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Featured Stories


Medicare Price Inflation Rebates, Part D ‘Redesign’ Proposed In Senate Finance Bill

Price inflation rebates are expected to generate $50bn in savings over 10 years, according to the Congressional Budget Office.

Pricing Debate Reimbursement Legislation

Acting FDA Commissioner Sharpless Offers A Familiar List Of Priorities

Many of Sharpless' priorities continue the work of his predecessor, but also are designed to make "immediate and significant impact."

FDA Leadership Regulation

Rivals Await CHMP Decisions On Drugs For NMOSD

The European Medicines Agency’s drug evaluation committee, the CHMP, is this week considering products from Alexion Pharmaceuticals and Roche/Chugai Pharmaceutical who are both vying for a share of the as yet untapped EU market for neuromyelitis optica spectrum disorder.

Europe Approvals Drug Review

GW Pharma's Cannabinoid Medicine Epidyolex Among CHMP Hopefuls

Seven new medicines, including GW Pharma's orphan cannabidiol product, Epidyolex, are due for an opinion from the European Medicines Agency this week on whether they should be recommended for pan-EU approval.
Europe Approvals Drug Review

US FDA Must Explain How It Defines ‘Innovation’ In Awarding Hatch/Waxman Exclusivity, Court Says

Agency's decision that Indivior’s Sublocade blocked Braeburn’s long-acting buprenorphine formulation Brixadi lacked ‘substantive guideposts’ in how innovation is defined for purposes of deciding scope of three-year exclusivity, US judge says.

Legal Issues FDA Rare Diseases
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US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – June 2019

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
International Europe Australia

NEW from CMIC: Tailoring Bioanalytical Testing In A New Era Of Drug Development

With unrelenting pressure to enhance the speed, efficiency and cost-effectiveness of drug discovery and development, companies need to be confident their Bioanalytical testing is not only tailored to these translational goals, but delivers added value in an environment in which scientific innovation, commercial imperatives and unmet patient needs are rapidly transforming the drug-development paradigm.

Read the Whitepaper

Embedding Time-Critical Scheduling in Drug Production

Manufacturing is the engine room of the pharmaceutical industry. Ultimately, a medicine has little value if it does not reach patients on schedule, in the required quantity and quality. Download this whitepaper which discusses time-critical scheduling in drug production.

Download Whitepaper
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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

US FDA Warns Indoco To Delve Further Into Manufacturing Deviation

On paper, the tablet press was in control. In reality, it was not. What did that mean for the company? A lot more than it appeared to realize.

Enforcement Manufacturing Quality

Latest From Regulation

Boehringer's Ofev Faces Efficacy Hurdle For SSc-ILD Indication At US FDA Advisory Cmte.

The Arthritis Advisory Committee will give its take on Boehringer Ingelheim's forced vital capacity data as the drugmaker seeks to land add an indication for a rare lung disease to the label of its tyrosine kinase inhibitor Ofev.

Advisory Committees Immune Disorders

Major Inquiry Into EMA Pre-Submission Meetings And Bias Risk Concludes

The European Ombudsman has recommended how the European Medicines Agency can avoid even the perception that the decisions it takes on marketing authorization applications are influenced by the pre-submission interactions it has with drug developers.

Regulation Approvals

US FDA Invites Randomized Trial Designs With Real-World Elements

Agency is eager to engage with sponsors on ‘well thought-out proposals' to include real-world data sources in randomized studies, Office of New Drugs director Peter Stein says but adds that believability and robustness of the data are the agency’s primary concern.

Clinical Trials Research and Development Strategies

Latest From Policy

How Risky Is Amgen's At-Risk Launch Of Herceptin, Avastin Biosimilars?

In ongoing patent litigation with Genentech, Amgen may need to reveal its counsel's advice on whether it should launch, while Genentech must produce its settlement agreements with Mylan, Celltrion, and Pfizer.

Biosimilars Intellectual Property

Industry Demands Rethink Of German HTA Data Requirements

The pharmaceutical industry is calling for more flexible evidence requirements for health technology assessments in Germany after the country’s HTA body, IQWiG, claimed that too many new products entering the market lack additional benefit.
Health Technology Assessment Reimbursement

Will Slew of Patent Bills Lower Drug Prices?

Legislation is targeting a wide range of patent practices, from product hopping to patent infringement settlements and inter partes review.

Legislation Pricing Debate

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Major Inquiry Into EMA Pre-Submission Meetings And Bias Risk Concludes

The European Ombudsman has recommended how the European Medicines Agency can avoid even the perception that the decisions it takes on marketing authorization applications are influenced by the pre-submission interactions it has with drug developers.

Regulation Approvals

German HTA Body Slams Lack Of 'Real Innovation'

Too many new drugs have the same mechanism of action, says Germany’s health technology appraisal institute, IQWiG.
Research & Development Innovation

Adaptive Trial Designs Need Elaborate Firewalls To Prevent Data "Leakage," US FDA Says

Sponsors should realize that only a very few people – think 4, not 50 – will be permitted to be unblinded, CDER's Laura Lee Johnson tells the DIA annual meeting.

Clinical Trials Research and Development Strategies

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

Sunset Begins For Roche's Herceptin As Amgen/Allergan Biosimilar Launches

Amgen and Allergan launched the first US biosimilar for Roche's Herceptinand the Swiss pharma's Avastin – at a 15% discount to the brand-name products' list prices. Infographic reviews Herceptin's past and its future competitors.

Biosimilars Launches

When It Comes To FTC M&A Review, The Times May Be A Changin'

Spark signaled in an SEC filing that its merger with Roche could be delayed into 2020, fueling more speculation that FTC is increasing scrutiny over biopharma mergers.

M & A Pricing Debate

Pharma's Big Defeat: US Rebate Proposal Hits The End Of The Road

White House will not move forward with a rebate proposal the drug industry supported as a way to lower patient drug spending.

Regulation Reimbursement

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

How Ocular Therapeutix Recovered From US FDA’s Second Dextenza CRL

A new approach, total dedication and lots of practice made a difference for the Massachusetts start-up after FDA approval was twice deferred over manufacturing quality concerns.

Drug Review Manufacturing

US FDA Trains Reviewers For Consistency On Post-Q12 Manufacturing Changes

Anticipating the eventual adoption of ICH Q12, the US FDA is training staff on some of its key principles. An agency official says ICH Q12 necessitates a new way of thinking about and reviewing regulatory submissions for post-approval changes and such training is necessary to ensure review consistency.

Manufacturing Quality

Final ICH Q12 Post-Approval Changes Guideline Expected In November

A final revision of the ICH Q12 lifecycle management guideline is expected to overcome a conflict with EU variations legislation and offer more clarity on what is, and what is not, an established condition subject to post-approval change reporting requirements.

Manufacturing Quality
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