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NICE Board Approves Landmark Changes To Increase Flexibility Of Drug Evaluation Methods And Processes In England

Big changes are in store at UK health technology assessment body NICE aimed at improving the way medicines are assessed.

United Kingdom Cost Effectiveness Health Technology Assessment

Pfizer’s COVID-19 Vaccine Data In Young Children Could Place US FDA In Awkward Position Again

The agency is considering how to move forward as Pfizer studies a third shot after missing an efficacy endpoint in children age 2 to 5.

Coronavirus COVID-19 Vaccines Clinical Trials

Paxlovid Prescribing Complicated By Dosing Adjustment For Renal Impairment, Drug-Drug Interactions

In the EUA for Pfizer’s COVID-19 oral antiviral treatment, US FDA required a reduced dose for some renally impaired patients that is ‘incongruent with how Paxlovid is packaged,’ meaning that pharmacists have to manually make changes to each blister pack. Prescribers will have to navigate an extensive list of contraindicated medicines due to CYP3A effects.

Drug Review Coronavirus COVID-19 Review Pathway

Spotlight On Coronavirus

EU Bodies Back Mix-And-Match Approach For COVID-19 Boosters

New advice on the use of "mix-and-match" primary and booster vaccine regimens has been published by the EMA and the ECDC, while a new CEPI-supported clinical trial will test heterologous booster combinations involving Medigen’s COVID-19 vaccine and other jabs.

Europe Coronavirus COVID-19

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Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

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Performance Trackers

Keeping Track: Idorsia’s Quviviq Is FDA’s First Novel Approval Of 2022; AbbVie’s Rinvoq Gains Eczema Claim

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

US FDA Performance Tracker Approvals Complete Response Letters


Global Pharma Guidance Tracker – December 2021

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

US FDA’s New Drug Median Review Time Held Steady At Eight Months In 2021

The median review time for novel agents at CDER hasn’t changed in five years. Our infographic offers a look at the tortoises and hares (all of them winners because they got approved).

US FDA Performance Tracker Approvals

Keeping Track: Breakthrough Designations Fuel Expansion Of Genomically-Defined NSCLC Therapy

US FDA Performance Tracker Review Pathway

Pink Sheet Podcast: Makena Withdrawal Hearing, Califf And Trust In FDA, COVID-19 Pill Dispensing

Pink Sheet reporters and editors discuss how the hearings for the withdrawal of Avastin’s accelerated approval in breast cancer could inform the same process for Makena, Robert Califf’s view that public trust in the agency will be rebuilt, and a request to increase the dispensing fees associated with COVID-19 treatments Paxlovid and molnupiravir.

Drug Approval Standards Coronavirus COVID-19

IP Questions Could Dog The WHO's BioHub Pandemic Project

The World Health Organization’s BioHub project is gathering momentum, with the spotlight on the equitable and timely sharing of viruses and other biological materials to develop medical products for use in future health emergencies such as a pandemic. But while its objectives are lauded by many, concerns have been raised about the intellectual property implications of the project.

Pink Sheet Perspectives International

Molnupiravir To Reach 105 LMICs Through MPP Agreement

Almost 30 generics firms based across 11 countries have signed up to agreements with the Medicines Patent Pool to facilitate the supply of oral COVID-19 treatment molnupiravir to 105 low- and-middle-income countries. The move follows an agreement signed in October by the MPP with Merck.

International Coronavirus COVID-19

Hits, Misses & Key Firsts For EMA’s PRIME Scheme

The rate at which investigational drugs were accepted onto the European Medicines Agency’s priority medicines scheme dropped in 2021. Meanwhile, more much-needed treatments that had been developed under the scheme went on to win EU marketing approval.

Europe Research & Development

Latest From Policy

Medicare’s Final Coverage Decision On Alzheimer’s Drugs: Thoughts From A Former CMS Chief

Mark McClellan discusses whether CMS’s pending final version of the Medicare national coverage determination on Alzheimer’s drugs might change from the draft and whether the decision should be viewed as a precedent for drugs granted accelerated approvals.

Medicare Reimbursement

Better Discount To Bylvay £255,000 List Price Sways England’s NICE

Bylvay, the first licensed treatment for the rare liver condition PFIC, is cost effective, health technology assessment body NICE now says of the Albireo Pharma drug.

United Kingdom Cost Effectiveness

Republicans Ratchet Up Attacks On US FDA’s COVID Response

Pair of letters that target research focus and therapeutic review speed is a potential preview of the kind of oversight that the agency may be subject to if the GOP retakes control of the House this fall.

FDA Politics

Clinical / R&D Explore this Topic

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Latest From Research & Development

Hits, Misses & Key Firsts For EMA’s PRIME Scheme

The rate at which investigational drugs were accepted onto the European Medicines Agency’s priority medicines scheme dropped in 2021. Meanwhile, more much-needed treatments that had been developed under the scheme went on to win EU marketing approval.

Europe Research & Development

‘Challenges Ahead’ For Cell And Gene Therapy, Notes Catapult’s New Chairman McCubbin

The ex-GSK supply head Ian McCubbin will join the independent UK organization aimed at advancing cell and gene therapies, but notes issues with scale and manufacturing ahead.

Executive Changes Personalized Medicine

First Academic Sponsor On EMA’s PRIME Pledges Cheaper CAR-Ts

An investigational CAR T-cell therapy that hospital researchers in Spain believe they could produce at a third of the price of commercially available CART19 products has been accepted onto the European Medicines Agency's priority medicines scheme.

Europe Drug Review

Commercial Explore this Topic

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Latest From Commercial

Entry Reminder For Pharma Intelligence Awards Japan

The 4 February entry deadline is looming for the inaugural Informa Pharma Intelligence Awards Japan, which will be held in Tokyo on 12 May 2022 to recognize and reward the very best innovations and achievements in pharma and biotech, highlighting Japan's integral role in the global healthcare market.

Japan Commercial

J.P. Morgan Day 4: Preparing For The Year Ahead

Daily notebook from the virtual J.P. Morgan Healthcare Conference: Updates from Galapagos, Ipsen, LG Chem and Hanmi; experts discuss deal and financial outlook at Biotech Showcase, plus the impact of RMAT and the changing landscape for rare diseases. 

Companies Deals

Aduhelm & Medicare: HHS Reconsideration Of Premium Hike May Ease Blowback On Coverage

Biogen’s Alzheimer’s drug may not cause as much of a financial headache to American seniors as expected, which could dampen criticism of Medicare’s upcoming coverage determination. But questions remain about what exactly HHS will be able to do about Part B premiums.

Pricing Debate Medicare

Manufacturing Explore this Topic

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Latest From Manufacturing

The Quality Lowdown: More Inspection Delays, More Findings On Sterility And Investigations

US FDA hits firms in New Jersey, South Korea and China with warning letters. Meanwhile, Catalent and several outsourcing facilities work on Form 483 inspection findings as Mylan, Viona and Lohxa announce drug recalls.

Manufacturing Quality

Robotic Aseptic Filling Could Help Production, But Faces Regulatory Inconsistency

Use of robotic aseptic manufacturing techniques is increasing, but regulatory agencies are giving conflicting feedback, according to an industry executive. The dilemma points to the need for more development of and consistency in regulation for advanced manufacturing.

Manufacturing Quality

GAO Examines How US Learned To Use Defense Production Act More Effectively Against COVID-19

Report says agencies took steps to use DPA more effectively, but HHS still working on a strategy for DPA use that will strengthen domestic supply chains and manufacturing.

Manufacturing Regulation
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