Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Featured Stories



COVID Vaccines: CDC Panel Says Older People ‘Should’ Get An Extra Dose

However, David Kaslow, director of the FDA’s vaccines office, says only a ‘may’ recommendation is supported and that giving an extra dose after June ‘may not be optimal’ if vaccines are reformulated for the fall.

Advisory Committees Vaccines Policy

EU Parliament OKs Legislation To ‘Reduce Cost & Burden’ Of Patent Extensions

Legislation intended to remove the fragmentation in the supplementary protection certificate system has been OKd by the European Parliament, which will try to reach agreement with the EU member states following the June parliamentary elections.

Europe Intellectual Property Legislation

Accelerated Approval Now Starting Point For Gene Therapy Development, US FDA’s Marks Says

Expedited approval pathway had been a secondary option when traditional approval was not possible, but the CBER director wants surrogate endpoints increasingly considered from the beginning, especially with pediatric rare disease gene therapies.

Gene Therapy Review Pathway Drug Approval Standards

Biosimilar Policy Shifts Around The Globe

Biosimilars: US FDA’s Updated Scientific Thinking Led To Interchangeability For Amgen's Wezlana

Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.

Drug Review Profile Biosimilars

Read all of the Pink Sheet stories on biosimilars...

Latest News

Pink Sheet Podcast

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

More Podcasts

Performance Trackers

Keeping Track: Iovance’s Amtagvi Approval Brings T Cell Therapy To Solid Tumors

Melanoma treatment Amtagvi is US FDA’s biologics center’s first novel approval of 2024.

Gene Therapy Biologics Approvals

Global Pharma Guidance Tracker – January 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.

Guidance Documents Regulation International


Multimedia

Singulair’s Psychiatric AE Risks Still A Problem, But US FDA Has Limited Mitigation Options Remaining

Stakeholders suggested a ‘Dear Healthcare Provider’ letter or speaking about the risks to professional societies to emphasize the psychiatric adverse events that prompted a boxed warning for the now-generic asthma drug montelukast. The NY Attorney General is adding more pressure.

Drug Safety Post Market Regulation & Studies

Oncopeptides’ Pepaxto Withdrawal Speeds Through In 7 Months Under Expedited Procedures

Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.

Post Market Regulation & Studies Review Pathway

Wezlana Chronology: From Biosimilar To Interchangeable In The Blink Of An Eye

Pink Sheet’s Drug Review Profile looks at the timeline behind the development and FDA review of Amgen’s Wezlana (ustekinumab-auub), an interchangeable biosimilar to Janssen’s Stelara.

Drug Review Profile Biosimilars

Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance

Pipeline is concentrated around Phase II, but sponsors have a few chances to see how FDA handles its ‘foundational constructs’ for psychedelic drugs, led by Lykos’ pending NDA for PTSD and Compass Pathways’ Phase III synthetic psilocybin COMP360 for treatment-resistant depression.

Drug Approval Standards Clinical Trials
Regional Comparisons

How The EU & UK’s Contrasting Approaches To AI Regulation Could Impact Pharma

While EU preparations are underway to introduce strict legal requirements for all AI systems, the UK has doubled down on its flexible, non-regulatory framework. In this second of a two-part article, a lawyer explains the pros and cons of each for pharma and medtech firms.

Artificial Intelligence Digital Health

For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards

Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.

Drug Approval Standards Guidance Documents

FDA-EMA Pilot Advice Scheme On Complex Generics Sees Slow Uptake

While approaching the third year of its launch, the parallel advice program has seen a handful of applicants, but regulators on both sides of the Atlantic remain optimistic.

Generic Drugs Regional Comparisons

Regulatory Reliance Pathways: Challenges And Opportunities Ahead

International interest in fast-track regulatory reliance and collaboration pathways such as Project Orbis and the ACCESS Consortium has grown in recent years, a trend that looks set to continue in 2024. But some policy experts have warned that faster approvals are not always better, with one academic claiming the bar for marketing authorizations has dropped “far too low.”

BioPharmaceutical Drug Review
See All
Recent Stories

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add three new products, including Velsipity, Pfizer's treatment for moderately to severely active ulcerative colitis in patients 16 years of age and older.

Europe Approvals

HTA Evidence Used By England’s NICE ‘Consistently Poor’

An analysis spanning two decades found that 65% of health technology assessments in England were based on evidence of poor or unacceptable quality, raising concerns around the efficacy of drugs reaching patients.

BioPharmaceutical Cost Effectiveness

Germany’s Confidential Pricing Move Could Protect Companies From Potential Trumpian US Reference Pricing

Confidential pricing would give companies more flexibility to negotiate discounts and prevent withdrawals.

Europe Germany

Threat of Shutdowns No Longer Deterrent To Hiring, Staff Retention, US FDA’s Marks Says

Despite Marks' relatively upbeat attitude, FDA experts warn that even absent government shutdowns or minimally impactful ones, the current cycle of continuing resolutions and the lingering threat of budget sequestration is harmful to the agency’s operation.

FDA Legislation

FDA Still Soliciting Applications For START Pilot As Deadline For Rare Disease Program Looms

Agency anticipated receiving more applications for the program, which aims to bring Operation Warp Speed-like response to investigational rare disease therapies, than it has so far, though a last-minute ‘flood’ is still expected. CBER and CDER are accepting requests through 1 March.

Rare Diseases Drug Review

How Lilly Is Helping To Address The UK’s ‘Postcode Lottery’ For Cancer Drugs

Some innovative cancer drugs are not reaching eligible patients in the UK, despite securing positive reimbursement opinions from NICE. Eli Lilly explains how industry can be “part of the solution” through partnership initiatives.

Europe United Kingdom

Pfizer Ponders Next Move After English HTA Rejects Oxbryta Again Despite Appeal

In spite of successfully appealing against previous negative guidance, Pfizer has again failed to secure a positive recommendation from England’s health technology appraisal institute for Oxbryta for hemolytic anemia caused by sickle cell disease, and has been asked to provide more evidence.

Europe United Kingdom

Singapore & South Korea’s Recognition Of GMP Inspections To Cut Burden For Companies

A new agreement signed between Singapore’s Health Sciences Authority and South Korea’s Ministry of Food and Drug Safety means drug manufacturers in the two regions will be subjected to fewer duplicative good manufacturing practice inspections.

Singapore South Korea

Doctors’ Protests Intensify In Korea As Essential Healthcare Challenges Highlighted

South Korea’s healthcare services face both longer-term systemic challenges and short-term disruption from ongoing doctor walkouts over government plans to boost medical trainees. Meanwhile, the local pharma industry is calling for new measures to support the supply of essential drugs.  

South Korea Policy

PBM Action Lags In Congress And At FTC As Targeting Commercial Plans Divides Republicans

PBM reform isn’t expected to ride along with the next government funding packages, which could push any prospect of legislative reform closer to 2025. Meanwhile FTC says it is facing difficulty getting all the information for its investigation. 

Legislation PBMs

Medicaid Payment Model For Sickle Cell Gene Therapy May Have Limited Impact Until 2026

As further details emerge, questions continue about whether the CMMI model could delay access to Lyfgenia and Casgevy; states will be added on ‘rolling basis.’ A new administration could change or cancel the model, but a CMS official predicts that is unlikely.

Reimbursement Policy

Quality Officers Call For New Approaches To Reduce Global Manufacturing Change Complexity

Pharmaceutical quality leadership proposes eight-step “dance” with complex global regulatory system for allowing manufacturing processes to improve more quickly. The data showed many authorities take more than the recommended six months to decide on post-approval changes, with assessments taking almost eight years in some cases.

Manufacturing Quality
UsernamePublicRestriction

Register