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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 Regulation

The US VA And Alzheimer’s: A Misunderstood Decision

US Department of Veterans Affairs' head for pharmacy benefits management says her agency’s coverage of Leqembi and Aduhelm is actually closely aligned with that provided by Medicare, in contrast to the initial characterization of the VA taking a different stance on the drugs.

Government Payers Medicare Reimbursement

DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure

Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.

Enforcement Compliance Legal Issues

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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: 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

Set Alert for Policy & Regulation

Latest From Regulation

Novavax Readying Multiple COVID-19 Vaccine Candidates To Ensure Fall Availability

CBER’s Marks said US FDA is working with Novavax on manufacturing to allow its protein-based vaccine to be ready for a fall roll-out. After some concerns about international coordination, multiple regulators seem to be settling on a monovalent approach for fall vaccinations.

Coronavirus COVID-19 Vaccines

WHO To Review Impact Of Mechanism For Tackling Substandard & Falsified Drugs

Recent incidents of illness and death caused by contaminated cough syrups show that there is a need to review the “member state mechanism” that is intended to coordinate efforts to tackle poor quality medical products, the World Health Organization says.

International Drug Safety

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add a new product – Tibsovo, Servier’s treatment for IDH1-mutated acute myeloid leukemia and IDH1-mutated cholangiocarcinoma.

Europe Approvals

UK Aims To Quadruple Patient Recruitment To Industry Clinical Trials By 2027

The UK government has set aside dedicated funds to deliver ambitious changes that would make it quicker and easier for companies to trial more of their products in the National Health Service. 

United Kingdom Clinical Trials

Broad Heart Failure Label Ushers Lexicon’s Inpefa Into SGLT2 Inhibitor Market

Sotagliflozin’s cardiovascular outcomes trials support the most expansive heart failure risk reduction claim approved by the US FDA in the class, a turnaround from the drug’s setbacks in type 1 diabetes.

US FDA Performance Tracker Approvals

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

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

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.

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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