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GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows

A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.

Reimbursement Medicare Policy

EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications

Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.

Europe Regulation BioPharmaceutical

Partisan Politics Returns To US FDA Congressional Oversight

The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.

FDA Politics Regulation

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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 – March 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

CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings

FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.

FDA Legislation

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
Regional Comparisons

Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?

EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.

Generic Drugs 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
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Recent Stories

No Korea-Originated New Drugs Approved Domestically In 2023

Notable new drug approvals in South Korea last year included Pfizer’s Tukysa, Genentech’s Columvi and BeiGene’s Tevimbra, but the tally did not include any domestically-originated products. Alzheimer’s disease therapy lecanemab may be on the horizon this year.

South Korea Approvals

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

US FDA Performance Tracker Approvals

Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development

Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.

Reimbursement Rare Diseases

Industry & Regulators To Align Advice on COVID-19 Vaccine Updates

A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.

International Coronavirus COVID-19

Lack Of Industry Involvement In EU HTA Scoping Process Exacerbates ‘Unworkable’ Timelines

Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.

Europe Approvals

CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings

FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.

FDA Legislation

Medicare Reimbursement For Part B Drugs Is 48% Above 340B Prices To Hospitals, MedPAC Finds

New study updates past commission analyses and highlights the significant margin between Medicare payments for drugs and the prices paid by 340B-eligible providers.

Reimbursement Medicare

Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing

Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.

Supply Chain Manufacturing

EU Stakeholders Devise Six-Point Plan To Improve Cross-Border Clinical Trials

Sponsors need guidance on ethics requirements and clarity around national regulations to conduct cross-border clinical trials in the EU, a multi-stakeholder forum says.

Europe EU

Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings

Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.

Japan Pricing Debate

China’s Public Payer Wants To Define Innovative Drugs As Those With ‘Novel Benefits’

China’s public payer perceives innovative drugs in a different way from that of the country’s top drug regulator, a former senior healthcare security official with knowledge of the matter reveals. The posture has unnerved pharma companies, which have been hit by sharp price discounts.

China Research & Development

Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck’s V116

As Merck’s 21-valent vaccine approaches its 17 June user fee goal, the US CDC’s vaccine committee is looking at new adult age-based recommendations and bracing for a full pipeline led by GSK’s 24-valent candidate.

Vaccines Research & Development
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