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Hahn Says COVID Vaccine Review Could Take Months As Trump Floats Rejecting New EUA Guidance

Commissioner’s comments were yet another sign that US FDA won’t clear a vaccine ahead of the election, but hours later the president suggests the White House may decline to clear the agency’s new guidance on emergency use authorization standards for COVID-19 vaccines, raising new concerns about political interference in any decisions.

Coronavirus COVID-19 Vaccines FDA

Off-Label Use: US FDA Backs Away From ‘Totality Of Evidence’ Standard In Proposed Reg

New proposed rule says a manufacturer’s knowledge of the unapproved use of a product does not alone determine intended use. Former FDA lawyer says rule could set off fireworks over the scope of what the agency considers evidence of off-label use.

FDA Advertising, Marketing & Sales Regulation

EMA Pushes For More EU Support For COVID-19 Vaccine Work

Preparing for the assessment and post-approval monitoring of COVID-19 vaccines is taking up a lot of resources at the EMA, which has called on the European Commission to provide more support for such activities. The agency has also confirmed that no data have yet been submitted for its planned rolling reviews of potential vaccines.

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

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

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

China Regulatory Express: What You Need To Register Drugs

China releases technical requirements for foreign drug makers to register their chemical drugs in the country, and issues patent linkage details, which a legal expert says needs to be closely examined.

Regulation Review Pathway

Could A COVID-19 Vaccine Gain EUA Without Sponsor Cooperation?

The possibility, which seems driven by the culture of the times, may be legally possible, but experts raised many practical concerns.

Coronavirus COVID-19 Vaccines

New Canadian Rule Allows Rolling Data Submissions For COVID-19 Drugs, Vaccines

The Canadian authorities have put in place an expedited pathway for authorizing new COVID-19 drugs and vaccines that offers a more agile approach to reviewing data than what was previously allowed.

Coronavirus COVID-19 Canada

‘No Turning Back’ On Regulatory Changes at UK MHRA

The UK medicines regulator has a “unique opportunity” to evaluate the systems it operates and to “do things differently", according to its long-term interim head, June Raine.

United Kingdom Regulation

Latest From Policy

‘March In’ Plan Unveiled By Democratic Think Tank: A Battle Biopharma Would Welcome?

In sign of how much has changed in four years, industry might be better off if Biden takes CAP’s advice and launches ‘march-in’ actions to address pricing of COVID products.

Pricing Debate Intellectual Property

Biden's Drug Pricing Administrative Actions Could Focus On Medicare Demos

Center for American Progress suggests pricing reforms for the 'next Administration' in lieu of legislation.

Elections Pricing Debate

Six Pharma CEOs To Testify In House as Democrats, Trump Compete For Attention On Drug Pricing

While neither party is likely to make any big policy changes this year, the action from both sides of the aisle indicates politicians still see going after pharma as a winning issue with voters even as polls show voters are focused elsewhere. 

Pricing Debate Elections

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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