Industry News

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biotechnology and medical device industries, that incorporates key recommendations from the FDA’s recent draft guidance on informed consent.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.

Deerfield, Ill., U.S., April 28, and Osaka, Japan, April 29, 2015 – Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that they have reached an agreement expected to resolve the vast majority of ACTOS (pioglitazone HCl) product liability lawsuits pending against Takeda in the U.S. Takeda will take a $2.7 billion charge against earnings in the fourth quarter of fiscal year 2014 to cover the settlement and the costs associated with defending remaining cases and for other related litigation. The settlement will become effective if 95 percent of current litigants and claimants opt into the settlement. Once that threshold is achieved, Takeda will pay $2.37 billion into a settlement fund. However, that figure will rise to $2.4 billion if 97 percent or more of the current litigants and claimants opt to participate in the settlement.

European Commission has granted marketing authorization in Europe for 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.

(Business Wire India); Biocon Ltd, Asia's premier biopharmaceuticals company, today announced that its Contract Research subsidiary Syngene International Ltd (“Syngene”) has filed the Draft Red Herring Prospectus (DRHP) with the Securities and Exchange Board of India (SEBI) on April 22, 2015, seeking approval for an Initial Public Offering (IPO). This is an offer for sale (OFS) by Biocon of a part of its shareholding in Syngene. Biocon along with its subsidiary Biocon Research Limited (BRL) currently holds an 84.5% equity stake in Syngene.

Novo Nordisk, a world leader in insulin and diabetes care,  has launched Saxenda (liraglutide 3 mg), the first glucagon-like peptide-1 (GLP-1) receptor agonist the United States.  Saxenda is a drug used to treat obesity.  Saxenda has approved in the US, EU and Canada.