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Sanofi's Admelog, a Humalog Follow-On, Approved In US As 'Black Hole' For Insulins Looms

Short-acting insulin approved under 505(b)(2) pathway appears poised to receive three years of Hatch-Waxman exclusivity but would lose nine months of this protection under FDA's current interpretation of the 'transition provisions' for certain protein products that take effect in March 2020.

Approvals Biologics Review Pathway

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 Health Technology Assessment

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 United States

Identifying Deceptive Rx Advertising: FDA Rejects PhRMA's Criticisms Of Its Study

US agency disagrees that study of consumer and healthcare professional ability to detect deceptive promos is unnecessary; final guidance on product name placement in labeling and advertisements mirrors 2013 draft.

Advertising, Marketing & Sales Regulation FDA
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China Approves Lundbeck Antidepressant In Year-End Dash

China FDA greenlights Lundbeck's Brintellix for severe depression, and more new drug approvals may be on the way. Physician education will be key for Brintellix, given relatively low number of psychiatrists in China.

Approvals Regulation China

Latest From Regulation

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

EU Guideline On Investigational ATMPs Delayed Until Q3 2019

Several factors have contributed towards a delay in the European Medicines Agency's much awaited guideline on investigational advanced therapy medicinal products, which was initially due to be finalized in the second quarter of 2017.

Clinical Trials Regulation

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

Latest From Policy

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

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

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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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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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

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Latest From Manufacturing

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

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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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.

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