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Warnings for Japanese pharmaceutical market may lead to more lenient price controls

Pharmaceutical Technology

Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 billion) in total sales in 2021 and is expected to grow 1.1% Among the 37 member companies, 17 of them are overseas companies and 20 of them are Japanese companies with a 10%+ overseas pharma sales ratio.

Marketing 173
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Warnings for Japanese pharmaceutical market may lead to more lenient price controls

Pharmaceutical Technology

Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 billion) in total sales in 2021 and is expected to grow 1.1% Among the 37 member companies, 17 of them are overseas companies and 20 of them are Japanese companies with a 10%+ overseas pharma sales ratio.

Marketing 130
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California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

CivicaRx is a non-profit generic drug company producing affordable insulin biosimilars in collaboration with the Juvenile Diabetes Research Foundation (JDRF). In-house manufacturing the norm. Most of the US insulin market is controlled by three pharma companies: Sanofi, Eli Lilly, and Novo Nordisk.

Insulin 328
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In the News: November Regulatory and Development Updates

Camargo

House of Representatives passed the “ Fairness in Orphan Drug Exclusivity Act ” to require proof from biopharma companies introducing improved versions of orphan drugs that they do not expect to recoup R&D costs through US sales in 12 years. GDUFA has changed this picture, at least for complex drug products.

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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

Rolling submissions, which are currently in use for COVID-19 drugs, would be extended to other drugs, such as those which address significant new and emerging infectious diseases in Canada, or which treat, prevent, or diagnose serious or severely debilitating diseases or conditions. Biologic Drugs. On-site Evaluations.

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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. They said: “This assertion raises some difficult questions.

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Pharma in Brief: The 2021 Year in Review

Pharma in Brief

In response to the COVID-19 pandemic, in 2020, the Minister of Health signed interim orders designed to streamline the process to authorize the importation or sale of drugs, vaccines, and medical devices used to diagnose, treat, mitigate, or prevent COVID-19. Major Policy Initiatives. (a) a) COVID-19.