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



Like Sands Through The Hourglass, So Are The Days Of Woodcock’s Acting FDA Commissionership

Janet Woodcock has been a no-nonsense acting commissioner, but there’s plenty of drama in the nomination process as opposition and support for her to become permanent head of the US FDA continues to mount while the wait for President Biden’s nominee drags on.

FDA Leadership Politics

US Supreme Court Gives PTO Director Chance To Impact Outcome Of Patent Disputes

High court finds PTAB judges were unconstitutionally appointed; ruling is unlikely to benefit one party over another in inter partes review proceedings, attorneys say, but that could depend on the director. PTO is expected to provide guidance on how and when to request review of Patent Trial and Appeal Board decisions.

Intellectual Property Legal Issues Policy

EMA Doubles Number Of EU Early Access Approval Recommendations

The EU’s special provisions for speeding new products towards approval proved more popular than ever with drug sponsors last year.

Europe Approvals Regulation

Spotlight On Coronavirus

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: US FDA Clears Pfizer’s Prevnar 20; Dermavant Submits Tapinarof; Adamis Returns With Zimhi

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

US FDA Performance Tracker Drug Approval Standards Approvals

Global Pharma Guidance Tracker – May 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

Woodcock Highlights US FDA Opioid Plans Amid Sen. Manchin And Others’ Criticisms

The statement outlining opioid priorities in the FDA’s FY 2022 budget request comes on the heals of Sen. Manchin’s criticism of the acting commissioner and FDA opioid policy.

Legislation Leadership

UK Regulator Eyes Expedited Process For Securing Full ICH Membership

The UK is on a mission to re-join the International Council for Harmonisation as a fully active member with voting rights.

United Kingdom International

Keeping Track: StrataGraft Continues US FDA’s Biologic Center Approvals Streak; Another CRL For Avenue’s Tramadol IV

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

US FDA Performance Tracker Complete Response Letters

DTC Ads Might Inflate Medicare Drug Spending But Clear Cause-And-Effect Is Elusive, GAO Concludes

Sens. Durbin and Grassley hope report will help revive their flagging legislation that would require Rx ads to include list prices Senators claim that the Government Accountability Office concludes that direct-to-consumer spots for prescription drugs drives ‘drastic’ increases in Medicare costs.

Advertising, Marketing & Sales Medicare

US FDA Focuses On Harmonization With The Launch Of Generic Drug Cluster

To improve common standards for global development for generics and access to generics, FDA has launched the Generic Drug Cluster through the Global Generic Drug Affairs team established by the FDA’s Office of Generic Drugs. The agency has listed objectives through which it aims to increase scientific alignment among leading generic drug regulatory agencies. 

FDA Regulation

COVID-Era Trial Flexibilities, Equity Focus, Could Be Used To Reshape Cancer Study Enrollment

US FDA is open to keeping COVID-necessitated trial changes that may have had unexpected benefits. The agency is also looking at building on pandemic’s focus on health disparities and inequities to push for more generalizable and inclusive clinical trial designs.

Diversity & Inclusion Clinical Trials

Latest From Policy

How Do You Build A Clinical Trial Network Focused On Diversity?

Stakeholders discuss network models, barriers to their creation, and what is needed for them to be successful at PhRMA meeting.

Clinical Trials Diversity & Inclusion

DTC Ads Might Inflate Medicare Drug Spending But Clear Cause-And-Effect Is Elusive, GAO Concludes

Sens. Durbin and Grassley hope report will help revive their flagging legislation that would require Rx ads to include list prices Senators claim that the Government Accountability Office concludes that direct-to-consumer spots for prescription drugs drives ‘drastic’ increases in Medicare costs.

Advertising, Marketing & Sales Medicare

Medicaid Programs Should Be Able To ‘Compel’ Value-Based Contracts, State Association Official Says

Existing value-based contracts, which are voluntary for manufacturers, do not lower costs for states, National Association of Medicaid Directors executive director Matt Salo suggests.

Pricing Debate Medicaid

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

COVID-Era Trial Flexibilities, Equity Focus, Could Be Used To Reshape Cancer Study Enrollment

US FDA is open to keeping COVID-necessitated trial changes that may have had unexpected benefits. The agency is also looking at building on pandemic’s focus on health disparities and inequities to push for more generalizable and inclusive clinical trial designs.

Diversity & Inclusion Clinical Trials

US FDA Plans To Get Tougher On Oncology Dose Optimization

FDA’s Rick Pazdur notes that while the agency recently allowed Amgen to conduct a key dose comparison study for its landmark KRAS inhibitor post-market it will be less willing to do this in the future, particularly in settings that are less refractory.

ASCO Cancer

BIO Notebook: Going Fast And Being Precise

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

Clinical Trials Drug Safety

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

Sanofi/Merck Launch First 6-In-1 Combo Vaccine In US After Two-And-A-Half Year Supply Buildup

Five years after European licensure and launch, and 30 months after FDA approval, Vaxelis enters the US market offering an advantage of fewer shots than current pentavalent vaccines for protection against six diseases in children six weeks to four years old.

Vaccines Launches

BARDA Funding Freeze Risks Companies Abandoning COVID Therapeutic Work

BARDA’s suspension of funding for COVID-19 therapeutics risks repeating mistakes of past pandemics as it may cause industry to pull out of the development space, experts say. Industry sources are concerned the Biden administration is focusing on funding NIH at the expense of BARDA.

Coronavirus COVID-19 Research & Development

Pfizer’s Outlier Quarter, At Both Extremes

Investors are trying to wrap their minds around exactly how big Pfizer’s COVID vaccine business will end up being. But they also have questions about Pfizer’s prospects at the opposite end of the patient-population spectrum.

FDA Gene Therapy

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

PIC/S Wants To Know: What About ‘Authorized Persons’ For Batch Release Outside The EU?

International association of pharmaceutical inspectorates launches industry consultation on aligning with the one EU GMP provision it spurned years ago.

Manufacturing Quality

Domestic In-Person Inspection Work Could Be Back To Normal This Summer, Woodcock Says

Foreign facility visits may take longer to reach usual levels because of the ongoing coronavirus outbreaks in other countries.

Coronavirus COVID-19 Manufacturing

BIO 2021 Notebook: Biogen CEO On Corporate Responsibility

News and views from day four of the BIO Digital annual meeting include the FDA's plans to use carrots not sticks to improve diversity and reflections on how the pandemic has strengthened biopharmaceutical supply chains. 

Clinical Trials Companies
UsernamePublicRestriction

Register