Industry News

The European Commission has granted marketing authorization in Europe for Sanofi's Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a next-generation basal insulin for the treatment of type 1 and type 2 diabetes mellitus in adults. Its significant milestone for Sanofi. This gives people with diabetes and their physicians a new option to manage their condition.

aTyr Pharma, a biotherapeutics company engaged in the discovery and development of physiocrine-based therapeutics to address rare diseases, announced  that Resolaris has been granted Orphan Drug designation by the US Food and Drug Administration (FDA) for the treatment of facioscapulohumeral muscular dystrophy (FSHD).  Resolaris, an investigational new drug,  is being developed as a first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component.

Three Indian pharmaceutical companies, namely Alembic Pharmaceuticals, Hetero Labs and Torrent Pharmaceuticals have get the US Food and Drug Administration (FDA) approval for generic versions of Abilify (aripiprazole). Aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.   Teva Pharmaceuticals has also get  similar approval.

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Last week 7.8 magnitude earthquake hit Nepal. In response to this Novo Nordisk India has shared  donation of  75,000 insulin vials to the Indian government’s relief operations. The insulin valued at Rs.1 crore. This is to support people with diabetes who have been affected by the earthquake and who currently need access to this life saving medication. As damage and destruction has made living in Nepal citizens, people with diabetes in Nepal are facing difficulty to get medications.

Elekta is a Swedish company that provides radiation therapy, radiosurgery, related equipment and clinical management for the treatment of cancer and brain disorders,  has introduced its new Leksell Gamma Knife Icon.  The benefits of precision cranial radiosurgery are now available for more patients with a wider variety of brain tumor types and sizes.  This latest generation stereotactic radiosurgery system for the brain, integrates advanced motion management, dose delivery and imaging technologies, significantly increasing the versatility of Gamma Knife radiosurgery. Elekta unveiled Leksell Gamma Knife Icon at the 3rd ESTRO Forum in Barcelona.

National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT), authorize only 5 institutes across the country to get registration for the Institutional Committee for Stem Cell Research (IC-SCR) to review and monitor stem cell research at the institutes.

United States Food and Drug Administration (FDA) has approved a revision to the duration of the bolus delivery for the Aggrastat (tirofiban HCl) high-dose bolus (HDB) regimen launched by Medicure Inc, a specialty pharmaceutical company. Aggrastat is Antiplatelet drug. It is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).

Firecrest eConsent is a next-generation electronic informed consent solution introduced by  ICON plc, a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, that incorporates key recommendations from the FDA’s recent draft guidance on informed consent.  It is designed to enhance the engagement of patient populations in the development process. One of the critical parts to improving this engagement is improving the informed consent process.

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The European Medicines Agency (EMA) has recommended approval for Opdivo (nivolumab). Opdivo is indicated for treatment  of adult patients with advanced (unresectable or metastatic) melanoma.