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Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

Bayer Consumer Health Yet To Turn Corner Due To Supply, Innovation Detours

Company needs to get beyond a supply problem for products including iconic Bayer Aspirin brand and heat up Coppertone sun care and sunscreen product sales with line extensions to help drive the consumer health business to heights envisioned as part of an expansion a few years ago.

Consumer Commercial

Revised Korean Innovative Drug Pricing System Draws Strong Pharma Objections

Local and multinational pharma associations voice objections to proposed revisions to innovative drug pricing system in South Korea as part of a revised US trade deal, respectively demanding a complete change to the revised rules and dubbing it "unrealistic", with almost no new drugs expected to qualify for preferential pricing.

South Korea Pricing Debate

Good News For Australian Sponsors Sourcing APIs From Canada

Australian and Canadian drug regulators have extended their mutual recognition agreement on good manufacturing practice inspection and certification to include active pharmaceutical ingredients.

Australia Canada

Firms Face New Australian Rules On Autologous HCTs From Mid-2019

Companies in Australia are being urged to make sure their autologous human cell and tissue products will meet new regulatory requirements starting in July next year.
Australia Regulation

Bring Them On: 40 Orphan, Cancer Drugs Set For Priority Review In China

New treatments for spinal muscular atrophy, glioblastoma, Gaucher's disease and others could be soon be hitting the China market following the awarding of priority reviews to a large list of novel therapies.

China Rare Diseases

Overseas Regulator Helps Ipsen Score A First In Australia

Ipsen’s tyrosine kinase inhibitor, Cabometyx, is the first product to be registered under a new Australian procedure that aims to get prescription drugs to market faster by using medicine assessments already conducted by comparable overseas regulators.

Australia Approvals
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Europe

Set Alert for Europe

Latest From Europe

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

French Launch Fast-Track Clinical Trial Approval Scheme

Sponsors are being invited to trial a new fast-track system for authorizing clinical trials as part of French preparations for the new EU trial rules that are set to come into force in 2020.

Clinical Trials France

Health Must Be At Center Of Post-Brexit Relationship, Say Industry & NHS Bodies

UK industry and National Health Service bodies say that the “political declaration” on the future UK-EU relationship fails to address key public health issues such as regulatory cooperation, collaboration in science and innovation, and tackling counterfeit medicines.
Brexit Regulation

Four Drugs Set For EU Approval, EMA Holds Fire On Pacritinib

The European Medicines Agency this week recommended marketing approval for four medicines, including a drug for use in countries outside the EU.

Europe Approvals

Pharma Wants Clarity On Use of EMA’s New Myeloma Endpoint

Companies want to know whether the European Medicines Agency's draft guideline on a new endpoint for multiple myeloma studies can be applied across different regulatory procedures.
Europe Clinical Trials
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United States

Set Alert for United States

Latest From United States

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

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

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

Pain Therapeutics Appeals Remoxy CRL In Likely Last Ditch Effort To Save Abuse-Deterrent Opioid

Meeting with US FDA in January will aim to reverse fourth rejection in 10 years; firm still criticizing agency even as it works to reconcile their positions.
Complete Response Letters Neurology
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