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New UK authorisation procedure will draw on international drug approvals

Drug Discovery World

The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) new International Recognition procedure (IRP) will allow it to draw on the expertise of regulators in other countries when authorising medicines.

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UK lags behind on access to treatments for rare diseases

Drug Discovery World

The UK lags comparable countries, including France and Germany, on the degree of availability of treatments for rare diseases, according to a new report. The report by the BIA and consultancy firm PwC has highlighted the progress that has been made in improving access to rare disease treatments in the UK, and the challenges that remain.

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UK regulator gives green light to combination for multiple myeloma

Drug Discovery World

The therapy is now recommended within an NHS setting for the treatment of adults with newly diagnosed MM where an autologous stem cell transplant (ASCT) is unsuitable. The post UK regulator gives green light to combination for multiple myeloma appeared first on Drug Discovery World (DDW).

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This week in drug discovery (1-5 January) 

Drug Discovery World

The top stories: China’s NMPA okays maribavir for post-transplant cytomegalovirus Takeda’s Livtencity (maribavir) has been approved in China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease.

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Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations

FDA Law Blog: Biosimilars

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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UK life sciences can lead the way in cannabinoid R&D, says report

Drug Discovery World

The report suggests the UK can build on the success of GW Pharmaceuticals, whose multiple sclerosis treatment product nabiximols was the first natural cannabis plant derivative to gain market approval in any country.

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