U.S. regulators on Wednesday approved a second gene therapy for a blood cancer, a one-time, custom-made treatment for aggressive lymphoma in adults. It uses the same technology, called CAR-T, as the first gene therapy approved in the U.S. in August, a treatment for childhood leukemia from Novartis Pharmaceuticals. The treatment, called Yescarta, wi
City of Hope, a world-renowned independent research and treatment center for cancer and diabetes, will be one of the first authorized centers in the nation to provide axicabtagene ciloleucel, which the U.S. Food and Drug Administration announced today is the first approved CAR-T cell therapy for adult patients with certain types of large B-cell lym
Diagnosed with Duchenne muscular dystrophy when he was 2, Tommy Parzymieso, a 9- year-old Eggert Elementary student, has been battling the disease most of his life as his family seeks a drug to aid his fight against the progressive muscle-wasting condition. The meeting was held after PTC Therapeutics, the company that developed the drug, filed on t
The U.S. Food and Drug Administration approved a new form of cell-based gene therapy for adults with certain types of large B-cell lymphoma, marking only the second time a gene therapy has been approved for the disease. The FDA said diffuse large B-cell lymphoma is the most common type of non-Hodgkin's Lymphona in adults and there are approximately
Oct. 19 The Foundation Fighting Blindness announced Wednesday that it has named Benjamin Yerxa as its new CEO, effective immediately. He previously served as president and co-founder of Envisia Therapeutics, a privately held biotechnology company that works on ocular therapies. He also served in posts at several ophthalmology-based R&D organizati
GALENA BIOPHARMA, INC. (NASDAQ:GALE) Files An 8-K Entry into a Material Definitive AgreementItem 1.01 Entry into a Material Definitive Agreement. On October 12, 2017, Galena Biopharma, Inc. (Galena) and Cardinal Health (Cardinal), entered into a settlement agreement and mutual release (Agreement) to which parties agreed to resolve
WASHINGTON- Novo Nordisk said that the Endocrinologic and Metabolic Drugs Advisory Committee or EMDAC of the US Food and Drug Administration voted 16-0 in favour of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. Based on the data included in the New Drug Application for semaglutide, the FDA aske
WASHINGTON- Today, Congressman Ted W. Lieu issued the following statement after the Food and Drug Administration approved the use of gene therapy for certain types of non-Hodgkin lymphoma. Immunotherapy is a promising and important new area of cancer treatment and advancements in this field have the potential to cure certain cancer patients.
SPECTRUM PHARMACEUTICALS, INC. (NASDAQ:SPPI) Files An 8-K Other EventsItem 9.01Other Events On October 17, 2017, Spectrum Pharmaceuticals, Inc. (the Company) announced the oral presentation of interim data from a Phase 2 clinical study evaluating poziotinib in EGFR Exon 20 Mutant Non-Small-Cell Lung Cancer (NSCLC) by scientists fromthe MD And
News: The Company presented encouraging interim data from its phase II study evaluating Poziotinib in EGFR Exon 20 mutant non-small cell lung cancer at the 18th IASLC World Conference on Lung Cancer in Japan. The transaction provides Endocyte with 177 Lu-PSMA-617, a phase III-ready prostate cancer drug. Endocyte plans to seek regulatory approval to
Oct. 18 Two Tucson- area companies showcased new technologies to the Department of Defense recently after winning national honors for innovation. Tucson- based NuvOx Pharma, founded by University of Arizona radiology professor Dr. NuvOx already is conducting pre-clinical studies of the drug for treatment of traumatic brain injury with the Navy, u
Oct. 18 A gene therapy treatment for some hard-to-treat lymphomas was approved Wednesday by the U.S. Food and Drug Administration. It was developed by Kite Pharma, which was recently purchased by Gilead Sciences. The first treatment, Kymriah, or, tisagenlecleucel, was approved Aug. 30 for some pediatric and young adult patients with acute lymphob
TapImmune Inc., a leading clinical-stage immuno-oncology company with ongoing clinical trials in ovarian and breast cancer, announces a letter from the CEO. I feel humbled by the opportunity to speak to you for the first time as CEO of TapImmune. I hope that by describing my perspective on our industry and my vision for TapImmune within it, I mig
Projected full-year adjusted diluted EPS from continuing operations is now $2.48 to $2.50, which represents an increase at the mid-point of the guidance range. In September, Abbott received U.S. FDA approval for its FreeStyle Libre glucose monitoring system as a replacement 1 for finger stick blood glucose monitoring. This revolutionary technolo
NORTH CHICAGO, Ill. and SOUTH SAN FRANCISCO, Calif., Oct. 18, 2017/ PRNewswire/ AbbVie, a global biopharmaceutical company, and Harpoon Therapeutics, a biotechnology company developing novel T-cell recruiting biologic therapies, announced today that they have entered an immuno-oncology research collaboration. The goal of the collaboration is to i
Release date- 17102017- NEW YORK- Actinium Pharmaceuticals Inc., a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, announced today that it will present at the BIO Investor Forum being held on October 16-17th at the Westin St. Francis Hotel in San Francisco, California.
Release date- 17102017- PRINCETON, N.J.- Agile Therapeutics Inc.,, a women's healthcare company, today announced the presentation of additional results from the Phase 3 SECURE trial of its investigational low-dose combination hormonal contraceptive patch, Twirla. Anita Nelson, MD, Professor and Chair of Obstetrics and Gynecology at the College of O
LONDON and PHILADELPHIA, Oct. 18, 2017/ PRNewswire/ AMO Pharma Limited, a privately held biopharmaceutical company focusing on rare, debilitating childhood onset neurogenetic disorders with limited or no treatment options, presented positive interim analysis of data from the first cohort of its study of AMO-02 in congenital myotonic dystrophy.
Arix Bioscience notes Harpoon Therapeutics' immuno-oncology collaboration with AbbVie. LONDON, 18 October 2017: Arix Bioscience plc, a global healthcare and life science company supporting medical innovation, is pleased to note that Harpoon Therapeutics, an Arix Bioscience Group Business, and AbbVie have entered into an immune-oncology research...
LONDON- AstraZeneca plc and Merck& Co. Inc. announced the US FDA has accepted and granted priority review for a supplemental New Drug Application for the use of Lynparza tablets in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastati
AstraZeneca PLCs Imfinzi cancer treatment has cleared another regulatory hurdle after the US Food and Drug Administration accepted a supplemental Biologics License Application for the treatment of certain lung cancer patients. Specifically, the application is for the use of Imfinzi in people with stage III unresectable non-small cell lung cancer...
Release date- 17102017- SEATTLE- Atossa Genetics, a clinical stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, announced today that the Ernest Mario School of Pharmacy at Rutgers, The State University at New Jersey, plans to conduct a study utilizing Atossa's intraductal..
Bergen, Norway, October 18, 2017- BerGenBio ASA, a clinical-stage biopharmaceutical company developing novel, selective Axl kinase inhibitors for multiple cancer indications, announces that the randomised Phase 1 b/2 clinical study of BGB324 in combination with either the MAPK inhibitors MEKINIST plus TAFINLAR or the immune checkpoint inhibit
BeyondSpring Inc., a global clinical stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company s Chief Medical Officer and Head of Business Development, Dr. BeyondSpring has advanced its lead asset, Plinabulin, into a global Phase 3 clinical trial for NSCLC treat
BioLineRx Ltd., a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today that Genentech, a member of the Roche Group, has commenced a Phase 1 b/2 study for the treatment of gastric cancer with BL-8040 in combination with atezolizumab, Genentech's anti-PDL1 cancer immunotherapy agent. The clinical study...