Industry News

- 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.
- Read more about Biotronik launch Eluna 8 pacemaker in Japan
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.
- Read more about AbbVie Announces FDA Acceptance of New Drug Application for a Once-Daily Formulation of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) to Treat Genotype 1 Chronic Hepatitis C Virus Infection
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.
- Read more about GSK receives European marketing authorisation for Nucala® (mepolizumab) in 31 countries
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).
- Read more about Boehringer Ingelheim and MD Anderson Cancer Center join forces to discover new treatment approaches for pancreatic cancer
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.
- Read more about Greatbatch Receives FDA Approval of Algovita(R) Spinal Cord Stimulation System
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.
- Read more about Lilly's phase 3 study shows once-weekly Trulicity is effective as add-on treatment to Sulfonylurea
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.
- Read more about Launch of a first Pharmacovigilance peer network - PV India
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.
- Read more about Quantum Pharma pleased to announce licensing deals in Germany
Quantum Pharma Plc, the growing service-led niche pharmaceutical manufacturer, developer and supplier to the health and care sectors, is pleased to announce a further three out-licensing deals in Germany, though Lamda (UK) Limited, Lamda Laboratories SA and Lamda Pharmaceuticals SA (collectively ‘Lamda’), part of its Niche Pharmaceutical division. These agreements form part of the core strategy for this division.

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- Read more about PhaseBio Receives FDA Orphan Drug Designation for Vasomera (PB1046) for the Treatment of Cardiomyopathy Associated With Dystrophinopathies
PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company and leader in the field of biopolymer-based drugs, focused on developing treatments for metabolic and specialty cardiopulmonary disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Vasomera (PB1046) Injection for the treatment of cardiomyopathy associated with dystrophinopathies: Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD) and X-linked dilated cardiomyopathy (XL-dCMP).