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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.

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.

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.
Big Pharma’s Review Performance
Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else
Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.
Read more analyses built on Pink Sheet Performance Tracker data...
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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

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.
European Performance Tracker
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Commercial Explore this Topic
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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.
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.
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.
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.
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.
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.
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