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Off-Label Communications: US FDA Won't Impede Discussions With Payers, Gottlieb Says

Guidance, to be issued 'very soon,' will provide a safe harbor for discussions between manufacturers and payers about off-label drug uses, Commissioner Scott Gottlieb says.
Regulation FDA Reimbursement

CMDh Steps In As Firm Finds No Takers To Replace UK As Reference Member State

The coordination group of EU member state regulators was recently presented with an exceptional case where all concerned member states initially refused to become the new reference member state for a drug evaluated by the UK. The group explained that 'unscheduled switches' can result in unforeseen workload, resulting in member states refusing to take on the RMS role.
Brexit Regulation Europe

CJEU Ruling Clarifies Roles Of Member States And Courts In Determining Data Exclusivity

A ruling by Europe's top court has clarified the respective roles of member state agencies and courts in cases where the starting date for the data exclusivity period is called into question.

Drug Review Intellectual Property Legal Issues

Celebrex CV Risk v. Naproxen, Ibuprofen: US FDA Does Not Recommend Differential Labeling

Advisory committee to evaluate whether PRECISION trial shows celecoxib cardiovascular safety is comparable to naproxen and ibuprofen and if naproxen and ibuprofen use should be contraindicated with aspirin.

BioPharmaceutical Regulation Advisory Committees

FDA Performance Tracker

Keeping Track: A Fresh Wave Of Approvals

The latest drug development news and highlights from our US FDA Performance Tracker.
Drug Review Regulation United States

Policy & Regulation Explore this Topic

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US FDA Biosimilar Guidance Update Will Relax Interchangeability Standards

Updated interchangeability guidance is one of several 'incremental reforms' agency is working on that could ease development burden for biosimilars, Commissioner Scott Gottlieb says.

Biosimilars Drug Approval Standards Regulation

Latest From Regulation

Mandatory Joint Clinical Assessments Won’t Compromise HTA Quality Or Member State Decisions, Says Eurordis

Eurordis, the network of rare disease patient organizations, has defended EU proposals on wider cooperation on health technology assessments and rejects complaints lodged by member states.

Europe Health Technology Assessment

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

Gottlieb On Medical Marijuana: Smoking Is Not Effective Way To Deliver API

US FDA Commissioner tells Congress that agency is 'very open' to considering use of active ingredients in marijuana to ease chronic pain.

Legislation Drug Approval Standards

Latest From Policy

US Mulls TPP Re-entry, Critiques Japan Reforms

President Trump has indicated the US may be interested in rejoining the Trans-Pacific Partnership free trade talks, but there would be multiple obstacles, not least whether strict US conditions could be met, including in the pharma IPR area. PhRMA meanwhile voices concerns over recent Japanese reforms.
Policy Trade

He's Handled More ANDA Cases Than Anyone, And Now He's Retiring: Judge Sleet Reflects On His Career

In an interview with the Pink Sheet, Delaware District Judge Sleet discusses patent reform fallout and major issues facing district courts.

Legal Issues Intellectual Property

China First: Beijing's Bolstering Of Generics Rekindles IPR Fears

The message is unmistakably clear: new policies are putting China first to make drugs more accessible and affordable, including widely prescribed products for cancer. Tactics including compulsory licensing, tax incentives, and substitution to support the use of domestic generics should ring alarm bells for multinationals, observers say.

China Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

Tumor Mutation Burden Biomarker Inches Closer To Acceptance In Cancer

Data from AACR puts use of tumor mutation burden as biomarker for lung cancer outcomes in spotlight, but some experts argue the test is not ready for prime time.

Clinical Trials ImmunoOncology

Expanded Access Programs Eyed For Data-Gathering Purposes

Protocol-driven approach could generate reliable data about investigational drug's efficacy and safety in patients who do not qualify for clinical trials, PhRMA's Moscicki says; Johns Hopkins' Sharfstein cautions this could turn expanded access programs into burdensome studies that take away from primary purpose of providing access to investigational therapies.

Clinical Trials Drug Safety

Trial Simulation, Drug Selection To Be Focus Of US FDA's Drug Development Modeling Pilot

Meeting requests from sponsors that focus on safety prediction will also be prioritized.
Clinical Trials Research & Development

Commercial Explore this Topic

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Latest From Commercial

Rebates And Discounts Have A Big Impact On US Drug Prices, IQVIA Report Shows

A new US drug spending report from IQVIA parses out how rebates impact drug spending and explores affordability for patients. The data show drug makers offset about 28% of drug spending and provide some support to industry's arguments on drug pricing. 

Pricing Strategies Pricing Debate

FDA's Gottlieb Applauds Drug Rebates At Point-Of-Sale

The US FDA commissioner called recent initiatives to get drug rebates to patients at point-of-sale "healthy" public policy, and suggested insurance premiums have been subsidized by sick patients, addressing CNBC's health care conference.
Government Payers Private Payers

US FDA Approval Versus Patient Access: A Real-World Anecdote

During meeting on real-world evidence, FDA’s Bob Temple describes real-world problem of patient access: his struggles to convince his insurer to cover Lilly/BI's diabetes drug Jardiance – which he helped review.  
Reimbursement Drug Approval Standards

Manufacturing Explore this Topic

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Latest From Manufacturing

Regulators Encourage Science And Risk-Based Approaches In NDAs For Peptides And Oligonucleotides

Regulators in the US and the EU urged manufacturers to follow the general principles set in International Conference on Harmonization guidelines in developing new oligonucleotides and peptide drugs. They say that in the absence of tailored guidance, sponsors should take a science- and risk-based approach in developing these products, which have flooded the development pipeline.

US States Europe

US FDA Developing Database Of Medical Review Decisions, Gottlieb Tells Congress

'Knowledge management platform' will identify agency's scientific precedents; Commissioner Gottlieb says it is one of FDA's top three initiatives, along with continuous manufacturing and real-time safety monitoring.

Drug Approval Standards Manufacturing

Report: Global API GMP Inspection Coordination Increasing Under Joint Program

Regulators report that an international collaboration on GMP inspections of API sites has bolstered the exchange of information between participating health authorities, yet the information technology system that supports the system could use some improvement.

United States Manufacturing

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Primatene Mist NDA Expected By July After FDA OKs OTC Asthma Inhaler Trial

Amphastar plans this month to begin what it expects to be its final study to support an NDA to relaunch Primatene Mist. If the results support accurate self-selection and usage of the product by consumers, Amphastar should be ready to re-submit the NDA during the current quarter.
Respiratory Consumer

P&G Adds Merck's Brands, Expands Consumer Health Categories, Footprint

P&G’s planned acquisition of Merck KGaA’s consumer health care business will grow its consumer health portfolio 50%, expand its OTC drug and supplement business abroad and open up new categories.  CEO David Taylor frames the acquisition as another step in the firm's ongoing portfolio shakeup.
International Germany

J&J Consumer Health On Solid Footing With Help From Personal Care Sales

Analysts say firm’s consumer health division is showing signs of a comeback, with worldwide sales up 5.3% to $3.4bn, boosted 3.7% from currency exchange on strong beauty segment sales, driven by increased online marketing, and strengthening OTC drug sales.

Consumer Advertising, Marketing & Sales