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Senate Drug Pricing Bill Lowers Manufacturer Discounts In Part D Catastrophic Phase

Revised bill released by the US Senate Finance Committee adjusts the manufacturer discount program in Medicare Part D and includes new provisions aimed at easing beneficiary cost sharing obligations.

Pricing Debate Legislation Reimbursement

Daiichi Sankyo Plays Long Game With Quizartinib Outside Japan

Japanese company Daiichi Sankyo has its eye on first-line FLT3-ITD AML indication after rejection of relapsed/refractory plans in EU and US.

Europe Drug Review Cancer

Patient Voice Makes Impact In Scientific Advice From EU HTA Network

The EU network of health technology assessment bodies says it is seeing the benefit of systematically involving patients when companies approach it for early scientific advice on evidence generation.

Health Technology Assessment Regulation Europe

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Performance Trackers

Keeping Track Of Thanksgiving Leftovers: Risdiplam, Artesunate Highlight Glut Of Submissions/Filings

Yes, we know they should be out of the fridge by now, but here are the highlights of submissions and filings during the Thanksgiving week.

US FDA Performance Tracker Drug Review Regulation

Global Pharma Guidance Tracker – November 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.

International Europe Australia

Policy & Regulation Explore this Topic

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Latest From Regulation

Brinavess' US Review: EU Postmarket Data Unlikely To Save Troubled AFib Drug

Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug;  FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.

Advisory Committees Cardiovascular

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

MSF Wants Faster Deployment Of Ebola Vaccine At ‘Fair’ Price

As stockpiles of Ebola vaccine are being built up around the world, Médecins sans Frontières has said more action is needed to ensure sufficient numbers of vaccinations are available for use in current and future outbreaks. 

Congo (Democratic Republic) Infectious Diseases

Voluntary EU Joint Clinical Assessments ‘Risk Access To Medicines’

Softening provisions to make EU-wide joint clinical assessments voluntary would make proposed legislation on HTA cooperation redundant, says Eurordis.

Europe Comparative Effectiveness

Innovative Trial Designs Are 'Life And Death Matter' For Pharma, Amgen Tells US FDA

Amgen exec calls for more informal agency feedback and alignment between review divisions in understanding design methodologies.

Clinical Trials FDA

Biosimilars: US FDA Considering ‘Guardrails’ To Prevent Misinformation

Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.


Biosimilars Biologics

Latest From Policy

The Absurd Innovation Debate: Dueling Views Of HR 3 Miss The Point

White House Council of Economic Advisors says US House drug price “negotiation” bill will reduce the number of innovative medicines by 100 over a decade; the Congressional Budget Office says more like 8-15. Both analyses miss the point – but also show that industry is losing a crucial piece of political ground.

Pricing Debate Research & Development

MSF Wants Faster Deployment Of Ebola Vaccine At ‘Fair’ Price

As stockpiles of Ebola vaccine are being built up around the world, Médecins sans Frontières has said more action is needed to ensure sufficient numbers of vaccinations are available for use in current and future outbreaks. 

Congo (Democratic Republic) Infectious Diseases

Voluntary EU Joint Clinical Assessments ‘Risk Access To Medicines’

Softening provisions to make EU-wide joint clinical assessments voluntary would make proposed legislation on HTA cooperation redundant, says Eurordis.

Europe Comparative Effectiveness

Clinical / R&D Explore this Topic

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Latest From Research & Development

The Absurd Innovation Debate: Dueling Views Of HR 3 Miss The Point

White House Council of Economic Advisors says US House drug price “negotiation” bill will reduce the number of innovative medicines by 100 over a decade; the Congressional Budget Office says more like 8-15. Both analyses miss the point – but also show that industry is losing a crucial piece of political ground.

Pricing Debate Research & Development

Biogen’s Big Day Arrives, But Aducanumab Results Don’t Answer Key Question

Biogen presented highly anticipated data in Alzheimer’s disease at CTAD for its Phase III EMERGE and ENGAGE studies, but one major question remains unanswered: will the FDA approve the drug? 

Clinical Trials Neurology

Adaptive Clinical Trials: US FDA Offers More Advice On Bayesian Designs

Final guidance provides more details on clinical trial designs that use Bayesian adaptive features; says monitoring committee recommendations may deviate from the anticipated algorithm.

Guidance Documents Clinical Trials

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Latest From Commercial

Galectin’s NASH Phase III Trial Will Use Surrogate Measures Of Esophageal Varices

Other NASH registration trails have targeted fibrosis, but Galectin's mostly-resolved discussions with US FDA will allow the belapectin program to focus of signs and symptoms of the disease.

Liver & Hepatic Drug Approval Standards

Vaccine Development Challenges Include Extensive Quality Control, Sanofi's Loew Notes

Sanofi spends 70% of vaccine production on quality control, Sanofi Pasteur exec VP David Loew tells the Pink Sheet; company is working on next generation flu vaccines that may provide greater efficacy.

Vaccines Research & Development

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

Manufacturing Explore this Topic

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Latest From Manufacturing

Global Scare Over Nitrosamine Impurities Extends To Diabetes Medication

Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.

Manufacturing Quality

PIC/S: How Inspectorates Should Assess Pharma Quality Systems For Changes

Draft recommendation offers path to ICH Q12 regulatory relief.

Manufacturing Quality

Drug Shortages, AMR & Cancer High On New EU Commissioner’s Agenda

The new EU commissioner for health has been given a number of high-priority tasks, including medicines supply and tackling antimicrobial resistance. These topics will be taken up by the European Commission’s advisory body, the Pharmaceutical Committee, in its new work plan.

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