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EMA To Explain How Trial Transparency & Data Redaction Can Live Together

The European Medicines Agency is working to align the redaction and data anonymization principles underpinning two EU clinical trial transparency initiatives to ensure consistency in disclosure requirements.

Europe Clinical Trials Compliance

EU Adopts New Rules On UK-Wide Approvals For Novel Drugs

Having been passed by the European Parliament and now the Council of the EU, new legislation will clear up some of the issues raised by Brexit relating to trade in medicines between Great Britain and Northern Ireland.

Europe United Kingdom Brexit

One-Page Patient Medication Information Document Moves Forward Under Proposed Rule

After decades of work, the US FDA released proposed requirements for a simplified version of the Medication Guide for all products. Electronic distribution in lieu of paper ‘upon a patient’s request’ would be allowed. Comments sought on the value of consumer testing of the documents.

Drug Safety Post Market Regulation & Studies 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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Keeping Track: Entasis’ Antibiotic Xacduro, Two Opioid Misuse Therapies Clear US FDA; Pfizer’s Paxlovid Makes It Official

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 – April 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

Policy & Regulation Explore this Topic

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Latest From Regulation

1 June Marks Historic Day For Patent Protection In Europe

The forthcoming unitary patent system and Unified Patent Court promise to make applying for patents in Europe and litigating infringements simpler and less costly for applicants.

Europe Intellectual Property

International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine

A workshop led by the European Medicines Agency and the US Food and Drug Administration sought to reach alignment on adapting COVID-19 vaccines to emerging virus variants.

International Coronavirus COVID-19

UK Parliamentarians Call For A New, Internationally Competitive Pricing System

Much-needed investment could be lost if the “uncompetitive” sales rebate rate is not reduced as part of talks on a new UK drug pricing scheme, some parliamentarians are warning.

Europe United Kingdom

Intercept’s Ocaliva: ‘Dangling’ PBC Indication At Risk As Near-Term NASH Approval Looks Unlikely

Accelerated approval for primary biliary cholangitis in 2016 came with three postmarketing requirements, but studies were terminated early; firm working toward sNDA submission in 2023 for regular approval, but US FDA says reports already are overdue and it expects to take PBC indication back to an adcomm.

Review Pathway Post Market Regulation & Studies

EU CHMP Opinions And MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Drug Review Europe

EU Marketing Setback For Ipsen’s Connective Tissue Disease Drug

The European Medicines Agency is standing by its recommendation to reject Ipsen’s EU marketing authorization application for Sohonos, for treating fibrodysplasia ossificans progressiva.

Europe Approvals

Latest From Policy

Japan Eyes Cutting Reimbursement For COVID-19 Drugs

Japan will end full reimbursement coverage for COVID-19 therapeutic drugs from October, after downgrading the status of the virus to the same level as seasonal flu in early May. As authorities discuss the possible coverage reduction, a larger than usual price cut may also be applied to Shionogi's oral COVID antiviral Xocova.

Japan Pricing Debate

Supplemental Filings: Califf Discusses Revolving Door; Poll Examines Public Trust In FDA Approvals

Commissioner expresses concern about agency lawyers leaving and then representing US FDA’s opponents in court. Also, as lawsuits about abortion pill continue, KFF finds the public trusts FDA more than the judiciary on determining products’ safety and effectiveness.

FDA Legal Issues

Medicaid ‘Price Verification’ Audit Proposal Aims To Promote Cell, Gene Therapy Rebate Concessions

CMS proposed rule impact may be ‘modest’ but is framed as ensuring patient access to cutting edge treatments by helping to control Medicaid spending. Biden administration initiative also aims to address misclassification of brand drugs, duplicative 340B discounts, and PBM spread pricing.

Reimbursement Medicaid

Clinical / R&D Explore this Topic

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Latest From Research & Development

Is US FDA Preparing to Remove Some Fed Study Requirements For Generic Bioequivalence?

New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.

Generic Drugs Clinical Trials

India Clinical Trials Scenario: Leaders From Novartis, IQVIA, PwC Signal Winds Of Change

Leaders from Novartis, IQVIA and PwC discuss the ground situation for trials in India as regulatory reforms, improved infrastructure and clinical expertise provide opportunities. Potential in areas like orphan diseases and tips for peer Amgen on getting trials going in India were among other highlights.

Research & Development Clinical Trials

Industry Leaders Speculate On FTC Vs. Amgen/Horizon Fallout

Pfizer chief clinical officer William Pao, Roche pharma CEO Teresa Graham and others weighed in on what FTC’s action could mean for pharma M&A at the Financial Times Pharma Summit.

M & A Deals

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Latest From Commercial

Novo Nordisk’s Obesity Drug Activities Break UK Rules Again

The company has been found in breach of the UK code once again for its work with pharmacists,  although this time Novo Nordisk has escaped the heaviest censure.

Companies Commercial

Regeneron CEO Takes Industry Counterview On FTC Suit: ‘I’m Glad They’re Looking Into This’

Leonard Schleifer said it is time for US regulators to review whether certain rebate practices are anti-competitive, while speaking at the Financial Times US Pharma & Biotech Summit in response to the FTC’s effort to stop Amgen’s acquisition of Horizon.

M & A Enforcement

First OTC Oral Contraceptive Has Advisory Panel’s Unanimous Support Despite FDA’s Data Concerns

FDA officials again made clear concerns about “improbable dosing” data in HRA’s sNDA for 0.075-mg norgestrel tablet branded Opill before advisory panel voted at close of a two-day meeting conducted 60 years after first Rx oral contraceptive approved in US.

FDA Drug Approval Standards

Manufacturing Explore this Topic

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Latest From Manufacturing

UK In Major Move To Boost Commercial Clinical Trials & Improve Life Sciences Environment

The publication of two major reports has led the UK government to announce a £650m “Life Sci for Growth” package to bolster the life sciences sector.

Europe United Kingdom

The Quality Lowdown: Blast From Past At Sun Mohali, Touch Of Future With IT/OT Integration

Ranbaxy consent decree is invoked again after the FDA’s latest inspection unveils backdating at Sun’s Mohali plant. FDA probes Intas plant’s many deceptions, Ipca stumbles on investigations without start dates and Sure-Biochem must admit missing client’s contamination.

Manufacturing Quality

EU Drug Approvals Could Be Denied If Environmental Risks Not Properly Assessed

As part of its revision of the EU medicines legislation, the European Commission is proposing tighter rules to reduce the environmental impact of medicines. Companies may want to start thinking now about whether their current environmental risk assessment processes would meet the likely new requirements.

Europe Legislation
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