Industry News

Stryker Corporation, one of the world's leading medical technology companies instruments division of interventional spine business unit has received clearance from the US Food and Drug Administration (FDA) to market its expanded indications of VertaPlex HV for the treatment of sacral insufficiency fractures.

U.S. health regulators approved Praxbind, a reversal agent made by Germany Private held Boehringer Ingelheim, for use in emergency situations by patients taking the company's widely used Pradaxa blood thinner. Praxbind, an intravenous injection, is the first reversal agent approved specifically for Pradaxa and works by binding to the drug compound to neutralize it.

Sandoz Canada launch a brand new multi-platform application, which allows healthcare professionals to have this crucial information at their fingertips. Sandoz Pro app (sandozpro.sandoz.ca) allows users to view information on availability of injectable medicines. This new tool is designed for healthcare professionals and buyers who want to make the most of their time, as it helps them plan their injectable drug supplies and make informed decisions at all times.

Nestle India on Friday said all samples of its Maggi noodles have passed the required tests as directed by the Bombay High Court but it would hit the market after some time as the newly-manufactured product has to go through fresh tests.

Nestle India said on Friday that 100 percent of the Maggi instant noodles' samples tested in three laboratories have been cleared and that the noodles are safe for human consumption.

Merck, a leading science and technology company relaunch its brand identity. It will introduce  new logo reflect the transformation into a global science and technology company. Outside the United States and Canada, the company will operate uniformly as Merck.

Roche Pharma India recently introduce  two innovative medicines for the treatment of HER2-positive metastatic breast cancer, a particularly aggressive form of the disease. The new drugs, Perjeta and Kadcyla, have been shown to both extend survival and improve quality of life in their approved applications for metastatic HER2-positive breast cancer.

Incyte Corporation and Merck, known as MSD outside the United States and Canada, today announced the expansion of the companies’ ongoing clinical collaboration to include a Phase 3 study evaluating the combination of epacadostat, Incyte’s investigational selective IDO1 inhibitor, with Keytruda^® (pembrolizumab), Merck’s anti-PD-1 therapy, as first-line treatment for patients with advanced or metastatic melanoma. The Phase 3 study, which is expected to begin in the first half of 2016, will be co-funded by Incyte and Merck.

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.

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.