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Results Imminent From Sweden’s Pilot Of Novel Antibiotic Reimbursement Model

If successful, a new Swedish model for reimbursing antibiotics that involves guaranteed minimum annual revenues for companies, could be tested on other kinds of products.

Reimbursement Europe Sweden

EU Refines Simultaneous Scientific Advice Pilot With Focus On Clinical Trials

Improvements have been made to the second phase of an EU pilot that allows drug sponsors to obtain simultaneous scientific advice from two member states.

Europe Clinical Trials Innovation

UK HTA Body To Conduct More Appraisals, And Faster, Through Proportionate Approach

Faced with the rise in its workload, the UK’s health technology assessment body NICE is exploring ways of tailoring its approach to appraisals according to the type of product under consideration.

Europe United Kingdom Health Technology Assessment

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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

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

US Bill Seeks To Eliminate Biosimilar Interchangeability Trial Burden

Sen. Mike Lee, R-UT, has introduced draft legislation in the US that would stop the FDA from requiring biosimilars to conduct ‘unnecessary’ switching studies in order to obtain an interchangeability designation.

Legislation Regulation

Roche Wants EU Pharma Legislative Revision To ‘Dare Something New’

New, more flexible regulatory approaches will be needed to deal with the integrated therapies coming through company pipelines, and the European Medicines Agency should play a “key orchestrating role” in smoothing the way, says Sabine Atzor, Roche’s head of EU regulatory policies.

Europe Legislation

EMA Launches First RWE Studies Under Big Data Project

The European Medicines Agency has partnered with eight institutions having access to real-world healthcare data to enable its DARWIN EU project to deliver real-world evidence to the EU medicines regulatory network when needed.

Europe Real-World Evidence

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

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

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

First Draft Of WHO’s Pandemic Treaty: IP Waivers, Tech Transfer & Price Transparency

A World Health Organization negotiating body will shortly examine the “zero draft” of a proposed pandemic treaty aimed at better preparing the world for future health crises. But the international pharmaceutical industry claims the draft as currently worded could actually undermine equitable access to pandemic countermeasures.

International Coronavirus COVID-19

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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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