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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

WHO Wants More Transparency From Industry On Falsified Medicines Scourge

The World Health Organization estimates that one in 10 Medicines in the developing world are falsified. It says that the pharmaceutical industry needs to be more transparent about the problem.

Drug Safety Healthcare Systems Quality

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 United Kingdom

Drug Sponsors Mostly 'On Track' With Postmarket Study Requirements

US FDA's annual report on the status of postmarketing requirements and commitments shows 84% of open postmarket requirements for NDAs and 91% for BLAs were progressing on schedule as of Sept. 30, 2016; about half have not yet begun.

BioPharmaceutical Regulation FDA
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Policy & Regulation Explore this Topic

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Bladder Pain, Interstitial Cystitis And The Move Toward Patient-Focused Drug Development

Patients with the conditions experience the same symptoms, US FDA advisory committee concludes. Industry sponsors had advocated for combined trials, but panel did not agree with firms' recommendations on study duration and outcome measures.

Advisory Committees Clinical Trials Drug Approval Standards

Latest From Regulation

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

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

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

Latest From 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

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

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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

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

Breakthrough, Fast-Track Pathways Match Their Hype Of Reduced Development Times - JAMA

Although study was meant to be critical of expedited pathways, it showed that drugs with at least one of the designations experience lower clinical development times.

Review Pathway Drug Approval Standards

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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

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Latest From 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

Will Continuous Manufacturing Mean Continuous Generic Delay? FDA Hears AAM's Warning

Association for Accessible Medicines calls for US FDA to guard against use of continuous manufacturing methods to protect brand drugs from batch-manufactured generic drugs that may be of lower but still acceptable quality. Then FDA approves first generic of a continuously manufactured drug.

Manufacturing Quality

Global Pharma Guidance Tracker – November 2017

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.

International Australia

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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
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