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UK Retiring eSUSAR Portal For Reporting Clinical Trial Safety Issues

Study sponsors still using the MHRA’s eSUSAR website for trial safety reporting are being urged to update their processes by 30 September. 

Clinical Trials Brexit Regulation

Plans Press On To Harmonize Decentralized Clinical Trial Requirements In EU

Participants from all areas of the research community will be able to share their perspectives on decentralized clinical trials with the EU regulators, who plan to publish recommendations on the topic later this year.

Clinical Trials Regulation Europe

Patent Settlements and Medicare Negotiation: What Leverage Does Pharma Have To ‘Game’ Price Reform?

Brand drug companies might be able to use patent settlements with generic and biosimilar makers to get out of the drug price negotiations that will be created under the US legislation nearing enactment, but sponsors could run into regulatory and antitrust obstacles.

Legislation Pricing Debate Intellectual Property

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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: Enhertu, Nubeqa Grow With RTOR; Interchangeable Cimerli And Another Nuplazid CRL

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

United States US FDA Performance Tracker Approvals


Global Pharma Guidance Tracker – July 2022

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

New Graft Probes Cast Shadow Over China's Drug Pricing, Reimbursement Systems

While new legislation has pushed prescription drug pricing high up the political agenda for US lawmakers, the issue has also come into the spotlight again for Chinese regulators, which have just launched new investigations into two officials. While the two countries are taking drastically different routes to tackling pricing, the developments show compliance risks remain high in China.

China Reimbursement

One Year On, US FDA Generic Drug Cluster Focuses On Facilitating Collaboration

Following its inaugural year, the FDA’s Generic Drug Cluster has formed data sharing arrangements concerning a number of vital indications.

Generic Drugs Review Pathway

All Eyes On Rwanda As Africa Builds Up Regulatory & Manufacturing Abilities

The small central African country has been chosen to host the planned African Medicines Agency and is also set to be a key player in medicines and vaccines manufacturing technology on the continent.

Middle East and Africa Rwanda

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 Commissioner Califf Takes On Misinformation, Starting With ‘Rumor Control’

Agency leader expects to spend about a year developing a strategy to combat misinformation. On 5 August, the agency unveiled what appears to be an early component of the initiative – a web page titled Rumor Control, with facts about the safety and components of COVID-19 vaccines.

FDA Leadership

Maureen Kenny, 1963-2022

Kenny, a mainstay of our publications for three decades, has passed away in London.

Regulation BioPharmaceutical

Latest From Policy

Medicare Price ‘Negotiation’ : Manufacturer Compliance Gets Tougher Enforcement Provision

As legislation authorizing Medicare price 'negotiation' clears the Senate and appears on its way toward enactment after years of efforts by US congressional Democrats, and opposition by Republicans and the pharmaceutical industry, the bill continues to be tweaked.

Pricing Debate Medicare

Health System Reform Crucial For ATMPs

The difficulties in getting advanced therapies, such as Novartis’ CAR T therapy Kymriah, to patients have shifted and manufacturing capacity is no longer the biggest issue.

Europe Gene Therapy

Don’t Look Up? Congress Can’t Ignore Risk To Small Molecule Drugs In Pricing Bill, Investors Warn

A budget-neutral fix that would extend the time before small molecule drugs are subject negotiations but increase the minimum discounts for the products is floated as the pricing legislation moves toward a Senate floor vote.

Pricing Debate Medicare

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Latest From Research & Development

Monkeypox: Siga Says FDA Hasn’t Indicated Emergency Use Authorization An Option for Tpoxx

Siga CSO Dennis Hruby talked with the Pink Sheet about the company’s plans for development of Tpoxx for monkeypox in the US. If the necessary emergency declaration is made that would let FDA issue EUAs, the company would likely try to apply with its current clinical trial-less data set.

United States Clinical Trials

Coming Soon: New US FDA Opioid Plan

Commissioner Robert Califf said the new plan should be released in August and include prongs to continue fighting the ongoing prescription opioid epidemic, as well as confront a new synthetic fentanyl and methamphetamine problem.

Risk Management Neurology

US FDA’s Project Site Selector Kicks Off With A Look At Why Cancer Trials Go Overseas

Speed, logistics and global regulatory demands are all reasons why sponsors increasingly look outside the US to enroll cancer trials, industry reps say during the inaugural event for the Oncology Center of Excellence's new initiative; OCE director Pazdur says multiregional trials can help provide patients access to important new drugs quickly in the US or worldwide.

Clinical Trials Research & Development

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Lilly Needs Updated FDA Authorization To Sell COVID Antibody On Commercial Market

Biden administration will run out of supply of Lilly’s covid antibody bebtelovimab in August, forcing a shift to commercial market due to lack of funds. The transition will require changes to the emergency use authorization and involve a price hike.

United States Biologics

Podcast Special: The Shifting Landscape For Drugs And Devices Post-Roe v. Wade

A special podcast looks at the implications for FDA-regulated sectors, from the abortion pill and OTC daily and emergency contraceptives to intrauterine devices and period-tracking apps, of the US Supreme Court’s historic overturning of Roe v. Wade.

Legal Issues Gynecology & Urology

Citeline And Norstella Merge To Provide End-To-End Solutions For Pharma

Publisher’s Spotlight: Citeline, the publisher of Pink Sheet, is to merge with fellow pharmaceutical solutions provider Norstella.

Companies Commercial

Manufacturing Explore this Topic

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Latest From Manufacturing

All Eyes On Rwanda As Africa Builds Up Regulatory & Manufacturing Abilities

The small central African country has been chosen to host the planned African Medicines Agency and is also set to be a key player in medicines and vaccines manufacturing technology on the continent.

Middle East and Africa Rwanda

Novavax’s Vaccine Switched Manufacturing Facilities Multiple Times Prior To EUA

One switch raised questions, but by the time the COVID-19 vaccine reached commercial scale, the changes were considered minor.

Coronavirus COVID-19 Manufacturing

US FDA Explains How It Is Embracing Remote Assessments Post-Pandemic

Agency provides new details on plans for various remote methods of assessing manufacturing establishments that became popular when investigators were prevented by COVID-19 pandemic travel restrictions from visiting sites in person.

Manufacturing Drug Approval Standards
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