Pink Sheet is part of the Informa Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories


NICE Overcomes UK Reimbursement Doubts Over Forxiga, US FDA Says No To Approval

The health technology appraisal body for England and Wales now says Forxiga can help fill an unmet need for patients with inadequately controlled type 1 diabetes despite optimized insulin therapy. US regulators, meanwhile, have declined to approve the product for use in these patients.
Health Technology Assessment Approvals Market Access

Generic Drug Application Submission Downturn Continued In June

Approvals also plummeted, but US FDA remains on a record-breaking pace.

Generic Drugs Approvals Regulation

EMA Reviews Meningioma Risk With Cyproterone Medicines

The European Medicines Agency is looking into the magnitude of meningioma risk with high doses of cyproterone medicines. 
Europe France Regulation

US FDA, Advisory Committees Rarely Disagree

A Milbank Quarterly study and a Pink Sheet analysis show that disagreement between the US FDA and its advisory committee meetings doesn't happen often; it is even rarer for the agency to approve a drug against the advice from a panel.
Advisory Committees Approvals Drug Review

Dsuvia: A Dull US FDA Review Preceded The Controversial Approval

US FDA's review of AcelRx's opioid Dsuvia did not presage the external fireworks that came following the approval.

Drug Review Profile Neurology Regulation
Advertisement

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
Advertisement

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

US FDA Compounding Oversight: Not As Bad As FDA Makes It Sound?

HHS Inspector General paints a more positive picture of FDA’s efforts to bring high-volume compounding into better regulatory control than the agency’s own statements might suggest. That could mean the initiative is able to recede a bit from the top-priority status it has had at the agency for almost a decade.

Manufacturing Quality Regulation

Latest From Regulation

AbbVie And Allergan: Five Big Review Questions To Worry About

Mega-merger's top US drug candidates are seeking space in crowded fields. That means they have to get through the FDA fast, and priority review vouchers figure prominently in both improving and lowering the odds.

Drug Review M & A

Pink Sheet Podcast: Mid-Year Drug Approvals, Drug Pricing Hits And Misses, A Plea For More Naloxone, And Gottlieb Goes To Pfizer

A look back at the implications of the mid-year approval total, developments in drug pricing efforts on and off Capitol Hill, the FDA's plea for generic naloxone, and former commissioner Scott Gottlieb heading to Pfizer's board of directors.
Approvals Pricing Debate

NZ Plans New Medicinal Cannabis Regulatory Scheme & Agency

A new regulatory scheme for medicinal cannabis products, complete with a brand new agency, is on the cards in New Zealand, based on a strict licensing and quality control system that is intended to increase the supply of, and patient access to, such products.
New Zealand Regulation

Latest From Policy

A Short Eulogy For The Rebate Rule

The rebate rule is dead, but we should pay tribute to the failed endeavor.

Pricing Debate Medicare

Drug Price Transparency Bills May Be Empty Calories

Price justification legislation is advancing in both chambers of Congress. But CBO scores them as no savings. 
Pricing Debate Legislation

In A Win For Amgen, Court Blocks Sanofi/Regeneron's Praluent Sales In Germany

A court in Dusseldorf ruled that Praluent infringes a patent for Amgen's better-selling PCSK9 inhibitor Repatha, saying that Sanofi and Regeneron must stop selling their biologic in Germany. It's unclear whether there will be any readthrough to ongoing patent disputes in other countries.

Intellectual Property Legal Issues

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

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

An Ex-Commissioner’s Bleak Take On The State Of Biopharma Innovation

Former US FDA Commissioner Robert Califf remains eager to encourage broader use of real-world evidence – but his blunt, pessimistic read on the state of biopharma innovation is remarkable coming from a former FDA head.

United States Clinical Trials

EU Council Calls For More Action On Developing New Antimicrobials

The Council of the EU has published its conclusions on making the EU a “best practice region” in combatting antimicrobial resistance. While there are plenty of recommendations, little concrete action is proposed.

Europe Netherlands

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

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

BIO 2019 Notebook: Lartruvo Lookback, M&A Soars, BIO Vs. ASCO

News and views from day four of the BIO International Convention: Former FDA official Amy McKee said "everything worked right" with accelerated approval and removal of Lilly's Lartruvo; emerging company M&A deals nearly double in 2018; and the ASCO effect on the 3-6 June BIO meeting.

Drug Review Review Pathway

A New Drug Price Milestone

Much like Genzyme’s Ceredase did two decades ago, Novartis’ Zolgensma is setting a new pricing benchmark. The first million-dollar product is launching in the US and it will actually cost more than $2 million.

Pricing Debate Rare Diseases

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

NZ Plans New Medicinal Cannabis Regulatory Scheme & Agency

A new regulatory scheme for medicinal cannabis products, complete with a brand new agency, is on the cards in New Zealand, based on a strict licensing and quality control system that is intended to increase the supply of, and patient access to, such products.
New Zealand Regulation

US, EU Hit Inspection Deal Milestone; Batch Test Waiver Kicks In

After 20 years in the making, the landmark GMP inspection MRA between the US and the EU is finally fully implemented. In addition, a batch test waiver has started to apply under the deal.

Manufacturing Europe

Mutual Recognition's Next Evolution May Be Sharing Info On India And China Inspections

Now that US FDA has approved the final EU authority, mutual recognition efforts could expand and deepen. Former FDA chief counsel Rebecca Wood discusses the future of approval standards harmonization in Pink Sheet interview.

Manufacturing Legal Issues
UsernamePublicRestriction

Register

Advertisement