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EMA Tightens Clock-Stop Rules To Address Impact On Drug Approval Timelines
The European Medicines Agency says that in 2022, the average time taken up by clock-stops exceeded the average time of drug assessment.
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Uptake Of Innovation Is UK’s ‘Biggest Hurdle’ In Life Sciences Competitiveness
The latest report on the competitiveness of the UK’s life sciences sector shows that the nation “continues to underperform” on its potential in terms of the adoption of new treatments and innovation, according to industry body the ABPI.
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In Vitro Triumph: European Pharmacopoeia Abolishes Rabbit Pyrogen Test
The use of the RPT is to no longer be required in any text of the European Pharmacopoeia and medicine developers will have to select a suitable in vitro test to control the pyrogenicity of their product.
Diversity Action Plans
Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups
Clinical Trial Diversity Action Plan Waivers Will Be ‘Very Rare,’ US FDA Official Says
Clinical Trial Diversity: US FDA’s Califf Calls For Global Focus
Pink Sheet Podcast: What’s In And Out Of US FDA’s Diversity Action Plan Guidance, AI Guidance Also Coming
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Pink Sheet Podcast
Performance Trackers
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US FDA’s June Approvals Forecast: Nearly 30 Goal Dates Suggest Hot Start To Summer
June goal dates include RSV and pneumococcal vaccines, two COPD therapies, Rocket and Sarepta gene therapies, and lots of oncology.
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Global Pharma Guidance Tracker – June 2024
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.
US FDA Performance Tracker
European Performance Tracker
Multimedia
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Approval Geography: Novel Agent Landscape Across US And EU
Pink Sheet infographic shows how a large majority of novel drugs make it past the US FDA before receiving approval in the European Union. Lag times ranged from almost five years to less than two weeks.
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US FDA’s Dry July? Few Goal Dates Portend Quiet Month For Approvals
Sun’s deuruxolitinib and Novo Nordisk’s insulin icodec stand out as new molecular entities among the small cluster of US FDA user fee goal dates in July.
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China Sets Clinical Trial Record But Starting Studies Can Be Challenging
Antibody-drug conjugates, GLP-1 receptor agonists and cell/gene therapies propelled a big increase in clinical trial registrations in China last year, but why do sponsors sometimes remain reluctant to actually start studies?
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US FDA User Fee Conundrum: Collections Increase After 25% PDUFA Rate Hike
With likely more fee-paying applications arriving at the agency, sponsors may be wondering whether user fees should have been increased as much as they were at the start of FY 2024.
Regional Comparisons
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US FDA Offers Faster Route To Market Than EMA: Details On All 108 Approvals
Comprehensive table comparing all the novel agents approved by either the US FDA or the European Commission over 2023 through April 2024.
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Approval Geography: Novel Agent Landscape Across US And EU
Pink Sheet infographic shows how a large majority of novel drugs make it past the US FDA before receiving approval in the European Union. Lag times ranged from almost five years to less than two weeks.
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New Oncologics Overwhelmingly Approved In US Before EU
Ninety-five percent of novel cancer treatments approved in both the US and Europe received the FDA’s OK first, but Europe usually followed within a year, a Pink Sheet analysis shows.
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Getting To Global Is A Hurdle For Cell And Gene Therapies
Only three of the 10 new therapies approved by the US FDA also have been approved in the European Union, while both of the EU gene therapy approvals followed FDA clearance, a Pink Sheet analysis shows.
Recent Stories
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Ixchiq, Valneva's chikungunya virus vaccine
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
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Life After Chevron: User Fee Cycle May Help US FDA In Era Of Uncertainty
US federal agencies are entering a new era of uncertainty and increased litigation over their regulatory interpretations, but the FDA may benefit from the unique circumstances that have evolved through user fee legislation.
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Accelerated Approval: ALS Drug Could Test New Congressional Directive On Survival
Clene leadership spoke with the Pink Sheet about its push for accelerated approval for its ALS nanoparticle treatment. A new nudge from Congress asking the US FDA to consider survival data in accelerated approval could help.
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How The IRA Factored Into Akebia’s Price For Vafseo
Akebia says its price for Vafseo at about $15,500 per year, meant to reflect its potential value in dialysis as well as eventually in non-dialysis patients.
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Rise In Threats Prompts Call To Shield Expert Identities Under EU Access To Document Policy
The European pharmaceutical industry federation wants regulators who handle requests for access to documents to safeguard the identities of all experts and designated personnel, not just those engaged in animal studies.
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Medicines Patent Pool Calls For Equitable Access To Infectious Disease mAbs
In a joint proposal with its partners, the Medicines Patent Pool explores challenges in monoclonal antibody equity in low- and middle-income countries and provides actionable solutions to increase development and manufacturing.
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US FDA Offers Faster Route To Market Than EMA: Details On All 108 Approvals
Comprehensive table comparing all the novel agents approved by either the US FDA or the European Commission over 2023 through April 2024.
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Will US Clinical Study Diversity Guidance Cloud Chinese Firms’ Prospects For Going Global?
The latest FDA guidance will have profound impact to Chinese biotech sector at a time when going global and a US approval is vital to its very survival.
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Medicare Rx Negotiation More Insulated From SCOTUS Fallout, But Some Key CMS Decisions Could Be Vulnerable
Experts expect litigation challenging Medicare’s definitions of single-source drug and bona fide marketing to get a boost from recent Supreme Court rulings, but overall, the IRA is likely better positioned in a post-Chevron world than older Medicare statutes.
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Caveated Confidential Pricing Arrives In Germany But May Not Prove Attractive To Companies
A new act in Germany does not go far enough to address the deeply unpopular “guardrail” link between Amnog benefit assessment ratings and price negotiations, which can deter companies from launching.
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New UK Government ‘Championing’ Life Sciences, But No ‘Big Changes’ Expected For Pharma
While the new Labour government includes several “life sciences champions” and has pledged to turn the UK into a life sciences powerhouse, the UK BioIndustry Association head says major changes are unlikely for the pharma and biotech industry.
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