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Monkeypox Vaccine: US FDA Eyes Dose-Sparing Strategy For Jynneos

Switching method of administration from subcutaneous to intradermal would increase by five-fold the number of doses of Bavarian Nordic’s vaccine available to combat the outbreak; an EUA declaration would be needed to make this change, FDA commissioner Robert Califf said.

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

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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

Some US FDA Decisions May Have Been Different If Technology Had Been Upgraded, Woodcock Says

Principal Deputy Commissioner Woodcock is overseeing an enterprise-wide technology campaign intended to improve access to agency information and data.

FDA Drug Review

Firms Advised To Prepare Now For New EU Patent System

After many delays and disagreements, Europe’s Unified Patent Court is expected to open its doors in the first quarter of 2023, offering a more cost-effective option for patent protection and dispute settlement in the EU. The new system includes the possibility of taking out a “unitary patent” offering EU protection in practically all the EU member states. A guide to the key points of the new system is shown below.

Europe Intellectual Property

Austria Cannot Offer Short Timelines For Reviewing Clinical Trials Under CTIS

Austria may not be part of an important monkeypox clinical trial taking place in several European Economic Area countries, but discussions on the study made the Austrian regulator realize its limitations in undertaking fast-track evaluations under the EU Clinical Trial Regulation.

Austria Clinical Trials

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

Latest From Policy

Part D Price Negotiation Round One: Several Likely Candidates May Not Feel The Cut

Heavily rebated drugs may already be meeting the price goals established by the Senate legislation. As a result, price negotiation for drugs covered under Part B are likely to yield greater savings to the Medicare program than Part D.

Pricing Debate Legislation

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

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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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