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Featured Stories


Brexit: Number Of Drugs At Risk Of Shortage Cut From 108 to 39

The European Medicines Agency plans to work directly with the marketing authorization holders of products that are still at risk of supply shortages to address the outstanding issues.

Brexit Regulation Market Access

Pivotal Trials Are Cheaper For Unmet Needs And Orphan Drugs, JAMA Study Finds

Analysis of clinical trial costs for CDER’s 2015-2016 novel therapeutic approvals finds pivotal studies are most expensive when a new agent has a similar benefit to already marketed products with well-established clinical profiles. 
Clinical Trials Research and Development Strategies Drug Review

Cleveland Clinic “Outsourcing”? 503B Status Would Be Milestone For US FDA’s Compounding Model

Chronic problem with drug shortages is driving the Cleveland Clinic to consider registering as a 503B “outsourcing” facility. That could be a milestone in FDA’s efforts to encourage the model for high volume compounders.

To Lower Drug Prices, Look At Generic Industry Health Rather Than FDA, Woodcock Says

US FDA can encourage and increase competition, but cannot force generic companies to enter markets deemed unprofitable, CDER director says.
Pricing Debate Generic Drugs FDA

EMA Targets Sponsors That Post Trial Results Too Late

Too many clinical trial sponsors are late in to reporting their study results on the publicly available EU Clinical Trials Register, and the European Medicines Agency is planning to chase up the laggards.

Clinical Trials Compliance Europe
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European Performance Tracker

Global Pharma Guidance Tracker – August 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.
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Case Study: Broad Thinking Yields Big Results

There are numerous details when considering product packaging that require both creative thinking and feature prioritization. Rather than developing a standard solution for the current need, it’s imperative to think broadly and design options that are cost-effective, simplify operations and save time and/or resources.

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Generics In The US 2018

Read this eBook and learn more about the West AccelTRA elastomer components program that was designed to help in this effort. Learn how the AccelTRA component program has been helping generic biopharmaceutical manufacturers by providing a number of key features, for those high-volume products and where manufacturers would like to deal mostly with one high-performing elastomer component.

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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

The Quality Lowdown: The More Things Change …

US FDA inspection offers hints that Zhejiang Huahai’s genotoxic valsartan impurity could have been caught earlier, while EMA expands its quality review to other sartans that contain the same trouble-prone tetrazole ring. A micro lab will have to jettison its microbrewery, and compounding supplier Fagron must ID its API sources.

Manufacturing Quality Compliance

Latest From Regulation

New Patents Database To Help Countries Improve Medicines Procurement

The international drug industry group, IFPMA, the World Intellectual Property Organization and 20 big pharmas have launched Pat-INFORMED, a new patent database that can be used by governments to improve their medicines procurement programs. The R&D-based industry says it clearly links public patent information to registered medicines in a new, user-friendly online gateway. However, the European generics industry body Medicines For Europe says the move amounts to "patent linkage" and will have anti-competitive effects for generics firms. 

Emerging Markets Generic Drugs

Brazil Takes Steps Towards Harmonization On Pharmacovigilance

Brazil wants to update its pharmacovigilance rules and bring them into line with international standards.

South America Brazil

Stress Test For WHO’s Quality Certificate Scheme In The Americas

A project being run in the Americas will assess the way that the Certificate of a Pharmaceutical Product is used and whether it meets the needs of countries in the region. The move is part of the revision of the World Health Organization’s quality certification scheme.
Quality Regulation

Latest From Policy

Gilead Lowering HCV Drug List Prices With Authorized Generics

Approach has been endorsed by Express Scripts as more workable solution than trying to cut list prices for drugs already on the market.

Pricing Debate Pricing Strategies

Opioids Could Become Bioterror Weapons, US Fears; BARDA Funds Countermeasures

Opiant could get $4.6m to accelerate development of nasal nalmefene for treatment of opioid overdose.

Policy Research & Development

Biosimilar Action Packages Low On US FDA Priority List For Redaction And Posting

Final review documents have been posted for only four of 12 biosimilars due to a backlog in applications considered the third priority level for redaction – a categorization that seems out of sync with the agency’s approach to labeling and its emphasis on promoting price competition.


Biosimilars Drug Review

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Opioids Could Become Bioterror Weapons, US Fears; BARDA Funds Countermeasures

Opiant could get $4.6m to accelerate development of nasal nalmefene for treatment of opioid overdose.

Policy Research & Development

Repeated Questions Prompt EMA To Reconsider Guidance On Neonates

The European Medicines Agency wants to update its guidance on the investigation of drugs in term and preterm neonates to reflect the “considerable experience” it has gained in assessing pediatric investigation plans.
Clinical Trials Research & Development

Making Real World Evidence Less 'Messy' To Help With Drug Pricing

The Medicines Company's inclisirin CV trial is 100-fold cheaper with digitized records, while Lilly is still hunting for a good HBA1C dataset, and Merck worries about "idiosyncratic" data.

Pricing Strategies Research & Development

Commercial Explore this Topic

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Latest From Commercial

Novo Nordisk CEO Says Group Doubling Medical Supplies in UK Ahead Of Brexit

Novo Nordisk's chief says the Danish company is stockpiling medicines in case of "no deal" hard Brexit

Brexit Business Strategies

AbbVie Deployed Nurses As 'Runners And Cappers' In Humira Kickback Scheme, Suit Alleges

California Insurance Commissioner claims AbbVie gave kickbacks for healthcare providers to prescribe Humira and had nurse 'ambassadors' insert themselves between patients and physicians.

Advertising, Marketing & Sales Legal Issues

Cigna Acquisition Of Express Scripts 'Unlikely' To Harm Competition, DOJ Concludes

Department of Justice clears insurer Cigna to acquire PBM Express Scripts with no divestitures or other actions required by the two giants; American Antitrust Institute says it will "trigger a fundamental restructuring of the US healthcare system."

Pharmacy Benefit Management Private Payers

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Stress Test For WHO’s Quality Certificate Scheme In The Americas

A project being run in the Americas will assess the way that the Certificate of a Pharmaceutical Product is used and whether it meets the needs of countries in the region. The move is part of the revision of the World Health Organization’s quality certification scheme.
Quality Regulation

FDA Approving Complex Generics Pre-ANDA Meeting Requests At Higher Rates

Approval rates for complex-drug pre-ANDA meeting requests are climbing. FDA’s hope is that the meetings will hasten approvals of these hard-to-manufacture generics, which could put a dent in US healthcare costs.
United States Manufacturing

The Economics Of Drug Shortages: US FDA Seeks Broad Input

FDA is planning series of stakeholder meetings to identify new approaches to drug shortages, with particular interest in defining “essential” drugs. Agency is also looking outside for expertise, with Boston University’s Rena Conti tapped as advisor.
Manufacturing Regulation

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Freshkote Buy Narrows Eyevance's Focus

Agreement with Focus Laboratories includes all Freshkote formulations in multi-dose bottles and single-unit vials to market and commercialize the line worldwide.

Deals Ophthalmic

GSK Invests In OTC Production, Prepares To Divest Horlicks Nutritional Business

Latest consumer health investment was $36m upgrade to a Canadian facility, which by mid-2019 will begin making Voltaren OTC topical gel products. GSK's next move in consumer health divestment is its pending sale of its Horlicks business.

Consumer M & A

FDA OTC Switch Guidance Omits Some Turns As Approval Roadmap, CHPA Says

In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency has indicated would soon follow.  CHPA expects that identifying information away not within a Drug Facts label that will be considered in an FDA evaluation would be determined on a case-by-case basis, with a switch NDA sponsor and the agency agreeing to terms of approval during a proposal development and review.

Prescription To Otc Switch Drug Approval Standards
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