Industry News

- Read more about Unichem Lab gets USFDA nod for hypertension drug
Unichem Laboratories has received final approval from the US health regulator to market generic Irbesartan tablets, used in treating hypertension, in the American market.
- Read more about Takeda presents data from phase 3 study for multiple myeloma drug
Takeda Pharmaceutical Company Limited announced results from the TOURMALINE-MM1 trial presented at the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH), showing that treatment with NINLARO® (ixazomib) capsules is effective in extending progression free survival (PFS) with a manageable tolerability profile in patients with relapsed and/or refractory multiple myeloma. The TOURMALINE-MM1 trial is an international, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate once-weekly oral ixazomib plus lenalidomide and dexamethasone compared to placebo plus lenalidomide and dexamethasone.
- Read more about AstraZeneca and Voluntis to test companion mobile app in ovarian cancer studies with the US National Cancer Institute
AstraZeneca announced plans to test a digital support service for women undergoing treatment for recurrent platinum-sensitive high-grade ovarian cancer in clinical trials of cediranib plus olaparib. Voluntis has developed the service in close clinical collaboration with AstraZeneca and the US National Cancer Institute (NCI). It is delivered through a smartphone app paired with a web portal to help clinicians and patients manage side effects of hypertension and diarrhoea sometimes associated with combination therapy with cediranib and olaparib. Such side effects are traditionally described to care teams through manual, time-consuming and non-digitised channels.
- Read more about Dr. Reddy’s signs MoU with Life Sciences Sector Skill Development Council and Vishnu Institute of Pharmaceutical Education and Research to Strengthen the Skilled Labour Pool in the Life Science Industry
Dr. Reddy ’s announced the signing of a Memorandum of Understanding (MoU) with The Life Sciences Sector Skill Development Council (LSSSDC) and Vishnu Institute of Pharmaceutical Education and Research (VIPER) .The MoU is aimed at fostering market research collaboration between LSSSDC and industry par tners , that in turn will help align educational courses to industry requirements.The MoU will also collaborate to create pharmaceutical,biotechnology and clinical research occupation standards, as well as establish acompetency matrix for job roles in the pharmaceutical sector.
- Read more about Amgen and Merck Announce Cancer Immunotherapy Collaboration for Patients with Non-Hodgkin Lymphoma
Amgen and Merck known as MSD outside the United States and Canada, announced a cancer immunotherapy collaboration to support a Phase 1b/3 study investigating BLINCYTO® (blinatumomab) in combination with KEYTRUDA® (pembrolizumab) in patients with diffuse large B-cell lymphoma (DLBCL), which is the most common type of non-Hodgkin lymphoma (NHL). BLINCYTO is Amgen’s CD19 bispecific T cell engager (BiTE®), and KEYTRUDA is Merck’s anti-PD-1 antibody. The study is an open-label, multicenter, randomized trial to evaluate safety and efficacy in patients with DLBCL.
- Read more about European Medicines Agency validates Gilead’s marketing application for fixed-dose combination of Sofosbuvir/Velpatasvir for the treatment of Hepatitis C
Gilead Sciences, Inc. announced that its Marketing Authorization Application (MAA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection, has been fully validated and is now under assessment by the European Medicines Agency (EMA). The data included in the application, which was submitted on November 17, 2015, support the use of SOF/VEL among patients with genotype 1-6 HCV infection, including patients with compensated and decompensated cirrhosis.
- Read more about US FDA grants fast track status to Trevena's oliceridine for pain management
The United States Food and Drug Administration (FDA) has granted Fast Track designation to Trevena's oliceridine (TRV130) for the management of moderate-to-severe acute pain. Oliceridine is being developed as a potential replacement for currently approved intravenous opioid analgesics.
- Read more about Sun Pharma powered with USFDA approval of cancer drug
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.
- Read more about Cipla introduces “5 in 1” anti-ageing skin care product Cutisera
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.
- Read more about ADVAXIS RECEIVES ORPHAN DRUG DESIGNATION IN THE EUROPEAN UNION FOR ADXS-HER2 FOR THE TREATMENT OF OSTEOSARCOMA
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.