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Featured Stories


House Democrats Launch Price Negotiation Push: Extreme Plan Assures Strong Opposition

Pelosi is moving forward with a draconian plan to limit US prices to an international benchmark. For now, the “bill” is a three-page outline subject to considerable legislative drafting – and so extreme as to rule out bipartisan compromise for the time being.

Pricing Debate Legislation Medicare

‘Biased Trials Undermine EU Cancer Drug Approvals’

Nearly half of the pivotal randomized controlled trials supporting European marketing authorizations for new oncology drugs are at high risk of bias, claims a new study.

Europe Clinical Trials Drug Approval Standards

Drug Product Hopping Bill Should Specify Anti-Competitive 'Window', Congress Advised

House bill in the works to deter brand product switches should specify what behavior would be unacceptable, legal experts testify at congressional hearing.

Legislation Legal Issues Intellectual Property

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Performance Trackers

Keeping Track: US FDA Approvals For Ibsrela, Gvoke And Nucala; A BTD For Tepotinib

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

Global Pharma Guidance Tracker – August 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 International Australia

Policy & Regulation Explore this Topic

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Latest From Regulation

Pink Sheet Podcast: US FDA Launches Project Orbis And The Rare Disease Cures Accelerator, Looks For Abuse-Deterrent CNS Drugs

Pink Sheet reporters discuss the US FDA's work with other countries to review and approval of cancer therapies at the same time, a new database for rare disease clinical trial and natural history data, and the agency's exploration of abuse-deterrent CNS stimulants.

Drug Review Rare Diseases

Senate Wants Priority Review For 'Deemed' Biologics Not Approved By Deadline

Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.

Biologics Legislation

EMA OKs Seven New Drugs But Delivers Another Blow To Emmaus

Seven new drugs have this week moved closer to gaining EU approval following positive recommendations from the European Medicines Agency, but Emmaus’ glutamine product has fared less well and the company is considering another route for getting the drug to sickle cell disease patients in Europe

Europe Drug Review

Longer Medicine Supply Delays Expected In No-Deal Brexit

Delays in the delivery of medicines with short lead times will be longer than originally expected in the event of a no-deal Brexit, UK health care providers have been warned.

United Kingdom Brexit

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

Novartis Wants More Time To Answer EMA’s Zolgensma Questions

Novartis unit AveXis is one of several companies seeking extra time to address questions the European Medicines Agency has regarding their marketing applications. The company says it could get a decision on whether the product should be approved in the EU by year-end.

Europe Drug Review

Latest From Policy

‘Demystify’ Pricing, Say UK Parliamentarians

UK members of parliament have called on pharmaceutical companies to be more transparent in their pricing process and to improve the way they gather and present data for health technology appraisals. They also say that industry rebates should be ring fenced to fund new medicines.

Europe United Kingdom

Value-Based Contracts: Medicaid Best Price Concerns Could Be Eased With CMS Guidance

Absent any legislative remedy, an administrative fix could provide manufacturers with confidence that value-based arrangements won’t trigger a new best price, Duke Margolis policy experts propose.

Reimbursement Medicaid

Will Purdue Bankruptcy Filing Resolve 'Unrelenting Chaos' Of Opioid Litigation?

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Legal Issues Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

Clinical Outcome Assessments To Be Developed Under US FDA Grants

The projects could help streamline rare disease drug development, along with the Rare Disease Cures Accelerator.

Clinical Trials Drug Review

Pain/Addiction Products Need Regulatory Streamlining To Incentivize Development, Sponsors Say

Industry speakers offer series of suggestions for ways to incentivize development of pain and addiction products at US FDA public meeting on the opioid crisis.

Review Pathway Research & Development

Evolution In Clinical Outcome Assessments Reflected In US FDA’s Revised Gastroparesis Guidance

Agency recommends an anchor-based approach to statistical analyses of drug effects on core signs and symptoms.

Drug Approval Standards Clinical Trials

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Latest From Commercial

Will Purdue Bankruptcy Filing Resolve 'Unrelenting Chaos' Of Opioid Litigation?

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Legal Issues Policy

Purdue Nears Settlement Of Opioid Multidistrict Litigation, But State AGs Vow To Press On

Lead plaintiffs counsel have accepted Purdue's proposed settlement offer to resolve more than 2,000 opioid suits, but more than half of state attorneys general reject the proposal.

Legal Issues Policy

Novartis’ “Living Drugs”: Kymriah, Zolgensma – And Diovan?

Novartis is pioneering the new “living drugs” model. But its present financial performance benefits from regulatory problems that have beset generic competitors to a franchise written off for dead: the antihypertensive brand Diovan (valsartan).

Commercial Manufacturing

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA: Key FY 2019 Warning Letter Trend Is Inadequate Testing For API Impurities

This year’s 89 warning letters so far hit API testing for nitrosamines, aseptic facility design, contaminated water, API traceability and more.

Manufacturing Quality

FDA And EMA Evaluate Claims As Nitrosamine Worries Turn To Zantac

Pharmacy petitions for recalls after finding ‘inherent instability’ in antacid that could pose carcinogenic risk.

Manufacturing Quality

The US FDA Acts To Bolster Adverse Event Reporting For Compounded Drugs

After discovering one firm suppressed over 4,000 compounded-hormone adverse event reports, agency leans on compounders and outsourcers to improve reporting.

Manufacturing Quality
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