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Policy & Regulation

Set Alert for Policy & Regulation

Inter Partes Patent Challenges Are Constitutional, US Supreme Court Rules

But Patent Trial and Appeals Board must issue final written decision on all claims raised by challenger – not just some of them, court says; rulings in two closely watched cases mean that IPR proceedings can continue unabated, but generic drug and biosimilar sponsors may need to rethink how they go about challenging innovator patent claims.

Intellectual Property Biosimilars Generic Drugs

Global Pharma Guidance Tracker – March 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.
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Regulation

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Latest From Regulation

Right-To-Try Bill Heads To White House, Putting Firms In Driver's Seat

Proponent says companies ready to use new expanded access pathway that US FDA will have essentially no involvement in.
Legislation Clinical Trials

Insys' Sublingual Buprenorphine Spray Fails At US FDA Panel, But Some Members See Future In Limited Role

Main concerns involved the delayed onset to meaningful pain relief and the safety signal of hypoxia. 
Advisory Committees Neurology

Pharmas Join To Build Inflammation Biomarkers In Alzheimer's, Depression

Drug firms exploring link between inflammation and central nervous system disorders are now sharing resources through public/private Biomarkers Consortium project.
Clinical Trials Research & Development

UK MHRA To Boost Pharmacovigilance With More Focus On Office-Based Inspections

The UK medicines regulator is exploring how it can focus its pharmacovigilance inspections on areas of high-risk and reduce the number of days it spends on inspections. To this end, office-based inspections have emerged as a useful concept, and there are plans to use this approach more vigorously.
Compliance Safety

African Countries Adopt Treaty To Set Up New Medicines Agency

African health ministers have agreed on a treaty to set up a new pan-African agency to coordinate regional drug regulatory harmonization initiatives and pool limited regulatory expertise.

Regulation Middle East and Africa

Keytruda, Tecentriq Face Efficacy Questions In Urothelial Cancer

Monotherapy patients with tumors that have low PD-L1 expression experienced decrease survival in two confirmatory trials; however, the immune checkpoint inhibitors’ accelerated approvals are unlikely to be affected pending final results comparing use in combination with chemotherapy to chemo alone.


ImmunoOncology Clinical Trials
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Policy

Set Alert for Policy

Latest From Policy

Impax Defeats FTC Pay-For-Delay Complaint, Helped By Status As Sole Marketer Of Generic Opana ER

FTC Chief Administrative Law Judge finds procompetitive benefit of Endo-Impax patent settlement agreement outweighs unjustified no-authorized generic provision.

Generic Drugs Legal Issues

DTC And The Art Of Selling An Establishment Pricing Plan To A Populist President

The most surprising proposal coming out the Rose Garden drug pricing event was a call for disclosure of prices in DTC ads. As a policy idea, it may be a dud – but that doesn’t mean it isn’t a critical element of the plan.

Advertising, Marketing & Sales Pricing Debate

US Drug Pricing Reform: No More Medicare 'Gravy Train,' Azar Tells Pharma

HHS secretary urges serious proposals from biopharma on enhancing price negotiation in Medicare Parts D and B, promising action from the Administration whether the industry cooperates or not.

Pricing Debate Medicare

Amgen’s Challenge Over Sensipar Pediatric Exclusivity Moves To US Appeals Court

Amgen asserts FDA improperly tied pediatric exclusivity denial to lack of meaningful labeling resulting from the studies; justices question whether Amgen's data were adequate to support exclusivity but also agency's public silence on how it decides when a sponsor has 'fairly responded' to a written request.

Legal Issues Intellectual Property

CAR-T Therapy In Medicare: National Coverage Policy Could Come In 2019

Medicare begins analysis process for CAR-T cancer therapies in response to a request from UnitedHealthcare for a national coverage policy.
Medicare Cancer

Part B Drug Competitive Bidding Program Revival: Vendor Request Coming Soon

Distributors, specialty pharmacies and PBMs are in a better position now to act as vendors then they were a decade ago, when Medicare unsuccessfully tried to implement a Medicare Part B prescription drug competitive acquisition program, HHS Secretary Azar points out.

Pricing Debate Medicare
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