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US FDA Performance Trackers

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EU Performance Trackers

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Global Guidance Tracker

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Pathways & Standards


Has Competition Reassurance Helped Counter Combination Woes In The UK?

Has Competition Reassurance Helped Counter Combination Woes In The UK?

 
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The rate of non-submissions for combination therapies in England has been on a downward trend in the last two years.

US FDA’s New Voucher Fee Reveals Standard, Priority Review Cost Spike

US FDA’s New Voucher Fee Reveals Standard, Priority Review Cost Spike

 

The number of standard and priority reviews also decreased significantly in FY 2023 compared to the previous year, which caused the fee for redeeming a voucher to rise.

US FDA Eager To INTERACT With Start-Ups, Not Check Boxes

US FDA Eager To INTERACT With Start-Ups, Not Check Boxes

 
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A US FDA webinar for start-up sponsors showcased staff who sound enthusiastic about helping drug developers advance their projects, while also emphasizing the importance of early and continual engagement with the agency.

Califf: Rare Disease Hub Will Develop Methods To Guide Approvability Determinations

Califf: Rare Disease Hub Will Develop Methods To Guide Approvability Determinations

 

The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads. 

Regional Comparisons


How The UK, EU, Canada, Australia And Japan Are Tackling Diversity In Clinical Trials

How The UK, EU, Canada, Australia And Japan Are Tackling Diversity In Clinical Trials

 
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As efforts to improve diversity in clinical trials gain momentum globally, the Pink Sheet asked regulators in the UK, the EU, Canada, Australia and Japan about their efforts to support representative enrolment. 

EU Revokes Intercept/Advanz’s Ocaliva Approval As Moment Of Reckoning Nears in US

EU Revokes Intercept/Advanz’s Ocaliva Approval As Moment Of Reckoning Nears in US

 
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The EU marketing authorization for the primary biliary cholangitis treatment has now been revoked. Meanwhile the drug's approval is in jeopardy in the US, where an advisory committee will opine on whether the accelerated approval drug has confirmed clinical benefit.

England Lags Behind Eight European Countries On Innovative Drug Availability

England Lags Behind Eight European Countries On Innovative Drug Availability

 

In this third article of a series on new drug reimbursement recommendations by the HTA body NICE, the Pink Sheet finds that fewer innovative medicines are reimbursed in England than in eight other European nations.

Decoding Regulatory Agency Decisions: The Case of Amylyx’s Relyvrio/Albrioza In The US And EU

Decoding Regulatory Agency Decisions: The Case of Amylyx’s Relyvrio/Albrioza In The US And EU

 

Relyvrio/Albrioza, Amylyx’s ill-fated treatment for amyotrophic lateral sclerosis, was approved for marketing by the US Food and Drug Administration but rejected by the European Medicines Agency. The Pink Sheet explores how the two agencies applied the available regulatory flexibilities and the impact of other factors, such as regulatory precedence and patient influence, on decision-making.

Drug Review Profiles


US FDA Review Of Akebia’s Vafseo Informed By Roxadustat, Daprodustat Safety Concerns

US FDA Review Of Akebia’s Vafseo Informed By Roxadustat, Daprodustat Safety Concerns

 
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Vadadustat's review overlapped with two other oral HIF-PH class drugs. Safety issues with FibroGen/AstraZeneca’s roxadustat drew attention during vadadustat's first-cycle review, while GSK’s Jesduvroq labeling and postmarketing requirements informed the second-cycle approval.

Akebia’s Vafseo: Japanese Postmarketing Data, Narrowed Indication Eased Liver Toxicity Worries

Akebia’s Vafseo: Japanese Postmarketing Data, Narrowed Indication Eased Liver Toxicity Worries

 
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The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.

Vafseo Chronology: Complete Response Letter, Dispute Resolution And A Second-Cycle Approval

Vafseo Chronology: Complete Response Letter, Dispute Resolution And A Second-Cycle Approval

 
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The Pink Sheet’s Drug Review Profile looks at the timeline behind the development and US FDA approval of Akebia’s Vafseo, a treatment for anemia in chronic kidney disease patients on dialysis.

Biosimilars: US FDA’s Updated Scientific Thinking Led To Interchangeability For Amgen's Wezlana

Biosimilars: US FDA’s Updated Scientific Thinking Led To Interchangeability For Amgen's Wezlana

 
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Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.

Interviews


Has Competition Reassurance Helped Counter Combination Woes In The UK?

Has Competition Reassurance Helped Counter Combination Woes In The UK?

 
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The rate of non-submissions for combination therapies in England has been on a downward trend in the last two years.

‘There Is No Silver Bullet’ – Sandoz’s Haruvi Talks US Shortages

‘There Is No Silver Bullet’ – Sandoz’s Haruvi Talks US Shortages

 
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As Sandoz publishes a report on US drug shortages, including a call for policy and other improvements, the firm’s North America head and AAM Chair Keren Haruvi discussed potential solutions to ongoing supply-chain failures.

UK’s ISRCTN Registry Makes It Easier To Track Clinical Trial Transparency

UK’s ISRCTN Registry Makes It Easier To Track Clinical Trial Transparency

 
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The ISRCTN clinical trials registry has launched an improved dashboard to provide metrics that reveal how many studies are complying with key transparency requirements. Badges are in place for individual studies meeting the transparency criteria.

EUCOPE: EU Pharma Reform Positive, But Industry Needs Clearer Definitions

EUCOPE: EU Pharma Reform Positive, But Industry Needs Clearer Definitions

 

High unmet needs is among the terms and definitions in the EU’s regulatory reform package that are “very subjective” and require more clarity to improve predictability for the pharmaceutical industry, EUCOPE’s secretary general, Alexander Natz, tells the Pink Sheet.