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Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

India Regulatory Diary: Marketers Co-Accountable For Lapses In Manufacturing Quality

New rules in India specify that a marketer of a drug will share the onus for quality and compliance along with the manufacturer. Enhanced punishment for misleading advertisements for a range of illnesses is also proposed, while calls for a statute to regulate pharma's marketing practices grow louder.

India Regulation

US Researchers Working Toward Universal Coronavirus Vaccine

The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.

Vaccines Manufacturing

Stress Test: Coronavirus Challenges China Emergency Approval Mechanism

A regulatory pathway set up in China post-SARS is under stress test in the latest coronavirus outbreak, while emergency measures adopted by the country's regulator mean it’s much less burdensome to obtain approvals than before.

Review Pathway Regulation

UK Firms Asked To Check Coronavirus Supply Chain Impact

Amid concerns that the coronavirus outbreak could have an impact on the supply of APIs and other materials sourced from Chinese manufacturers, pharmaceutical companies are to assess their supply chain situation to help ensure patients do not experience medicine shortages.

United Kingdom Manufacturing

China Unlikely To Be Included In US FDA's Project Orbis In The Near Term

Oncology Center of Excellence Director Pazdur says there must be confidence that confidentiality agreements are universally accepted in response to request that China be included in the multi-regulator application assessment program.

Drug Review Cancer

Japan 2010s In Review: Specialize, Focus, Innovate

Reimbursement issues continued to dominate the policy sphere in Japan during the last decade, while new forms of therapy benefited from positive regulatory reforms. Meanwhile, consolidation and specialization were major threads running through the corporate sector.

Japan Reimbursement
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Europe

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Latest From Europe

UK Reveals Plans For ‘Dynamic’ Post-Brexit Regulatory System

At the end of the Brexit transition period, the UK will be charting its own course through the often choppy seas of medicines regulation. While it plans to retain the existing EU rules that have been transposed into domestic legislation, it also wants the freedom to tailor its regulations in areas like clinical trials, advanced therapies and product labeling.

United Kingdom Regulation

Europe Restricts Cyproterone Use Due To Meningioma Risk; Companies To Conduct Studies

The risk of developing meningioma with cyproterone-containing medicines is rare, but it is serious enough to merit restrictions on how such products are used, according to the European Medicines Agency.

Europe Drug Safety

Scotland Recommends Interim Funding For Regeneron/Sanofi’s Libtayo

Patient access schemes have helped the Scottish Medicines Consortium recommend rare disease products, including Regeneron/Sanofi’s Libtayo for skin cancer.

Europe United Kingdom

EU And US Orphan Drug Regimes: Benefits And Limitations Of International Cooperation

Daniel Kracov and Jackie Mulryne analyze the differences in data requirements for the authorization of orphan medicines in the EU and the US and the challenges they pose for global drug development.

Rare Diseases Europe

Potential Cardiovascular Blockbuster Inclisiran Among New Filings At EMA

The European Medicines Agency has agreed to review pan-EU marketing applications for a number of new medicines.

Europe Approvals

UK MHRA Looks Beyond Brexit Transition

Now that the UK has left the EU, the UK’s medicines regulator says it will use the rest of this year to work out how best to ensure continuity of drug regulation after the Brexit transition period ends on 31 December.

Brexit Regulation
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United States

Set Alert for United States

Latest From United States

Keeping Track: Quick Trips From Breakthrough Designation To Market

Phase III data earns a breakthrough therapy designation for Resverlogix’ apabetalone; previous companies to follow that strategy swiftly advance to NDA submission, as seen with Novartis’ capmatinib and Seattle Genetics’ tucatinib.

US FDA Performance Tracker Drug Delivery

Breakthrough Therapy Designations: Phase II Data Is Sweet Spot For US FDA Award

Pink Sheet analysis finds that evidence from early-stage trials supports most BTD requests, but about three in 10 designations are granted on the basis of pivotal-stage data.

Review Pathway Clinical Trials

Medicare-For-Hmmm: A Year Of House Hearings Show Democratic Disunity

Four House hearings show how far away even many Democrats are from supporting a single payer system in the US.

Medicare Pricing Debate

EU And US Orphan Drug Regimes: Benefits And Limitations Of International Cooperation

Daniel Kracov and Jackie Mulryne analyze the differences in data requirements for the authorization of orphan medicines in the EU and the US and the challenges they pose for global drug development.

Rare Diseases Europe

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

FDA Broke Catalyst's Orphan Exclusivity Due To Pricing, Not Clinical, Concerns, Firm Claims

Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).

FDA Legal Issues
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