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Featured Stories



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Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited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 Regulation

Lilly’s ‘High Quality’ Donanemab Data Supports Unrestricted Medicare Coverage, Firm Says

As FDA decision on Alzheimer’s product approaches, new paper outlines Lilly’s arguments for unfettered Medicare coverage for donanemab once it is approved.

Reimbursement Policy Medicare

EMA Addresses Need For Guideline On Antivirals & MAbs For COVID-19

New EU guidance will cover non-clinical and clinical development, trial design, endpoints, safety issues and comparators, as well as the use of immunobridging studies.

Europe Biosimilars Guidance Documents

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

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

A Visual Trip Through The Psychedelic Pipeline

Pink Sheet infographic breaks down the status of origins of 39 programs being pursued by 26 sponsors.

Clinical Trials Research & Development

Orphan Drug, Domestic Developers Shine In China Annual Approvals Tally

10 orphan drugs imported from overseas, and 40 new drug approvals, including many from domestic developers, capped 2023 as one of the busiest years for China's drug regulatory agency, as Beijing pivoted to emphasizing affordable innovation and expanding access to newer therapies for rare conditions.

China Approvals
Regional Comparisons

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

Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind

Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.

BioPharmaceutical Market Access
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Recent Stories

Accelerated Approval: US FDA’s Hammer Falls On Oncopeptides’ Pepaxto

Rejecting company’s appeal, CBER Director Peter Marks says the multiple myeloma drug should be withdrawn because its confirmatory trial failed to verify clinical benefit and evidence demonstrates the drug is not safe and effective for its current indication.

Post Market Regulation & Studies Review Pathway

In Washington, The Answer Is Drug Shortages But What Is The Question?

They’re all probing the drug shortage problem, each with a different line of inquiry: the Federal Trade Commission and the Health and Human Services Department, House Oversight Committee Democrats, and the bipartisan leadership of the Senate Finance Committee.

Manufacturing Market Access

New EU Filings

Acoramidis, AstraZeneca/BridgeBio Pharma's investigational treatment for patients with transthyretin amyloid cardiomyopathy, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Drug Review Europe

Pink Sheet Podcast: FDA And Psychedelic Drugs, Aduhelm Clinical Trial Data, Adcomm Candidates

Pink Sheet reporters and editors discuss the FDA’s approach to psychedelic drugs, whether postmarket clinical trial data from the Alzheimer’s drug Aduhelm will be published, and the FDA offering more time to find candidates for its new Genetic Metabolic Diseases Advisory Committee.

Neurology Post Market Regulation & Studies

Two Avian Flu Vaccines Among 10 New Products To Get EMA Nod

The European Medicines Agency has OKd two new H5N1 jabs, including a pandemic preparedness vaccine intended for use only if a flu pandemic is declared. Eight other products are also heading for EU-wide approval.

Europe Approvals

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

Two BLAs, One Suffix: FDA Diverges From Nonproprietary Naming Guidance For Amgen’s Wezlana

Assigning different suffixes to the prefilled syringe and intravenous formulations of Amgen’s ustekinumab biosimilar could create confusion and would not further the goals of the naming convention, the FDA said in explaining why it departed from its January 2017 final guidance.

Drug Review Profile Biosimilars

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

Birth Control Guidance For Insurers Aims To Boost Coverage, Smooth Exemption ‘Pathway’

Three-agency guidance, issued as Biden administration is hoping to emphasize reproductive rights in its reelection campaign, outlines the narrow set of circumstances in which a health plan doesn’t have to fully cover certain types of birth control.

Women's Health Reimbursement

Denmark Leads The Way On Speeding Up Approvals For Drug/IVD Combination Trials

While an EU-level project is underway to address delays to drug trials that are conducted in combination with IVD performance studies, Denmark has streamlined its processes to address the issue at the national level.

Denmark Europe

First-In-Class Vorasidenib Among Bumper Crop Of New EU Filings

Twelve new drugs are now being reviewed for potential EU marketing approval, including Servier’s vorasidenib for IDH-mutant diffuse glioma, which the company says could become the first targeted therapy for the malignant and incurable brain tumor.

Europe Drug Review

Australia Gears Up For More Action On Drug Shortages

The TGA has taken a series of actions to address supply chain issues, including on the regulatory front, but it says more remains to be done and is asking stakeholders for suggestions in a new online survey.

Australia Manufacturing
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