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FTC Commissioner Changes Could Impact Pharma Mergers, Scrutiny Of Biosimilars Uptake

President Biden’s picks to fill two commissioner posts may shift dynamics on pharmaceutical industry enforcement. Rohit Chopra’s nomination to Consumer Financial Protection Bureau removes strong critic of pharma mergers.

Enforcement Politics Generic Drugs

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. 

Japan Regulation Vaccines

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.

Europe Review Pathway BioPharmaceutical

Latest News

Performance Trackers

Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori

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

US FDA Performance Tracker Drug Review Approvals

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

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Latest From Regulation

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.

International Biosimilars

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.

Europe Russian Federation

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.

FDA Leadership

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.

Safety Europe

US FDA’s Median Review Time For Novel Drugs Held Steady In 2020

Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.

Approvals Drug Review

Sentinel Could Be Used For Pregnancy Safety Studies Under PDUFA VII

User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.

User Fees Drug Safety

Latest From Policy

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

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.

Medicare Pharmacy Benefit Management

Two-Tier Specialty Drug Policy: Part D Plans Gain Formulary Flexibility But Impact May Be Limited

Use of preferred and non-preferred specialty formulary tiers will be allowed but preferred tiers are not necessarily limited to generics and biosimilars and coinsurance for non-preferred specialty drugs cannot exceed 33%.

Pricing Strategies Medicare

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.

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

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

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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.

Regenerative Medicine Manufacturing

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.

Manufacturing Coronavirus COVID-19

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.

Manufacturing Quality
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