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Featured Stories


COVID-19: EMA Tackles Trial Data Interpretability

A draft EU guideline explains how companies can ensure that data from ongoing clinical trials remains relevant for regulatory decision-making despite problems posed by the COVID-19 pandemic.

Coronavirus COVID-19 Clinical Trials Regulation

Drug Industry Perks Mostly Dropped From COVID-19 Bill, But A Big One Remains

Early versions of US Congress's coronavirus relief bill contained a number of policies that would have benefited drug firms, but they didn't make it into the final bill. However, the $2 trillion package does provide pharmaceutical companies with relief from the threat of drug pricing reform until after the 2020 elections.

Coronavirus COVID-19 Pricing Debate Legislation

New Faces In US FDA Review Division Leadership

Final phase overhaul of FDA's new drug review groups includes half-a-dozen first-time division directors. Most have long experience at the agency – but not all with the drugs they will now oversee.

Drug Review FDA Leadership

Spotlight On Coronavirus

US FDA Eases Up On Adverse Event Reporting During COVID-19

Issued as part of the new approach to releasing guidances during the pandemic, FDA said flexibility was needed for two reasons: anticipated higher levels of absenteeism among staff for both sponsors and the agency, and the necessity of prioritizing a focus on adverse events for products used to treat coronavirus.

Safety Coronavirus COVID-19

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COVID-19 Pipeline Tracker

Product candidates in development worldwide to address the 2019-nCoV pandemic, categorized by treatment and prevention. Subscription required.

View Tracker

Performance Trackers

Inside The COVID-19 Pipeline

Around the world, government agencies, academic and other researchers and the biopharmaceutical industry have rushed to see what drugs could help treat COVID-19 and the symptoms it causes, and accelerate a vaccine that could help limit the spread of the pandemic. This chart will be updated daily as additional research gets underway. 

Coronavirus COVID-19 Vaccines Clinical Trials

Global Pharma Guidance Tracker – February 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 International

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Latest From Regulation

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

Pink Sheet Podcast: Another Coronavirus Stimulus Bill, Remdesivir’s Brief Orphan Status, Teva Sues Over Copaxone Regulation

Pink Sheet editor and reporters discuss the effects of the latest coronavirus stimulus package on pharma, Gilead’s request for rescission of an orphan designation, and Teva’s suit over Copaxone regulation. 

Coronavirus COVID-19 Legislation

Zolgensma and Seven Other Products Get CHMP Thumbs Up

Zolgensma should receive a conditional approval, says the European Medicines Agency’s drug evaluation committee, the CHMP.

Europe Approvals

More Time For EU Nitrosamine Evaluations Due To COVID-19

Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.

Coronavirus COVID-19 Manufacturing

A Look At The New Leadership Team At NICE

The new appointments to the top jobs at NICE may bring continuity at a challenging time for the institute, but perhaps not the real change that some in the industry say is needed. 

Health Technology Assessment Regulation

UK Attacks Pandemic With Funding For Drug And Vaccine Trials

Efforts are under way in the UK on many fronts to develop new treatments and vaccines for coronavirus infection, including researching new uses of existing products and clinical trials of new vaccines.

United Kingdom Coronavirus COVID-19

Latest From Policy

England's NICE To Focus On COVID-19 And Other Critical Therapies

The health technology assessment institute is taking a virtual approach to meetings and has said that it can provide free fast-track advice for companies developing novel diagnostics or therapeutics for the coronavirus.

Coronavirus COVID-19 Health Technology Assessment

COVID-19 Lesson: India Earmarks $1.3bn To Reduce Dependence On China

In a bid to ensure long-term medicines security, the Indian government has earmarked $1.32bn to promote domestic production of 53 APIs, including lopinavir and ritonavir currently being evaluated to treat COVID-19 cases, as well as antibiotics, for which India is highly dependent on China.

Coronavirus COVID-19 Risk Management

Inside The COVID-19 Bill: Breaking Down The Pharma Policy Provisions

What's in – and what fell out of – the massive US stimulus package.

Coronavirus COVID-19 Legislation

Clinical / R&D Explore this Topic

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Latest From Research & Development

UK Attacks Pandemic With Funding For Drug And Vaccine Trials

Efforts are under way in the UK on many fronts to develop new treatments and vaccines for coronavirus infection, including researching new uses of existing products and clinical trials of new vaccines.

United Kingdom Coronavirus COVID-19

EMA Updates Board On Business Continuity And Coronavirus

The European Medicines Agency’s first management board meeting of 2020 was held virtually and was shortened but covered a number of topics including COVID-19.

Europe Regulation

Gilead’s Robust Expanded Access For Remdesivir Signals Confidence In Study Enrollment

US FDA has granted about 250 COVID-19 patients expanded access to Gilead’s investigational antiviral; the adaptive trial now underway in US aims for 400 patients.

Coronavirus COVID-19 Review Pathway

Commercial Explore this Topic

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Latest From Commercial

TV Drug Advertising Spend Rising, But Few Brands Provide Pricing Info

DTC spending had shown an uptick in 2020 compared with 2019. Many advertisers are not, however, providing clear drug pricing information in their TV spots, despite some voluntary commitments to do so.

Advertising, Marketing & Sales Ad Campaigns

Biosimilar Competition: Still More Focus On FDA Than FTC

A joint meeting of the US FDA and the FTC on biosimilar competition may have delivered a symbolic message about the need for a ‘level playing field’ in the biologics market – but it did not deliver much in the way of an actionable agenda for antitrust regulators.

Biosimilars Enforcement

Palforzia Peanut Allergy Immunotherapy: Aimmune CEO On REMS Restrictions, Manufacturing

Aimmune CEO Jayson Dallas tells the Pink Sheet how physicians and patients are being certified to use Palforzia and how the product's food-based manufacturing process is actually an advantage. 

Safety Manufacturing

Manufacturing Explore this Topic

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Latest From Manufacturing

Quality Experts Advise Industry To Move Products To Local Sites In Responding To COVID-19

Quality experts with AstraZeneca and Thermo Fisher describe how their companies are responding to the COVID-19 pandemic – but urge industry not to lose focus on monitoring unrelated drug products.

Manufacturing Quality

More Time For EU Nitrosamine Evaluations Due To COVID-19

Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.

Coronavirus COVID-19 Manufacturing

UK Attacks Pandemic With Funding For Drug And Vaccine Trials

Efforts are under way in the UK on many fronts to develop new treatments and vaccines for coronavirus infection, including researching new uses of existing products and clinical trials of new vaccines.

United Kingdom Coronavirus COVID-19
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