When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results

When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results

“The first thing you feel when a trial fails is a sense of shame,” says physician Siddhartha Mukherjee. Then comes the “exhilarating — and dangerous” instinct to slice and dice the data to resurrect the drug’s potential.

Here Siddartha discusses the lure to make more of the science than is perhaps there, when stakes are high and we are desperate to find hope for patients who are out of treatment options. Continue reading “When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results”

Antibiotic resistant superbugs – should we be worried?

Antibiotic resistant superbugs – should we be worried?

Post contributed by Glenn Whiteside, Product Specialist for AdisInsight

I have a mate, let’s call him Steve, actually his name is Steve, and several years ago he noticed that the big toe on his right foot was turning black. Diagnosis revealed that he had poor circulation to his lower leg and foot because of venous occlusion caused years ago when he was stomped on in a rugby game. The long and short of it was that his toe needed to be amputated and a stent put into a vessel in his leg to fix the problem. Unfortunately for Steve and the three other guys in his room, they were all infected with MRSA (methicillin resistant Staphlococcus aureus). Steve ended up having two further amputations on his leg to try to stop the spreading infection. He tried every antibiotic in the arsenal, but none of them stopped the relentless progress of the infection, instead the bacteria just kept on eating his tissues. Steve was lucky in a way because he lived to tell his tale, albeit without the lower half of his leg. Continue reading “Antibiotic resistant superbugs – should we be worried?”

Naldemedine (Symproic®): First Global Approval – new therapeutic option for sufferers of opioid-induced constipation

Naldemedine (Symproic®): First Global Approval – new therapeutic option for sufferers of opioid-induced constipation

The recent first global approval of naldemedine has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

Continue reading “Naldemedine (Symproic®): First Global Approval – new therapeutic option for sufferers of opioid-induced constipation”

Ribociclib (Kisqali®): First Global Approval – next-gen cyclin-dependent kinase inhibitors a new standard of care for women with advanced breast cancer

Ribociclib (Kisqali®): First Global Approval – next-gen cyclin-dependent kinase inhibitors a new standard of care for women with advanced breast cancer

The recent first global approval of ribociclib has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

Continue reading “Ribociclib (Kisqali®): First Global Approval – next-gen cyclin-dependent kinase inhibitors a new standard of care for women with advanced breast cancer”

Fail Early, Fail Fast – and increase Likelihood of approval with biomarkers

Fail Early, Fail Fast – and increase Likelihood of approval with biomarkers

Our partners Amplion recently published an interesting blog post on the benefits of biomarkers in informing earlier decisions in the drug development process – “fail early, fail fast” to save time and money, and increase approval success. An interesting read, check it out! Continue reading “Fail Early, Fail Fast – and increase Likelihood of approval with biomarkers”

Telotristat Ethyl (Xermelo™): First Global Approval – first and only oral drug for cancer-related diarrhoea syndrome

Telotristat Ethyl (Xermelo™): First Global Approval – first and only oral drug for cancer-related diarrhoea syndrome

The recent first global approval of telotristat ethyl has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

Continue reading “Telotristat Ethyl (Xermelo™): First Global Approval – first and only oral drug for cancer-related diarrhoea syndrome”