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Summarising 2019: a year of firsts for the EMA
The EMA was a proactive force in 2019, granting marketing authorisation for a range of drugs. This article highlights some of the most important advancements made by the agency last year.
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Generics
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Governor of California proposes state-run drug label
In a bid to lower the costs of medicines, California's governor has suggested contracting generic drug manufacturers to make pharmaceutical products for the state to sell, according to reports.
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Novadoz Pharmaceuticals receives FDA go-ahead for Febuxostat generic
US-based Novadoz Pharmaceuticals has received FDA approval for their generic version of Febuxostat 40mg and 80mg tablets.
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Report links greater generic competition and lower generic drug prices
A new report from the FDA has shown that greater competition among generic drug makers is associated with lower generic drug prices.
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The first generics of Gilenya have been approved by the FDA
The first three applications for generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of MS have been approved.
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New opportunities for Indian pharma industry in Philippines, finds study
The Philippines’ 2019 Universal Health Care Act and regulatory tax reforms open new avenues for the Indian pharmaceutical industry, according to new research.
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Generics and biosimilars vital to reduce healthcare costs, finds EC
The EC has released a report that has found generics and biosimilars decrease wasteful spending and maintain health quality in the EU.
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Allergan to reportedly settle Alzheimer’s therapy lawsuit for $750m
Allergen is to reportedly settle a class-action lawsuit which alleges that it worked to delay generic competition for Alzheimer’s disease therapy Namenda.
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The potential of the Indian pharmaceutical industry
According to research from the Indian Pharmaceutical Alliance, the country’s pharma sector has capacity to grow. This article investigates some of the goals, challenges and proposals the report sets out for the industry.
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FDA approved 1,171 generic drugs in 2019
The FDA has released a statement on their generic drug approvals in FY 2019, revealing a new record high breaking above last year.
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First US state bans ‘pay-for-delay’ pharma practice
California’s state governor has signed a bill which will stop drug makers from paying generic drug producers to stay off the market.
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Biologics and generics reported to save NHS £700m
An NHS-wide plan to use more generic and biologic products has reportedly saved the healthcare provider £700 million since 2016.
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FDA announces expansion of generic impurity investigation
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
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China to relax generic drug import laws
The government in China has stated that small quantities of generic medicines that are legal in foreign countries will no longer be classed as “fake drugs”.
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Novo Nordisk files lawsuit against Mylan for generic application
The two pharmaceutical companies are facing a legal battle after Mylan filed a new drug application for a generic of Novo Nordisk’s Victoza.
