Pharma News

US Food and Drug Administration (FDA) has approved Eli Lilly and Company Humalog 200 units/mL KwikPen (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog (insulin lispro 100 units/mL) Humalog U-200 KwikPen is used to improve glycemic control in people with type 1 and type 2 diabetes.

The Food and Drug Administration (FDA)  has approved Actavis' Viberzi (eluxadoline) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhoea (IBS-D).
IBS-D is a multifactorial disorder marked by recurrent abdominal pain or discomfort and altered bowel function that affects as many as 15 million adult Americans, impacting about twice as many women as men. There are few treatment options available for IBS-D, particularly options that relieve both the diarrhea and abdominal pain associated with IBS-D.

Biocartis and Fast-track diagnostics, have entered into a strategic collaboration to develop a range of multiplex infectious disease tests to run on the Biocartis Idylla system. As part of the collaboration, tests from Fast-track diagnostics’ comprehensive infectious disease menu will be developed for use on Biocartis’ innovative molecular diagnostics (MDx) platform, Idylla. Idylla is a fully-automated MDx system that delivers accurate, rapid tests in virtually any setting, from virtually any biological sample type, and without the need for pre-processing or specialist training.

Ayurvedic Drug Manufacturers’ Association (ADMA) is planning to meet the commerce ministry next week to get some relief on the obligation to pay heavy access benefit sharing (ABS) levy.

A new study said An unlisted chemical compound in fragrance which is one of the main constituents of lavender oil can cause allergic eczema.

Lemtrada (alemtuzumab), is new drug developed for treatment of Multiple Sclerosis (MS) reduces the relapse rates. Recently, Samuel F. Hunter, MD, PhD, President of the Advanced Neurosciences Institute in Franklin, Tennessee, presented a paper at the 2015 Annual Meeting of the Consortium of Multiple Sclerosis Centers in Indianapolis, Indiana on outcomes in patients with relapsing multiple sclerosis treated with Lemtrada (alemtuzumab).

The Indian Council of Medical Research (ICMR) will soon start research on stillbirth to identify and understand the local causes and risk factors from the medical and sociological perspective. ICMR's initiative on stillbirth is significant as nearly 3 million third-trimester stillbirths occurring worldwide each year and 98 per cent of these occur in low-income and middle-income countries.  More than 1 million stillbirths occur in the intrapartum period, which can largely be prevented. The cause of stillbirth remains unidentified in India.

ViiV Healthcare, Aurobindo Pharma, and the Clinton Health Access Initiative, Inc. (CHAI) announced that Aurobindo Pharma, has submitted to the Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for dolutegravir 50mg, for tentative approval, for  HIV treatment. Upon receiving tentative approval from the FDA, Aurobindo Pharma will be able to supply dolutegravir 50mg via the President’s Emergency Plan for AIDS Relief (PEPFAR) programme, following completion of required local regulatory approval process, in the licensed countries outside of the United States, as per the agreement signed between Aurobindo Pharma and ViiV Healthcare in 2014. This is the first ANDA for a generic version of dolutegravir, less than two years after FDA approval of Tivicay (dolutegravir) for sale in the United States.

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The Government proposes to soon open 1000 more stores under the ‘Jan Aushadhi Scheme’ to make available quality generic medicines at affordable prices through these special outlets.

Using a partial synthetic process, by extracting trabectedin or ET-743, a compound found in marine invertebrate., scientists are producing a natural cancer drug. They are isolating the genetic blueprint of the ET-743's producer by using advanced sequencing techniques. The insights will make it possible for scientists to culture the bacteria in the laboratory without its host.