Life sciences industry calls for better funding for medicine and technology regulator

31 January 2023 - The life sciences, health and medicine sectors have come together to call for improved funding of ...

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Achieving patient centeredness in Medicare’s new drug price negotiation program

27 January 2023 - The Inflation Reduction Act mandated the creation of a Drug Price Negotiation Program focused on developing a ...

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Big pharma groups rejoin battle with governments on drug prices

24 January 2023 - Tight budgets and US reforms are ending a truce between the industry and health authorities. ...

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Update on US FDA emergency use authorisation of Evusheld

26 January 2023 - The US FDA has stated that AstraZeneca’s Evusheld (tixagevimab and cilgavimab) is not currently authorised for ...

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Patent reform and lower drug prices should be bipartisan priorities

25 January 2023 - As the 118th Congress convenes this month in Washington D.C., many pundits and advocates have little ...

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A “method of use” to prevent generic and biosimilar market entry

25 January 2023 - A critical pathway that generics and biosimilars manufacturers have used to circumvent patent thickets has been “skinny ...

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Pricing of medicines in Switzerland | Three yearly price review: What are the most important changes for 2023?

24 January 2023 - The Federal Office of Public Health reviews the price of every medicinal product that is reimbursed under ...

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The FDA’s power to approve drugs faces sweeping challenge in lawsuit seeking to pull abortion pill from US market

24 January 2023 - Anti-abortion physicians are suing to overturn the FDA’s approval of mifepristone, which dates back more than two ...

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Despite court ruling, FDA will continue with its approach to approving orphan drug exclusivity

23 January 2023 - In an unexpected move, the FDA will continue to apply exclusive marketing rights for so called ...

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TGA commences evaluation of Moderna COVID-19 vaccine (Spikevax) for potential transition to full registration

20 January 2023 - The TGA has commenced evaluation of an application from Moderna to transition its COVID-19 vaccine, Spikevax, ...

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Novartis warns US plan to curb drug prices could hit key research

21 January 2023 - US Government plans to rein in drug prices could discourage work in some of Novartis' most ...

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UK's voluntary scheme for branded medicines, pricing and access (VPAS) faces a potential crisis

19 January 2023 - The UK has a “voluntary scheme for branded medicines, pricing, and access” or VPAS, which sets a ...

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FDA’s breakthrough program: faster drug OKs without sacrificing safety

18 January 2023 - A FDA program markedly cut the time and cost of bringing to market new drugs, without ...

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Medunik Canada obtains new Notice of Compliance from Health Canada for Ruzurgi (amifampridine) following a favourable Canadian Federal Court of Appeal ruling

17 January 2023 - Medunik Canada is pleased to announce that on 9 January 2023, the Federal Court of Appeal of ...

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A new US law aims to reduce drug prices. But first, it might raise them.

14 January 2023 - A new US law meant to blunt drug prices could reduce pharmaceutical-company revenue by about $40 billion ...

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