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Featured Stories

Pfizer Appears Slightly Ahead Of Moderna In COVID-19 Vaccine Race

Neither has announced a firm timeline, and the difference between Pfizer's 'October' and Moderna's 'November' could be mere hours or a few weeks, but Pfizer, by dint of luck or experience, is now in a position to offer the more optimistic projection on when it will seek an EUA. Both firms release their Phase III trial protocols, which seem in line with US FDA guidance.

Vaccines Clinical Trials Coronavirus COVID-19

EMA Aims For Better Info On Benefit-Risk Balance To Support Drug Choices In Pregnancy

The European Medicines Agency is developing a strategy to ensure that women have sufficient information to make informed choices about taking medicines during pregnancy and breastfeeding.

Europe Drug Safety Regulation

340B Showdown: HHS Facing Mounting Congressional Pressure To Halt Pharma Challenges

Bipartisan congressional letters seek relief from HHS but the Trump Administration has taken aim at 340B providers itself and may not be inclined to help.

Pricing Strategies Medicaid Legislation

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: Gavreto, Sogroya Bring Annual CDER Novel Approvals To 40; New Analgesic Products Make It Past US FDA

The latest drug approval 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

Pfizer COVID-19 Vaccine Trial Diversity Slips As Enrollment Rises, Unlike Moderna

Trial diversity is among the issues that stakeholders worry could hinder vaccine uptake.

Coronavirus COVID-19 Clinical Trials

Pink Sheet Podcast: COVID-19 Stresses Manufacturing, Vaccine Placebo Controls, Thorny FDA Precedents

Pink Sheet reporters and editor discuss the pandemic’s effects on non-coronavirus-related product manufacturing, US FDA efforts to ensure vaccine sponsors maintain placebo controls once a product is available, and precedents that burden the agency.

Coronavirus COVID-19 Vaccines

First EMA Nod For Generic Xarelto; Apotex Pulls Upkanz For Neurodegenerative Disease

While Accord HealthCare has convinced the European Medicines Agency that its rivaroxaban generic should be approved in the EU, Bayer has warned that patent protection for Xarelto continues until at least late 2023. The EMA this week also recommend approval for a number of other new drugs.

Drug Review Europe

EMA Endorses Use Of Dexamethasone In COVID-19

Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.

Europe United Kingdom

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

UK Presents New Licensing Pathway For Innovative Drugs

A “powerful new vision” for the post-Brexit UK regulatory framework was unveiled at a conference organized by the BioIndustry Association and the medicines regulator, the MHRA.

United Kingdom Regulation

Latest From Policy

Waylivra Funding Success In England & Germany

Akcea Therapeutics has lowered its asking price in England for its antisense therapy for familial chylomicronaemia syndrome. It has also struck a pricing and reimbursement deal for the drug in Germany.

Germany United Kingdom

World First Or Beating The US? China Ups COVID-19 Vaccines Game

Touting its coronavirus vaccines as a "global public good", China is quietly preparing for the first general approvals and launches, possibly within weeks, developers say. But who will be first in line to receive them? And at what cost? Distribution and pricing are just some of the unanswered questions.

China Coronavirus COVID-19

COVID-19 Vaccines: US Distribution Plans Include ‘Data Lake’ For Centralized Tracking

Most vaccines will be distributed centrally by McKesson, but those with ultra-cold storage requirements will be shipped directly from the manufacturer to the vaccination site. Data exchange system will enable public and private databases to talk to each other and help ensure individuals receive timely revaccination with a second dose of the same vaccine regardless of location.

Coronavirus COVID-19 Vaccines

Clinical / R&D Explore this Topic

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Latest From Research & Development

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

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

Lilly’s Olumiant Could Get Blood Clot Redemption With EUA For COVID

When the US FDA approved Olumiant (baricitinib) for RA, it insisted on a lower dose because of fears of blood clots. Now that an NIH trial has shown that the product plus Gilead’s Veklury (remdesivir) provided a statistically significant reduction in time to recovery versus remdesivir alone for hospitalized COVID patients, Olumaint may get an emergency use authorization from FDA to treat a condition that itself causes blood clots. That doesn't mean the black box is going away; it's just a reminder that there is as much magic and mystery to medicine sometimes as there is science. 

Coronavirus COVID-19 Clinical Trials

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Latest From 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

Countering Coupons: Large Employers Will Boost Copay Accumulator Programs In 2021

Annual large US employer health benefits survey also evaluates plans for managing the cost of cell and gene therapies in the coming years, anticipating growing use of outcomes-based contracts, but very limited uptake of payment-over-time models.

Gene Therapy Private Payers

Manufacturing Explore this Topic

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Latest From Manufacturing

Deadly COVID-19 Hand Sanitizer Production Surge Prompted US FDA's New Import Alert Category

New import alert category and border testing required after reduced standards put dangerous sanitizers into hands of US consumers.

Manufacturing Quality

US FDA Assesses Over 500 Biopharma Plants Remotely Via Records Review; Refines Process

Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.

Quality Compliance

New COVID-19 Vaccines May Be Accelerated By Using Existing Manufacturing Platforms, US FDA's Marks Says

FDA's CBER director says the development of new COVID-19 vaccines can be accelerated by using manufacturing platforms developed for other types of vaccines, thereby reducing the need for product-specific data.

Manufacturing Quality
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