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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 Policy

All Eyes On Pricing Model As EU Crunch Time Nears For First Ophthalmic Bevacizumab

If Outlook Therapeutics’ Lytenava secures EU approval for wet AMD, the company says it expects to price the drug as a lower cost alternative to biosimilars and premium branded products for the condition, and higher than off-label compounds.

Europe Ophthalmic Approvals

Pakistan Explains Updated Risk-Based Criteria For GCP Inspections

Pakistan’s drug regulator is hoping that improved transparency on its inspection protocols will help research entities better prepare for good clinical practice inspections.

Pakistan Clinical Trials 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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Performance Trackers

BeiGene’s Tevimbra And The End Of The COVID Inspection Era

US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.

US FDA Performance Tracker Approvals Manufacturing

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

With Reform Efforts Persisting, PBM Trade Association Sets Lobbying Record

Infographic details who gave what to whom as all segments of the US healthcare industry gear up for the presidential election cycle.

PBMs Elections

US FDA Looks To Re-Establish African Foreign Office, Add Brazil Post

As Congress pressures FDA to increase foreign inspections, the agency unveils plans to strengthen its overseas presence, including new offices and more staff in the New Delhi, India, post. Deputy Commissioner Kimberlee Trzeciak notes the moves are resource dependent.

Manufacturing Clinical Trials

Novo Nordisk’s Semaglutide Achieves ‘Cardiodiabesity’ Label

With Wegovy’s new indication for cardiovascular risk reduction in patients with overweight and obesity, the migration of diabetes drugs from a single disease state to address a host of interrelated conditions reaches a new milestone.

US FDA Performance Tracker Approvals

Alzheimer’s And Surrogate Endpoints: FDA’s On A Case-By-Case Basis Per New Guidance

After Aduhelm and Leqembi rendered the 2018 guidance moot, FDA formally acknowledges the possibility of using surrogate endpoints for accelerated approval in Alzheimer’s in updated draft but says acceptability of the any endpoint will depend on details of specific therapeutic program.

FDA Guidance Documents
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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Recent Stories

US FDA’s Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments

FDA’s efforts to tackle misinformation may face fewer legal obstacles moving forward, following oral arguments at the Supreme Court on a case that could have broad ramifications for how the government communicates public health information.

Legal Issues FDA

The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews

Oncologic Drugs Advisory Committee was swayed by views of its disease area experts in favorably reporting out Geron’s imetelstat for myelodysplastic syndromes and supplemental applications for the CAR-T products Carvykti and Abecma in earlier lines of multiple myeloma.

Advisory Committees Drug Review

US FDA Alzheimer Guidance Update Reflects Changes In Biomarkers – And Leadership

Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in 2013. The history of the guidance is a reflection of structural and leadership changes in the neurology review team at FDA.

Guidance Documents Drug Approval Standards

AstraZeneca Joins The $35 Inhaler Club; Medicare Patients Waiting On Congress For Membership

AZ’s move follows Boehringer’s announcement earlier this month and parallels what insulin sponsors did – but almost in reverse. For inhalers, political pressure on out-of-pocket costs has produced copay caps in the commercial market first, not Medicare.

Pricing Debate Medicare

EMA Decision Time For Aztreonam-Avibactam; High-Stakes Meeting For Lecanamab

The European Medicines Agency is this week deciding whether a number of new drugs should win EU approval.

Europe Approvals

Australia To Give Consumers More Formal Role In HTA Processes

The health department says consumers and patients should be able to initiate health technology assessments because many potentially helpful and lifesaving medicines might never be assessed for funding due to “a lack of commercial incentive for pharmaceutical companies.”

Australia Health Technology Assessment

Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development

Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering independent valuation of models should be available by year-end as part of FDA’s involvement with Coalition for Health AI.

Artificial Intelligence Research & Development

‘The Run Is Worth The Slide:’ FDA Advisors Urge Expansion Of J&J’s CAR-T Carvykti Despite Initial Upfront Treatment Risks

Oncologic Drugs Advisory Committee also favors earlier use of Bristol-Myers Squibb’s Abecma in multiple myeloma, although some members raise concerns about lack of plateau in progression-free survival benefit and equivocable overall survival data.

Advisory Committees Drug Safety

New EU Filings

Seladelpar, CymaBay Therapeutics's investigational treatment for primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Drug Review Europe

EC Defends Data Protection Cut As EU ‘Pharma Package’ Nears Crucial Milestone

Proposals to overhaul the general pharmaceutical legislation will ensure that the EU “continues to have one of the most generous systems of incentives in the world,” the European Commission says.

Europe Intellectual Property

EU Reaches Last-Minute Agreement On Health Data Space After Tough Negotiations

European co-legislators have reached a compromise on the text of the European Health Data Space that will see the controversial opt-out mechanism included in the framework

BioPharmaceutical Research & Development

Vertex Resolves To Reverse English Funding Rejection For CRISPR Sickle Cell Gene Therapy

The health technology assessment institute, NICE, is not yet ready to recommend Casgevy for sickle cell disease and says it wants more data. Meanwhile, an access agreement relating to the treatment’s use for transfusion-dependent β-thalassemia is making progress in England, as are reimbursement talks for SCD in other European countries.

United Kingdom Cost Effectiveness
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