Featured Stories
How The UK, EU, Canada, Australia And Japan Are Tackling Diversity In Clinical Trials
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.
EMA Tackles Hurdles To Using Single-Arm Trial Data For Pivotal Evidence In Filings
The European Medicines Agency has highlighted issues for drug developers to consider when seeking to submit clinical data from SATs as the pivotal evidence in their marketing authorization applications instead of randomized controlled trial data.
Ipsen On Working With The UK’s Health Authorities To Make Industry’s Voice Heard
Improvements in the UK’s manufacturing and clinical trial ecosystems are on the “Christmas list” of Ioana Parsons, Ipsen’s general manager for the UK & Ireland.
Artificial Intelligence: How Regulators See It
Artificial Intelligence: CDER’s New Council Takes Charge Of Oversight, Coordination
The Artificial Intelligence Council takes over work that three different entities in the US FDA’s drugs center had been performing. The new, centralized entity will develop and promote consistency in AI-related activities and advance innovative uses.
Read all of the Pink Sheet's artificial intelligence coverage...
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Performance Trackers
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.
Global Pharma Guidance Tracker – August 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
US FDA Review Of Akebia’s Vafseo Informed By Roxadustat, Daprodustat Safety Concerns
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
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
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.
Clinical Trials In China: As US Lawmakers Consider Crackdown, Here Are The Implications
If the US Congress continues to target trials at Chinese military hospitals, the impact could be relatively small, while a broader focus could upend multinational development programs.
Regional Comparisons
EU Revokes Intercept/Advanz’s Ocaliva Approval As Moment Of Reckoning Nears in US
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
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
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.
Pink Sheet Podcast Special: Why The US Approves Most New Drugs Before The EU
Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments.
Recent Stories
Brazilian Regulator ‘Very Progressive’ On Decentralized ATMP Manufacturing
Regulators in Europe and Brazil have demonstrated a commitment to making decentralized manufacturing a reality, the CSO of GermFree, a company that provides mobile and modular cleanrooms for manufacturing advanced therapies, tells the Pink Sheet.
Evergreen With Envy: Halozyme’s Subcutaneous Conversions Grow As Rivals Hope To Break In
Halozyme’s Enhanze technology has now brought seven monoclonal antibodies, including Ocrevus and Tecentriq, from IV to subcutaneous delivery, but Alteogen and other high-concentration formulation players hope to join the party as Medicare pricing issues help drive interest.
US FDA’s CBER Seeks Associate Director Overseeing Rare Disease Work
Rare disease activities within the biologics center will gain more prominence with a senior official overseeing them.
Shot Across The Bow? Express Scripts Lawsuit Aims To Prevent Fall-Out From FTC PBM Report
Pharmacy benefit manager sues Federal Trade Commission, claiming chair Khan has orchestrated a campaign against PBMs that is not based in fact.
How To Decarbonize Pharmaceutical R&D
As the planet heats up and sea levels rise, the need to reduce carbon emissions is becoming ever more urgent. The life sciences industry is just one of many that are looking to cut the carbon it reduces.
EU Pharma Calls For Better Metrics On True Impact Of Clinical Trial Disclosure
European pharmaceutical industry group, EFPIA, says it is committed to supporting clinical trial transparency, but wants greater clarity on how disclosed data are effectively contributing to public health improvements so that investments can be prioritized in areas providing the greatest benefit.
Drug Pricing And The US Presidential Campaign: A Non-Issue?
The new US Medicare drug price negotiation authority got a brief mention during the 10 September presidential debate, not that anyone is likely to be talking about it afterwards.
Geopolitics, US BIOSECURE: Pharma Looks To Redistribute CDMO Footprint
A senior McKinsey executive discusses trends in the CDMO sector amid geopolitical tensions, the spurt in customer queries at Indian firms and also facets of the deals scenario.
The Anti-Sintilimab Guidance? US FDA Gives Advice On Oncology Multiregional Trials
Studies should enroll a representative subgroup of US patients based on the incidence or prevalence of cancer in the US, and the comparator arm should use the US standard of care when possible, the FDA says in draft guidance.
Final Chance To Have Your Say: Take Our Reader Survey This Week
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
EU Decision Time For Orphan Drugs Marstacimab, Serplulimab And Mirvetuximab Soravtansine
The European Medicines Agency is this week expected to decide whether to recommend for pan-EU marketing approval for Pfizer’s marstacimab, Henlius Biotech’s serplulimab and ImmunoGen’s mirvetuximab soravtansine.
French Plan To Require Pregnancy Risk Pictogram On All Medicines
New requirements proposed by the French regulator are intended to increase the impact and effectiveness of the pictogram showing the risks of taking medicines in pregnancy.
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