Industry News

- Read more about Abbott get approval an Australia for freestyle® Libre Flash Glucose Monitoring System
Abbott announced that it has received approval from the Therapeutic Goods Administration (TGA) in Australia for its FreeStyle® Libre Flash Glucose Monitoring System, a revolutionary new glucose sensing technology for insulin-using Australians with diabetes. The system eliminates the need for routine finger pricks1, reading glucose levels through a sensor that can be worn on the back of the upper arm for up to 14 days. In addition, no finger prick calibration is needed a key differentiator from current continuous glucose monitoring systems.
- Read more about Durvalumab granted Breakthrough Therapy designation by US FDA
AstraZeneca and MedImmune, its global biologics research and development arm, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen.
- Read more about FDA approves medtronic deep Brain Stimulation for people with Parkinson's Disease with recent onset of motor complications
Medtronic plc announced U.S. Food and Drug Administration (FDA) approval of Medtronic Deep Brain Stimulation (DBS) Therapy for use in people with Parkinson's disease of at least four years duration and with recent onset of motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication. In 2002, the FDA initially approved Medtronic DBS Therapy for use in patients with advanced Parkinson's disease. Medtronic DBS has demonstrated improvement in motor complications, quality of life, activities of daily living and reduction in medication usage in individuals with Parkinson's disease.
- Read more about Cipla acquired two US Drug Industries in 550 million dollor
Drug major Cipla has acquired two US-based firms InvaGen Pharmaceuticals and Exelan Pharmaceuticals for $550 million, the company said in a regulatory filing here on Thursday.

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- Read more about Dr.Reddy's Lab to buy back shares at Rs.3,500 per equity share
Pharma major Dr.Reddy's Laboratories has decided to buyback around 44,84,049 of equity shares of around 2.6 percent for Rs.1,569.4 crore as it has strong cash flows.
- Read more about Biota receives FDA fast track designation for its antiviral BTA585
Biota Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its antiviral compound, BTA585, for the treatment of respiratory syncytial virus (RSV) infections in infants, young children and adults.
- Read more about FDA issues recommendations to reduce the risk for Zika virus blood transmission in the United States
As a safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection.

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- Read more about Remedy Pharmaceuticals announces FDA Orphan Drug Designation in two CNS Indications
Remedy Pharmaceuticals, a privately-held, Phase 3-ready pharmaceutical company focused on bringing life saving hospital-based treatment to people affected by central nervous system (CNS) related edema, announced that the United States Food and Drug Administration (“FDA”) has granted orphan drug designation to its lead drug, CIRARA™, for both the treatment of acute subarachnoid hemorrhage and acute spinal cord injury.
- Read more about U.S. FDA approves two supplemental indications for Harvoni® in Chronic Hepatitis C patients
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved additional indications for Harvoni® (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease.
- Read more about Amgen blood cell disorder drug meets primary goal in phase 3 trial
Amgen announced that the randomized, double-blind, placebo-controlled Phase 3 Aranesp® (darbepoetin alfa) ARCADE trial met its primary endpoint of reducing the incidence of red blood cell transfusions in anemic patients with low and intermediate-1 risk Myelodysplastic Syndrome (MDS) at the end of the blinded 25-week study period. Aranesp also significantly improved erythroid response, a key measure of the formation of new red blood cells. Detailed results will be submitted to a future medical conference and for publication.