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Featured Stories



US FDA Gene Therapy Staff-Up: Glass Three-Quarters Full?

Aggressive staffing goals for FDA’s gene and cell therapy review group might not be fully achieved – but the head of CBER believes the new organization is on track to deliver on his high expectations going forward.

Gene Therapy Leadership Drug Review

European Parliament Supports Explicit Patent Linkage Ban

An explicit ban on patent linkage would ensure that competition to originator drugs is not delayed, according to off-patent industry group Medicines for Europe.

Europe Intellectual Property Regulation

BIO Chair Ted Love On Drug Pricing And Political Pressure

Biopharma veteran Ted Love assured industry that the sector remains fundamentally strong during remarks at the BIO CEO & Investor Conference.

Leadership Pricing Debate Politics

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...

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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: 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
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Recent Stories

US Toning Down China CDMO Tension But New Restrictions Emerge

The latest developments in a US Congressional draft bill to curb Chinese biotech operations in the US is separating contract manufacturing and research from gene sequencing service providers, which may give China's major contract players reasons to breathe easy. 

China United States

IRA Innovation Debate Showcased At House Hearing On Rare Disease Legislation

Bills to narrow the Medicare price negotiation program’s reach generated extensive discussion at the hearing.

Pricing Debate Rare Diseases

US FDA’s Califf: We Don’t Need Much Help From Congress On Rare Diseases

The FDA commissioner also does not want the agency setting goals for rare disease treatment development.

Rare Diseases Gene Therapy

EU Parliament Backs Plan To Allow Pre-Grant Opposition To Patent Extension Requests

Members of the European Parliament have ignored pleas from the EPP political group and the German Federal Council to drop a proposal allowing third parties to oppose the granting of a supplementary protection certificate.

Europe Legislation

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

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

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

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

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
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