New cancer drugs approvals underpinned by flawed evidence
A new report has shown that trial evidence alone is not enough when approving new cancer drugs and that an assessment of that evidence is also needed.
List view / Grid view
A new report has shown that trial evidence alone is not enough when approving new cancer drugs and that an assessment of that evidence is also needed.
Lanadelumab, a preventive treatment for hereditary angioedema, has been recommended as a cost-effective use of NHS resources.
A new initiative has already collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in three countries.
Purdue has filed for bankruptcy protection after a settlement offer from the company over the opioid crisis was rejected by 24 states.
GVOKE injection has received regulatory approval from the FDA for the treatment of severe hypoglycemia in patients with diabetes.
A settlement has purportedly been agreed between Purdue Pharma and 23 US states to resolve the opioid crisis case against the company.
A report has found that the rejection of a settlement offer from Purdue has led to the company arranging to file for bankruptcy.
An annual report has found that the pharmaceutical sector is the lowest regarded industry among US citizens.
The voretigene neparvovec gene therapy treatment has been highlighted in draft guidance by NICE for availability on the NHS.
The efficient handling of information and resources is key for achieving success within a commercial organisation. Against the backdrop of ICH Q10 – the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Christian Rack discusses five things you can implement right now to…
China has expanded a pilot drug bulk-buying programme to almost the entire country which is adding pressure on pharma companies.
A Phase III trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer demonstrated no survival benefit.
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
Fast Track designation has been granted to Farxiga to prevent heart and kidney failure in patients with chronic kidney disease.
NICE and GW Pharma will work together to address the issues highlighted in its evaluation of cannabidiol for treating two types of epilepsy.