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Pharma Blames EU IVD Regulation For Clinical Trial Delays

The challenges posed by the implementation of the EU IVD Regulation are having a negative impact on medicine trials using diagnostics. Many of such studies are currently stalled and research-based drug companies are calling on all partners to engage in dialog to find an urgent solution.

Clinical Trials Regulation Diagnostics

A Milestone Moment For Pharmacogenomics: US FDA Ready To Drop ‘Voluntary’ Program

The US FDA’s plan to update a 20-year-old guidance on pharmacogenomic data submissions is a good time to reflect on the dramatic transformation of industry attitudes and approaches to targeted medicine over the past two decades.

Guidance Documents Personalized Medicine Regulation

Device Component Of Intarcia’s Diabetes Treatment ITCA 650 Worries FDA

If FDA chief scientist grants Intarcia’s request for advisory committee meeting, CDER wants to provide input on issues to be considered. Director Cavazzoni says the novel drug-device combination product does not notify the user of a critical failure or infusion status.

Advisory Committees Combination Products Drug Review

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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: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Approvals US FDA Performance Tracker Neurology


Global Pharma Guidance Tracker – February 2023

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

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Latest From Regulation

Electronic Records: US FDA Updates Guidelines On Use In Clinical Investigations

Revised draft guidance includes recommendations on preparing for FDA inspections, considerations for real-world data and digital health technologies, and the need for service level agreements between sponsors and IT providers.

Digital Health Compliance

Mixed Support For ABPI's UK Price Scheme Proposals

The UK pharma industry body has set out bold proposals for a new drug pricing agreement from 2024, but not everyone is convinced. Generics companies are pressing for more of a say in the negotiations, while patient groups want to know more about how the deal would help improve access to medicines.

Europe United Kingdom

FDA’s Califf Calls For Return To Large, Simple Trials Without The ‘Useless Stuff’ That Slows Development

US FDA Commissioner Califf praises both Project Pragmatica and the ‘very powerful’ partnership between OCE Director Rick Pazdur and National Cancer Institute Director Monica Bertagnolli.

Clinical Trials Regulation

‘Stop Fighting Us’ On Inspections, US FDA’s Califf Tells Industry; Foods Modernization Will Bring ‘Big Change’ To Drug Quality Systems

Commissioner Califf underscores need to keep inspections systems ‘tuned up’ to prevent manufacturers from ‘losing their edge’ on quality.

Manufacturing Regulation

US FDA Program Streamlining COVID-19 Treatment Development Still Working As Emergency Ends

Any program changes would not occur until after a thorough assessment, the agency said.

Coronavirus COVID-19 Research & Development

Biogen/Ionis’ Tofersen: US FDA Considering Both Accelerated And Regular Approval In ALS

FDA seeks advisory committee input on whether there is ‘convincing evidence’ to support regular approval for treatment of SOD1-ALS patients even though lone Phase III trial failed its primary endpoint; companies filed for accelerated approval on the basis that a reduction in plasma neurofilament light chain is reasonably likely to predict clinical benefit.

Advisory Committees Drug Review

Latest From Policy

‘Gene Silencing’ Drug Oxlumo Wins English Funding After Alnylam Improves Discount

Health technology assessment institute NICE has reversed its provisional rejection of Oxlumo for treating the rare disease, primary hyperoxaluria type 1.

Europe Cost Effectiveness

Single Product, Single Price: Medicare Will Include All Versions Of Active Ingredient For Negotiation

The US Medicare agency intends to treat all dosage forms of the same active ingredient as a single drug for purposes of its new price negotiation authority. The approach will have implications for product branding and line extension strategies.

Reimbursement Medicare

Medicare Seeks Input On Dispute Resolution, Civil Penalties For Rx Pricing Program

Calculating a ‘fair price’ for new versions of already negotiated moiety is also one of several that CMS is requesting input on in its recently released initial guidance on the negotiation program.

Reimbursement Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

US FDA Program Streamlining COVID-19 Treatment Development Still Working As Emergency Ends

Any program changes would not occur until after a thorough assessment, the agency said.

Coronavirus COVID-19 Research & Development

Fastest Ever Review For A Product In EMA's PRIME Scheme

The European Medicines Agency says that when it comes to products developed under its priority medicines scheme, dialog is crucial to ensure that the data generated for marketing applications are sufficiently robust and mature and facilitate a timely review.

Europe Review Pathway

EMA Dismisses Claims That RWD Is The ‘Wrong Remedy’ For Drug Development Challenges

The European Medicines Agency has responded to an analysis that argued that generating evidence for decision making in health care using observational real-world data, and thus potentially replacing randomized controlled trials, “is the wrong remedy for the challenges in drug development.”

Europe Real-World Evidence

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Latest From Commercial

UK ABPI Suspends Novo Nordisk Over Code Breach

Novo Nordisk has been given a two-year suspension from membership of the Association of the British Pharmaceutical Industry for breaching the association’s code of practice.

Advertising, Marketing & Sales Ad Complaints

Medicare Price Negotiations: Competitors’ Net Prices, Clinical Benefit Are ‘Starting Point’ For Initial Offer

CMS chose the prices of therapeutic alternatives and these competitors’ comparative benefits as the ‘foundation and starting point’ for setting an initial offer for drugs subject to negotiation, ahead of other factors Congress laid out it could consider that are more singularly focused on the specific drug at issue.

Pricing Debate Medicare

Leqembi Coverage By Veterans Affairs Department Sign Of Success For Eisai’s Payer Engagement Strategy

Alzheimer’s product is following a different playbook than Aduhlem, reflecting better data – and hard-earned lessons. Eisai estimates that 80-90% of veterans who are eligible for Leqembi treatment based on the FDA label would also fit the VA’s criteria.

Government Payers Medicare

Manufacturing Explore this Topic

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Latest From Manufacturing

‘Stop Fighting Us’ On Inspections, US FDA’s Califf Tells Industry; Foods Modernization Will Bring ‘Big Change’ To Drug Quality Systems

Commissioner Califf underscores need to keep inspections systems ‘tuned up’ to prevent manufacturers from ‘losing their edge’ on quality.

Manufacturing Regulation

Global Regulators Outline Quality Expectations For Cell And Gene Therapy Raw Materials

The International Pharmaceutical Regulators Programme explains how manufacturers of cell and gene therapy products can assess and mitigate the potential risks associated with product raw materials.

International Gene Therapy

Transparency Looms Large In US FDA’s Next-Pandemic Legislative Agenda

Agency’s proposals for pandemic preparedness reauthorization would build on CARES Act provisions to gain greater visibility into global pharmaceutical supply chains, while also seeking deeper understanding of manufacturing quality management activities. Also included in FY 2024 budget request: long-sought drug destruction and drug recall authorities.

Quality Supply Chain
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