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Featured Stories

US FDA’s Two-Month Safety Window For COVID Vaccines Based On Adverse Events In Other Products

In remarks fleshing out the ‘EUA Plus’ guidance before it became a political football, Operation Warp Speed’s Slaoui said that an FDA analysis concluded that 90% of adverse events related to vaccination take place within the first 42 days.

Coronavirus COVID-19 Politics Vaccines

'Sakigake' Treatment Gives Enhertu Rapid Japan OK For Gastric Cancer

Japan approves a batch of new products and indications, including Daiichi Sankyo's Enhertu in a high-need indication after a rapid review and Takeda's Zejula, which will be made available to selected patients before its reimbursement listing.

Japan Approvals Regulation

EMA Consults On Using Registry Studies As RWE Source

A draft EU guideline explains how disease registries can be used to supplement evidence in the pre-authorization phase and provide infrastructure for post-authorization evidence generation.

Clinical Trials Guidance Documents Europe

Latest News

Coronavirus 2019-nCov novel coronavirus concept resposible for asian flu outbreak and coronaviruses influenza as dangerous flu strain cases as a pandemic 3d rendering

COVID-19 Pipeline Tracker

Product candidates in development worldwide to address the 2019-nCoV pandemic, categorized by treatment and prevention. Subscription required.

View Tracker

Performance Trackers

Keeping Track: New Nucala Indication; BMS’ Ide-Cel Clears Filing Hurdle; First Applications From Telix And ADC Therapeutics

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

US FDA Performance Tracker Approvals Drug Review

Global Pharma Guidance Tracker – August 2020

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

Televise The COVID-19 Vaccine Advisory Committee Meetings

With the meetings available on television, access can be assured for just about everyone, and the US FDA can avoid another gut punch to its credibility.

Advisory Committees FDA

US FDA Talking Tough On ANDAs, Says Extensions On Complete Responses Need Justification

But most generic sponsors already give reasons for needing more time to respond to a complete response letters, so the status quo may not change despite the new guidance.

Generic Drugs Complete Response Letters

Biogen's Aducanumab Advisory Committee Will Test US FDA's 'Substantial Evidence' Flexibility

Given inconsistent study results, robustness of the efficacy evidence is expected to be key focus of the 6 November meeting of the Peripheral and Central Nervous System Drugs Advisory Committee; review could put a December 2019 guidance on the ‘substantial evidence’ standard to the test and offer insight into the amount of flexibility the agency is willing to exercise for neurodegenerative diseases with high unmet need.

Advisory Committees Drug Approval Standards

Italy: Pharma May Have To Disclose Confidential Info Under New Pricing Rules

Drug companies have their last chance to negotiate which documents and information Italy’s regulator, AIFA, will be entitled to request of them when they submit pricing and reimbursement applications.

Health Technology Assessment Italy

UK/EU Industry ‘Still Working In The Dark’ On Post-Brexit Regulation

As the final scheduled round of post-Brexit trade talks begins amid growing concern over the prospect of a deal and the pervasive threat of COVID-19, the pharmaceutical industry in the UK and the EU have issued an urgent call for an MRA on medicines GMP. They also want to see a one-year phase-in of medicines-related aspects of the Northern Ireland Protocol.

Europe United Kingdom

Pink Sheet Podcast: US FDA Power Plays, Vaccine EUA Without The Sponsor, RBG’s Impact On Pharma

Pink Sheet reporter and editors examine the struggle over the FDA’s reputation, whether a coronavirus vaccine could be made available without sponsor cooperation, and the late Supreme Court Justice Ruth Bader Ginsburg’s legacy for pharma.

Coronavirus COVID-19 FDA

Latest From Policy

COVID-19 Vaccines: HHS Advisory Committee Urges ‘Great Caution’ On Use Of EUA

Biologics license application is preferred route to market, but if emergency authorization is given it should happen with full transparency and be communicated in a clear manner to strengthen public confidence, National Vaccine Advisory Committee says.

Coronavirus COVID-19 Vaccines

Italy: Pharma May Have To Disclose Confidential Info Under New Pricing Rules

Drug companies have their last chance to negotiate which documents and information Italy’s regulator, AIFA, will be entitled to request of them when they submit pricing and reimbursement applications.

Health Technology Assessment Italy

US FDA’s First Amendment Defense

Before taking over the US health department, Alex Azar helped bring landmark litigation challenging the scope of FDA’s regulatory authority under the First Amendment. Now his tenure is ending with a First Amendment defense of the agency.

Advertising, Marketing & Sales Legal Issues

Clinical / R&D Explore this Topic

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Latest From Research & Development

J&J COVID Vaccine: Single-Dose Format Will ‘Expedite’ Phase III Trial

Effectiveness can be evaluated more quickly because researchers won’t have to wait for the second dose, company executive notes during briefing on the launch of the Phase III study.

Coronavirus COVID-19 Vaccines

Gilead’s Immunomedics Buy: Five Things To Worry About

Acquisition is based on the prospects for Immunomedics’ Trodelvy, but regulatory changes, manufacturing challenges, and research dynamics could upset even the best-laid plans.

Clinical Trials Commercial

Coronavirus Notebook: EU Invests In Convalescent Plasma, ACT-Accelerator Wants More Vaccines

InflaRx and Relief Therapeutics/NeuroRx are investigating potential new treatments for COVID-19-induced pneumonia and for coronavirus-related ARDS.

Europe Switzerland

Commercial Explore this Topic

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Latest From Commercial

Gilead’s Immunomedics Buy: Five Things To Worry About

Acquisition is based on the prospects for Immunomedics’ Trodelvy, but regulatory changes, manufacturing challenges, and research dynamics could upset even the best-laid plans.

Clinical Trials Commercial

Novavax Push For COVID-19 Vaccine Manufacturing Capacity Delays Flu Vaccine Application

As CEO Erck touts that its COVID vaccine has the 'best data,' Novavax prepares to enter Phase III trials and inks deal with Serum Institute to boost production even as its 'almost a perfect flu vaccine' remains on hold.

Vaccines Manufacturing

Webinar Recording: India Supply Chain Issues Against The Backdrop Of COVID-19

Join Anju Ghangurde and Vibha Ravi in this recorded session from Informa Pharma Intelligence's recent 24-hour webinar series on COVID-19: Lessons Learned And A Path Forward.

India Coronavirus COVID-19

Manufacturing Explore this Topic

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Latest From Manufacturing

UK/EU Industry ‘Still Working In The Dark’ On Post-Brexit Regulation

As the final scheduled round of post-Brexit trade talks begins amid growing concern over the prospect of a deal and the pervasive threat of COVID-19, the pharmaceutical industry in the UK and the EU have issued an urgent call for an MRA on medicines GMP. They also want to see a one-year phase-in of medicines-related aspects of the Northern Ireland Protocol.

Europe United Kingdom

McKesson Tapped For COVID-19 Vaccine Kits To Meet 1 October Distribution Goal

US HHS turns to COVID-19 vaccine distributor to assemble vaccine administration kits, citing revised vaccine delivery schedule.

Coronavirus COVID-19 Distribution

FDA Officials Cite Reasons For Denying Application Reviews Over Data Integrity Breaches

Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.

United States BioPharmaceutical
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