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Featured Stories


A Tale Of Two DMD Drugs: Theme And Variation In Controversial US FDA Reviews

Despite obvious similarities in the contentious reviews of Sarepta’s Vyondys 53 and its predecessor Exondys 51, drug developers should focus on the differences between the two reviews.

Rare Diseases Approvals Drug Approval Standards

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 BioPharmaceutical

Medicare Part D Generic Substitution Rates Lower For Higher Cost Brands

Study sponsored by Association for Accessible Medicines suggests quirks in Part D benefit design and rebating practices are driving the trend.

Generic Drugs Reimbursement Medicare

Spotlight On Drug Pricing

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Performance Trackers

Keeping Track: Nektar Withdraws Oxycodegol NDA As Novel Submission Pileup Continues

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

US FDA Performance Tracker Drug Review Regulation

Global Pharma Guidance Tracker – December 2019

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation International

Policy & Regulation Explore this Topic

Set Alert for Policy & 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

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

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

Clinical / R&D Explore this Topic

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Latest From Research & Development

EU Looks At New Ways To Tackle Antibiotic Market Failure

A novel Swedish payment scheme and transferable exclusivity vouchers for new antimicrobials are among mechanisms being examined by the European Commission for encouraging the development of new drugs to tackle the growing problem of antibiotic resistance. 

Europe Innovation

US FDA Approval Of Lynparza For Pancreatic Cancer Opens Door For PFS Endpoint In Disease

AstraZeneca's PARP inhibitor Lynparza becomes first US FDA-approved drug for pancreatic cancer based on progression-free survival endpoint, providing regulatory precedent for other sponsors to use that development approach; all other pancreatic cancer drugs had been approved based on an overall survival benefit.

Approvals Cancer

New Gene Therapies For Pediatric Diseases Win EMA PRIME Designations

Just two of six applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical needs to patients faster were successful last month.

Research and Development Strategies Europe

Commercial Explore this Topic

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Latest From Commercial

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

J.P. Morgan Notebook Day 4: Novartis CEO Weighs In On AI, Sangamo’s Next Steps And More

Additional highlights from the J.P. Morgan Healthcare Conference, including Takeda’s partnering outlook, Sage’s guidance on Zulresso sales, Frequency’s next steps for its hearing loss drug and Revance’s preparations to take on the aesthetics market. 

Business Strategies Artificial Intelligence

J.P. Morgan Day 3: Skyrizi Momentum Builds, What's Next For Amarin, Viatris Debuts And More

Daily round-up from the J.P. Morgan Healthcare Conference in San Francisco: AbbVie's Skyrizi takes psoriasis lead, Amarin goes it alone, Viatris debuts, BeiGene on US drug pricing and Roche think neuroscience is the new oncology.

Business Strategies Launches

Manufacturing Explore this Topic

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Latest From Manufacturing

Pink Sheet Roundtable: Experts Advise On How To Prepare For DSCSA In 2020

2020 is when supply chain partners must agree on a vision for the track-and-trace anticounterfeiting system due in November 2023, experts tell the Pink Sheet.

Manufacturing Quality

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

The Quality Lowdown: Warning Letters, Nitrosamine Recalls And Sen. Warren's Generics Manufacturing Plan

Manufacturers warned on quality basics like testing and keeping records and reminded about nitrosamine deadlines; Senator Elizabeth Warren clarifies government drug manufacturing idea.

Quality Manufacturing
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