Industry News

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.

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.

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.

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.