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COVID-19 Vaccines: AstraZeneca’s UK Study Not Good Enough For US FDA Authorization, Slaoui Says

Operation Warp Speed chief scientific advisor confirms doubts about the Phase III data from two UK and Brazil studies; says efficacy results in US trials of AstraZeneca and Janssen vaccines expected by mid-January.

COVID-19 Vaccine 'Brexit Bonus' A Myth

The Pink Sheet explains the procedures underpinning the UK’s emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine.

United Kingdom Europe Coronavirus COVID-19

Pfizer’s Expected 2020 COVID-19 Vaccine Production Fell By 50% After Scaleup Delays

Pfizer is producing vaccine doses at scale now that it has buttoned down the manufacturing process.

Vaccines Manufacturing Quality

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: Keytruda Adds TNBC Claim; Finerenone, Brincidofovir, HTX-011 Submitted; CRL For Supernus’ ADHD Drug

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

US FDA Performance Tracker Drug Review Approvals

Global Pharma Guidance Tracker – November 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

UK Faces Distribution Challenges With Pfizer/BioNTech Vaccine

New guidance from the UK regulator covers distribution and deployment of Pfizer/BioNTech's COVID-19 vaccine, which will be complex because of the temperature storage requirements and the large packs in which the vaccine doses will be delivered.

United Kingdom Coronavirus COVID-19

Fauci Apologizes For UK V US Vaccine Comments: Not Better, Not Worse, Just Different

The UK’s rapid authorization of the Pfizer/BioNTech COVID-19 vaccine has sparked a public debate over regulatory processes at some of the world’s key regulatory bodies.

United Kingdom Coronavirus COVID-19

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

US FDA Expands Drug Development Tool Qualification Program With ISTAND Pilot

ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.

Clinical Trials Drug Approval Standards

Azurity’s Xatmep Promotional Email To Healthcare Professionals Gets Dinged By US FDA

In second letter this year targeting email communications, OPDP says that putting the methotrexate oral solution’s risk information below the signature block does not offer ‘prominence and readability’ comparable to the information on the drug’s effectiveness for the treatment of acute lymphoblastic leukemia that was in the body of the email.

Advertising, Marketing & Sales Cancer

CBER Will Need About A Week To Complete COVID Vaccine Assessment Following Advisory Cmte., Marks Says

Timeline is the most pessimistic public projection to date, but still incredibly fast. Clinical trial patients on placebo could be contacted and offered the vaccine after an EUA is granted.

Coronavirus COVID-19 Vaccines

Latest From Policy

What To Consider For German Orphan Drug Price Negotiations

The German pricing and reimbursement system has been successful in recognizing the value and uniqueness of orphan drugs.

Europe Germany

Medicare Walks Back Proposed Payment Policy For 505(b)(2) Physician Administered Drugs

CMS acknowledges stakeholders may need more details about the plan before it is finalized and a delay will give the agency more time to consider the issue.

Medicare Reimbursement

Canada Counters Drug Shortages With Export Bans

Canada has announced new restrictions on exports to help mitigate the impact of measures in the US to lower medicine prices there.

North America Canada

Clinical / R&D Explore this Topic

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Latest From Research & Development

With Warp Speed Decisions Already Made, Transitioning To Biden Admin Should Be No Trouble, Slaoui Says

As vaccines near availability, Moncef Slaoui says his full-time role at OWS may be ending. He has not met with the Biden Transition team, but notes that other Warp Speed officials have.

Vaccines Coronavirus COVID-19

Novavax May Seek COVID-19 Vaccine Emergency Authorization In US Based On UK Data

With its US/Mexico Phase III trial delayed due to manufacturing questions, Novavax has aligned its UK study with FDA guidance. It hopes for interim data from that study during Q1 2021.

Coronavirus COVID-19 Clinical Trials

Coronavirus Notebook: UK On Cusp Of First Vaccine Approval, Moderna To File mRNA-1273 in US & EU

Russia says it will make the first deliveries of its $10-per-dose Sputnik V vaccine in January, while international regulators say vaccine trials should continue for as long as possible to generate longer-term evidence on their benefits and risks. A UK research body has stressed that drugs repurposed for COVID-19 also need to undergo thorough safety and efficacy testing as reports suggest the UK regulator could approve a vaccine within days.

United Kingdom Russian Federation

Commercial Explore this Topic

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Latest From Commercial

Catchup Capsule: Key APAC Insights You Need To Read

Given its ever-growing role as a critical component of the global biopharma industry, you can’t afford not to be up to speed on Asia. This biweekly selection of insights from our experienced on-the-ground team will help.

Asia Pacific Coronavirus COVID-19

Lilly's US Bamlanivimab Contract Raises Difficult Allocation Considerations

The price of the antibody monotherapy for COVID-19 will be $1,250 per vial for wealthy countries. CEO David Ricks outlined the company's guidelines for pricing and distributing a limited supply.

Coronavirus COVID-19 Pricing Debate

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

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA Warning Letters Hit Two Firms For Slipshod Failure Investigations And Lax Approach to Cleaning

The US FDA tells manufacturers in two recent warning letters to get to the root cause of contamination problems and take a more proactive approach to cleaning and equipment maintenance.

Enforcement Manufacturing

Novavax May Seek COVID-19 Vaccine Emergency Authorization In US Based On UK Data

With its US/Mexico Phase III trial delayed due to manufacturing questions, Novavax has aligned its UK study with FDA guidance. It hopes for interim data from that study during Q1 2021.

Coronavirus COVID-19 Clinical Trials

US FDA Reaffirms Commitment To Resuming Domestic Inspections As Industry Frustration Grows

Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.

Manufacturing Complete Response Letters
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