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Featured Stories


FDA's Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments

Questions linger about the role the White House played in pushing the EUA, which comes with large product donations from Bayer and Sandoz that are expected to alleviate supply chain pressures for the drugs. 

Clinical Trials Coronavirus COVID-19 FDA

J&J Ramps Up Manufacturing Capacity To Produce 1 Billion Doses Of Candidate COVID-19 Vaccine

Company expects clinical trials to begin by September and says first batches could be available for emergency use authorization in early 2021; J&J pledges vaccine will be available to public on not-for-profit basis.

Coronavirus COVID-19 Vaccines Research & Development

US FDA Offers More Advice On Mid-Trial Changes For Pandemic-Impacted Studies

A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.

Regulation Coronavirus COVID-19 Clinical Trials

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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Latest News

Coronavirus 2019-nCov novel coronavirus concept resposible for asian flu outbreak and coronaviruses influenza as dangerous flu strain cases as a pandemic 3d rendering

COVID-19 Pipeline Tracker

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

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Performance Trackers

Keeping Track: US FDA Okays BMS’ Zeposia In MS, Nixes Lilly/BI’s Empagliflozin For Type 1 Diabetes

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.

US FDA Performance Tracker Approvals Drug Review

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

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Latest From Regulation

Russia May Cap Drug Prices In Fight Against COVID-19

As part of its efforts to preserve patient access to medicines amid the COVID-19 pandemic, Russia is planning to cap drug prices if increases of more than 30% are detected. It will also allow online sales of non-prescription drugs and may also tighten the rules on fake and substandard products. 

Russian Federation Pricing Debate

European CHMP Opinions and MAA Updates

This is an 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

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated to include two new products, including Alnylam Pharmaceuticals' Givlaari for treating acute hepatic porphyria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

Europe Approvals

French Clarify Use Of Plaquenil & Kaletra In COVID-19

France is exploring the use of hydroxychloroquine and lopinavir/ritonavir in COVID-19, but only in hospitalized patients and in clinical trials, and has banned all exports of the products to avoid possible shortages. 

France United Kingdom

COVID-19 May Delay WHO’s Prequalification Of Drugs, Devices, IVDs

Work and movement-related restrictions are affecting the ability of companies to provide a timely response to questions relating to their prequalification dossiers.

International Coronavirus COVID-19

Coronavirus Update: R&D Starts, Product Delays, Continuing Collaboration

In addition to our daily in-depth coverage of key events relating to the coronavirus pandemic, we’re bringing you a periodic round-up of other significant developments. 

Coronavirus COVID-19 Drug Review

Latest From Policy

Biopharma COVID-19 Collaborations May Avoid Antitrust Hurdles, FTC And DOJ Suggest

FTC and DoJ issue guidance for businesses working together to tackle coronavirus pandemic; BIO is 'pleased' they intend to help facilitate critical partnerships.

Coronavirus COVID-19 Enforcement

US FDA Commissioner Hahn’s Star Turn: Baptism By Fire Turns Perilous

Stephen Hahn’s low visibility period as the newly installed FDA commissioner comes to an abrupt end. Trump offers generous praise amid COVID-19 response – but how quickly might that change to blame?

Coronavirus COVID-19 Leadership

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

Clinical / R&D Explore this Topic

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Latest From Research & Development

Dosing Guidance Lacking For Leading COVID-19 Antiviral Therapies, ASHP Analysis Shows

Health-system pharmacist organization assesses the evidence behind off-label use of existing drugs for COVID-19, along with top investigational prospects like Gilead’s remdesivir. 

Coronavirus COVID-19 Clinical Trials

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

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

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

US FDA Allows Outsourcers To Compound Hydroxychloroquine As COVID-19 Drives Demand

The US FDA has added hydroxychloroquine sulfate to the list of drugs outsourcing facilities can compound as pharmacy group calls for more such approvals with COVID-19 driving demand for additional prescription and over-the-counter drugs.

BioPharmaceutical 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
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