosciences’ orphan drug CDCA, a university hospital has resumed supplying pharmacy compounded versions of the drug after addressing initial problems with the sourcing of raw materials.

Netherlands Manufacturing

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

Roche Fined For Anticompetitive Behavior In Romania

Roche plans to appeal against a penalty imposed by the Romanian competition authorities for implementing strategies that were said to delay the entry of competing biosimilar and generic products. 

Romania Government Payers

EU Parallel Trade: The ‘Most Effective Savings Tool Available’

The EU association representing parallel traders says cheaper parallel imports are vital in keeping medicines affordable for member states.

Europe Denmark
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Policy

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Latest From Policy

Pharma Industry Broadens Its Approach To Expanded Access

Novartis co-leads industry forum on preapproval access that aims to share best practices and engage patient groups; Janssen is launching three pilots to leverage collection of preapproval access data.

Real-World Evidence Clinical Trials

What’s Next After 20 Years Of NICE?

Meindert Boysen, head of NICE’s Centre For Health Technology Evaluation, shares advice for companies aiming to get their medicine to patients. His golden rules: engage in early advice and be more realistic about pricing.

Policy Pricing Strategies

Profile: Meindert Boysen On What Companies Should Expect From NICE And The Benefits Of Hill Walking

In an exclusive interview with the Pink Sheet, senior NICE director Meindert Boysen reveals the best advice he ever received and how companies whose products are under review can improve their chances of success.

Europe United Kingdom

China Coronavirus Outbreak Response Critical As First US Case Confirmed

A quickly spreading coronavirus outbreak in China could upend the country’s healthcare priorities as the health regulators and reimbursement agency officials gear up to “control and prevent” the worst public health emergency since the deadly SARS outbreak in 2003.

China Infectious Diseases

India Rare Disease Policy Proposes Crowdfunding But Patients Feel Let Down

Draft policy moots crowdfunding for high-cost rare diseases alongside financial support for those "amenable to one-time treatment" but falls way short of some patient groups' expectations.

India Policy

At Muted J.P. Morgan, Focus Is Execution, But US Pricing Is Persistent Overhang

Political worries aside, industry is confidently executing on focused strategies as it welcomes a new decade, even if a lack of deal news at the J.P. Morgan Healthcare Conference didn't excite investors.

Pricing Debate Business Strategies
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