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The Evolving Door? What Having A ‘Big Data’ Commissioner Might Mean For US FDA

Robert Califf’s nomination to return as FDA commissioner will raise protests about a ‘revolving door’ pathway between industry and agency. But, in this case, it may be more apt to talk about how Califf’s time outside FDA led to evolving views on the role of big data in drug regulation.

FDA Leadership Clinical Trials

Former FDA Commissioner Hahn Faces Questions From House On Trump Interference, Other COVID Issues

The request for an interview by the House Select Subcommittee on the Coronavirus Crisis seeks more information on the actions by President Trump and others to influence FDA decisions on HCQ, convalescent plasma, and vaccine decisions.

Coronavirus COVID-19 FDA Regulation

Medical Benefit, Hospital Drugs Exempt From Detailed Cost, Coverage Reporting In Final Rule

The most detailed US reporting requirements regarding prescription drug costs and coverage will target medicines reimbursed under the retail pharmacy benefit.

Pricing Strategies Reimbursement Policy

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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

EU Legislators Firm Up Commission’s Plans To Overhaul Pharma Rules

Efforts to overhaul the EU pharmaceutical legislation have been given added impetus after the European Parliament called for action to boost innovation and medicines access, shore up manufacturing and supply chains, and examine the link between R&D spending and drug prices.

Europe Legislation

EU Accelerated Assessment Tracker

The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from Roche and CSL Behring/UniQure.

European Performance Tracker Review Pathway

Health Canada Ponders UK Model On Easing Biosimilar Study Requirements

Discussions are ongoing at Health Canada on the feasibility of adopting the UK model of easing clinical study requirements for biosimilars, said director general Celia Lourenco at a recent event. Meanwhile, the US FDA’s stance is unchanged for now.

Regulation Biosimilars

Comirnaty mRNA Vaccine First To Get EU Clearance For Under-12s

The EMA is going all out to maximize coverage of the EU population with both vaccines and treatments for COVID-19.

Europe Coronavirus COVID-19

ICH Makes Progress On Tackling Safety Data ‘Overload’

Changes to an ICH guideline could help drug companies that are being deluged with post-approval safety information to cut down on noisy, low-value data.

Safety International

EMA Moves To Ensure ‘Smooth’ Evaluation Of Drug Approval Dossiers

Drug sponsors seeking centralized EU marketing authorizations now have the opportunity to have simpler pre-submission “interactions” with the European Medicines Agency six months before the submission to help avoid complications down the line. Full meetings may still be appropriate for complex issues such as requests for accelerated assessment or conditional approval.

Europe Drug Review

Latest From Policy

Pharma Will Need To Embrace More Inward-Looking China

The world’s second-largest economy is fast moving away from reforms and open to a "dual circulation" model, focusing on domestic market consumption while reducing export-driven production. Executives and investors shared views at a conference on whether multinational pharma firms are still welcome in China and what opportunities may lie in the drastic policy shift.

China Market Access

US CDC Panel Moves To Simplify Pfizer/BioNTech, Moderna COVID-19 Vaccine Booster Recommendations

Citing considerations of simplification, implementation and equity, Advisory Committee on Immunization Practices says everyone ages ≥50 years should get an mRNA vaccine booster dose and recommends all individuals ≥18 years have the option of getting one, without regard to occupational exposure or underlying medical conditions.

Coronavirus COVID-19 Vaccines

Pfizer Getting $529 Per Course For Paxlovid Under US Contract; Did Merck Drive A Harder Bargain?

US government is paying Merck & Co. around $181 more per course of treatment for its oral antiviral for COVID-19, molnupiravir, than it is to Pfizer for its competing drug.

Coronavirus COVID-19 Government Payers

Clinical / R&D Explore this Topic

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Latest From Research & Development

EU Legislators Firm Up Commission’s Plans To Overhaul Pharma Rules

Efforts to overhaul the EU pharmaceutical legislation have been given added impetus after the European Parliament called for action to boost innovation and medicines access, shore up manufacturing and supply chains, and examine the link between R&D spending and drug prices.

Europe Legislation

Califf Outlines Clinical Trial Reform Message, Which Could Travel With Him To Commissioner’s Office

US FDA commissioner-nominee Califf calls for streamlining clinical trial bureaucracy, as well as open access to clinical data.

Clinical Trials Research & Development

First Trials Report Reveals Uneven State of China Drug Development

Growing over 9% and domestic study sponsors take over 70% of the drugs in different stages, China clinical study sector attracts renewed interests post COVID, but underneath an uneven and less efficient field, noted a just released regulatory report.

Clinical Trials 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

EU Legislators Firm Up Commission’s Plans To Overhaul Pharma Rules

Efforts to overhaul the EU pharmaceutical legislation have been given added impetus after the European Parliament called for action to boost innovation and medicines access, shore up manufacturing and supply chains, and examine the link between R&D spending and drug prices.

Europe Legislation

US FDA ‘Quietly Working Hard’ To Develop Advanced Manufacturing Framework

Soon-to-be-released white papers will FRAME how FDA plans assess products manufactured with advanced technologies as part of an initiative to reduce uncertainty for sponsors.

Manufacturing Regulation

Voluntary Limits On Antibacterial Discharges Increase As Fear Of Resistance Grows

Pharmaceutical companies are ratcheting up voluntary efforts to control discharges of antimicrobials from their plants and those of their active pharmaceutical ingredient suppliers so they won’t contribute to antimicrobial resistance. But will it be enough to fend off regulation in countries like India?

Manufacturing Compliance
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