Industry News

Glenmark Pharmaceuticals granted tentative approval by the US health regulator to sell Rufinamide, which is used to treat seizures caused by Lennox-Gastaut syndrome.

DeNovo Sciences, Inc., an innovator of cutting edge products of liquid biopsy, sign an agreement with START (South Texas Accelerated Research Therapeutics), a San Antonio based phase I medical oncology programme, one of the world’s largest of its kind with clinical trial sites on three continents.  As per agreement, START will collect blood samples of  cancer patients and use DeNovo instruments and reagents for circulating tumour cells (CTC) enrichment and purification. This will further will then be sent to a large genomics lab for whole genome sequencing. In addition, START and DeNovo have signed a separate agreement to test the ability of Denovo CTC platform to capture CTCs for use in patient derived xenograft (PDX) mice models for drug discovery and biomarker development purposes.

Vanda Pharmaceuticals (NASDAQ: VNDA) is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders to address unmet needs.,  has received the 2015 Industry Innovation Award from the National Organization of Rare Disorders (NORD) in recognition of company's work in developing Hetlioz (tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).  This award was presented to Vanda at the 2015 Portraits of Courage Gala in Washington D.C. on 18th May.

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.

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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Japanese pharmaceutical industry comprising of both multinationals and generic companies, have shown keen interest in working with the Indian counterparts in contract manufacturing service space.

The pharmaceutical major Cipla Limited has signed an pact with Serum Institute of India Ltd (SII) to exclusively market flu vaccine Nasovac-S in India. Under this agreement, SII will develop and manufacture the vaccine, and Cipla will market it in India. The vaccine will be manufactured in Serum’s world class production facilities approved by the WHO.

FICCI launched the first edition of ‘Advantage Health Care - India 2015’, which will be held from October 5-7, 2015 at Pragati Maidan, New Delhi. The objective of ‘Advantage Health Care - India 2015’ is to promote India as a premier global healthcare destination and to enable streamlined medical services exports from India.