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Featured Stories


Sanofi Tries To Stop Lantus Biosimilar By Getting Supreme Court To Review PTAB, Again

Sanofi seeks to delay decision clearing path for Mylan's Lantus biosimilar; says it should be able to get rehearing based on Federal Circuit's ruling that PTAB judges were not constitutionally appointed.

Legal Issues Intellectual Property Policy

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 Clinical Trials

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 Drug Approval Standards

Spotlight On Drug Pricing

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Performance Trackers

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 Review Pathway

Global Pharma Guidance Tracker – January 2020

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.

Guidance Documents Regulation Europe

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Latest From Regulation

India Proposes Tiered Approach To Oversee Genome Editing

India has proposed three categories for grouping genetically edited organisms based on the complexity of modifications.

India Gene Therapy

First African Approvals For Merck’s Ebola Vaccine

Regulators have pulled out all the stops in their efforts to get the Ebola vaccine to the marketing authorization stage in Africa. 

Congo (Democratic Republic) Burundi

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.
Drug Review Europe

Pfizer Warns Doctors About Blood Clot Risk With Xeljanz

Now that the European Medicines Agency has finalized its formal safety review procedure into Xeljanz, Pfizer is telling health care professionals what precautions they must take when prescribing the drug.

Europe Drug Safety

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

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

Latest From Policy

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

Sanofi Improperly Listed Lantus Patent In FDA's Orange Book, Appeals Court Finds

First Circuit reverses dismissal of direct purchasers' suit alleging improper listing of patent on device drive mechanism delayed competition; district court to decide if this constitutes antitrust violation.

Legal Issues Intellectual Property

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

Clinical / R&D Explore this Topic

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Latest From Research & Development

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

Novel Ticagrelor Reversal Agent Wins Place On EMA’s PRIME

Only two of seven recent applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical needs to patients faster made the grade.

Europe Regulation

For Coronavirus, US FDA Is At The Podium But Not On The Task Force

The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.

FDA Infectious Diseases

Commercial Explore this Topic

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Latest From Commercial

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

At Muted J.P. Morgan, Focus Is Execution, But US Pricing Is Persistent Overhang

Political worries aside, industry is confidently executing on focused strategies as it welcomes a new decade, even if a lack of deal news at the J.P. Morgan Healthcare Conference didn't excite investors.

Pricing Debate Business Strategies

J.P. Morgan Notebook Day 4: Novartis CEO Weighs In On AI, Sangamo’s Next Steps And More

Additional highlights from the J.P. Morgan Healthcare Conference, including Takeda’s partnering outlook, Sage’s guidance on Zulresso sales, Frequency’s next steps for its hearing loss drug and Revance’s preparations to take on the aesthetics market. 

Business Strategies Artificial Intelligence

Manufacturing Explore this Topic

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Latest From Manufacturing

Biogen’s Recipe For Success In Knowledge Management

Biogen’s “recipe-driven qualification” knowledge management program standardizes data collection and reporting in the laboratory, with efficiency gains of 66%.

Manufacturing Quality

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

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
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