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Aduhelm Approval Raises Concerns About US FDA Leadership, Senate Finance Chair Suggests

Ron Wyden points to expectations Biogen’s drug will impose a heavy cost burden on Medicare as he questions FDA’s decision to approve aducanumab. He also expresses interest in a government-sponsored technology assessment program that could help establish the value of drugs.

FDA Pricing Debate Regulation

Alzheimer’s Can Follow HIV And Become Chronic Condition If Science Advances, Woodcock Argues

The acting US FDA commissioner equates drug development in the neurodegenerative diseases to work on HIV.

Neurology Research and Development Strategies Regulation

US Survey Shows Pharma More Open To Remote Patient Monitoring

COVID-19 is driving changes to how clinical trials are being conducted in the US, with 44% of respondents who participated in a recent survey saying they have adapted or plan to become decentralized in coming months.

United States Clinical Trials Coronavirus COVID-19

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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 Approval Binge Includes Brexafemme, Wegovy, Ryplazim, Truseltiq, Lybalvi, Tembexa

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

US FDA Performance Tracker Approvals Drug Approval Standards

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

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Latest From Regulation

Interpol-Led Campaign Seizes Nine Million Falsified Medical Products

This year’s Pangea operation has led to the seizure of millions of falsified medicines and other products and the closure of 113,000 websites.

Europe Switzerland

Roche’s Novel Ranibizumab Implant Among Myriad New Filings In EU

The European Medicines Agency has added 13 new drugs to its list of products that are under review for potential pan-EU marketing approval.

Drug Review Europe

China Reg Express: Anti-Blocking Law, Inspection Guideline And Gene Therapy Follow-Up Studies

A sweeping "anti-blocking" law, patent legislation, gene therapy study guidance and new regulations on inspections are all within a flurry of regulatory activity in China.

China Legislation

COVID-19 IP Waiver 'Breakthrough' At WTO Meeting

Health advocates hail the move but the EU and UK still insist a waiver is not the solution to boosting the availability of coronavirus vaccines.

International Europe

More Pressure On COVID-19 Product Protections As Euro Parliament Backs IP Waiver

Expectations will be high after the COVID-19 product IP waiver plan took a big step forward and G7 leaders prepare for discussions on the global recovery from coronavirus, tackling climate change and other weighty subjects.

Europe United Kingdom

Combined Trial Reviews To Become The Norm In UK From 2022

Having gained enough experience with the combined ethics and regulatory review of clinical trial applications, the UK will make this its only route for evaluating new drug trial applications starting next year.

United Kingdom Clinical Trials

Latest From Policy

COVID-19 IP Waiver 'Breakthrough' At WTO Meeting

Health advocates hail the move but the EU and UK still insist a waiver is not the solution to boosting the availability of coronavirus vaccines.

International Europe

DTC For Accelerated Approval Drugs: US FDA Is Taking Another Look At Disclosure On Websites

Study will assess responses of cancer survivors and caregivers to disclosures that a drug received accelerated approval. FDA analysis found that 73% of 26 accelerated approval drugs cited approval pathway on product websites.

Approvals Drug Approval Standards

Tech Transfer Deals See Argentina And Serbia Produce COVID Vaccine

The Russian Direct Investment Fund says it has 20 technology transfer and production agreements in place in 13 countries across the world.

Europe Serbia

Clinical / R&D Explore this Topic

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Latest From Research & Development

Larimar Secures PRIME Designation In EU For Neurological Disease Drug

The European Medicines Agency has accepted Larimar’s potential treatment for Friedreich’s ataxia onto its PRIME scheme for helping to get medicines for unmet medical needs to patients faster.

Europe Research & Development

Regulators Moving Ahead Of Industry In China? Officials, Execs Weigh In

While regulators are steaming ahead to accelerate clinical trial and product approvals, China's pharma industry still lacks innovation. Underlying the hot investment, multi-million deals and IPOs is a lingering reliance on 'fast-following,' regulators and pharma execs tell the DIA China meeting.

China Regulation

Real-World Data Of Cancer Drugs In Elderly Could Push Regulators Toward Broader Trial Eligibility

Medicare patients fared worse than pivotal trial populations on cancer drugs, two recent papers conclude, offering more ammunition for an increased regulatory focus on more generalizable trial populations. Current drug labels may portray an inaccurate risk-benefit calculation in older populations, which account for most cancer cases.

Real-World Evidence Clinical Trials

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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

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Latest From Manufacturing

The Quality Lowdown: The Warning Letter Monsoons That Might Follow The Inspection Drought

Selective whistleblower allegations, investigative reports hint at drug GMP issues awaiting US FDA inspection resumption; GSK sotrovimab EUA gets root cause provision; API GMP compliance work acknowledged; Aziyo recalls bone matrix associated with tuberculosis outbreak, and other matters in this latest update.

Manufacturing Quality

Public-Private Consortium To Strengthen Essential Medicines Supply Under White House Initiative

President Biden’s 100-day plan relies on Defense Production Act authorities to increase resilience of critical domestic pharmaceutical supplies.

Manufacturing Quality

Tech Transfer Deals See Argentina And Serbia Produce COVID Vaccine

The Russian Direct Investment Fund says it has 20 technology transfer and production agreements in place in 13 countries across the world.

Europe Serbia
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