Industry News

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.

Taro Pharmaceutical Industries has posted strong net profit growth of 70 per cent during the fourth quarter ended March 2015 to US$ 153 million from $90 million in the similar period of last year. Its net sales up by 30.5 per cent to $244 million from $187 million. With smart improvement in earnings, EPS worked out to $3.56 as against $2.10 in the last period. Its R&D expenses raised to $23.9 million from $13.1 million and selling, marketing, general and administrative expenses declined by 16.5 per cent to $22.2 million from $26.6 million.

Indoco Remedies, has posted its standalone net profit during the fourth quarter ended March 2015 to Rs.18.75 crore from Rs.18.55 crore in the corresponding quarter of last year due to higher R&D expenditure. Its R&D expenditure increased by 78.2 per cent to Rs.7.45 crore from Rs.4.18 crore. The company's standalone net sales increased by 13.8 per cent to Rs.211.59 crore from Rs.185.86 crore. Its EBIDTA moved up by 11.2 per cent to Rs.37.66 crore from Rs.33.88 crore. EPS remained almost same at Rs.2.03.  The board of directors has recommended equity dividend of 80 per cent i.e. Rs.1.60 per share for the year 2014-15.

US Food and Drug Administration (FDA) has approved  Neupogen, a drug originally used to treat side effects of chemotherapy,is the first ever approved for the treatment of acute radiation injury and the approval came as a result of research performed by the University of Maryland School of Medicine (UM SOM) scientists.

The European Medicines Agency (EMA) has recommended extending the use of Imbruvica (ibrutinib) for treatment of patients with Waldenstrom’s macroglobulinaemia. The medicine is indicated for adults who have received at least one prior therapy or as a first line treatment for patients unsuitable for chemo-immunotherapy.

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The US Food and Drug Administration (FDA) granted Orphan Drug Designation to Aura Biosciences' drug AU-011 for the treatment of uveal melanoma. The FDA’s Orphan Drug Designation programme provides orphan status to drugs and biologics, which demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions in the US.