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How Biocon Site Prevented FDA 'OAI' Finding From Derailing Biosimilars

By carrying out certain corrective and preventive actions, a Biocon facility in Bangalore, India, averted an "official action indicated" finding US FDA officials had proposed in an establishment inspection report, one that could have potentially delayed approval of two Mylan biosimilars. Key issues at the site included visible particles in sterile injectable drug products as well as various aseptic processing practices.

Manufacturing Quality India

UK’s NICE Aims To Knock Firms’ Health Economic Models Into Shape

The scientific advice department at UK HTA body NICE is offering a new peer-review service to companies that want to make sure their economic models are as watertight as possible for making submissions to health technology assessment agencies and payers. One pilot project has already taken place.

Health Technology Assessment United Kingdom Comparative Effectiveness

Mandatory Provider Training For Opioids Embraced By PhRMA

Trade association members also commit tens of millions of dollars to set up addiction prevention programs and create new health care tools.

Neurology Policy BioPharmaceutical

Drug Pricing: US Senate Hearings Conclude With No Clear View On Legislation

Measures that would increase financial transparency and empower federal government to negotiate drug prices highlighted by National Academies representative who discussed recent report on drug affordability, but former Congressional Budget Office Director Holtz-Eakin warns Senate HELP Committee against taking measures that merely shift costs from one party to another.

Pricing Debate Pharmacy Benefit Management Policy
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Opioid Packaging: Is Non-Inferiority Enough For A New Claim?

Industry exec suggests new packages need be merely no worse than the classic amber vial to gain a claim, but US FDA says packaging intended to fight abuse should be better.

Review Pathway Innovation Neurology

Latest From Regulation

Orphans Dominate Products Seeking End-Of-Year Joy From CHMP

Five of the nine products that could this week be recommended for EU approval have orphan designation. The final meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London.

Drug Review Approvals

NICE Upholds Advice Against NHS Use Of Orexigen’s Obesity Drug Mysimba

UK HTA body NICE has rejected an appeal against its July decision not to recommend the use of Orexigen’s obesity drug Mysimba in England.

Reimbursement United Kingdom

The Impact Of Brexit – Delays, Safety Impacts And Costs Across Four Scenarios

A report from the Office of Health Economics in the UK has quantified the potential levels of drug shortages and delays in new product launches and the sharing of safety information if the country leaves the EU without comprehensive free trade or mutual recognition deals.

Brexit Regulation

Latest From Policy

PhRMA Sues To Block 'Unprecedented' California Price Reporting Law

Ban on WAC price increases violates Commerce Clause and reporting requirement violates First Amendment, PhRMA contends; complaint says state officials have not clarified whether law is retroactive.

BioPharmaceutical Policy

How To Make Collaborative HTA Work In Europe: A Guide From EUnetHTA

A new report from the European HTA network Collaboration on health technology assessments and joint work, such as relative effectiveness assessments, will better succeed if they fit with member state procedures, according to an analysis from the European Network for Health Technology Assessment.

BioPharmaceutical Comparative Effectiveness

Value-Based Contracts Getting More Safe Harbor Attention From OIG

But so far, OIG has declined a blanket safe harbor for proposed value-based payments, saying it still wants to consider proposals case-by-case. Discussions between the office and stakeholders are continuing, Bristol-Myers Squibb's Mike Ryan says.

Pricing Strategies Medicare

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Latest From Research & Development

Gene Therapy Guidances Will Focus On Specific Diseases, Gottlieb Says

US FDA's first such guidance will focus on hemophilia, commissioner tells Congress.

FDA Research & Development

Will ‘Transformative’ UK Life Sciences Sector Deal Help Offset The Brexit Effect?

The UK government has published its life sciences sector deal, which it says will allow the UK to respond to the challenges and opportunities of demographic change and pioneering research and development – although there is no mention of the “Brexit effect.”

Innovation Research & Development

EMA Points Out Shortfalls To Avoid When Seeking Novel Methodology Qualification

A new EMA checklist of “essential considerations” for the successful qualification of novel methodologies covers common issues that have compromised applications for qualification in the past.

Research & Development Research and Development Strategies

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Latest From Commercial

Pharma Faces More Probes On Generic Price Hikes in UK

As Concordia finds itself in the dock again, this time over its pricing of the essential thyroid treatment liothyronine, the UK's Competition and Markets Authority has recently opened four new investigations into "suspected abuse of dominance" concerning generics.

Legal Issues Pricing Strategies

Merck KGaA Says Outcomes-Based Pact With NHS England 'Precedent-Setting'

Merck KGaA Healthcare CEO Belén Garijo tells the Pink Sheet that outcomes-based reimbursement deals like the one it has done with NHS England “are the way of the future”.

Approvals Commercial

Generic Price-Fixing Lawsuit Grows As More Companies, Two Executives Named Defendants

US state attorneys general name executives from Mylan and Emcure as defendants, and list may further expand as investigation continues into additional companies and drugs.

Generic Drugs Legal Issues

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA's First 90-Day Letters To Deliver Inspection Outcomes After Jan. 1

Happy New Year – or not! Firms inspected by US FDA since Oct. 1 will receive word within 90 days whether their facilities received passing – or failing – grades under timelines mandated by GDUFA II and incorporated into the agency's new Concept of Operations agreement, FDA officials tell FDLI meeting.

Manufacturing Quality

Industry Outlines Concerns Over EU Proposals On Pharmaceuticals In The Environment

EFPIA has generally welcomed the European Commission’s consultation on pharmaceuticals in the environment, but says it also has concerns over certain aspects of the proposals that it thinks are impracticable and could delay patient access to medicines.

Risk Management Quality

Liposomal Drugs Should Not Be Compounded – Until Technology Catches Up

US FDA’s Pharmacy Compounding Advisory Committee agrees with AbbVie that liposomal drugs and products using hot melt extrusion should be listed as prohibited from compounding – but the panel also hopes to see technology advance to change that conclusion.

Advisory Committees Manufacturing

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Latest From Consumer

Consumer Health Weekly Trademark Review Dec. 5, 2017

Compiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.

International Canada

Amarin Not Giving Up On Omega-3 Trade Battle

Amarin asks Federal Circuit Court to direct US ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs. Company questions FDA's request for policy deference given resource constraints and says Supreme Court rulings show compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information renders a product an unapproved drug or represents false advertising.

Consumer Drug Approval Standards

Consumer Health Weekly Trademark Review Nov. 28, 2017

Compiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.

International Canada
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