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Latest News & Analysis

The ICER Process: Allergan Engagement Improves Cost Effectiveness Rating For Ubrelvy

ICER president Steve Pearson is ‘cautiously optimistic’ that net pricing for acute migraine treatments will align with benefits once discounts are factored in.

Pricing Strategies Reimbursement

US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

Drug Review Drug Approval Standards

Gene Therapy Approvals By US FDA Could Double In 2020

CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.

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

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

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

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

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

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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