Sun Pharmaceutical Industries Ltd. has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec®, Imatinib Mesylate tablets 100mg and 400mg. Gleevec® is the registered trademark of Novartis Pharmaceuticals Corporation.
Cipla Ltd, a global pharmaceutical company announced that it has launched a novel “5 in 1” anti-ageing skin care product Cutisera developed by Stempeutics. Cutisera has been developed using bio-active factors derived from human adult stem cells to enhance the rejuvenation of ageing skin.
Advaxis, Inc., a clinical-stage biotechnology company developing cancer immunotherapies, announced that the European Medicines Agency (EMA) granted Orphan Drug Designation for ADXS-HER2 for the treatment of osteosarcoma.
Biotronik, the world’s leading manufacturer of MR conditional cardiac devices, has announced that its Eluna 8 pacemaker is now available in Japan. The pacemaker is approved for 1.5 tesla (T) full-body MRI scans, and ultra-high strength 3.0 T MRI scans with an exclusion zone.
AbbVie, a global biopharmaceutical company, announced its New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) for a once-daily, fixed-dose formulation of the components of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). VIEKIRA PAK is an all-oral, interferon-free treatment approved with or without ribavirin (RBV) in the United States for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis. VIEKIRA PAK is not for people with decompensated cirrhosis.
GlaxoSmithKline announced that the European Commission has granted marketing authorisation for Nucala® (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in adult patients. As a result Nucala is now approved for use in the 31 European countries covered by the European Medicines Agency (EMA).
Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center today announced a collaboration focused on developing innovative medicines for pancreatic ductal adenocarcinoma (PDAC). The new collaboration combines MD Anderson’s unique understanding of potential drivers of PDAC with Boehringer Ingelheim’s experience in drug discovery and development.
Greatbatch, Inc. announced that it has received approval from the United States Food and Drug Administration (FDA) for its Algovita® Spinal Cord Stimulation (SCS) System to treat chronic intractable pain of the trunk and/or limbs.
New data from a completed phase 3 trial show Trulicity (dulaglutide) 1.5 mg plus a sulfonylurea was significantly more effective than a sulfonylurea alone in lowering hemoglobin A1c (A1C) from baseline after 24 weeks of treatment. Trulicity is Eli Lilly and Company's once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes. These data, from the Trulicity AWARD-8 clinical trial, were presented for the first time today at the 2015 International Diabetes Federation (IDF) World Diabetes Congress in Vancouver, Canada.
TAKE Solutions launched PV India, a unique pharmacovigilance peer network, organized and managed by one of TAKE’s Life Sciences division, Navitas. At the time when the pharma industry is facing business challenges and the government of India citing delayed regulatory approvals as a primary concern, it is imperative for Pharma companies to arrive at solutions to tackle these problems.
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