Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories



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 Vaccines

What Justice Ginsburg’s Death Means For Pharma

A more conservative US Supreme Court may mean a less authoritative FDA, and drug pricing won’t get as much attention in the presidential campaign, which is a good thing.

Legal Issues Elections FDA

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 M & A

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: 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

Set Alert for Policy & Regulation

Latest From Regulation

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

Virtual Advisory Committees: US FDA Clears A Big Test With OxyContin Meeting

Meeting to address opioid abuse crisis was also a trial of whether FDA could conduct important public business using online-only technology.

Advisory Committees Coronavirus COVID-19

Latest From Policy

US FDA Races To List Essential Medicines For Domestic Manufacture By White House Deadline

With list due 4 November, there may not be time for public comment. Meanwhile, where will biopharma find fill/finish capacity?

Manufacturing 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

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

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

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

Commercial Explore this Topic

Set Alert for Commercial

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

Set Alert for Manufacturing

Latest From Manufacturing

US FDA Races To List Essential Medicines For Domestic Manufacture By White House Deadline

With list due 4 November, there may not be time for public comment. Meanwhile, where will biopharma find fill/finish capacity?

Manufacturing Policy

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
UsernamePublicRestriction

Register