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Featured Stories


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 Pharmacy Benefit Management

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 Drug Safety

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 Government Payers

US FDA’s Opaque Galafold Review: A Rare Misstep In The Trump Era

When FDA reversed course and allowed Amicus to file for Accelerated Approval of migalastat, plenty of people suspected politics were at play. The agency's handling of the review won’t do anything to allay those suspicions.

Voucher Bargain: US FDA Lowers Redemption Fee; NDA And BLA Review Costs Decrease

Additional fee will be less than traditional PDUFA application fee in FY 2019, meaning voucher redemptions will cost less than double a typical application review.
FDA Review Pathway Regulation
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US FDA Performance Tracker

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.

Read Now

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.

Read the eBook and discover more

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

European CHMP Opinions And MAA Updates

This is a monthly update listing recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Europe Approvals Drug Review

Latest From Regulation

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

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

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

Latest From Policy

India Rolls Out Modicare - Can It Redefine Healthcare Access, Market Potential?

India has rolled out its massive government-funded health care program, expanding access to treatment to more than 100 million families. Though ambitious and complex and a scheme that could face intense scrutiny in the run up to general elections next year, the sheer scale of the initiative may also throw up significant market expansion or partnering opportunities for hospitals and pharma.
India Policy

AstraZeneca FluMist Supply Jumps With CDC's Seal Of Approval

US FDA's approval kept very limited amounts available the past two flu seasons; 2.7 million doses to be shipped for the 2018-2019 season.
BioPharmaceutical Policy

Trump's Chinese Import Tariff Hike Could Take Toll On Consumer Health Sector

Low margins, limited supplier alternatives leave little room for OTC drug marketers in the US to maneuver as ingredients continue  to be subject to Chinese import tariffs.

 

Consumer China

Clinical / R&D Explore this Topic

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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

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

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

Commercial Explore this Topic

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Latest From Commercial

AstraZeneca FluMist Supply Jumps With CDC's Seal Of Approval

US FDA's approval kept very limited amounts available the past two flu seasons; 2.7 million doses to be shipped for the 2018-2019 season.
BioPharmaceutical Policy

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

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

API Makers Must Control Dangerous Impurities Better, FDA Compliance Official Says

The compliance chief for FDA’s center for drugs said API makers need to do a better job of testing their products for impurities to avoid exposing patients to safety risks, as has occurred with at least one supplier’s valsartan API.

Manufacturing Quality

Trump's Chinese Import Tariff Hike Could Take Toll On Consumer Health Sector

Low margins, limited supplier alternatives leave little room for OTC drug marketers in the US to maneuver as ingredients continue  to be subject to Chinese import tariffs.

 

Consumer China

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

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Trump's Chinese Import Tariff Hike Could Take Toll On Consumer Health Sector

Low margins, limited supplier alternatives leave little room for OTC drug marketers in the US to maneuver as ingredients continue  to be subject to Chinese import tariffs.

 

Consumer China

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

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
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