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MHRA publishes guidance on medicine regulation after Brexit

pharmaphorum

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If

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The social media problem for healthcare

World of DTC Marketing

SUMMARY: The Facebook whistleblower lawsuit can be summed up in one sentence: Facebook prioritizes engagement above all else because it leads to more profits even if that engagement containing inflammatory information. A year ago, Facebook was making a hard charge to get the pharma business.

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In the News: October Regulatory and Development Updates

Camargo

In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective 

Pharmaceutical Technology

Every major pharma company is now involved in CGT development which has resulted in the approval of 28 therapies by the FDA thereby making CGT no longer a niche category of therapies. This is a primary factor for the staggeringly high unit cost of CGT. plan a, plan b, … charter flight standby option).

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Hungary steps out of line with EU to order Russia’s COVID-19 vaccine

pharmaphorum

Hungary is to order a consignment of Russia’s Sputnik V COVID-19 vaccine, as the country struggles to contain the infection rate. According to press reports , the decision puts Hungary on “collision course” with the EU, which has not approved the vaccine or plans to review it either.

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The Brexit deal; shot in the arm or kick in the teeth for the pharma sector?

pharmaphorum

The UK Government and EU Commission trumpeted their Brexit trade deal, struck at the end of December, as ‘comprehensive’, the ‘biggest yet’ But a closer inspection of the EU-UK Trade and Cooperation Agreement (TCA) renders these statements largely illusory for the pharma sector. The Medicinal Products Annex.

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Pharmaceutical Market Access: Strategies, Challenges, and Key Trends for Success

Pharma Marketing Network

Each country, and sometimes even individual states, has unique pricing regulations, reimbursement systems, and healthcare policies that dictate how drugs reach patients. Rising Pricing Pressures and Cost Containment Governments and insurers are tightening cost controls to manage healthcare expenditures.