Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories


Amarin’s Vascepa: US FDA Panel To Scrutinize Breadth Of CV Risk Reduction

REDUCE-IT enrolled a higher risk group than the broad population targeted by Amarin’s proposed indication statement, agency says; although reviewers conclude an interaction between the mineral oil placebo and statins cannot be excluded, any impact would have been small and unlikely to change overall treatment effect.

Advisory Committees Drug Review Cardiovascular

Jumping Before They Were Pushed – Kiadis And Aradigm Withdraw EU Filings

Notice of the withdrawal of pan-EU marketing authorizations applications by Kiadis Pharma and Aradigm are noted in the agenda of the latest meeting of the European Medicines Agency's key scientific committee, the CHMP. 

Drug Review Europe BioPharmaceutical

Gottlieb On Pursuing Legislative Reform: Start Small, Build Later

Former US FDA commissioner Scott Gottlieb encouraged stakeholders at the Association for Accessible Medicine's GRxBiosims 2019 meeting to start small in scope when pushing for legislative changes, which makes it easier to build on later.
Generic Drugs Legislation Policy

Spotlight On Drug Pricing

House Price 'Negotiation' Plan: It Is Even Worse Than It Sounds

The House Democratic leadership is pushing an international benchmark price for its 'negotiation' plan in the US. The summaries have focused on the maximum price, but the one-sided “negotiation” process suggests that the minimum is the more relevant number – and it is likely to be quite low.

Pricing Debate Reimbursement

Read More

Pharma Report Store

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now:

Shop Now

Performance Trackers

Keeping Track: Biosimilars, Novel Approvals, And Ebola

The latest drug development news and highlights from our US FDA Performance Tracker include a Neulasta biosimilar approval for Sandoz, novel approvals for Celgene's Reblozyl and Giskit B.V.'s ExEm Foam, and a submission for Regeneron's Ebola candidate.

US FDA Performance Tracker Approvals Drug Review

Global Pharma Guidance Tracker – October 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

Set Alert for Policy & Regulation

Latest From Regulation

US FDA Oncology Leadership Shuffle Moves Patricia Keegan To OCE; Gootenberg Takes On Recruitment

US FDA's reorganization of drug reviews splits Keegan's old OHOP division into two.

Cancer Drug Review

Vaccine Maker Bankruptcy Shows Regulatory Perils Of Business In China

China's Changchun Changsheng Biotech has been officially declared bankrupt, ending long-running speculation. The major vaccine maker’s dramatic fall has several take-away lessons for health companies operating in China, where several new regulations are taking effect.

China Business Strategies

Importation, Pricing Policies Raised Concerns For US FDA's Project Orbis

Allowing multi-regulator collaboration on oncology application assessment may run into pricing issues if Canada and Australia gain access to novel drugs before European countries, US FDA's Pazdur says.

Pricing Debate Drug Review

Trump's International Pricing Proposal Being Revised To Adopt ‘Most Favored Nation’ Policy – Azar

HHS Secretary Alex Azar says that reshaping Administration’s upcoming proposed rule would drive Medicare Part B drug prices even lower than previously projected. As Part B drug costs are being blamed for higher premiums, the policy revisions are at OMB, but plan would reemerge as "a notice of proposed rulemaking if that comes out,” Azar said.

Pricing Debate Regulation

WHO Prequalifies Ebola Vaccine To Speed Up Availability In Africa

Following its recent EU approval, moves are under way to make Merck’s Ervebo vaccine available in countries at risk of Ebola.

Middle East and Africa Congo (Democratic Republic)

Myeloma BCMA Therapy In Spotlight: EMA Considers Fast Tracking GSK Filing

The European Medicines Agency is this week deciding whether GlaxoSmithKline’s planned EU marketing application for its BCMA-targeting therapy merits an accelerated assessment.

Drug Review Europe

Latest From Policy

International Horizon Scanning Initiative To Level Pricing Playing Field

Nine countries are joining forces on horizon scanning with the aim of improving their chances of securing lower prices for high-cost drugs.

Europe International

Gene Therapy Payment Models Could Be One Focus For 'Cures II'

House Republicans are eager to keep working on legislation to permit innovative payment models for curative gene and cell therapies. Democrats, for now, are focused on other priorities.

Gene Therapy Reimbursement

England’s NICE Backs Epidyolex For Seizures, Sativex For MS Spasticity

Health technology assessment body NICE has given the thumbs-up to Epidyolex and Sativex, which become the first plant-derived medicinal cannabis products to secure routine NHS funding. It has also issued positive guidance on other products including nabilone, but turned down the use of cannabis-based drugs in chronic pain.

United Kingdom Reimbursement

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

UK BIA Targets Next Government With ‘Biotech Manifesto’

The BioIndustry Association has laid out its wishlist for the next UK administration, including deep regulatory alignment with the EU after Brexit, a more “flexible” approach to health technology assessment appraisals of new drugs, and support for R&D.

United Kingdom Brexit

Gene And Cell Therapies In Asia: Indian Environment Evolving But Multiple Issues Unresolved

India has taken strides towards creating a supportive environment for its nascent gene therapy research, but the R&D and regulatory infrastructure is still evolving amid concerns over potential product costs.

Asia Pacific India

EMA Accepts First Diabetes Drug Onto PRIME

Provention Bio’s teplizumab, a potentially game-changing treatment for preventing or delaying type 1 diabetes, is one of three investigational products to be newly accepted onto the European Medicines Agency’s popular priority medicines scheme.

Drug Review Research & Development

Commercial Explore this Topic

Set Alert for Commercial

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

Set Alert for Manufacturing

Latest From Manufacturing

ANDA Sponsors Urged To Ask DMF Holders About 'Hidden Facilities'

FDA generic drug reviewers often stumble over "hidden facilities" that are listed in drug master files but not the ANDAs; industry official offers some tips to bridge this communications gap with DMF holders.

Manufacturing Quality

Mylan Warning Letter Exposes Challenges In Valsartan Supply Chain Chemistry

Nitrosamines taint Mylan’s valsartan API solvent recovery, whether outsourced or in-house; firm mulls US FDA's request for ‘material systems review.’

Manufacturing Quality

FDA’s OPQ Chief Tells Generic Drug Makers Its Time To Up Their Quality Game

The head of US FDA’s drug quality office comments on quality-related topics at the GRx-Biosims meeting; sheds more light on facility rating system plan.

Manufacturing Quality
UsernamePublicRestriction

Register