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Featured Stories


Industry Pricing Tactics Are Driving Europe’s Cross-Country Backlash

A recent event in Brussels organized by the European Public Health Alliance found that cross-country initiatives on pricing and calls for more R&D and clinical trial transparency are gathering momentum in Europe, but there is still some way to go to address the imbalances in the system. The Pink Sheet spoke to EPHA's Yannis Natsis about the issues raised at the organization's fourth forum on medicines access.

Europe Pricing Debate Pricing Strategies

Co-Pay Charity Settles Charges It Conspired With Teva, Biogen, Novartis On Kickbacks

The Assistance Fund directed donations received from the companies to patients taking their multiple sclerosis drugs, the US Department of Justice announced. Further settlements may be pending.

Compliance Legal Issues Medicare

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 Exec Chat

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

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Performance Trackers

Keeping Track Of User Fee Decisions And Filings: Adakveo, Brukinsa And Fetroja Mark Massive Week Of Novel Approvals

The latest news on US FDA user fee decisions and submissions to the agency.

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 Nominee Makes A Good First Impression, But This Is Still An Odd Transition

Stephen Hahn mostly coasted through a confirmation hearing to be the next FDA commissioner – but he still didn’t really give any indication of why he wants the job.

FDA Leadership

Generic Drug Approvals In US Off To Slow Start In FY 2020

US FDA reports another low tally of full approvals in October, but stakeholders are not worried given the agency's history of record-breaking totals year over year.

Generic Drugs Review Pathway

WHO Forges Ahead With New Framework To List Regulatory Authorities

The World Health Organization is to consult on a policy document explaining how it intends to evaluate and list regulatory authorities that meet certain criteria. The new concept of “WHO-listed authority” will replace the current “stringent regulatory authority.”

International Regulation

Brazilian Regulator Wins Place On ICH Management Committee

Brazil’s pharmaceutical industry has welcomed the election of medicines regulator ANVISA to the management committee of the International Council for Harmonization.

South America Brazil

Remote Decentralized Clinical Trials Could Solve RCT Problems

A new project by Europe’s Innovative Medicines Initiative that is comparing decentralized and traditional clinical trials was launched just before Janssen announced its own decentralized trial.

Europe Clinical Trials

Drug Importation Is A High-Profile Addition To US FDA’s Regulatory Agenda

Agency is targeting January 2020 for release of controversial proposed rule to allow importation of certain types of prescription drugs from Canada; although most Rx drug-related proposed and final rules on the Fall 2019 regulatory agenda are making repeat appearances, a final rule on electronic distribution of prescribing information has fallen off the list.

Pricing Debate Post Market Regulation & Studies

Latest From Policy

Remote Decentralized Clinical Trials Could Solve RCT Problems

A new project by Europe’s Innovative Medicines Initiative that is comparing decentralized and traditional clinical trials was launched just before Janssen announced its own decentralized trial.

Europe Clinical Trials

Patent Judges Could Get Congressional Fix After Federal Circuit Ruling

Legal experts testify that best option is for all decisions of the Patent Trial and Appeal Board to be reviewed by PTO director; House IP subcommittee wants to restrict ruling that PTAB judges were not constitutionally appointed.

Intellectual Property Legal Issues

Medicare Add-On Payments For New Dialysis Drugs Limited To ‘Innovative’ Products

Centers for Medicare and Medicaid Services narrows the types of drugs eligible for add-on payments in the Medicare end-stage renal program as it tries to balance efforts to promote innovation with controlling costs.

Reimbursement Renal

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

US FDA's Stein: 'Cognitive Dissonance' Exists Between Review Divisions In Regulation Of Biosimilars

US FDA's Office of New Drugs director Peter Stein explained that different review divisions take different approaches in their regulation of biosimilars, but feels their frameworks will become more unified as they gain experience in reviewing biosimilar programs.

Biosimilars Drug Approval Standards

Keeping Track Of Review Designations: BTDs For X4, F2G, And BMS; Another QIDP For Allergan

The latest news about products accepted into US FDA expedited review programs.

US FDA Performance Tracker 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

Commercial Explore this Topic

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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

Set Alert for Manufacturing

Latest From Manufacturing

US FDA Suggests Using ICH Drug Guidance To Meet Device Quality Requirements for Transdermals

FDA’s draft guidance on transdermal and topical delivery systems says manufacturers can leverage pharmaceutical development studies principles for device design control requirements.

Manufacturing Quality

US FDA's Marks: Gene Therapy Success Could Hinge On Regulatory Convergence

Biologics center's director encourages sponsors to invite other regulators to early FDA meetings in effort to scale up markets.

Regenerative Medicine Manufacturing

Generic Industry Not Sold On Benefits Of FDA Emerging Technology Program

FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.

Manufacturing Quality
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