Aurinia announces the Great Britain marketing authorisation of Lupkynis (voclosporin) for the treatment of lupus nephritis

30 November 2022 - MHRA Approval follows European Commission marketing authorisation of Lupkynis to treat adults with active lupus nephritis in ...

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Swiss National Council votes to accept FDA approved medical devices

29 November 2022 - On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to ...

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FDA looks to modelling and simulation tools to streamline product reviews

28 November 2022 - The US FDA recently published a report on how it uses modelling and simulation, highlighting the untapped ...

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Bayer’s Nubeqa receives MHRA approval to treat metastatic prostate cancer

28 November 2022 - The treatment will be made available immediately through an early access deal with NHS England. ...

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An open letter to doctors from the TGA

28 November 2022 - The TGA welcomes feedback and is committed to continuously improving processes and communications.  ...

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DARWIN EU welcomes first data partners

23 November 2022 - EMA has selected the first set of  data partners to collaborate with DARWIN EU, the Data Analysis ...

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Bristol Myers Squibb warns US price reforms will dent drug development

20 November 2022 - Biggest shake-up in pharma pricing in decades prompts companies to shelve some potential therapies. ...

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FDA cancer chief wants quicker ways to pull failed drugs

17 November 2022 - Makena highlights need to make system more nimble. ...

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Getting the price right: lessons for Medicare price negotiation from peer countries

9 November 2022 - The US pays more for brand-name prescription drugs than any other country and new legislation from August ...

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Inflation Reduction Act drug pricing provisions aren’t at all like price controls in Europe

18 November 2022 - The opposition to the prescription drug pricing provisions in the Inflation Reduction Act can be hyperbolic.  ...

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A tussle over medicines pricing is looming in Britain

15 November 2022 - Agreement to limit the size of the NHS drugs bill under strain. ...

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CHMP issues opinion related to review of medicines within the Janus kinase inhibitor class

11 November 2022 - AbbVie announced today the EMA's CHMP has adopted an opinion following a nine month review of the ...

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Implementation of the Patented Medicine Prices Review Board's proposed Guidelines will harm Canadian patients

10 November 2022 - Innovative Medicines Canada is calling on Health Canada to direct the Patented Medicine Prices Review Board (PMPRB) ...

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Aleta Biotherapeutics receives Innovation Passport Designation for biologic CAR T-cell therapy engager ALETA-001

7 November 2022 - ALETA-001 was developed to address the urgent unmet need of patient relapse after CD19 targeted CAR ...

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Omeros Corporation receives decision from FDA on formal dispute resolution request for narsoplimab

8 November 2022 - Decision denies Omeros’ appeal requesting immediate labeling discussions. ...

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