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Merck Molnupiravir Advisory Committee To Consider Pregnancy Risk, Viral Mutations

US FDA seems poised to authorize the oral COVID treatment, but panel discussion will likely highlight the limitations of the antiviral.

Advisory Committees Coronavirus COVID-19 Drug Review

Pfizer’s Comirnaty: Emerging Myocarditis Signal Drew Flurry Of Attention During Compressed BLA Review

Multiple offices within CBER worked to get a handle on the myocarditis issue in the midst of a three-month review of the COVID vaccine, with US FDA staff undertaking a quantitative benefit-risk assessment and negotiating with Pfizer on postmarket safety studies.

Drug Review Profile Vaccines Safety

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 Clinical Trials

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Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

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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.

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Equitable Access To Vaccines To Figure In Global Pandemic Treaty

Amid growing concern over the new Omicron variant of the coronavirus, member states of the WHO are gathering this week to discuss the negotiation of a convention on future pandemic preparedness and response, with access to medical countermeasures on the agenda. A parallel WTO ministerial meeting that would have discussed the proposed TRIPS IP waiver has been postponed until further notice.

Coronavirus COVID-19 Vaccines

UK MHRA On ‘Steep Learning Curve’ For Post-Brexit Safety Reporting

The UK medicines regulator has made changes to its guideline on pharmacovigilance procedures to ensure it can continue receiving all necessary safety information in a timely manner now that it has left the EU. It has also explained the safety reporting procedures for products marketed in Northern Ireland, which are still governed by EU medicines regulations. 

United Kingdom Drug Safety

US FDA’s Comirnaty Review By The Numbers

A timeline of the review and development of the first COVID-19 vaccine to win BLA approval.

Drug Review Profile Coronavirus COVID-19

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

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

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

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

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

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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

Equitable Access To Vaccines To Figure In Global Pandemic Treaty

Amid growing concern over the new Omicron variant of the coronavirus, member states of the WHO are gathering this week to discuss the negotiation of a convention on future pandemic preparedness and response, with access to medical countermeasures on the agenda. A parallel WTO ministerial meeting that would have discussed the proposed TRIPS IP waiver has been postponed until further notice.

Coronavirus COVID-19 Vaccines

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
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