Amgen and UCB, which were due to be quizzed by the European Medicines Agency in May about the investigational drug romosozumab that they are co-developing for osteoporosis, should soon find out whether their responses were good enough for the agency to recommend the medicine for pan-EU approval.
Romosozumab Among Latest Drugs Up For CHMP Opinion
Four drugs are up for an opinion this week on whether they should be granted EU-wide approval, including Amgen/UCB's osteoporosis drug romosozumab.
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Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.
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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
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Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.
Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry
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Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.
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Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.
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Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.
Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry
• By
Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.