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Latest News & Analysis

Health Technology Assessments And the Trouble With Rare Disease Treatments

To get their gene or cell therapies through health technology appraisals, companies need to agree to gather longer-term evidence, be upfront about what treatments can really deliver and remember to ask for patient input.

Europe Health Technology Assessment

Only One In Seven PRIME Applications Meet EMA Test

Of the 14 applications for entry onto the European Medicines Agency’s priority medicines scheme during the first two months of 2019, only two – from AstraZeneca and Freeline – made the grade.
Europe Market Access

ICH Consults On Guideline To Improve Bioanalytical Data Consistency

The finalization of a new international guideline that proposes a harmonized approach on bioanalytical method validation is expected to reduce the need for additional validation experiments and support streamlined global drug development.
International Regulation

Running The Gauntlet: Takeaways From The First Round Of HHS Hearings In 2019

Release of the White House budget proposal kicked off the first round of hearings on HHS with a new Democratic majority in the House and a new HHS budget czar in the Senate. HHS Secretary Azar did his best to set a constructive tone for advancing drug pricing policies – and maintaining his own position – in the year to come.  
Legislation Leadership

Athenex Sues FDA To Get Vasopressin On List Of Drugs That Can Be Compounded

Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.

FDA Legal Issues

Woodcock: Concerns About US FDA's Biosimilars Suffix Policy Detached From Reality

In an exclusive interview, Center for Drug Evaluation and Research Director Janet Woodcock contends that industry concerns about FDA's new suffix policy aren't reflective of real-world problems.
Biologics Biosimilars

Zulresso Postmarket Commitment Hints At Easier Dosing In Postpartum Depression

US FDA wants Sage Therapeutics to explore Zulresso use in alternative settings in a postmarketing trial. A successful study could expand access to the new approved brexanolone, whose administration is now long, complicated, and restricted to certified healthcare facilities.
Approvals Neurology

FDA Aims For Greater Role In Pharma Business Continuity Planning

Legislative proposals described in the US FDA’s FY 2020 budget request justification document would give the agency more authority to oversee business continuity planning at pharmaceutical companies with the idea of preventing shortages of essential drugs.

Manufacturing Quality

Canada Plans New Agency To Negotiate Drug Prices & Tackle Soaring Costs

A proposed new drugs agency with the power to evaluate the effectiveness of medicines and negotiate prices with manufacturers is seen as the first step towards a national pharmacare program offering universal drug coverage in Canada.
Pricing Debate Reimbursement

Saudi FDA Consults On Compassionate Use Program Requirements

The Saudi drug authority has clarified the roles and responsibilities of the various players involved with giving patients access to drugs under development on compassionate grounds.
Saudi Arabia Regulation

Danish Agency Claims A First In Raw Data Analysis

The Danish Medicines Agency says it is about time that EU regulators developed US FDA-style capabilities to analyze raw data so that they can make better use of the opportunities provided by big data. Agency chief Thomas Senderovitz tells the Pink Sheet how Denmark is setting up a unique data analytics center for drugs and devices without reinventing the wheel.
Denmark Europe

US FDA “Enriches” Trial Guidance With Recent Examples

Illustrating that principles articulated in 2012 draft are being broadly accepted at FDA, final guidance on enrichment strategies for clinical trials adds new examples from across the agency’s drug review divisions.
Clinical Trials Drug Approval Standards
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