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Pandemic Treaty Could Have IP & Other Implications For Pharma

Equitable access to pandemic medicines and vaccines will be at the core of the WHO’s future global pandemic treaty. Exactly what this will mean for the pharmaceutical industry remains to be seen, but it is likely that companies wanting access to virus samples and other materials will need to agree to benefit sharing in the form of IP and technology transfer.

International Coronavirus COVID-19 Regulation

Cancer Drug Dose Optimization Benefits Include Better Pivotal Trial Retention, Fewer Clinical Holds

US FDA is asking oncology sponsors for randomized studies comparing at least two doses early in development; despite concerns about delaying approval, FDA and industry reps say approach will increase success of registrational trials and reduce likelihood of market withdrawal due to toxicity.

Clinical Trials ImmunoOncology Research & Development

US FDA Mum On Whether Woodcock Would Stick Around Long-Term For Califf

Woodcock’s willingness to stay on at US FDA for more than a transitional period after Robert Califf’s expected confirmation as commissioner may depend on exactly the type of authority and tasks he’d be willing to delegate to her. Plus, some other agency personnel updates.

FDA Leadership 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

BioMarin’s Voxzogo Accelerated Approval Based Mostly On One-Year Data

US FDA advisory committee had encouraged a two-year endpoint for achondroplasia treatments, but BioMarin attributes success to having ‘partnered closely’ with the agency. Confirmatory trial still being discussed.

Approvals Drug Approval Standards Drug Review


Global Pharma Guidance Tracker – October 2021

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

Policy & Regulation Explore this Topic

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Latest From Regulation

Pink Sheet Podcast: Woodcock’s Legacy, Merck’s Oral COVID-19 Pill, 340B Case At Supreme Court

Pink Sheet reporters and editor review US FDA Acting Commissioner Janet Woodcock’s long career and update Robert Califf’s confirmation process, consider the advisory committee for Merck’s COVID-19 pill, and discuss an under-the-radar case on 340B policy at the US Supreme Court.

FDA Leadership

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

Advisory Committees Drug Review

Off-Patent Industry Calls For Security Of Supply Legislation In EU

Medicines for Europe has urged the European Commission to enshrine security of supply considerations for essential medicines into legislation. Without these, it says, additional cost containment measures for off-patent medicines under consideration by member states could threaten access by making production unsustainable for manufacturers.

Supply Chain Generic Drugs

US FDA’s Drugs Center Wins Round One In Makena Dispute With Covis On Document Production

Company is not entitled to CDER's unredacted materials or predecisional drafts and emails on the proposed withdrawal of accelerated approval. However, presiding officer Celia Witten sets a 24 January deadline for CDER’s document production and requests the center re-examine what materials from a medical policy council meeting can be released.

Review Pathway Post Market Regulation & Studies

Evolution of Rx Drug Promotion: Researchers Eye Data Brokers, Digital Tools, Global Influencers

US FDA staff acknowledge the challenge of assessing promotions on the internet as experts note trends and topics for future research, including the use of metadata and embedded advertisements, TikTok promotions, and DTC ads extending into countries that prohibit them.

Advertising, Marketing & Sales FDA

US FDA Wants Assessment Of New Drug Review ‘Culture’ Amid Modernization, Other Changes

The New Drug Review Program is seeking a contractor to survey employees on the impact of team culture on performance and overall effectiveness.

FDA Leadership

Latest From Policy

Payer Transparency Reforms: Moving From Rebates To Drug Access Restrictions

Institute for Clinical and Economic Review analysis of whether payers are providing “fair access” to fairly priced drugs was hampered by a lack of transparency among payers, leading to calls for reform.

Reimbursement Pricing Strategies

Step Therapy: As Bill Aims To Routinize Processes, Study Finds Policies Often Stricter Than Clinical Guidelines

Chronic migraine and anti-inflammatory treatments were most often subject to step therapy, Tufts researchers found. Policies varied from payer to payer, raising concerns over the impact of shifting requirements for treating the same disease as patients move among insurers.

Reimbursement Policy

Evolution of Rx Drug Promotion: Researchers Eye Data Brokers, Digital Tools, Global Influencers

US FDA staff acknowledge the challenge of assessing promotions on the internet as experts note trends and topics for future research, including the use of metadata and embedded advertisements, TikTok promotions, and DTC ads extending into countries that prohibit them.

Advertising, Marketing & Sales FDA

Clinical / R&D Explore this Topic

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Latest From Research & Development

From Bedside To Bench: A New Paradigm For Assessing New Treatments

It is time for payers to stop passively accepting uncertainty and instead help to generate evidence on new medicines, says Hans-Georg Eichler from Austria’s association of insurers.

Drug Review Health Technology Assessment

Real-World Evidence Registry Aims To Build Research Credibility Through Transparency

Pre-registration of study protocols will be voluntary and concerns with revealing proprietary information, among other issues, could be a deterrent to participation. But the developers of the registry hope that researchers will conclude the benefits of doing so outweigh the risks.

Real-World Evidence Research & Development

How Star Wars Explains Biosimilar Labeling Problems

US FDA largely writes biosimilar labels that are the same as their reference products even though it’s not required, which could hinder product development and uptake, experts say.

Biosimilars Research & Development

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Pharma Still Hoping To Block US Medicare Price-Setting Legislation

While Democratic politicians – and most voters – want to see drug pricing negotiations introduced in the US for the first time, pharma leaders still believe a deal on out of pocket costs will be agreed instead.

Pricing Debate Legislation

COVID-19 Leads To Less Industry Spend On Docs, But Not Necessarily Less Influence

Drug and medical device company payments to doctors and hospitals for non-research related activities dropped for the first time in 2020 since CMS’s Open Payments database began collecting the information. 

Advertising, Marketing & Sales Coronavirus COVID-19

Pink Sheet Podcast: Gene Therapy In Europe, Lilly’s Olympic TV Ads, 'Most Favored Nation' Rule

Pink Sheet reporters and editors discuss Bluebird Bio’s decision to pull its gene therapy business from Europe, Eli Lilly potentially pushing regulatory boundaries with its Olympic TV spots, and the CMS decision to scrap the Trump aministration’s most favored nation reimbursement rule.

Commercial Strategies Gene Therapy

Manufacturing Explore this Topic

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Latest From Manufacturing

USP Nitrosamine Impurities Chapter Reflects Careful Coordination With US, EU Authorities

The USP’s general chapter on nitrosamine impurities provides guidance on assessing risks and testing levels of the carcinogens in pharmaceuticals.

Manufacturing Quality

As COVID-19 Response Capacity Loans Languish, DFC Punts GAO’s Questions About It To DOD, HHS

Loan program launched in June 2020 to strengthen domestic supply chains for COVID-19 response was deluged with applications, but has not completed any loans, and the GAO has a good idea why.

Coronavirus COVID-19 Manufacturing

Resiliency Roadmap Update: US FDA Exceeds FY 2021 Inspection Projections

While better than one its ‘best case’ scenarios, FDA has completed just 31% of 15,514 domestic surveillance inspections planned for FY 2021, applications are still being delayed, and foreign inspections have for the most part yet to be tackled.

Manufacturing Quality
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