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Policy & Regulation

Set Alert for Policy & Regulation

Priority Reviews At US FDA: From Third Quarter Spikes To A Third Quarter Trough

Priority review announcements saw significant dip in third quarter 2018, while they usually experience a spike during the period; breakthrough therapy designations remained in double digits.
Review Pathway Research & Development Drug Review
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Regulation

Set Alert for Regulation

Latest From Regulation

Expanded Access Data Can Support Approval Decisions, US FDA Says

Formal reg not needed, according to agency; officials agree that regulatory flexibility is best way to offer sponsors advice, saying data collected during compassionate use can be helpful in guiding regulatory decisions. 
Clinical Trials Review Pathway

Unlicensed Stem Cell Clinics Are 'Surrogate' For Right To Try, US FDA's Marks Says

CBER director said unlicensed stem cell clinics often report adverse events not made public, which is a concern under Right To Try.
Drug Safety Clinical Trials

Keeping Track Of Immuno-Oncology: An Updated Guide To Applications At FDA

Infographic highlights products in the burgeoning PD-1/L1 checkpoint inhibitor class either approved or under review, from the Pink Sheet's FDA Performance Tracker. 
 
Cancer Approvals

US FDA Office Of New Drugs Likely To Be Headed By Deputy Director Stein

Peter Stein is a familiar face within OND and has been working alongside CDER Director Janet Woodcock on the proposed “modernization” of OND. As a previous recruit from outside FDA, Stein has had time to make the key connections and adjustments to working inside government.
FDA Leadership

UK Agency Boss Hudson Leaves Brexit Challenge To Successor

A new leader is needed for MHRA as UK agency CEO Ian Hudson announces he'll leave next September. Someone else will have to reshape and guide the agency after Brexit.
Europe Brexit

European CHMP Opinions And MAA Updates

This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Drug Review Europe
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Policy

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Latest From Policy

Acthar Proposed Giveaway Program Raises Kickback Concerns, OIG Says

High price of Mallinckrodt’s H.P. Acthar Gel is important factor in conclusion, HHS Office of Inspector General advisory opinion notes.

Pricing Debate Medicaid

Medicare's Part B Reform Proposal May Be Gaining Momentum; Congress Not Hearing Strong Protests

Muted stakeholder reactions may reflect Trump Administration efforts to address physician concerns in its Medicare Part B drug payment reform.

Pricing Debate Medicare

Outcomes-Based Funding Deals On The Up In EU But Are They The Right Tool?

Outcomes-based reimbursement agreement are becoming increasingly popular in Europe. They’re complicated, there’s no “one size fits all” and it’s important companies and payers alike know what’s involved, says a forthcoming report.

Europe Government Payers

Outcomes-Based Contracts May Be Negotiated By Michigan Medicaid

Michigan follows Oklahoma in gaining approval to negotiate supplemental rebates in the context of value-based contracts for drugs. Oklahoma now has four novel contracts in place.

Pricing Strategies Reimbursement

Express Scripts New Flex Formulary Will Prefer Lower-Priced Brand Alternatives

Gilead’s authorized generics for Epclusa and Harvoni will be first alternatives to benefit from preferred coverage on the pharmacy benefit manager's National Preferred Flex Formulary.

Pricing Strategies Market Access

Scottish HTA Okays Neuroblastoma Ultra Orphan Qarziba

The Scottish Medicines Consortium has recommended EUSA’s ultra-orphan neuroblastoma treatment Qarziba.

Health Technology Assessment Government Payers
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