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One Down, Two To Go: Pfizer/BioNTech Booster Decision Creates Pressure For More Extra Shot Authorizations

Inequity created by limiting the mRNA vaccine’s third dose to only those individuals who received a primary series of the same vaccine, as well as resulting operational complexities, warrant consideration of a mix-and-match approach with Moderna and J&J products, CDC advisors say; however, FDA appears most focused on vetting manufacturer-specific data on homologous boosting.

Advisory Committees Coronavirus COVID-19 Vaccines

Walensky Defends Decision To Go Against Advisors On Pfizer COVID Booster Recommendation

‘If I had been in the room, I would have voted yes,’ CDC director says of ACIP. ‘This was a scientific close call. ... And that was how my recommendations came out after listening to all of their scientific deliberations.’

Coronavirus COVID-19 Vaccines Advisory Committees

EU Decision Imminent On Comirnaty Booster, Data Expected On Use In 5-11 Year Olds

The European Medicines Agency also expects to reach some conclusions on the use of MAb-based COVID-19 treatments by the end of October.

Europe Coronavirus COVID-19 Vaccines

Spotlight On Coronavirus

Real-World Evidence Will Take Center Stage At US FDA Advisory Committee On COVID Boosters

If regulators agree with Pfizers conclusions – and briefing documents suggest thats a big if – about real-world studies showing Comirnatys effectiveness waning over time, thereby justifying the need for a booster dose, it could be part of a historical moment for FDA’s use of RWE.


Advisory Committees Coronavirus COVID-19

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Pink Sheet Podcast

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

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Performance Trackers

Keeping Track: US FDA Is Approving JAK Inhibitors Again, Starting With Incyte’s Opzelura; Seagen’s Tivdak Cleared

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

US FDA Performance Tracker Approvals Complete Response Letters


Global Pharma Guidance Tracker – August 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

EU Joint Regulatory Assessment Project Bears Fruit In COVID-19

The European Medicines Agency has reported progress with a collaborative project that involves other regulators in its assessments of COVID-19 products, and with the EU Medicines for All initiative for evaluating products for non-EU markets.

Europe Regulation

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated two add two new products, including BioMarin’s Voxzogo (vosoritide) for treating achondroplasia in children.

Europe Approvals

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 To Coordinate GMP Inspections Via Online Portal

The EMA hopes that the use of a single portal by drug companies and EU/EEA inspectorates to coordinate on good manufacturing practice inspections will drive greater efficiency.

Europe Manufacturing

Regulatory Reliance Behind The Success Of African COVID-19 Vaccine Approvals

Regulatory reliance and work-sharing are becoming increasingly popular as a way of avoiding duplication and speeding up drug and vaccine assessments, but while there are many benefits, regulators should also be aware of some potential pitfalls, delegates at the TOPRA annual symposium heard this week.

International Regulation

EU CHMP Opinions and MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Europe Drug Review

Latest From Policy

Pfizer COVID Booster Recommendations From CDC Panel Narrower Than FDA's EUA

Advisory Committee on Immunization Practices fails to pass an interim recommendation endorsing third dose of vaccine in health care workers and others at risk of occupational or institutional exposure, with panelists raising concern that the target population was overly broad.

Coronavirus COVID-19 Vaccines

USPTO Faces Growing Pressure To Enter Battle Over Drug Pricing

Members of Congress, companies and government agencies want the Patent Office to change policies that they say impede generic drug competition. The latest effort is focused on PTO’s discretionary denial of inter partes review petitions, which is the subject of a bipartisan congressional letter and cert petition to the US Supreme Court.

Intellectual Property Legal Issues

The Fifth Element? A New Look At The CMS ‘Four-Part Test’

Given the US government’s continued interest in service fees paid to PBMs, sponsors would be wise to ensure that such fees are not contingent upon the volume or value of referrals or other business.

Government Payers Enforcement

Clinical / R&D Explore this Topic

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Latest From Research & Development

Drug Rejection Hearings Are Having A Moment At US FDA

With Intarcia's request, the rarely used mechanism could now produce two hearings this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.

Complete Response Letters Drug Review

Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors

Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’

Review Pathway Clinical Trials

Back to The Past: The Case for Improving Upon, Not Throwing Out Traditional Cancer Phase I Study Designs

US FDA has pushed sponsors away from the traditional dose-finding designs for cancer drugs in recent years. But academics continue to make a case for keeping the 3+3 design with some improvements.

Clinical Trials ImmunoOncology

Commercial Explore this Topic

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Latest From Commercial

COVID-19 Leads To Less Industry Spend On Docs, But Not Necessarily Less Influence

Drug and medical device company payments to doctors and hospitals for non-research related activities dropped for the first time in 2020 since CMS’s Open Payments database began collecting the information. 

Advertising, Marketing & Sales Coronavirus COVID-19

Pink Sheet Podcast: Gene Therapy In Europe, Lilly’s Olympic TV Ads, 'Most Favored Nation' Rule

Pink Sheet reporters and editors discuss Bluebird Bio’s decision to pull its gene therapy business from Europe, Eli Lilly potentially pushing regulatory boundaries with its Olympic TV spots, and the CMS decision to scrap the Trump aministration’s most favored nation reimbursement rule.

Commercial Strategies Gene Therapy

A Prior Auth Truce? Novartis Willing to Embrace ICER-Like Price Determinations For Increased Access

Novartis gets some praise for being willing to embrace cost-effective drug prices, but health policy analysts are skeptical the industry would truly adopt the idea for its best-selling drugs, particularly if the appropriate guardrails were put in place to ensure broader budget impact was controlled.  Holes were also poked in the way Novartis determined the total cost of drug utilization management on the US health system. 

Pricing Debate Cost Effectiveness

Manufacturing Explore this Topic

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Latest From Manufacturing

CDER Pilot Program Offers Potential New Pathway For Approval Of Novel Pharmaceutical Excipients

After decades without an approval pathway for excipients, FDA pilot program paves the way for innovation.

Manufacturing Quality

EMA To Coordinate GMP Inspections Via Online Portal

The EMA hopes that the use of a single portal by drug companies and EU/EEA inspectorates to coordinate on good manufacturing practice inspections will drive greater efficiency.

Europe Manufacturing

US FDA Must Assess Business Impact Of Final Interstate Compounding MOU, Court Rules

Summary judgment puts 20-year-old effort to define ‘inordinate’ out-of-state drug compounding back on slow track.

Distribution Compliance
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