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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.

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.

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.
Leqembi’s March Toward Medicare
Leqembi’s FSS Pricing Meets ICER’s Cost-Effectiveness Threshold; VA Requiring Coverage With Evidence
Eisai/Biogen Alzheimer’s treatment isn’t actually on the VA formulary, but Leqembi’s Federal Supply Schedule price, coming in at just over $20,000 annually, could address spending concerns.
Leqembi Coverage By Veterans Affairs Department Sign Of Success For Eisai’s Payer Engagement Strategy
Eisai Pricing For Lecanemab Reflects Concern With Medicare ‘Sustainability,’ ‘Giving Back,’ Firm Says
Transparency In Alzheimer’s: AdComm Expected On Regular Approval For Eisai/Biogen’s Leqembi
Pink Sheet Podcast: Medicare Inflation Rebates And Negotiation, Leqembi Reimbursement, US FDA Gene Therapy Chief
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Pink Sheet Podcast
Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.
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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
US FDA Performance Tracker

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.
European Performance Tracker
Policy & Regulation Explore this Topic
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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.
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.
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.
‘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.
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.
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.
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.
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.
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.
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.
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.
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.”
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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.
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.
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.
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.
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.
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.
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