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Pfizer COVID Shot: Unanimous Vote Obscures Reservations About Vaccinating All Children 5-11

Many of US FDA's outside vaccine advisors wanted to wait for more data before widespread inoculations of kids 5-11, but felt some high-risk populations should get access to vaccine right away. They urged CDC to provide additional guidance on which children should be targeted.

Advisory Committees Vaccines Coronavirus COVID-19

Blow For Seagen As England Rejects Funding For Advanced Breast Cancer Drug Tukysa

England’s health technology assessment body said it would continue to work with Seagen to address the reasons why its newly published draft guidance has recommended against using Tukysa on the National Health Service.

Cost Effectiveness United Kingdom Health Technology Assessment

Fewer Observations, Shift In Emphasis Seen In FDA's Pandemic-Reduced Inspections

US agency mostly saw less of the same when it scaled back inspectional activity during COVID-19, but observed more training and equipment issues.

Manufacturing Quality Compliance

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 Clears Opioid Seglentis And Anti-Opioid Zimhi; CRLs For Revance, United; Delay For UCB

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

US FDA Performance Tracker Drug Review Approvals


Global Pharma Guidance Tracker – September 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

Accelerated Approval Roadblock: Agenus’ PD-1 Stumble Reflects Pathway’s Regulatory Risk

Agenus was banking on US FDA taking the full six months to act on Keytruda application in same cervical cancer indication where it was seeking accelerated approval; agency took less than two months, making it among the fastest oncology supplemental approvals in the last two years.

Review Pathway Post Market Regulation & Studies

Novavax Files COVID-19 Vaccine Candidate With UK Regulator

The company says it expects a “positive decision” on the first approval application for a protein-based coronavirus vaccine in the UK. If approved, NVX-CoV2373 would become the fifth COVID-19 jab to reach the market there.

Europe United Kingdom

EMA Tells Marketing Authorization Applicants How To Run Registry-Based Studies

Advice on the acceptability of registry-based studies as a source of evidence for regulatory purposes is included in new guidance from the European Medicines Agency.

Regulation Europe

US FDA Should Explain How It Uses Patient Experience Data In Drug Approvals – Report

Review documents do not always reflect whether PED was considered as part of an application, and stakeholders cannot easily determine how such data are used in the agency’s regulatory decision-making, an independent consultant review found.

Drug Review Clinical Trials

EMA Moves Ahead With Tailored Scientific Advice For Biosimilars

A European Medicines Agency pilot scheme offering tailored scientific advice on biosimilar development has been viewed by applicants as a “valuable opportunity” and the process will continue as part of regular operations, according to an agency report.

Biosimilars Europe

Battle Over US FDA’s ‘Intended Use’ Rule Continues

PhRMA and Pfizer attorneys criticize the rule’s broad evidence standard, lack of safe harbors, and disregard of the First Amendment. Opposition to the rule is expected to continue to play out in lawsuits.

Advertising, Marketing & Sales Legal Issues

Latest From Policy

‘Skinny Label’ Case Gives Brands A ‘Blueprint’ To Alter Use Codes In Patent Litigation

Federal Circuit ruling in GSK v. Teva shows brands can broaden a use code to include other patented indications years into litigation, AAM attorney says. The case is ‘scarier’ for biosimilar makers since they must market their products, Teva lawyer notes.

Advertising, Marketing & Sales Biosimilars

Alcohol, Repeat Attendees Could Raise Red Flags On Speaker Programs, OIG Attorney Says

Benjamin Wallfisch, a senior attorney at the Office of the Inspector General in the US Department of Health and Human Services, recently discussed how companies can avoid apparent violations of anti-kickback law while hosting educational programs.

Compliance Legal Issues

Medicare And Alzheimer’s Drugs: Recent NCDs Mainly Omit Research Requirement, Biogen Notes

Biogen suggests potential precedents in past coverage decisions for upcoming Medicare determination on Aduhelm and other amyloid-directed monoclonal antibodies during earnings call.

Reimbursement Medicare

Clinical / R&D Explore this Topic

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Latest From Research & Development

Database In Works To Help Drugmakers Avoid Molecules That Trigger Immune Reactions

Individuals from pharma, biotech, technology and academia create shared database to facilitate development of therapeutic proteins that are unlikely to provoke immune reactions.

Biologics Research & Development

EMA Tells Marketing Authorization Applicants How To Run Registry-Based Studies

Advice on the acceptability of registry-based studies as a source of evidence for regulatory purposes is included in new guidance from the European Medicines Agency.

Regulation Europe

PRIME: EMA Says Yes To Only Three Of Twenty Hopefuls

The past few months have seen the European Medicines Agency award its much sought-after priority medicines designation to treatments for Hunter syndrome, bubble boy disease and narcolepsy.

Europe Regulation

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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

Continuous Manufacturing Guidance From US FDA Aims For Wider Industry Adoption

Draft tracks ICH document, which touts the ‘efficiency, agility, and flexibility’ of continuous manufacturing while acknowledging the challenges around the developing practice, ‘particularly for products intended for commercialization internationally.’

Manufacturing Guidance Documents

EU Ups The Ante On Opposition To COVID-19 IP Waiver

Leaked documents show that the European Commission has prepared a new proposal on compulsory licensing of coronavirus products to be tabled at the World Trade Organization’s Ministerial Conference next month.

International Europe

EFPIA On Why More EU Drug Price Transparency Isn’t The Answer

As discussions continue over the European Commission’s plans to overhaul the EU pharmaceutical legislation, the R&D-based pharma industry body EFPIA says that any new pharma policy framework will need to be stable, fast, effective and globally competitive.

Europe Regulation
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