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Featured Stories


Interchangeability Won’t Solve US Biosimilar Market’s Woes, FDA’s Gottlieb Says

FDA's Biosimilar Action Plan aims to boost approvals, but Commissioner Gottlieb says he's had a change of heart about how much impact an interchangeability designation can have on market uptake.

Biologics Biosimilars Regulation

NHS England Offers Vertex Final Orkambi Deal

The increasingly public row between Vertex and NHS England continues as NHS England claims it has offered Vertex the “largest ever financial commitment of its type” in its 70-year history. Meanwhile, Vertex has revealed that it is offering a price that is significantly lower than the list price.

Europe United Kingdom Cost Effectiveness

Novartis Puts A Halt To Drug Price Increases While Awaiting More On Trump's Blueprint

Novartis joined Pfizer in agreeing to hold off on any further US drug price increases this year, saying the decision was prudent in the current environment. On Trump's drug pricing blueprint, Novartis said it is carefully monitoring how policy evolves this year before charting a course for 2019.

Sales & Earnings Pricing Strategies Pricing Debate

Parliament Tells PM To Take 'All Necessary Steps' To Keep UK In EMA After Brexit

Members of parliament in the UK want the government to take "all necessary steps" to keep the country in the EU medicines regulatory network after Brexit. It's not that easy, though.

Europe Brexit Regulation
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US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – June 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.
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Clinical and Research Excellence Awards 2018 eBook

The Clinical and Research Excellence (CARE) Awards provides an opportunity for the pharma industry to celebrate all its achievements, and pay tribute to the people and teams behind these feats. 2017 was a successful year for the industry, which was evident by the volume and quality of the entries received for this year’s CARE Awards.

Read the eBook and discover more

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

Industry Urged To Watch And Wait For US/China Tariff War To Blow Over

Don’t do anything rash to avoid US tariffs on drug products, ingredients and supplies from China, consultants advise. It would be better to just wait to see if the tariff war blows over.

Manufacturing Trade United States

Latest From Regulation

Suffix Smackdown: Gottlieb Calls Issue 'Red Herring' For Biosimilars

'This is important for our own pharmacovigilance,' US FDA commissioner says. 'We still have an open question on whether or not we’re going to apply a suffix or change also the branded company’s name as well.'

Biosimilars Biologics

Biosimilar Labeling: US FDA’s Final Guidance Means Status Quo For Sponsors

Advice document, little changed from a March 2016 draft, continues to reflect agency’s view that clinical studies supporting a demonstration of biosimilarity should not be included in labeling.

Biosimilars Regulation

Commission Offers Fixes To Speed Up EU Trials Of GMO-Containing ATMPs

The European Commission is making use of opportunities available under existing legislation to help facilitate clinical trials of advanced therapy products containing genetically modified organisms. 
Europe Clinical Trials

Latest From Policy

Can Patents Be Wiped Out Because Of A Litigator's Misconduct? Regeneron Asks Supreme Court

Regeneron challenges Federal Circuit finding that withholding information in discovery constitutes inequitable conduct; district judge orders firm to pay Merus $10.5m in attorneys' fees and costs.

Legal Issues Intellectual Property

Lilly CEO Breaks From PhRMA, Innovators With Support For CREATES Act

Legislation that would prevent REMS from blocking generics appears to be gaining momentum.
Generic Drugs Pricing Debate

Sharing Information With US FDA Advisory Committee Can Invalidate Patent, Jazz Finds

Federal Circuit rules that material about Xyrem's REMS distribution system provided for advisory committee review constitutes prior art.

BioPharmaceutical Policy

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

French Industry Welcomes Moves To Speed Up Access To Innovative Drugs

A French government/industry discussion forum has come up with concrete plans for accelerating access to innovative medicines by streamlining clinical trial approval and price negotiations.

France Innovation

Ex-US FDA Director John Jenkins Sketches Regulatory Path For Esperion's Bempedoic Acid

Imbalance in deaths in study of novel cholesterol drug has been a concern, but Esperion made the case for safety during a July 10 investor day, which featured presentations by ex-FDA director John Jenkins and Cleveland Clinic cardiologist Steve Nissen.

Clinical Trials FDA

Breakthrough, Priority Review Designations Could Set High-Water Marks In 2018

Announcements of designations for both US FDA's expedited pathway are on torrid paces through first half of 2018. 
Drug Review Review Pathway

Commercial Explore this Topic

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Latest From Commercial

Amazon OTC Line's Impact On Pricing Grows Along With Its SKUs

Amazon's Basic Care OTC brand SKUs have doubled units since last year's launch and is putting great pricing pressure on private label competitors, says a Jefferies analyst. But a private label consultant says the e-commerce giant's threat to competitors in the consumer health market is over-hyped.

Advertising, Marketing & Sales Business Strategies

Pfizer Agrees To Roll Back Prices On 40 Drugs, Yielding To Pressure From Trump

After a conversation with President Trump, CEO Ian Read agreed to cancel price increases on 40 drugs that took effect July 1, to give the administration time to work on its blueprint for improving the health care system.

Pricing Debate Pricing Strategies

Trump Tries To Shame A Defiant Pfizer On Drug Pricing

President Trump called out Pfizer’s recent price increases on Twitter July 9. Pfizer was one of only four companies that took a second round of price increases in 2018, according to analysts at Morgan Stanley. CEO Read has long defended the industry's pricing practices, even as public criticism of the high drug prices has grown. 

Pricing Debate Pricing Strategies

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA Shortages Task Force Looks More Broadly To Tackle Root Causes

FDA’s latest drug shortages task force aims to encourage investment in the reliable manufacture of generic sterile injectables that are fundamental to the practice of medicine. While the agency’s first task force continues to work with industry to avert shortages, the second will strike at underlying structural issues that cause persistent shortages of these critical medicines.

 

United States Manufacturing

FDA's CMC Guidance For Investigational Gene Therapies Reflects Broader CMC Evolution

New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference.

Manufacturing Regenerative Medicine

Illegal Emissions Force Sanofi Production Stoppage

Sanofi is working on technical improvements after its Mourenx site in southwest France was found to be emitting illegally high levels of solvents. Production at the site is on hold.

Manufacturing Compliance

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

House Passes US OTC Monograph Reform And Committee Clears HSA Change

Next step for OTC monograph reform legislation is Senate consideration; market exclusivity periods are likely focus of House/Senate conference. Separate bill to allow consumers to use health savings accounts to buy OTC drugs without a doctor's prescription clears House Ways and Means panel.

Consumer Legislation

Innovation In OTC Switches Takes Multimedia Approach In US FDA Draft Guidance

Sponsors can point consumers to video displays, website information and mobile apps to help them choose products that have been switched from Rx to OTC. Draft guidance on innovative switch applications to be followed by rule-making in near future.

Consumer Prescription To Otc Switch

Amazon OTC Line's Impact On Pricing Grows Along With Its SKUs

Amazon's Basic Care OTC brand SKUs have doubled units since last year's launch and is putting great pricing pressure on private label competitors, says a Jefferies analyst. But a private label consultant says the e-commerce giant's threat to competitors in the consumer health market is over-hyped.

Advertising, Marketing & Sales Business Strategies
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