New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests:
Jump To Section
Featured Stories

China Approves Record New Cancer, Orphan Drugs In 2020 But Access Challenges Remain
Throughout 2020, China’s drive to introduce more and newer drugs to the market did not slow but was rather accelerated by the COVID-19 pandemic. But can people afford them?

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.

Hungary Breaks Ranks With EU & Authorizes Use Of AstraZeneca Vaccine
Hungary is going its own way when it comes to coronavirus vaccines, but its decision to allow the emergency use of the Oxford University/AstraZeneca vaccine may be only a symbolic expression of the government’s growing impatience with the EU.
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
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Regulation
Pandemic Accelerates US FDA’s Use Of Real-World Data From Clinical Trial Design To Supply Chain
FDA’s Amy Abernethy describes how agency’s use of real-world data has evolved in response to COVID-19 and the ‘a-ha’ moment of leveraging different data sources to understand the coronavirus. Takeda R&D President Andrew Plump notes difficulties with platform trials and limitations on data sharing.
Global Regulators Issue Advice On Clinical Comparability Of Biosimilar MAbs
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.
Even As Acting US FDA Commissioner, Woodcock Still Holds Multiple Positions
To help with the transition to Biden’s COVID-19 response, Woodcock will retain some therapeutic development duties in the program the Trump administration had called Operation Warp Speed.
Rejection Rate Soars In Q4 For EU Fast-Track Requests
October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.
Stakeholders To Have Say On Future Medicines Verification System In UK
The UK government says it will begin a consultation on a future falsified medicines scheme for Great Britain within a year after the passage of new legislation on medicines and medical devices. Moves are also under way to ensure the smooth supply of medicines from GB to Cyprus, Ireland, Malta and Northern Ireland.
Japan Regulators Kept On Track Despite Pandemic
While it was not as affected as some other countries, Japan still had the pandemic to deal with and regulators responded while managing to keep up regular product review work, including several world-first approvals. Coronavirus vaccine roll-outs and the first general annual reimbursement price cut are on the cards for this year.
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?
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.
Medicare Part D Protected Classes Targeted in Last-Minute Payment Demo Update
If not reversed by the Biden Administration, demo program that puts plans at increased risk in catastrophic phase would also enhance negotiating leverage for drugs in the protected classes.
Clinical / R&D Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Manufacturing
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.
COVID-19: US Acted To Beat Other Countries To Next 1.25M Doses Of Regeneron Cocktail
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.
2020 In Review: Despite Pandemic, The US FDA Issued Just 20% Fewer Drug GMP Warning Letters
The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.