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Successfully navigate the complex worlds of compliance, legislation, policy regulation, and industry developments with the expertise of our worldwide network of expert analysts and journalists.
Our team of global contributors helps you to anticipate challenges, minimize risks and maximize opportunities. Pink Sheet is the biopharma industry’s go-to source for business-critical insights and policy and regulatory intelligence.
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Pink Sheet gives you the power to go behind the regulatory and compliance headlines to understand the implications of worldwide industry developments on your business.
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With a network of journalists and analysts crisscrossing the globe, our industry experts and thought leaders track product progress from submission to approval. We also draw on the strength and expertise of the rest of the Pharma Intelligence family of analytical and market intelligence tools.
Analysis and opinion covers key topic areas such as:
Pink Sheet
Razor-thin majorities in both chambers of Congress mean Democrats can’t enact a bold agenda, and the pandemic and attendant recession mean that the initial legislative focus won’t be on Rx issues.
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The UK regulator, the MHRA, has published guidance on its new integrated pathway for innovative drug approvals, which it says is intended to bring together partners including health technology assessment agencies, health care bodies and patient organizations to offer “sustained collaboration” with drug developers.
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Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.
Topic Coronavirus FDA
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Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated
Topic Vaccines Coronavirus Distribution
Pink Sheet
Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.
Topic Pharma-Brexit Brexit Regulation
Pink Sheet
The Cancer Drugs Fund has improved access to oncology drugs, but if it is to remain fit for purpose it will need to evolve.
Topic Cancer
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Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.
Topic Infectious Diseases
Pink Sheet
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.
Pink Sheet
The US FDA has experienced an extended period with an acting commissioner. However, the agency continues to achieve its user fee dates, and hardly appears rudderless. Still, having a confirmed commissioner will give FDA more stability and power. But with application review looking to become more efficient and flexible, what could a new commissioner do to change the relationship between industry and FDA?
Topic FDA
Pink Sheet
An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.
Topic EU Innovation Regulation
Pink Sheet
Building more cold chain warehouses, finding alternative sources of medicine supplies, and halting parallel exports to mitigate product shortages. Just some of the ideas for tackling the consequences of a no-deal Brexit scenario put forward by industry representatives at a recent parliamentary committee hearing.
Topic Pharma-Brexit Brexit EU
Pink Sheet
The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.
Topic Coronavirus Vaccines
Biomedtracker, Trialtrove, Pharmaprojects, Scrip, Pink Sheet...
Access the infographic below which explores the number of treatment drugs for COVID-19 currently in clinical trials or in development, events including progress updates, partnerships, regulatory and trial announcements etc, and the number of articles published on COVID-19 as of March 3, 2020. This data has been tracked and reported via Informa Pharma Intelligence’s clinical, regulatory and commercial data and analytics, and news and insight tools including Biomedtracker, Trialtrove, Pharmaprojects, Scrip, Pink Sheet, Medtech Insight, and Generics Bulletin etc.
Topic Coronavirus
Pink Sheet
Just as they did during the heparin crisis a decade ago, pharmaceutical companies must coordinate on coronavirus, Rx-360 CEO says.
Topic Manufacturing Vaccines Coronavirus
Pink Sheet
US FDA’s Medical Countermeasures Initiative authorities like emergency use authorization have not yet had much of an impact on drugs and biologics, but agency is committed to supporting a swift response to the new strain of coronavirus.
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Biomedtracker provides real-time analysis of major market-moving events in the pharma and biotech industries. With catalyst tracking and expert insights, Biomedtracker helps you stay on top of breaking events, the drugs pipeline, upcoming milestones, companies, and deals – and their impact on the markets you care about.
A well-respected and trusted industry source for the last 15 years, Generics Bulletin from Informa Pharma Intelligence provides in-depth news and analysis on issues that matter most to businesses across the generics, biosimilars and value-added medicines industries.
HBW Insight is a single source of regulatory, legislative, legal and commercial news and insight connecting the dots across 3 sectors, including over the counter medicines, vitamins and dietary supplements, and cosmetics, which have increasing points of intersection, helping you to anticipate global challenges, risks, and opportunities.
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