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‘A Forever Battle:’ Patent Reform, Launch Prices, And Where Lower Rx Price Advocates Will Go Next

Pharma’s opponents believe passage of the Inflation Reduction Act represents a momentum shift that will make it easier for politicians (even some Republicans) to take on the industry. They’ll need to count on that as they still have a long list of targets ahead on their lower-drug pricing agenda.

Pricing Debate Legislation Intellectual Property

Advanced Therapies: Payment Revolution Must Accompany Industrial Revolution In Europe

The advanced therapies sector is undergoing something of an industrial revolution, but access issues for products coming to market remain, says Miguel Forte, CEO of Bone Therapeutics. However, there are opportunities to create a better environment for the sector, including regulatory change and more harmonization of HTA processes.

Europe Market Access Gene Therapy

What Might FDA Do Post Roe? Eliminate Mifepristone REMS

Attorneys say the biggest step FDA could take to expand access to medication abortion would be to eliminate REMS requirement for mifepristone. Timeline notes steps Biden administration and Congress have taken since the Supreme Court’s ruling overturning the right to an abortion.

FDA Drug Safety Politics

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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

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

Pink Sheet Podcast: Monkeypox Vaccine EUA, Drug Pricing Bill Fallout, US FDA’s IT Upgrade

Pink Sheet reporters and editor discuss the new monkeypox vaccine EUA, the potential impact of drug pricing legislation, and how things may have been different if the FDA already had a desired technology upgrade.

Infectious Diseases Pricing Debate

Study Offers Support For Biosimilar-To-Biosimilar Switching

A new paper has examined the issue of biosimilar-to-biosimilar switching, concluding that it is a safe and effective clinical practice but highlighting a lack of current health authority regulations or guidance on the subject.

Biosimilars Regulation

EU Boosts COVID-19 Vaccine Supplies With Moderna & HIPRA Deals

New supply arrangements with the two firms are expected to offer greater protection to people in Europe as the autumn/winter season approaches. The EU’s health crisis preparedness body HERA has also identified its “top three health threats.”

Europe Coronavirus COVID-19

UPDATED: Who Can Sign US FDA EUAs? Expect Center Directors And Their Deputies Going Forward

Agency policy now allows several others, along with the FDA chief scientist, to authorize emergency use of products, including CBER Director Peter Marks, who signed the EUA for the modified dosing of the monkeypox vaccine.

Leadership Review Pathway

EQRx Revises Plans To Get Chinese Licensed Drugs To US Market

The company has filed its first drug in the UK and initiated a US-based Phase III trial; US drug pricing legislation underscores the company's value proposition, CEO argues, since payers will still be under pressure.

Clinical Trials Cancer

Latest From Policy

Lost In Translation? New Zoonotic Virus Naming Gets China's Largest Physician Platform In Trouble

China's largest physician portal DXY has been banned from posting on a major social media platform after naming a new zoonotic virus after the place where it originated.

Coronavirus COVID-19 China

Patient-Focused Drug Development Events May Be Giving Way To Small, Private Meetings With FDA

Patient listening sessions, which are easier to schedule, have overtaken traditional patient-focused drug development meetings in terms of volume, although US FDA’s data may be incomplete.

Research & Development Review Pathway

Pediatric Disincentive? Implications Of US Pricing Bill

The ripple effects from the pending drug price reform legislation in the US would include fundamentally changing the math on the incentive to encourage pediatric research on new products.

Pediatrics Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

Patient-Focused Drug Development Events May Be Giving Way To Small, Private Meetings With FDA

Patient listening sessions, which are easier to schedule, have overtaken traditional patient-focused drug development meetings in terms of volume, although US FDA’s data may be incomplete.

Research & Development Review Pathway

Pediatric Disincentive? Implications Of US Pricing Bill

The ripple effects from the pending drug price reform legislation in the US would include fundamentally changing the math on the incentive to encourage pediatric research on new products.

Pediatrics Policy

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

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Latest From Commercial

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

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

Manufacturing Explore this Topic

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Latest From Manufacturing

US FDA Training Up Inspectorate To Oversee Quality Of Novel Manufacturing Technologies

Agency is hiring contractor to identify gaps in the ability of inspectors, investigators and compliance officers to oversee manufacturing quality in the context of new and emerging technologies – and to identify organizations that could fill the gaps through training.

Innovation Quality

Aspen Setback Illustrates Need For Africa To Build Up Vaccines Market

A coordinated effort will be needed if Africa is to increase its manufacturing capacity and ensure a market for domestically produced vaccines.

Middle East and Africa Vaccines

EMA To Update Active Substances Guide To Address Nitrosamine Contamination

The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions. 

Manufacturing Regulation
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