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Policy & Regulation

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Drug/Software Combos Likely Won't Require Pre-Market Review By US FDA

But sponsors should sometimes seek advisory comment. Agency explains that most drug-use-related apps will be considered promotional labeling. FDA seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-focused software.

Digital Health Advertising, Marketing & Sales Regulation
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Regulation

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Latest From Regulation

Irish $1.9bn Tax Bill 'Out Of Nowhere' Perplexes Perrigo, Troubles Analysts

Perrigo appeals tax assessment Ireland levied in late December on Rx ingredient royalty rights firm gained when it became incorporated in Dublin but no longer owns, Analysts allowed President and CEO Murray Kessler. benefit of doubt he'll lead Perrigo out of prolonged slump when he joined firm in November after extensive executive experience with tobacco firms and in other consumer goods markets, but they're more circumspect about its chances of prevailing in Irish tax disagreement.

Consumer OTC Drugs

How CAR-Ts Are Changing The Lifecycle Paradigm For ATMPs

CAR T-cell therapies have resulted in the industry and regulators exploring unconventional approaches to collecting real-world safety and efficacy data from existing registries. Can this approach also work for other types of cell and gene therapy products in the future? Delegates at a conference in London explored the topic.
Europe Regulation

UK NICE OKs Melanoma Combo Treatment From Array/Pierre Fabre

Array BioPharma/Pierre Fabre’s combination treatment for metastatic melanoma has received NICE's go-ahead for funding under the national health service in England and Wales.
Health Technology Assessment Reimbursement

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

NICE Clears Verzenios For Breast Cancer After Lilly Offers UK Discount

Verzenios, Lilly’s new drug for metastatic breast cancer, has been OKd by NICE for use on the national health service in England and Wales. In terms of gaining market share it is some way behind two other competitor drugs, Pfizer’s Ibrance and Novartis’s Kisqali, but it has some clinical advantages that could allow it to gain uptake.

Reimbursement Government Payers

Sanofi's Sotagliflozin: Risk Of Ketoacidosis Divides US FDA Advisory Committee

Some Endocrinologic and Metabolic Drugs Advisory Committee members said a REMS is sufficient, but others worried that proposed risk management plans were not proven effective.
Metabolic Disorders Advisory Committees
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Policy

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Latest From Policy

PhRMA Adds Genentech, Gilead To Its Ranks Ahead Of House Democrats’ Drug Pricing Scrutiny

Roche, through Genentech, returns to the PhRMA fold after leaving the trade group in 2009; Gilead is a first-time member; both are retaining their BIO memberships as well.

Pricing Debate Research and Development Strategies

CVS Medicare Part D Plan With Pass-Through Rebates Has Limited Uptake

Low enrollment indicates that beneficiaries have trouble figuring out whether reductions in cost sharing would offset a much higher premium.

Medicare Pharmacy Benefit Management

ICER’s ‘Unsupported Price Increase’ Report Due This Fall

Report by the Institute for Clinical and Economic Review will seek to inform the public policy debate on price increases for prescription drugs.

Pricing Debate Policy

Roche Calls For Harmonized Regulations As Subcutaneous Herceptin Declined Trial Waiver In India

Roche has sought a harmonized regulatory approach for approval of innovative medicines and formulations in India, after its request for a trial waiver for subcutaneous Herceptin was turned down by an expert panel.
India Policy

Bio Industry Warns UK Orkambi Inquiry Against Publishing Confidential Price Information

Vertex and bioindustry groups have called on a UK inquiry investigating the availability of the cystic fibrosis drug Orkambi on the National Health Service not to publish confidential information.

Europe United Kingdom

Mexican Pharma Industry Joins Anti-Corruption Crackdown

The Mexican research-based pharmaceutical industry has pledged to crack down on corruption as the country’s new president says the vice must be eliminated to deliver better health system.

Mexico Government Payers
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