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Featured Stories


US FDA Reorg: Centers Will Report Directly To Gottlieb; 'Flattened' Structure Will Make Future Political Transitions Easier

Principal Deputy Commissioner Sherman remains top policy guru and will oversee consolidation of functions currently scattered throughout FDA into the Office of Operations.

Leadership FDA Regulation

Drug Importation Can Be Triggered By 'Excessive' Price Increases; Now US FDA Has To Decide What That Means

Did FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar have a change of heart on importation? Or are they being pressured from above?

Pricing Debate FDA Regulation

BeNeLuxA Makes First Positive Reimbursement Decision On Biogen’s Spinraza

In a BeNeLuxA first, Belgium and the Netherlands have reached an agreement with Biogen to reimburse rare disease treatment Spinraza after joint health technology assessment and pricing negotiations.

Europe Austria Belgium

Vivli Nonprofit Hopes To Be One-Stop Shop For Clinical Trial Data

GlaxoSmithKline, Pfizer, and Biogen are among those participating in new data-sharing and analytics platform; 2,500 trials currently available to researchers.

BioPharmaceutical Policy Clinical Trials
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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

Swissmedic Cracks Down On Marketing Applications With Missing Data

Applications for marketing authorization or variations in Switzerland might have to repeat the first phase of Swissmedic’s evaluation process if they do not contain the necessary data upfront.
Switzerland Regulation BioPharmaceutical

Latest From Regulation

Biogen: BeNeLuxA Spinraza Talks “Collaborative And Constructive" But Not Without Challenges

Biogen, the first company to win a positive reimbursement decision from the BeNeLuxA groups, says the process was “constructive and collaborative.” However, differences in local laws mean there will initially be some differences in coverage.

Europe Belgium

International Regulatory Group Clarifies Biodistribution Study Requirements For Gene Therapies

A reflection paper by an international group of regulators, the IPRP, seeks to address the challenges gene therapy developers face with regard to the different regulatory expectations for biodistribution studies around the world.
International Regenerative Medicine

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Latest From Policy

Biogen: BeNeLuxA Spinraza Talks “Collaborative And Constructive" But Not Without Challenges

Biogen, the first company to win a positive reimbursement decision from the BeNeLuxA groups, says the process was “constructive and collaborative.” However, differences in local laws mean there will initially be some differences in coverage.

Europe Belgium

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

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

As Recalls Multiply, EU Agency Studies How To Rid Chinese Firm’s Valsartan API Of Probable Carcinogen

European authorities are examining how a manufacturing process change six years ago may have introduced a probable carcinogen into Zhejiang Huahai’s valsartan API that was only recently detected. They hope to learn how the firm could reduce or eliminate the impurity.

Manufacturing Quality

Who Wants To Be 'Essential'? US FDA Considers Critical Drugs List

To address chronic shortages, FDA may create list of 'essential' drugs, but will suppliers of those products be happy to be designated 'essential'? 
Manufacturing Generic Drugs

Expert Warns Of Looming 'Capacity Crunch' For New Cell And Gene Therapy Products

Capacity shortages are looming for manufacturers wanting to develop and commercialize cell and gene therapy products over the next five years, an industry survey shows. The key finding: these firms should quickly build and staff the manufacturing facilities they will need.

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

J&J Maintains Consumer Business Outlook Despite 'Disappointing' Quarter

Consumer Sales & Earnings

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
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