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From Trial Hold To Post-EUA Surveillance: FDA Wants J&J To Monitor COVID-19 Vaccine Data For Clots

Safety data does not look to be a barrier J&J vaccine’s authorization, but FDA says it will recommend surveillance for further evaluation of thromboembolic events. The agency says it currently cannot rule out a causal relationship with the vaccine. One of these cases prompted a study hold last fall.;

Coronavirus COVID-19 Vaccines Drug Safety

UK: Commercial Framework Sheds Light On Working With NHS And NICE

The final text brings some changes, including the introduction of an escalation process when companies and NHS England cannot agree.

Europe United Kingdom Market Access

US FDA's Ebola Drug Approvals Showcase Efficiencies With Master Protocols

Agency approved Regeneron’s monoclonal antibody cocktail Inmazeb and Ridgeback’s mAB Ebanga on data from a multi-arm, adaptive trial in which several investigational agents were independently compared to a control group. Efficacy for both drugs was demonstrated on a mortality endpoint, with lingering uncertainties to be addressed through postmarketing studies.

Drug Review Profile Approvals Review Pathway

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Performance Trackers

Keeping Track: Novartis Entresto Wins Expanded Heart Failure Claim; Padcev, Vicineum Seek Bladder Cancer Approvals

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

Approvals Biosimilars Drug Approval Standards

Global Pharma Guidance Tracker – January 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

China Lays Out Requirements For Biosimilar Extrapolation

In what could be a blow to some aspiring developers eyeing the nascent but growing biosimilars market in China, new rules lay out when extrapolation of approved indications of reference biologics will be allowed, meaning this will not be automatic.

China Coronavirus COVID-19

Inmazeb Brought Regeneron A Priority Review Voucher, But Not The Type It Wanted

Sponsor preferred a tropical disease voucher because it could be redeemed for a supplemental application, but the FDA awarded a voucher under the medical countermeasures program, which prohibits redemption for supplements; agency says it takes a case-by-case approach to deciding whether tropical disease and rare pediatric disease vouchers can be redeemed for supplements.

Drug Review Profile Approvals

Regeneron's Inmazeb Overcame FDA Combo Product Requirements With Nonclinical Evidence

The individual contribution of the three mABs in Regeneron’s Ebola treatment could not be clinically tested due to the highly lethal nature of the disease and the potential for development of resistance; instead, the FDA accepted nonclinical data demonstrating the mechanism of action for each component.

Drug Review Profile Approvals

Inmazeb Clinical Development Timeline

Chronicle of the development and review of Regeneron’s REGN-EB3, a triple mAB combination treatment for Ebola infection.

Drug Review Profile Approvals

Ebanga Clinical Development Timeline

Chronicle of the development and review of Ridgeback Biotherapeutics’ ansuvimab-zykl for treatment of Ebola infection.

Drug Review Profile Approvals

EMA Works On Defining Metadata From RWD Sources

As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.

Europe Drug Approval Standards

Latest From Policy

Rebate Proposals Targeting Single-Use Vials May Be Barking Up The Wrong Tree

Policymakers should instead focus on increasing efficiencies in drug development, distribution and reimbursement, National Academies report says, while also seeking broad policies like HHS direct negotiation for drug prices in Medicare.

Pricing Debate Medicare

Biden Launches Effort To Strengthen US Pharmaceutical Supply Chain

Executive order calls for short-term and long-term study, broad consultation, coordination with allies.

Manufacturing Policy

Drug Pricing Among Range Of Issues Senators Want HHS Nominee Becerra To Work On

Senate Finance confirmation hearing concluded without a vote on Xavier Becerra’s nomination as Health and Human Services Department secretary. Republicans continued to express concerns with his background and views. But he is expected to win enough votes to clear the committee.

Pricing Debate Legislation

Clinical / R&D Explore this Topic

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Latest From Research & Development

Coronavirus Notebook: UK Pledges To Donate Surplus Vaccines, UN Chief Wants Global Vaccination Plan

Janssen-Cilag has asked for a WHO Emergency Use Listing for its vaccine candidate, while azelastine and carrageenan are both showing promise as potential treatments for COVID-19.

Europe United Kingdom

COVID Therapeutics Progress (Or Lack Thereof) May Be Political Vulnerability For US FDA

COVID treatments have not advanced as rapidly or as publicly as vaccines. That may trigger some issues for the US FDA as Congress digs into the next phase of the COVID response – and starts to assess agency performance and leadership after the crisis.

Coronavirus COVID-19 Clinical Trials

US FDA Could Be Facing Bolus Of Pandemic-Related Applications

Acting CDER Director Cavazzoni says it is ‘a very active time’ as many clinical trials for COVID-19-related products are expected to read out soon.

Coronavirus COVID-19 Drug Review

Commercial Explore this Topic

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Latest From Commercial

CEOs Face Grilling On Vaccine Supply In EU

AstraZeneca's CEO and other leaders from COVID-19 vaccine companies will face some tough questions in Brussels, but the European Commission wants to put differences behind it and solve the vaccine supply problem as soon as possible.

Companies Commercial

US FDA Commissioner Race: Transparency Comes To Forefront With Study Of Refuse-To-File Letters

Of the two main contenders to lead FDA, Josh Sharfstein is seen as much more likely to open up review decisions to public scrutiny, while Janet Woodcock might be a vote for the status quo and more deferential to industry concerns.

FDA Politics

COVID-19 Will Forever Change The Workplace, But Not Necessarily For The Better, Merck’s Frazier Says

Limiting interactions to two-dimensional settings will hinder collaboration, innovation and the mentoring of younger employees, Merck & Co. CEO Kenneth Frazier says. Frazier, who will retire in June, is looking forward to returning to public service but says ‘politics with a capital P is not my thing.’

Leadership Coronavirus COVID-19

Manufacturing Explore this Topic

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Latest From Manufacturing

US FDA Gives Industry An Extension On Nitrosamine Risk Assessments

Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.

Manufacturing Quality

Biden Launches Effort To Strengthen US Pharmaceutical Supply Chain

Executive order calls for short-term and long-term study, broad consultation, coordination with allies.

Manufacturing Policy

EU Regulators Take A Practical Approach To Addressing Nitrosamine Contamination

Regulators in the EU have decided on specific arrangements they plan to employ if sponsors detect and report nitrosamine impurities in their products being sold on the market.

Manufacturing Drug Safety
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