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Half Of US FDA’s Breakthrough Therapy Designations Have Resulted In Approval

Popular expedited review program results in a higher approval rate than the related fast track designation, but the COVID-19 era is seeing a drop in designations and a rise in complete response letters for BTD programs.

Review Pathway Drug Review Complete Response Letters

Is International Reference Pricing Still Relevant?

International reference pricing is becoming more irrelevant as increasing emphasis is placed on other cost-containment measures.

International Market Access Policy

Supply Concerns As India Fast Tracks COVID-19 Vaccines Approved By Certain Regulators

In an unusual move prompted by an enormous second wave of infections, India is accelerating approvals for COVID-19 vaccines granted emergency use authorizations by other selected regulators or on the WHO’s emergency use list without a local bridging study. While this seems a prelude to permitting private sales, where will the supplies come from?

India Coronavirus COVID-19 Vaccines

Spotlight On Coronavirus

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Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

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Click to read Six Themes That Will Shape Biopharma In Transformational 2021

Key Predictions From Industry Leaders

 

 

 

Performance Trackers

Keeping Track: US FDA Clears Another CAR-T And Another Novel ADHD Drug; Submissions Blossom

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

Approvals Drug Review ImmunoOncology

Global Pharma Guidance Tracker – March 2021

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.

Guidance Documents Regulation International

Policy & Regulation Explore this Topic

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Latest From Regulation

Breakthrough Therapy Designations At US FDA Stay Sluggish In 2021

With 12 new BTDs announced so far this year, 2021 is on pace to match the COVID-19-depressed total number of designations in 2020. Here’s a breakdown of the candidates that have received the designation.

Review Pathway Drug Review

Keeping Track: New Uses For Opdivo, Trodelvy; Nextstellis Introduces A Novel Estrogen

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

US FDA Performance Tracker Drug Review

Pink Sheet Podcast: COVID-19 Vaccine Blood Clots, Virtual Inspection Guidance, New CDER Director

Pink Sheet reporters and editors discuss the response to the rare blood clots seen with Janssen’s COVID-19 vaccine, the US FDA’s new virtual facility inspection guidance, and the new permanent director of the Center for Drug Evaluation and Research.

Coronavirus COVID-19 Vaccines

COVID-19 Therapeutic Trials: Investigators Should Join Forces Rather Than Conduct Single Site Studies

‘Treacherous combination’ of small clinical trials, lagging enrollment, unreported results and uncompleted trials is hindering COVID-19 research, former FDA Commissioner Califf says. Yale professor calls for a ‘Manhattan Project’ around knowledge and a change in the academic star system.

Coronavirus COVID-19 Clinical Trials

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

EMA Reviews GSK/Vir’s COVID-19 Antibody To Support Early Use By Member States

After preliminary discussions with its pandemic task force, the European Medicines Agency has begun reviewing GSK/Vir Biotechnology’s promising COVID-19 treatment to help EU national competent authorities make evidence-based decisions on its possible early use.

Coronavirus COVID-19 Review Pathway

Latest From Policy

Would Biden’s ‘Advanced Research’ Projects Mesh Well At NIH?

HHS Secretary Becerra answers questions about the scope of the proposed ARPA-H agency; more to come during NIH budget hearing.

Research & Development Politics

Revisiting Accelerated Approval: A Provocative Rebate Proposal

Formal MACPAC proposal to US Congress to consider enhanced rebates for drugs approved via the Accelerated Approval pathway could have a long shelf life in the context of debates over drug pricing – and over FDA regulatory reforms.

Reimbursement Review Pathway

PhRMA’s ‘Better Way:’ Remember COVID Success, Tweak Part B, And Bash HR 3

Trade group’s new agenda offers few original solutions to tackle US drug costs, relying on old standbys and reminders of what medical innovation might be lost if industry is financially targeted by policy makers with a strong nod to drug manufacturers role the current pandemic.

Pricing Debate Politics

Clinical / R&D Explore this Topic

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Latest From Research & Development

Would Biden’s ‘Advanced Research’ Projects Mesh Well At NIH?

HHS Secretary Becerra answers questions about the scope of the proposed ARPA-H agency; more to come during NIH budget hearing.

Research & Development Politics

COVID-19 Therapeutic Trials: Investigators Should Join Forces Rather Than Conduct Single Site Studies

‘Treacherous combination’ of small clinical trials, lagging enrollment, unreported results and uncompleted trials is hindering COVID-19 research, former FDA Commissioner Califf says. Yale professor calls for a ‘Manhattan Project’ around knowledge and a change in the academic star system.

Coronavirus COVID-19 Clinical Trials

Oncology Clinical Trial Eligibility Expansion A Focus For US FDA; Sponsors Overcoming Initial Hesitation

US FDA plans to release a second set of guidances to industry; sponsors caution that tradeoffs need to be clear from onset.

Clinical Trials Cancer

Commercial Explore this Topic

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Latest From Commercial

PhRMA’s ‘Better Way:’ Remember COVID Success, Tweak Part B, And Bash HR 3

Trade group’s new agenda offers few original solutions to tackle US drug costs, relying on old standbys and reminders of what medical innovation might be lost if industry is financially targeted by policy makers with a strong nod to drug manufacturers role the current pandemic.

Pricing Debate Politics

Pharma Not Immune From Coming Antitrust Wave In China

China's historic antitrust fine against Alibaba indicates regulatory attention to anticompetitive practices is mounting. While the pharma sector remains segmented, investigators appear to be taking a generally more sophisticated approach to transgressions.

China Legal Issues

Accelerated Approval, Real World Evidence Pilot From ICER, Aetion Picks HAE As First Therapeutic Area

ICER signals how it will pick other therapies for pilot in interview with Pink Sheet. Aetion believes project will help 'pressure test' the RWE field and show health plans and providers the value of using real world evidence to supplement clinical trial data.

Real-World Evidence Cost Effectiveness

Manufacturing Explore this Topic

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Latest From Manufacturing

Pink Sheet Podcast: COVID-19 Vaccine Blood Clots, Virtual Inspection Guidance, New CDER Director

Pink Sheet reporters and editors discuss the response to the rare blood clots seen with Janssen’s COVID-19 vaccine, the US FDA’s new virtual facility inspection guidance, and the new permanent director of the Center for Drug Evaluation and Research.

Coronavirus COVID-19 Vaccines

Industry ICH Proposal Would Limit International Regulatory Oversight Of Manufacturing Models

The focus would be on high-impact changes to high-impact models under approach advocated by BioPhorum, IQ Consortium and PPAR.

Manufacturing Quality

Woodcock: COVID Is Not The Time For Structural Changes At US FDA

Acting FDA Commissioner Janet Woodcock says FDA is interested in establishing new ‘Centers of Excellence’ but the current environment is not the right time to make changes at the agency. Woodcock also talked about where FDA will spend its new pandemic money and its reexamination of accelerated approval drugs in a wide-sweeping conversation with the Alliance for a Stronger FDA.

FDA Leadership
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