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FDA’s Robyn Bent On The Evolution of Patient-Focused Drug Development

The director of the agency’s patient-focused drug development program talks to the Pink Sheet about how the program has improved the development and evaluation of new drugs, initiatives underway, and plans to standardize and harmonize the process.

Interviews FDA Leadership

Former Indivior CMO Challenges HHS’ Exclusion For ‘Responsible Corporate Officer’ Misdemeanor

Former chief medical officer’s conviction for misbranding Suboxone does not warrant mandatory exclusion from healthcare programs, complaint argues. It says individuals in similar situations, specifically former Purdue execs, were subject to permissive exclusion.

Enforcement Legal Issues Policy

UK To Use Vaccine Taskforce Model For ‘Cutting-Edge’ R&D Funding Program

The latest initiative under the UK’s Life Sciences Vision is intended to fund the development of innovative treatments while saving the National Health Service “millions of pounds.”

Europe United Kingdom Research & Development

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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: Early Thanks Given By ImmunoGen, Provention Bio; More PD-1/L1 Combo Approvals

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

US FDA Performance Tracker Approvals Drug Review


Global Pharma Guidance Tracker – October 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

Collaboration Makes The (Real) World Go Round: Global Efforts Strive To Anchor RWE With Real-World Data Standards And Practices

Can the decentralized global healthcare ecosystem to turn real-world evidence from a buzzword to a useful approach to fit-for-purpose evidence generation?

Real-World Evidence Drug Approval Standards

Piloting Real-World Evidence: US FDA RWE Demonstration Projects

Agency offers three informal ‘buckets’ organized around data, study design and tools.

Real-World Evidence Regulation

GSK’s Blenrep: 15 Days From Confirmatory Trial Failure To Withdrawal Announcement

The first BCMA-targeting agent to gain approval in myeloma never became the blockbuster for which GSK had hoped, but Blenrep appears to have set a new standard for speed of voluntary withdrawal of an accelerated approval drug after a confirmatory trial failure.

Review Pathway Post Market Regulation & Studies

EU Finalizes Option To Omit Expiry Date On Inner Labeling Of Investigational Drugs

Revised labeling requirements for unauthorized investigational and auxiliary medicinal products under the EU Clinical Trial Regulation have been published in the Official Journal.

Europe Clinical Trials

Clinical Trial Diversity Would Benefit From Regulatory, Financial Incentives, Experts Say

Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.

Clinical Trials Diversity & Inclusion

Could US FDA Move Gene Therapy Regulation To Device Center In Years To Come?

CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.

Gene Therapy Manufacturing

Latest From Policy

Brazilian Regulator Consults On Improving Rules For Registering Biosimilars

ANVISA, Brazil’s medicines regulator, is asking for feedback on the regulatory pathway for biosimilars.

South America Brazil

As US House Changes Hands, CMS May Face More Oversight Than FDA

Key Republican committee chairs on health issues are familiar faces, largely supportive of the US FDA’s approach to drug regulation. Implementation of the new pricing law, however, will get a lot more scrutiny.

Reimbursement Politics

How Should The US Government Coordinate Emergency Clinical Trials?

Research institutions, CROs, biopharma industry and other stakeholders are asked to comment on potential governance structure that would determine when trials are needed to address disease outbreaks and other public health emergencies.

Clinical Trials Diversity & Inclusion

Clinical / R&D Explore this Topic

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Latest From Research & Development

Standardization Of Patient-Focused Core Clinical Outcomes Could Enable Labeling Comparisons

US FDA’s Theresa Mullin envisions having a national catalog of standard core clinical outcomes assessment measures that could apply to every disease area.

Clinical Trials Drug Approval Standards

New EMA Innovation Group To Provide Point Of Entry For Developers & Contribute To Regulatory Assessments

The European Medicines Agency’s newly established Quality Innovation Expert Group will focus on innovative pharmaceutical manufacturing approaches, starting with continuous manufacturing for biologicals and end-to-end processes, and decentralized manufacturing.

Innovation Manufacturing

Project Pragmatica: US FDA’s OCE Initiative Aims To Encourage Simple Clinical Trials

OCE Director Richard Pazdur says idea for the latest initiative stemmed from a clinical trial in lung cancer that he thought only needed to measure the impact on overall survival.

Clinical Trials Cancer

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Latest From Commercial

Political Trials On All Sides: Lilly CEO Laments Loss Of ‘Chamber of Commerce Republicans’

David Ricks says the challenging political environment is empowering regulators. The Lilly leader also talked Twitter and drug prices, in a STAT Summit interview.

Politics United States

Departing Words: Merck’s Ken Frazier Cautions Against Profit Maximization

Pharma CEOs must balance optimizing access and profitability, former Merck CEO and soon-to-be ex executive chairman of the company said. Frazier says health care industry must come to table and admit the “system ain’t working,” talks about the need to protect democracy, in a sweeping interview at the STAT Summit.

Leadership Pricing Debate

Naloxone Switch NDA Submitted As US FDA Signals Nonprescription Access Looks Safe, Effective

Harm Reduction Therapeutics submits NDA for OTC approval of a 3-mg naloxone nasal spray branded RiVive. CEO Michael Hufford says the NDA touches all the bases FDA detailed in notice it published on what’s needed in naloxone OTC switch proposals.

Prescription To OTC Switch Drug Approval Standards

Manufacturing Explore this Topic

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Latest From Manufacturing

Could US FDA Move Gene Therapy Regulation To Device Center In Years To Come?

CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.

Gene Therapy Manufacturing

New EMA Innovation Group To Provide Point Of Entry For Developers & Contribute To Regulatory Assessments

The European Medicines Agency’s newly established Quality Innovation Expert Group will focus on innovative pharmaceutical manufacturing approaches, starting with continuous manufacturing for biologicals and end-to-end processes, and decentralized manufacturing.

Innovation Manufacturing

EMA, PIC/S To Update 11-Year-Old GMP Guide On Computerized Systems

The European Medicines Agency and the international association of pharmaceutical inspectorates, PIC/S, say they need to make extensive changes to their guide on using computerized systems when manufacturing medicines.

Europe International
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