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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years. The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact.

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Should we be worried about pharma’s supply chain?

World of DTC Marketing

Ironically, in later times, the intense competition for out-of-patent drugs has subsided, which has led to spiraling rises in generic drug prices and shortages. Most of these generics are produced outside the US and recently there have been numerous recalls of generic drugs because of the failure of quality control.

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In the News: October Regulatory and Development Updates

Camargo

In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. The generic drug must also have the same labeling as the RLD (except for differences permitted under the Agency regulations).

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Pioneering access to complex generic products 

Drug Discovery World

This will continue to be the case going forward, but the nature of the off-patent landscape will evolve in line with ongoing changes in the segment’s ‘pipeline’: the originator products of today, which will become the generic and biosimilar medicines of tomorrow. There is significant need for more cost-effective generic versions.

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European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. This looks like it may change shape in the future for the region, if the proposal put forward by the commission is adopted.

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Country focus: China & APAC’s growing medical needs bring opportunities and challenges

pharmaphorum

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. In addition, the pharmaceutical industry in China is still heavily dependent on generic drugs.”.

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Katie Porter attacks pharma

World of DTC Marketing

So where to start… Congresswoman Porter may want to look at the percentage of generic drugs available virus branded (89%). I have worked with and stayed in contact with some R&D people within pharma and they have a different answer. In pharma R&D returns have declined to 1.8 percent—a slight decrease of 0.1

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