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Off-label Use

RX Note

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.

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Homeopathy

RX Note

The remedies may provide a placebo benefit or may be labelled as homeopathic but actually contain measurable concentrations of drugs, nutrients or dietary supplements. The Science Most evidence does not support the validity of homeopathy; however, many are advocates.

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EC approves first-line ovarian cancer treatment

European Pharmaceutical Review

The safety profile for rucaparib observed in the clinical trial was consistent with current US and European labels for rucaparib. Since most patients have an initial response to the treatment, 80 percent will experience recurrence and require subsequent therapies, according to a 2012 paper published in Annals of Oncology.

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The Guardian view on cystic fibrosis treatments: a rollercoaster ride for the sick | Editorial

The Guardian - Pharmaceutical Industry

Its groundbreaking Kalydeco drug was licensed in Europe in 2012 and useful at first to only a small percentage of sufferers. Kaftrio is the latest to be labelled unaffordable for a cash-strapped NHS. And they have been plunged to the depths when those new drugs have been denied them because of their cost. Continue reading.

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Vertex gets EU okay to treat younger cystic fibrosis patients

pharmaphorum

The new EU approval comes after the FDA approved the expanded label last year, and provides the first treatment option that tackles the underlying cause of CF in patients aged six to 11 with these mutations. Together these drugs cover the CFTR mutations seen in around half of all CF patients.

Labelling 134
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FDA firms up JAK inhibitor warnings after Xeljanz review

pharmaphorum

The regulator is adding new and revised warnings labels to the Pfizer products as well as Eli Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib), which are also approved to treat arthritis and other inflammatory conditions. The result? billion, but fell 15% in the second quarter.

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Daiichi Sankyo grabs first approval for blood cancer drug Ezharmia

pharmaphorum

The Ministry of Health, Labour and Welfare (MHLW) in Japan has cleared Ezharmia (valemetostat tosylate) based on the results of an open-label phase 2 trial which revealed a 48% overall response rate with the drug in previously-treated ATL patients.