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  • Roche announced the CE-IVD launch of the cobas® Liat® PCR System with four assays including first 20 minute real-time PCR nucleic acid test to detect Clostridium difficile (C. diff). Countries accepting CE mark are the first to receive access to the cobas® Cdiff test, which detects C. diff in stool specimens from symptomatic patients1 and provides rapid and definitive results in under 20 minutes. Timely and accurate diagnosis of this infection is important because it can quickly become life threatening, especially to high-risk patients such as the elderly, immuno-compromised and those undergoing antibiotic treatment.

  • Cipla Ltd, a global pharmaceutical company, announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Abacavir and Lamivudine Tablets USP, 600 mg/300 mg, from the United States Food and Drug Administration (USFDA).

  • U.S. Food and Drug Administration approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional.

  • The Department of Biotechnology (DBT), India and the Netherlands Organization for Scientific Research (NWO) / the Netherlands Organization for Health Research and Development (ZonMw) will soon jointly initiate research on Health care. This program provides funding opportunities for joint research cooperation between Dutch and Indian research groups.

    Three strategic issues to be addressed under this program. First, how can technology support people's health and well-being in order to help them function and participate in society outside of organized care? The point is to focus on health rather than on health care. By focusing on prevention, health and wellness, you reduce the need for professional health care. Second, how can technology make it easier for people to get closer to home? In many cases, it is more cost effective and better for patients to provide care outside of health care facilities. Chronic care should not be managed in hospitals. Rehabilitation should take place closer to home or even at home. Third, how can technology enable more effective and personalized care? Technology allows us to do more with less. The technology can allow for early and individualized diagnosis and prognosis, less invasive treatment and change work processes all together.

    The purpose of this joint research program is to stimulate a sustainable Indian-Dutch research collaboration by funding joint research projects in the field of medical devices with the explicit objective of contributing to more sustainable health care in India or Netherlands. It also aims to develop innovative technologies for a sustainable health system.

    In addition to providing solutions to the above questions, another objective is to stimulate the Dutch and Indian research fields of medical devices on the minimally invasive techniques.


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  • Alkem got EIR from the US FDA

    US FDA has issued an Establishment Inspection Report (EIR) for Alkem Labs's Ankaleshwar API Facility which was inspected in December 2016. The inspection has now been closed by the US FDA.

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  • Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Meropenem Injection 500 mg/vial and 1 g/vial. Aurobindo’s Meropenem injection is a generic equivalent of AstraZeneca Pharmaceuticals’ Merrem® Injection. The product will be launched immediately.

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