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Second Judge Rejects Constitutional Challenges To Medicare Price Negotiation Program

Delaware district judge rules against AstraZeneca’s claim the IRA violates its due process rights, echoing findings made by Ohio district judge in Chamber of Commerce’s suit. Only other IRA ruling to date dismissed PhRMA’s complaint on procedural grounds without addressing the merits.

Medicare Pricing Debate Litigation

Amgen Wins First Approval Through UK’s New International Recognition Procedure

The UK MHRA approved a new version of Amgen’s established bone cancer complication drug Xgeva based on a review conducted by the European Medicines Agency.

BioPharmaceutical Regulation Drug Review

NZ Govt Moves To Speed Drug Access Amid Plans To Wipe Out Major New Act

A parallel assessment mechanism that will allow new medicines in any therapeutic area to be considered for funding sooner is being introduced in New Zealand, where the new coalition government is working to repeal last year’s landmark Therapeutic Products Act.

New Zealand Drug Review Health Technology Assessment

Long Strange Drug Development Trips

Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance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

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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

Lilly CEO: Affordable Generics And IP Support 'Not Incompatible Ideas'

Lilly’s CEO indicates that the long-standing IPR debate that has generally divided the developed and developing world is largely a “false narrative.” The executive also called for lowering regulatory barriers in India amid expectations of the potential debut of Zepbound/Mounjaro in the country next year.

India Intellectual Property

Lumicell’s Cancer Imaging Drug Faces Clinical Meaningfulness, Anaphylaxis Risk Questions At FDA Panel

US FDA advisory committee briefing documents say drug-device combo Lumisight (pegulicianine) is effective at picking up cancer but it is not clear whether that translates to patient benefit.

Advisory Committees FDA

Vaccines In Brief: ACIP Recommends Valneva's Chikungunya Shot For Travelers, Lab Workers

CDC’s advisory committee also approves a VFC program update allowing for the rare, off-label use of tetanus toxoid- and diphtheria toxoid-containing vaccine in young children, and plans to move up timing of its COVID-19 vaccine recommendations for the 2024-2025 formulation.

Vaccines Advisory Committees

Drug Makers Look To Simplify Application Process With New ICH Guidance On Platform Methods

As ICH member countries prepare to implement Q2(R1)/Q14 guidelines, industry is focusing on provisions in both for platform analytical procedures, which applicants for drug approvals and biologics licenses could use to reduce method validation requirements. Pfizer undertook the first commercial application of the platform analytical approach, which is widely used in development.

Drug Approval Standards Quality

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 

Advisory Committees Drug Review

Three Major Regulators Launch Pilot To Reduce Duplication Of GMP Inspections

Regulatory bodies from Australia, Canada and the UK say a new pilot program will reduce the need for multiple inspections of the same site, while an MoU signed by Australia and Canada will cut the amount of documentary evidence required from drug sponsors seeking GMP clearances. 

Australia Manufacturing

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

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

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

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
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