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UK Government Reveals New Statutory Pricing Scheme

The scheme still includes high rebate rates, but a controversial life cycle adjustment mechanism has been dropped.

Europe United Kingdom Market Access

Controversial EU Study On Pharma Innovation & Access Sees The Light Of Day

Members of the European Parliament committee charged with leading the negotiations on the review of the EU pharmaceutical legislation have been presented with a study backing cuts in data protection and wider joint procurement of medicines outside emergency situations.

Europe EU Legislative Reform Legislation

US FDA’s Marks Willing To Accept Gene Therapies Occasionally Not Confirming Benefit

CBER director does not want to hold back potentially beneficial products, but also warned that patients will have difficult treatment decisions to make since an immune response might prevent a patient from receiving another gene therapy using the same vector ever again.

Gene Therapy Review Pathway Regulation

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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: US FDA Drugs Center Passes 50 Novel Agent Approvals In 2023

AstraZeneca’s Truqap and Evive’s Ryzneuta bring FDA center for drugs’ 2023 novel agent total to 51, while biologics center already sits on a record-breaking 14 novel approvals.

US FDA Performance Tracker Approvals Drug Review

Global Pharma Guidance Tracker – October 2023

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


Multimedia

Patient-Focused Listening Sessions For Medicare-Negotiated Drugs: Key Takeaways From Round One

Pink Sheet infographic breaks down the mix of patient advocacy groups, individual patients and clinicians offering input to CMS on the first 10 drugs facing Medicare price negotiation.

Clinical Trial Diversity Plans: Early Oncology Experience Shows More Work Needed, US FDA Says

Few plans submitted to FDA’s oncology review divisions in the wake of the April 2022 draft guidance were deemed acceptable, with enrollment goals being the most common topic of agency feedback. However, representatives from FDA and industry say the regulatory demand for such plans is pushing sponsors to build diversity into clinical trial programs from the start.

Generics Review Data From US FDA Reveals Positives, Negatives For Industry

While a decline in complete response letters in FY 2023 is good, the continued drop in ANDA submissions could be a bad sign for the industry’s long-term health, a former FDA official worries.

Vanda Launches Barrage Of Suits Against FDA Seeking To Retain Hetlioz Market

In 17 suits against FDA in the last two years, firm seeks to block generics of its sleep-wake disorder drug and gain a jet lag indication. CEO Mihael Polymeropoulos tells the Pink Sheet that FDA has retaliated against Vanda for its first suit challenging a partial clinical hold on another drug.

Regional Comparisons

Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind

Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.

Watching The Clock Stop: US/EU Regulatory Review Time Parity In Sight, Study Suggests

European Union reform proposals could reduce ‘clock stop’ time in drug reviews, which a new study identified as the primary driver of longer review times at the EMA compared with the US FDA.

International Regulators Say Collaboration Is Key To Tackling Pharma Globalization Challenges

Regulators from Canada, the UK and Australia discuss their experiences of working together under both the ACCESS Consortium, an international regulatory worksharing coalition, and Project Orbis, a parallel review process designed to speed up access to oncology medicines.

Project Orbis: More Cancer Drugs Available In Scotland Than England

The UK joined Project Orbis in 2021 with the aim of speeding up the regulatory process for promising cancer drugs, but fewer than half of the drugs licensed under this pathway are available on the NHS in England.

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Recent Stories

FDA Is ‘Getting More Aggressive’ In Going After Drug Efficacy Claims Outside Label

Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.

BIO’s New CEO Is Biotech Industry Veteran With Compelling Family Story, Ready To Take On The IRA

John Crowley will take the reins at BIO in March, about a year and a half after the departure of former CEO Michelle McMurry-Heath was announced.

Patient-Focused Listening Sessions For Medicare-Negotiated Drugs: Key Takeaways From Round One

Pink Sheet infographic breaks down the mix of patient advocacy groups, individual patients and clinicians offering input to CMS on the first 10 drugs facing Medicare price negotiation.

Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind

Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.

Preterm Birth Patients Sought By US FDA As Meeting On Treatment Development Looms

With the only FDA-approved treatment off the market, the FDA is looking for ideas for development of new preterm birth treatments.

US Supreme Court Seems Convinced Purdue Bankruptcy Plan Should Go Forward

Justices acknowledged that the release of the Sackler family from civil liability is a boon for them but appeared averse to rejecting a plan that is supported by the vast majority of victims of the opioid crisis.

US FDA’s START Program Might See Expanded Funding If Pilot Meets Speed Goals

The program bringing Operation Warp Speed-like treatment to rare disease product development could expand if successful, but will require more employees and thus funding commitments from Congress and industry, CBER Director Peter Marks said.

Did Product Quality Decline While US FDA Inspectors Were Away?

Academics assert more should be done to restore pre-pandemic site-inspection activity levels, especially abroad, following analysis of 10 years of data on US FDA inspection trends, costs and resources published in Health Affairs. 

Clinical Trial Diversity Planning Requires Prevalence-Based Enrollment Goals, Metrics For Gauging Success

Academic and industry experts caution against relying on historical enrollment numbers when setting new targets for under-represented populations and tout real-time monitoring dashboards, as well as a role for data monitoring committees, in assessing whether targets are being met in ongoing studies.

Bigger Trials, More RWE Needed for Future Crisis Response, Say EU Regulators

A report from the EU medicines regulatory network looks at what was done well in the response to the COVID-19 pandemic, and what needs to be improved if we are to be better prepared next time. 

The Next Big PBM Deal? Rumored Cigna-Humana Talks Raise Overlap Question

Vigorous regulatory scrutiny is a given, but opinions vary about how much the companies’ respective PBM businesses present a major antitrust risk.

Clinical Trial Diversity Plans: Early Oncology Experience Shows More Work Needed, US FDA Says

Few plans submitted to FDA’s oncology review divisions in the wake of the April 2022 draft guidance were deemed acceptable, with enrollment goals being the most common topic of agency feedback. However, representatives from FDA and industry say the regulatory demand for such plans is pushing sponsors to build diversity into clinical trial programs from the start.

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