Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories



Biden Team To ‘Explore’ Dose-Sparing Strategies For COVID-19 Vaccines, But Details Sparse

New US leadership has a more comprehensive COVID-19 strategy, but that doesn’t mean all the plans are fully fleshed out yet. While Biden team declines to provide any details on what new vaccine dosing strategies they plan to examine, CDC quietly updates its recommendations to allow six weeks between shots.

Coronavirus COVID-19 Vaccines Distribution

COVID-19: EU Dexamethasone Taw Filing Pulled

The withdrawal of the marketing authorization application for Dexamethasone Taw as a treatment for COVID-19 patients was revealed today in the January meeting agenda of the European Medicines Agency’s human medicines committee, the CHMP.

Europe Approvals Coronavirus COVID-19

The Tortoise, The Hare, And COVID Vaccines: The Hare Wins

Merck wasn’t as quick to the COVID vaccine race as some others, but it believed that its use of ‘proven platforms’ would win out in the end. Not anymore.

Vaccines Research & Development Clinical Trials

Latest News

Performance Trackers

Keeping Track: 2021’s First Novel Approvals Go To HIV And Heart Failure Therapies Opdivo Starts Year With A Bang

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

Approvals Drug Review Drug Approval Standards

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

CDER Planning Guidances On Single-Trial Approvals, Real-World Evidence

US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.

Guidance Documents Drug Approval Standards

EU Crunch Time For Two Drugs That Lost Their Fast-Track Status

Karyopharm and GSK should soon learn whether the European Medicines Agency will recommend EU approval for their respective products, selinexor and dostarlimab.

Europe Review Pathway

French HTA Body Backs Routine Six-Week Interval In COVID-19 Vaccine Dosing

France's health technology assessment body says that delaying by six weeks the second dose of the two mRNA vaccines approved for use against COVID-19 would allow at least 700,000 more people to receive their jab in the first month.

Europe France

How To Choose A Proprietary Rx Drug Name

US FDA final guidance describes possible study design to test whether selected names may misbrand a drug. Agency also okays use of two-letter USAN stems in product names and clarifies use of modifiers.

Advertising, Marketing & Sales Guidance Documents

Coronavirus Notebook: EU Publishes CureVac Vaccine Contract, AZ and Pfizer Under Attack Over Supply Cuts

The European Ombudsman has opened an inquiry regarding the disclosure of vaccine contracts with other companies, and the European Commission is planning a “sharing mechanism” for vaccines bought by EU member states.

Europe Coronavirus COVID-19

Pfizer/BioNTech’s COVID-19 Vaccine First To Be Approved In Australia

Australia will begin its coronavirus vaccination program with Comirnaty. The Oxford University/AstraZeneca vaccine is expected to be the next to receive approval.

Australia Coronavirus COVID-19

Latest From Policy

340B Dispute Resolution Process On Ice As Feuds Between Pharma, Providers, HHS Heat Up

Biden Administration’s regulatory freeze suspends HHS action to appoint an administrative dispute resolution board for the 340B program. Good news for manufacturers?

Reimbursement Pricing Debate

Trump’s Legacy Versus ‘March In’ Rights

Biden’s incoming Secretary of Health is a fan of ‘march in’ rights as a cost-containment tool for medicines. Two hold-overs from Trump Presidency may slow him down.

Elections Intellectual Property

Woodcock Faces Maze Of Rules To Become Commissioner Nominee

If Biden administration wants to nominate the acting commissioner, Vacancies Reform Act would dictate the timing. Woodcock can still get the nod and remain head of the agency during the confirmation process, just as Andrew von Eschenbach retained his acting title following his nomination in 2006.

FDA Leadership

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

Set Alert for Commercial

Latest From Commercial

Medicare Payment Cuts For Vaccines: MedPac Suggests Moving To New WAC-Reimbursement Formula

Proposal, which could be formally endorsed by MedPac this spring, would lower the payment rates for vaccines while simultaneously moving all preventative vaccine coverage to Medicare Part B. Commission signals further cuts to payment rate, through an average sales priced-based methodology that might eventually be recommended.

Vaccines Medicare

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

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

US FDA And NIST Form Partnership To Boost Advanced Manufacturing Techniques

The US FDA and NIST have agreed to help industry modernize and update pharmaceutical manufacturing methods and to improve supply chain resilience.

Manufacturing Quality

EDQM Sets 2023 Target For Modernizing ‘Certificates Of Suitability’

The European Directorate for the Quality of Medicines & HealthCare is proceeding carefully to find the right balance between serving the diverse requirements of various stakeholders that make use of its ‘certificates of suitability.’

Manufacturing Quality

US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing

The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.

Regenerative Medicine Manufacturing
UsernamePublicRestriction

Register