Legal and Regulatory - Page 1
Stay up to date with the latest Legal and Regulatory updates from the global pharmaceutical industryLatest Legal and Regulatory Update
An advisory panel for the US Food and Drug Administration has rejected the use of Amgen’s drug Xgeva to prevent prostate cancer from spreading to the...
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New cost-cutting Medicaid rule could save US billions
A newly proposed cost-cutting rule implemented into the US Medicaid programme could save the country up to $17.7bn over five years, say US health...
Roche’s skin cancer drug Erivedge given FDA nod
Roche’s skin cancer drug Eviredge, developed in collaboration with Curis, has been approved by the US Food and Drug...
FDA approves Amylin’s diabetes drug Bydureon
The US Food and Drug Administration (FDA) has approved Amylin’s once-weekly diabetes drug Bydureon at the third time of...
Pakistan Supreme Court orders release of pharma owners
Pakistan’s Supreme Court has ordered the release of two owners of pharmaceutical companies as part of an investigation into deaths caused by the reaction from drugs distributed by the...
Pakistan agencies arrest officials after fake drugs cause cardiac patients deaths
Federal agencies in Pakistan are investigating the cause of over cardiac patient deaths linked to fake drugs administered to some 40,000 patients at a Government run...
Merck settles Vioxx litigation in Canada
Merck has agreed to pay at least $21.5m to resolve claims against its painkiller drug Vioxx in...
Cannabis-based cancer pain drug could hit US shelves
A cannabis-based drug designed to treat cancer pain, developed by UK-based GW Pharma, could be available in the US by the end of...
AstraZeneca and Bristol-Myers Squibb diabetes drug rejected by FDA
Approval for AstraZeneca and Bristol-Myers Squibb’s diabetes drug dapagliflozin has been rejected by the US Food and Drug...
FDA calls for strictest warning on drug linked to brain infection
The US Food and Drug Administration plans to strengthen the warning label on lymphoma drug Adcetris over concerns that it may be linked to a rare, but deadly brain...
US user fee programmes to speed up drug approvals
The US Food and Drug Administration has recommended three user fee programmes that are designed to help speed up the delivery of safe and effective drugs to...
GSK responds to Argentinian court ruling over controversial vaccine trials
GlaxoSmithKline (GSK) will appeal to the Supreme Court of Argentina against a ruling issued by Judge Marcelo Aguinsky over the inadequate handling of administrative conduct during the...
GlaxoSmithKline fined over controversial vaccine trials on Argentine babies
GlaxoSmithKline has been fined by an Argentine court over the management of clinical trials of its pneumonia vaccine Synflorix, which allegedly killed 14...
FDA to review Pfizer’s experimental arthritis drug
The US Food and Drug Administration (FDA) has accepted a new drug application for tofacitinib, an experimental drug to treat moderately to severely active rheumatoid arthritis, for...
AstraZeneca’s Faslodex given final snub by NICE
The UK's National Institute for Health and Clinical Excellence (NICE) has snubbed AstraZeneca breast cancer drug Faslodex in its final guidance, deeming it an inefficient use of NHS...
US cracks down on prescription drug delays
The Obama Administration has issued an interim final rule to help prevent prescription drug shortages in the...
AstraZeneca compounds now available to UK researchers
A landmark agreement between the UK Medical Research Council (MRC) and AstraZeneca will allow researchers free access to a number of high potential...
Safety of MS drug questioned after patient dies
The safety of Novartis’ multiple sclerosis drug Gilenya is under investigation after a patient in the US died after taking the treatment for the first...
HHS overrules FDA decision on Plan B pill
A top health official from the Obama administration has overruled the decision by the US Food and Drug Administration (FDA) to make Teva Pharmaceuticals’ Plan B morning-after pill available...
Teva hopeful that FDA will lift age restriction on Plan B pill
Teva Pharmaceuticals is waiting on a decision from the US Food and Drug Administration on whether it will end the age restriction on who can buy its Plan B emergency contraceptive pill without...
NICE rejects Novartis eye drug for diabetic patients
A UK health watchdog has advised against the use of Novartis' drug Lucentis for the treatment of diabetic macular oedema, stating that it is too expensive for patients with the...
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