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

Featured Stories



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 Health Technology Assessment

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 Coronavirus COVID-19

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 Drug Review

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

Read More...

Latest News

Pink Sheet Podcast

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

More Podcasts

Performance Trackers

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

News and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Review Pathway Drug Review


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

Set Alert for Policy & Regulation

Latest From Regulation

COVID-19 Redefining Clinical Trial Transparency Expectations & Challenges

A senior Pfizer executive talks about the high regulatory expectations for public disclosure of clinical trial data for Comirnaty, the COVID-19 vaccine it developed in partnership with BioNTech. There were also concerns about re-identification of trial participants as many subjects took to social media to share their experiences with the Comirnaty study.

International Clinical Trials

Oncopeptides Rescinds Pepaxto Voluntary Withdrawal, Which Could Set Up Battle With US FDA

After more review of clinical trial data, the myeloma drug’s sponsor wants to talk to the FDA again, but Oncopeptides execs said they cannot disclose the scientific details that led to the decision.

Clinical Trials Drug Approval Standards

China Aims To Synchronize With Global Drug Approvals By 2025

China’s new Five-Year Plan for drug quality aims to address hurdles in clinical study ethics committee review while leaving out other restrictions including genetic material export and substandard clinical sites.

China Approvals

Coronavirus Notebook: Australia OKs Paxlovid, Lagevrio & Nuvaxovid, New Sputnik Data Show ‘Strong Protection’ Against Omicron

International regulators have broadened their discussions on the possible use of bivalent and multivalent vaccines, and the French presidency of the Council of the EU has called for “international solidarity” on vaccine provision.

Europe International

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

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

Latest From Policy

Beyond Vaccines: CDC's ACIP To Look At Antibodies For Respiratory Syncytial Virus Prevention

New maternal/pediatric work group will consider recommendations for use of RSV vaccines and monoclonal antibodies targeting protection of children <18 years. With several products in the late-stage pipeline, group has begun reviewing RSV epidemiology and discussing cost-effectiveness.

Advisory Committees Cost Effectiveness

US CDC Panel’s Pneumococcal Vaccine Recommendations Leave Confusion In Their Wake

Advisory Committee on Immunization Practices’ October vote on use of Pfizer’s Prevnar 20 and Merck & Co’s Vaxneuvance was more restrictive than intended, inadvertently leaving out guidance for people who were previously vaccinated with Prevnar 13.

Vaccines Advisory Committees

‘Skinny Label’ Litigation: Generic Firms Rethinking Strategy, May Pursue Legislation

Generic manufacturers are being cautious on label carve-outs to avoid claims of induced infringement. Bright line rules are necessary, attorney says, and if GSK v. Teva decision is not reversed, legislation will be needed to preserve skinny label. Insurers also face potential liability for placement of skinny-label generics on formularies.

Generic Drugs Intellectual Property

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

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

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

‘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

Commercial Explore this Topic

Set Alert for Commercial

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

Set Alert for Manufacturing

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
UsernamePublicRestriction

Register