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Featured Stories



Biden Vaccination Plan Would Grow Domestic Manufacturing Base

Proposal, which would increase capacity for pandemic supplies, is similar to ideas President Trump embraced pre-pandemic.

Coronavirus COVID-19 Vaccines Manufacturing

Not So Fast: Trump Team Paints US FDA Review Times As Too Slow

New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.

Drug Review FDA Politics

Constitutional Complaints In Germany Cast Doubt Over Fate Of UPC

The UK’s withdrawal from the EU could upset the Unitary Patent Court project.

Latest News

Performance Trackers

Keeping Track: J&J Amivantamab, Infectious Disease Agents From Iterum, VBI And Atox Submitted; Another Furoscix CRL

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

Approvals Complete Response Letters US FDA Performance Tracker

Global Pharma Guidance Tracker – December 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.

International Australia Hong Kong

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Latest From Regulation

FDA’s COVID-19 Pandemic Plan Calls For Ongoing Clinical Trial Innovation

Broader use of adaptive trial designs and master protocols, checklist-based application review, and enhancement of real-world monitoring of products are among the recommendations of US FDA's COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) report, an effort months in making based on interviews with agency management, staff, and outside stakeholders.

Coronavirus COVID-19 Clinical Trials

Migraine & Hepatitis B Prevention Products Among New EU Filings

The latest list of marketing authorization applications under review by the European Medicines Agency includes filings for eight new products.

Europe Approvals

Coronavirus Notebook: EU To Buy 30 Million Doses Of Valneva Vaccine, Russia To Issue Compulsory License For Remdesivir

The European Medicines Agency says hacked COVID-19 vaccine data has been leaked online, and Australia’s chief medical officer defends the Oxford/AstraZeneca vaccine against scientists’ claim that it is not effective enough.

Europe Coronavirus COVID-19

Another EU Filing Targets Burgeoning NMOSD Market

Viela and Roche both now have marketing applications that are being reviewed by the European Medicines Agency. If approved in the EU, their products will compete with Alexion’s blockbuster Soliris.

Europe Drug Review

Chi-Med's Surufatinib, Generic Ibrance Among Latest China Approvals

China's innovative drug makers step into the spotlight by grabbing green lights for cancer drugs in the country's latest batch of product approvals.

China Approvals

Woodcock To Be Acting US FDA Commissioner, Leaving Agency in Stable, Capable Hands

Agency has been prepping Woodcock for the temporary task but what will happen to her role on Operation Warp Speed remains unclear. The move should give Biden team cushion to confirm a permanent leader of whom a top contender is former senior FDA staffer Joshua Sharfstein, a proponent of drug reforms that may irk manufacturers.

FDA Leadership

Latest From Policy

Catchup Capsule: Key APAC Insights You Need To Read

Given its ever-growing role as a critical component of the global biopharma industry, you can’t afford not to be up to speed on Asia. This selection of recent insights from our experienced on-the-ground team will help.

Asia Pacific Coronavirus COVID-19

Lagging COVID Antibody Uptake Continues To Worry US Government

US hopes more publicity will boost use of Lilly and Regeneron COVID-19 antibodies, once anticipated to be in short supply, but federal officials lack any other clear strategy to help overwhelmed health systems. Meanwhile Operation Warp Speed is testing the treatments against new virus variants and working on developing antibody cocktails that could avoid escape mutants as FDA issues guidance on potency assays for sponsors.

Coronavirus COVID-19 Biologics

Permanent Vaccine Facility Should Be On Standby For Future Pandemics, Moncef Slaoui Says

Operation Warp Speed confirmed the necessity of having a facility on hand to develop and manufacture a vaccine for the next crisis, the outgoing advisor says.

Coronavirus COVID-19 Vaccines

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

FDA’s COVID-19 Pandemic Plan Calls For Ongoing Clinical Trial Innovation

Broader use of adaptive trial designs and master protocols, checklist-based application review, and enhancement of real-world monitoring of products are among the recommendations of US FDA's COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) report, an effort months in making based on interviews with agency management, staff, and outside stakeholders.

Coronavirus COVID-19 Clinical Trials

J.P. Morgan Day 4: Setting Goals For The Year Ahead

Daily round-up from the virtual J.P. Morgan Healthcare Conference: Viatris debuts; Chi-Med charts its own path; Novo takes another go at obesity; Sangamo moves forward with CAR-Treg; Intercept readies for resubmission; and ImmunoGen is relying on a safety advantage for its ADC. 

Business Strategies Companies

J.P. Morgan Day 3: Preparing For The Future, Whatever That Holds

Daily round-up from the virtual J.P. Morgan Healthcare Conference: Teva promises growth is coming; Relay joins Roche in the KRAS race; UCB embraces the digital age; Agios and Ionis prepare for commercial battles. 

Business Strategies Companies

Commercial Explore this Topic

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Latest From Commercial

Lagging COVID Antibody Uptake Continues To Worry US Government

US hopes more publicity will boost use of Lilly and Regeneron COVID-19 antibodies, once anticipated to be in short supply, but federal officials lack any other clear strategy to help overwhelmed health systems. Meanwhile Operation Warp Speed is testing the treatments against new virus variants and working on developing antibody cocktails that could avoid escape mutants as FDA issues guidance on potency assays for sponsors.

Coronavirus COVID-19 Biologics

J.P. Morgan Day 4: Setting Goals For The Year Ahead

Daily round-up from the virtual J.P. Morgan Healthcare Conference: Viatris debuts; Chi-Med charts its own path; Novo takes another go at obesity; Sangamo moves forward with CAR-Treg; Intercept readies for resubmission; and ImmunoGen is relying on a safety advantage for its ADC. 

Business Strategies Companies

J.P. Morgan Day 3: Preparing For The Future, Whatever That Holds

Daily round-up from the virtual J.P. Morgan Healthcare Conference: Teva promises growth is coming; Relay joins Roche in the KRAS race; UCB embraces the digital age; Agios and Ionis prepare for commercial battles. 

Business Strategies Companies

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Permanent Vaccine Facility Should Be On Standby For Future Pandemics, Moncef Slaoui Says

Operation Warp Speed confirmed the necessity of having a facility on hand to develop and manufacture a vaccine for the next crisis, the outgoing advisor says.

Coronavirus COVID-19 Vaccines

A Pandemic Template For Swift Approval? Veklury Stability Questions Deferred For Later Study

The US FDA shaved months from review of Gilead’s Veklury (remdesivir) for COVID-19 with post-approval commitments for multiple stability studies. The Pink Sheet takes a deep dive look at discussions within the agency and with the sponsor.

Manufacturing Quality

Biden Wants To Release More COVID-19 Vaccine, But Also Maintain Strategic Reserve

Rather than holding half of all vaccines produced to ensure administration of the second dose, only a portion would be held to cover for manufacturing or other problems.

Coronavirus COVID-19 Vaccines
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