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Ivermectin Settlement Brings Relief And Worry For US FDA Communications

The FDA’s decision to end litigation challenging an agency communication that tried to tackle COVID-19 misinformation leaves an appeals court opinion in place that could haunt it later. But continuing to fight the case could have left the agency in a far worse position.

Legal Issues Drug Safety Regulation

EMA Probe Finds No Link Between GLP-1s And Suicidal Thoughts & Actions

After reviewing the evidence from non-clinical studies, clinical trials, post-marketing surveillance data and other studies, the European Medicines Agency said there was no need to update the product information for 11 diabetes and weight management drugs.

Europe Drug Safety Metabolic Disorders

UK Industry Gets More Time To Adapt To Post-Brexit Import Rules

The BioIndustry Association has welcomed a decision to delay the deadline for compliance with new regulations on the classification of imported materials used in drug production, but says the border rules are still not proportionate for life science products.

Europe United Kingdom Brexit

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Pink Sheet Podcast

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

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PTC’s Upstaza Takes Gene Therapy Straight To Brain (And US FDA); Translarna To Return Mid-Year

In a year full of regulatory milestones for the firm, PTC Therapeutics hopes to set some approval precedents – and basically hopes its candidates have an easier time of it than they have had before.

US FDA Performance Tracker Gene Therapy Drug Approval Standards

Global Pharma Guidance Tracker – February 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

US FDA’s Bioresearch Monitoring Program Should Evaluate Hiring And Retention Strategies, GAO Says

BIMO inspections and investigators have declined since 2017, and investigators express frustration to the Government Accountability Office that their inspection classification recommendations are downgraded by the Center for Drug Evaluation and Research.

Clinical Trials Compliance

US FDA’s April Outlook: Decisions Pending For Rare Pediatric Diseases, New Antibiotics

User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.

Mifepristone Supporters Highlight Voter Trust In FDA Decisions Ahead Of Supreme Court Arguments

New poll from advocates pushing for courts and the states to stay out of FDA’s scientific decisions indicates majority of US voters support FDA drug safety determinations across party lines, though Republican support is more tentative.

United States Drug Safety

CDER, CBER Post FY 2023 Employee Gains, But Behind User Fee Hiring Goals

US FDA’s drug center reported a net increase of more than 300 employees in FY 2023, while the biologics center saw an overall increase of more than 30.

FDA User Fees
Regional Comparisons

For Generics, EU Reference Product Is Non-Negotiable – Even In Pilot On Parallel Advice

Acknowledging that it may be a barrier to some extent, EMA’s senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented.

Generic Drugs 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
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Minimal Residual Disease Gains Max US FDA AdComm Support For Myeloma Trials

The US FDA’s Oncologic Drugs Advisory Committee unanimously agreed that accelerated approvals should be enabled by multiple myeloma trials using MRD as a surrogate endpoint.

Advisory Committees Clinical Trials

Medicare Reaffirms Faith In Formulary Review Process Ahead Of Part D Changes

Dramatic transformation in the US Medicare Part D benefit design does not require any changes to CMS’ overall approach to reviewing formulary submissions from private drug plan sponsors, the agency says in its final guidance implementing the design changes for 2025.

Medicare Reimbursement

Pink Sheet Podcast: US FDA Adcomm Open Public Hearings, Clinical Trial Diversity Plans, Stealth’s Elamipretide

Pink Sheet reporter and editors discuss Richard Pazdur’s call for more diverse opinions in FDA advisory committee meeting open public hearings, agency questions about the stakeholders sponsors consult to execute clinical trial diversity plans, and the pending review of Stealth BioTherapeutics’ application for the Barth Syndrome candidate elamipretide.

Advisory Committees Clinical Trials

Estonian Biobank’s Personalized Medicine Project To Unlock New Insights For Drug R&D

A new center for personalized medicine in Estonia will see PacBio’s long-read whole genome sequencing technology used to unlock new information about how genetics impact patients’ drug responses, experts from the project tell the Pink Sheet.

Medical Device BioPharmaceutical

Califf Suggests Congress ‘Tighten Up Laws’ To Address Orange Book Abuses

US FDA Commissioner repeats longstanding FDA policy that the agency doesn’t have much power to address frivolous patent listings in the Orange Book, but seems to support Congress providing more authority.

Intellectual Property Generic Drugs

Rare Cancer Development Consortium Moving Toward Target Selection

An upcoming public meeting will include a look at platforms before the first targets are chosen.

Rare Diseases Research & Development

Preterm Birth Prevention Studies Need To Look Beyond Makena Endpoints, Experts Say

Gestational age and a binary, neonatal composite endpoint are insufficient to assess outcomes that are important to babies and families, clinicians and researchers say, suggesting development of continuous variables or scales with weighted components and a comparison of outcomes among newborns in gestational age ‘buckets.’

Drug Approval Standards Pediatrics

Industry Calls On G20 To Boost Regulatory Harmonization & Tackle AMR

Robust regulatory systems with effective approval pathways and surveillance mechanisms to ensure continuity in clinical research, manufacturing and supply are needed to prepare for current and future health threats, says industry.

International Market Access

English Funding For Aquipta Targets AbbVie’s Migraine Drug To 170,000 People

Aquipta is the first oral treatment that NICE has recommended for preventing chronic migraines in the fourth-line setting, and the second oral treatment for episodic migraines in the same setting. The drug has already secured reimbursement in Scotland, Sweden and Israel.

United Kingdom Cost Effectiveness

EU Parliament Adopts Updated Pharma Package Despite Some Political Disagreement

The European Commission’s proposed revision to the EU pharmaceutical legislation has taken another step forward after the European Parliament adopted its position on the draft text, which includes a seven and a half year baseline regulatory data protection period.

Europe EU

Minimal Residual Disease Inches Closer To Supporting Myeloma Accelerated Approvals

US FDA’s oncology advisory committee will discuss two meta-analyses supporting use of MRD as a surrogate endpoint to support accelerated approval in multiple myeloma trials.

Advisory Committees Drug Approval Standards

BIOSECURE: What’s Coming Next?

The potential impact of the BIOSECURE Act continues to spread as the Biden administration increases its focus on China. But with BIO's top lobbyist and the top House sponsor of the legislation now headed out the door, the future of the bill remains uncertain.

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