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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First interoperable, automated insulin dosing controller authorised by FDA
The FDA has authorised the first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customise their diabetes management.
MHRA announces recall of Medley Pharma ranitidine tablets
The UK MHRA has issued a recall of two ranitidine products from Medley Pharma as a precautionary measure due to possible contamination.
New Drug Application submitted for first-ever Progeria treatment
A New Drug Application has been submitted to the FDA for lonafarnib, the first-ever treatment for Progeria and Progeroid Laminopathies.
New steps taken to lower US prescription drug prices
The FDA has announced that a notice of proposed rulemaking has been issued that would allow for the importation of certain prescription drugs from Canada which could lead to lower prescription drug prices.
Lumasiran drug achieves primary and secondary endpoints in Phase III study
Lumasiran, an investigational drug to treat primary hyperoxaluria type 1, has met its endpoints in clinical trials.
Treatment for hyperkalaemia recommended by NICE for NHS
NICE has recommended patients in England have access to a new treatment option for treating hyperkalaemia (raised serum potassium levels) in adults.
EMA releases findings from pharmacovigilance report
A new pharmacovigilance document from the European Medicines Agency shows that the medicine safety system in the EU is effective.
Key trends studied for diabetes drug development in 2020
Functional links between metabolic, cardiovascular and renal diseases, as well as a focus on digital and a personalised approach will shape diabetes drug development in 2020, says new analysis.
Dr Stephen Hahn appointed as new FDA commissioner
Dr Stephen Hahn has been voted into the role of FDA commissioner by the US Senate, taking over the role from Ned Sharpless.
Roche purchase of Spark Therapeutics is given the go ahead in UK
The CMA has cleared the anticipated purchase of gene therapy company Spark Therapeutics by pharmaceutical company Roche Holdings.
Drug approved which reduces risk of cardiovascular events
The FDA has approved Vascepa (icosapent ethyl) as a secondary therapy to reduce cardiovascular events in adults.
Survey finds smaller enterprises will drive life sciences in Scotland
Researchers have revealed that small- and medium-sized companies will by key in the growth of the life sciences sector in Scotland.
Timetable reportedly set for national vaccine tracking system in China
A national vaccine tracking system in China will aim to be completed before 31 March 2020, a report has said.
Regulatory submissions made for dispersible formulation of dolutegravir
ViiV Healthcare has filed submissions to the FDA and EMA for the first dispersible formulation of dolutegravir (DTG) for children living with HIV.
