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Policy & Regulation

Set Alert for Policy & Regulation

Roche’s External Control Arms Show What Real-World Evidence Can Look Like In Practice

With Flatiron, Roche is at the forefront of the emerging field of RWE. Roche Pharma President O’Day described how the company is using such data in the real world of regulation and reimbursement.

Clinical Trials Digital Health Drug Review

Biosimilar Substitution: US State Laws Require Physician Communication And, In Some Cases, Lower Prices

Bills allowing pharmacies to substitute biosimilars for reference biologics have been enacted in all but six states. Interactive map notes state-by-state provisions.

Biosimilars State News Legislation
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Regulation

Set Alert for Regulation

Latest From Regulation

EMA 'Completely Reworks' Parts Of Gene Therapy Products Guideline

The European Medicines Agency has revised several sections of its 2001 guidance on the development and evaluation of gene therapy medicinal products based on stakeholder feedback and to address issues in light of the experience gained with these products.

Europe Regenerative Medicine

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

European Performance Tracker Drug Review

UK Regulator Considers Jail For Non-Compliance With Coming EU Safety Features

The Medicines and Healthcare products Regulatory Agency has issued for consultation proposals on how it will ensure the UK meets its obligations to transpose the safety feature provisions of the EU Falsified Medicines Directive.

Drug Safety Distribution

Novartis And Cohen: A View Into Pharma's Policy Concerns As Trump Took Office

As then-Novartis CEO Joe Jimenez worked with former Trump lawyer Michael Cohen on drug pricing issues, the pharma industry was preparing for the debate it's eventually getting to have.

Pricing Debate Regulation

Medicare Reimbursement For New Part B Drugs Lowered In Proposal

New specialty drugs will get lower interim payments from Medicare under proposed rule.
Regulation Medicare

Celgene, Agios Drug Enasidenib Among New Filings At EMA

Enasidenib, which last year became the first US-approved treatment for relapsed or refractory acute myeloid leukemia with an IDH2 mutation, is among a new crop of products being reviewed for marketing approval in the EU.

Drug Review Review Pathway
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Policy

Set Alert for Policy

Latest From Policy

Sharing Information With US FDA Advisory Committee Can Invalidate Patent, Jazz Finds

Federal Circuit rules that material about Xyrem's REMS distribution system provided for advisory committee review constitutes prior art.

BioPharmaceutical Policy

Beyond Rebates: PhRMA Wants HHS To ‘De-Link’ Supply Chain Compensation From List Price

Focus should not be limited to rebates in Medicare Part D, manufacturers advise in comments on HHS drug pricing blueprint. Pharmacy benefit managers raise anti-trust issues with shift to upfront discounts.

Pricing Debate Pharmacy Benefit Management

Express Scripts Pushing Manufacturers To Lower List Prices By Offering Cheaper Brand Alternatives

Companies should introduce same drug under new NDC at lower list price to overcome difficulties of reducing list prices on existing brands, PBM says.

Pricing Debate Pricing Strategies

UK NICE Knock Back For Janssen’s ‘Game-Changing’ Darzalex Combo

Draft guidance from the health technology assessment body, NICE, says that while Darzalex in combination with two other drugs is an innovative therapy for previously treated multiple myeloma, there is not enough long-term data to support its use on NHS England.

Health Technology Assessment Reimbursement

Vertex Refuses To Back Down On England Orkambi Deal

Vertex is staunchly defending its cystic fibrosis portfolio-based reimbursement deal rejected by NHS England and has called on the UK’s prime minister to intervene. The company says similar deals have worked well in Ireland and Sweden.

Europe United Kingdom

340B Reform: US House Bills Mark The End Of The Beginning

Energy & Commerce Health Subcommittee releases several discussion drafts at hearing on 340B drug discount program reform as the debate seems poised to move into the next phase.

Pricing Debate Legislation
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