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Featured Stories

Playing The Trump Card On Rx Pricing

Obamacare repeal has been replaced by rebrand as Trump administration plans to use ACA’s Medicare demonstration powers to send discount cards to seniors, one of a slew of health care announcements that include Rx importation, pre-existing conditions, insulin and EpiPens.

Pricing Debate Elections Medicare

India’s Draft Guidelines For COVID-19 Vaccines Follow WHO, US Lead

India has rolled out draft guidelines for development of vaccines with special focus on COVID-19 vaccines, drawing from those of other regulatory bodies and the WHO. Experts suggest the primary efficacy endpoint of minimum 50% is acceptable given that vaccines against respiratory diseases are difficult to develop though not necessarily enough to snuff out a pandemic.

Regulation Coronavirus COVID-19 Clinical Trials

EMA Explains Dos And Don’ts Of New Clinical Trials Portal

Drug companies will be able to “play around” with the new EU Clinical Trials Information System in a secure testing environment before it goes live in approximately 15 months.

Europe Clinical Trials Regulation

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.

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Performance Trackers

Keeping Track: Terlipressin Falls Short Of US FDA Approval; Novel NDAs From Pfizer And Apellis; New BTDs For Sanofi, BeyondSpring

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

US FDA Performance Tracker Drug Review Complete Response Letters

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

EMA Has Work Cut Out Before New Clinical Trial Portal Goes Live

Companies are being encouraged to become “early adopters” of the EU Clinical Trials Information System when it goes live in December 2021.

Clinical Trials Europe

EU Politicians Squeeze Pharma Execs On Coronavirus Vaccine Contracts

With coronavirus cases again on the rise in many European countries, members of two EU parliamentary committees asked industry representatives to explain why details of COVID-19 vaccine supply agreements are being kept under wraps.

Europe Coronavirus COVID-19

Improve Access to RWD In Asia To Make RWE Viable

Industry access to real world data for regulatory and market access purposes in Asia Pacific compares poorly with the US.

Asia Pacific China

UK To Diverge On Biosimilar Data Requirements

The UK regulator wants to be a “catalyst for change” in reducing regulatory burdens, saying that better regulation based on science is in everyone’s interest.

United Kingdom Europe

European CHMP Opinions and MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Drug Review Europe

Remdesivir’s Path To Orphan Designation Could Be Exploited By Others, Experts Warn

Congress should give FDA more flexibility to administer orphan designations, such as the ability to revoke designations later if the disease prevalence grows beyond the rare disease threshold.

Rare Diseases Drug Review

Latest From Policy

New York State To Conduct Its Own Review Of COVID-19 Vaccines In Another Blow To FDA’s Reputation

Governor Cuomo will establish two panels, one examining safety and efficacy and another considering distribution and pricing, to advise the state on how to approach use of coronavirus vaccines once one is approved.

Pricing Debate Coronavirus COVID-19

Lilly’s 340B Restrictions: Jury Is Still Out On Appropriateness, But Optics Are Bad, HHS Says

Letter from department’s general counsel responds to request from the company for a pre-enforcement advisory opinion. Despite the letter, Lilly maintains its ‘limited distribution program is fully consistent with applicable laws and regulations.’

Pricing Debate Pricing Strategies

Improve Access to RWD In Asia To Make RWE Viable

Industry access to real world data for regulatory and market access purposes in Asia Pacific compares poorly with the US.

Asia Pacific China

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

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

Continuous Manufacturing Centers Of Excellence Measure Resurfaces In US House

Stand-alone bill headed for Senate, where it fared poorly in coronavirus response legislative packages.

Manufacturing Legislation
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