Pink Sheet is part of the Business Intelligence Division 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


FDA Endocrinology Division To Be Led By Thanh Hai On Interim Basis; Guettier Leaving For Private Sector

Mary Thanh Hai ran the US agency's division for seven years before moving up in 2013; Guettier’s departure may provide an opportunity for CDER Director Woodcock to start to implement her vision for changes in the Office of New Drugs.

Drug Review Metabolic Disorders Leadership

EU Regulators Urge Pharma To Share Their Brexit Plans

Sponsors of medicines evaluated through the EU's decentralized procedure are being urged to share their plans regarding Brexit with national agencies as soon as possible to help with planning. The head of the Dutch Medicines Agency thinks that the human medicines sector can learn from the progress being made in the veterinary space on this front.

Brexit Regulation Europe

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 Policy

US FDA Readies For Assessment Of IND Communications With Sponsors

Third-party contractor will conduct evaluation of agency's communications with sponsors throughout IND process as part of PDUFA VI commitments.

Drug Review FDA Regulation
Advertisement

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Some Drug Prices Could Drop 40% Under Canada’s Cost Lowering Proposals

The prices of patented medicines overall are expected to go down in Canada under new proposed regulatory amendments.

Pricing Debate Canada Regulation

Latest From Regulation

EU Sets Up Database Of National GMO Requirements To Facilitate ATMP Trials

The European Commission has developed a database to help drug companies navigate the complex process of seeking environmental clearance from EU member states before they can initiate a clinical trial with ATMPs containing a genetically modified organism.

Clinical Trials Regulation

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

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

Latest From 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

US Retail Drug Spending Growth Slows Substantially In 2016

Retail drug spending rose just 1.3% in 2016, following growth rates of 8.9% and 12.4% in 2015 and 2014, respectively. Moderating trend is reported just ahead of two congressional hearings on drug pricing.

Pricing Debate Reimbursement

HHS Nominee Azar And The Taint Of Industry

During the first step of the confirmation process, HHS Secretary nominee Alex Azar did a good job of framing his industry background as useful experience for tackling drug prices. But wouldn’t it be nice if everyone agreed that 10 years as Lilly was something to be proud of?

Policy Leadership

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

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

Commercial Explore this Topic

Set Alert for Commercial

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

Set Alert for Manufacturing

Latest From Manufacturing

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

ICH Experts Aim To Set Elemental Impurity Exposure Limits For Topical Drug Products

ICH expert working group is encountering challenges in setting permitted daily exposure limits for elemental impurities in topical drugs, the group's rapporteur says. Nevertheless, the group is forging ahead and plans to have a Step 2 draft document ready for public consultation in May.

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

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

FDA's Nicotine Replacement Standards Review Could Open Door For E-Cigarettes

Latest steps by US FDA targeting tobacco-related health problems are a Nicotine Steering Committee, headed by Commissioner Gottlieb, and a public docket, including a meeting in January, for suggestions on how novel products could be evaluated as safe and effective NRTs.

Consumer Drug Approval Standards
UsernamePublicRestriction

Register

Advertisement