Skip to main content

October 2015

 

 

academics

 

Clinical research courses

Transplant surgeons claim to have used a 'heartin- a-box' device to "revive" hearts from people who have recently died and use the organs to save others. The USD 250,000 device is a wheeled cart with an oxygen supply, a sterile chamber, and tubing to clamp onto a donor heart and keep it fed with blood and nutrients. Doctors said it may extend the time a heart can last outside the body. In at least 15 cases, surgeons in the UK and Australia say they have used the system to successfully transplant hearts removed from patients after they have died.

For the first time, primitive human kidneys have been created in a laboratory dish, by using stem cells, which could be a key step towards the Holy Grail of fully-functional, lab-made transplant organs. The tissue is not a viable organ, but may be useful for other purposes such as replacing animals in drug toxicity tests, the team said.

Hyderabad-based Aurobindo Pharma received the final approval from the US Food and Drug Administration to manufacture and market generic Aripiprazole tablets used for treatment of psychotic conditions in the American market. The approval is for the tablets in the strengths of 2mg, 5mg, 10mg, 15mg, 20mg and 30mg.

Bangalore Calling, Bio-Pharma Candidates.

The U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR mutation or ALK translocation should have disease progression on appropriate targeted therapy prior to receiving Opdivo. In a Phase 3 trial, CheckMate -057, Opdivo demonstrated superior overall survival (OS) in previously treated metastatic non-squamous NSCLC compared to chemotherapy, with a 27% reduction in the risk of death (hazard ratio: 0.73 [95% CI: 0.60, 0.89; p=0.0015]), based on a prespecified interim analysis.1 The median OS was 12.2 months in the Opdivo arm (95% CI: 9.7, 15.0) and 9.4 months in the docetaxel arm (95% CI: 8.0, 10.7). This approval expands Opdivo’s indication for previously treated metastatic squamous NSCLC to include the non-squamous patient population. Squamous and non-squamous NSCLC together represent approximately 85% to 90% of lung cancer cases.