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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 Research & Development

Moderna’s COVID-19 Vaccine Packaging Poses Booster Tracking, Safety Surveillance Challenges, Experts Say

Since company is using same vial and NDC code for primary series and booster dose, which is half the amount, immunization registries will not be able to capture how much Moderna vaccine an individual actually gets for their third dose.

United States Advisory Committees Coronavirus COVID-19

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 Regulation

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

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

Full US FDA Independent Review Of Janssen Booster Data May Not Continue Post-EUA

The agency said its booster EUA decision was based on the immunogenicity studies that were submitted.

Coronavirus COVID-19 Vaccines

Lenzilumab & Evusheld Make It Onto EU List Of ‘Most Promising’ COVID-19 Treatments

Two products that were on the European Commission’s original list of the “top five” COVID-19 candidate therapeutics in development have been dropped from the latest “top 10” portfolio.

Europe Coronavirus COVID-19

US FDA Finds Pfizer’s COVID Vaccine For Kids 5-11 Worth The Risk Even In Lowest Incidence Model

Overall benefit still favorable when there could be excess hospitalizations due to vaccine-related myocarditis because of ‘the different clinical implications of hospitalization for COVID-19,’ FDA concludes ahead of the advisory committee.

Vaccines Advisory Committees

Accelerated Approval’s Double-Edged Sword Cuts Down Agenus’ Balstilimab BLA

With US FDA’s early conversion of Merck’s Keytruda to full approval for chemotherapy-experienced cervical cancer, Agenus lost its expedited path to market and has opted to focus on development of combination treatments instead.

Review Pathway Drug Approval Standards

239 Days: Oncopeptides' Myeloma Drug Pepaxto Comes Off Market Just Months After Accelerated Approval

Withdrawal announcement marks shortest interval ever from accelerated approval to market removal after OCEAN confirmatory trial showed an adverse overall survival trend and US FDA said a hypothesis-generating subgroup analysis would need to be borne out in another study.

Drug Safety Review Pathway

Latest From Policy

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

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

Pandemic Drives Rise In EMA Scientific Advice, But New EU Drug Filings Slow

The European Medicines Agency is expecting a lively pipeline of advanced therapy medicines over the next few years. It is also making final preparations for the introduction of the new EU clinical trials system from the end of January next year.

Europe Research & Development

Could Sponsors’ Supply Chain Policing Have Caught Alleged CRO Fraud?

The US FDA always encourages sponsors to ensure their suppliers and contractors are following the law, but agency inspectors may have been the only ones who could have discovered the data integrity problems that forced the downgrading of more than 100 generic drug applications.

Generic Drugs Research & Development

Pink Sheet Podcast: NIH Director Leaving, Federal COVID-19 Messaging Issues, FDA Assessment Costs

Pink Sheet editor and reporters discuss the impact of Francis Collins’ departure as NIH director, whether FDA and CDC COVID-19 messaging should be harmonized, and the narrowing gap between standard and priority assessment costs.

Leadership Coronavirus COVID-19

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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

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

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
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