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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.

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.

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.
Spotlight On Coronavirus
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.
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
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.
European Performance Tracker
Policy & Regulation Explore this Topic
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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.
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.
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.
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.
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.
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.
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?
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.
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.
Clinical / R&D Explore this Topic
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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.
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.
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.
Commercial Explore this Topic
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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.
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.
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.
Manufacturing Explore this Topic
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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.
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.’
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.
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