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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.;

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.

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.
Spotlight On Coronavirus
Biden Wants To Release More COVID-19 Vaccine, But Also Maintain Strategic Reserve
Rather than holding half of all vaccines produced to ensure administration of the second dose, only a portion would be held to cover for manufacturing or other problems.
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
US FDA Performance Tracker

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.
European Performance Tracker
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.
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.
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.
Inmazeb Clinical Development Timeline
Chronicle of the development and review of Regeneron’s REGN-EB3, a triple mAB combination treatment for Ebola infection.
Ebanga Clinical Development Timeline
Chronicle of the development and review of Ridgeback Biotherapeutics’ ansuvimab-zykl for treatment of Ebola infection.
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.
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.
Biden Launches Effort To Strengthen US Pharmaceutical Supply Chain
Executive order calls for short-term and long-term study, broad consultation, coordination with allies.
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.
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.
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.
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.
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.
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.
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.’
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.
Biden Launches Effort To Strengthen US Pharmaceutical Supply Chain
Executive order calls for short-term and long-term study, broad consultation, coordination with allies.
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.
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