AbbVie and partner Biogen are just months away from a European approval for their new multiple sclerosis mAb after the CHMP gave the drug a green light today. This is based on results from two clinical trials, Decide and Select, in which the drug, when injected every four weeks, improved results on key measures of MS disease activity in patients wi
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week Astellas Pharma Inc. and Medivation, Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of a type II variation to include data from the head-to-head TERRAIN trial of enzal
-Immunomedics, Inc. today announced that objective durable responses have been achieved with sacituzumab govitecan, its lead antibody-drug conjugate, in a number of patients with advanced, metastatic solid cancers, after failing multiple prior therapies, some including checkpoint inhibitors. The ADC has previously been granted Breakthrough Therapy.
Aurobindo Pharma Limited has gained last sanctioning from the US Food& Drug Administration to manufacture and market Esomeprazole Magnesium Delayed-release Capsules USP, 20 mg and 40 mg. The launch of this item is depended on the settlement terms/ litigation results with AstraZeneca. The sanctioned ANDA is bioequivalent and therapeutically equivale
Takeda Pharmaceutical Company Limited today announced that results from the international, randomized, double-blind, placebo-controlled TOURMALINE-MM1 Phase 3 clinical study, evaluating once-weekly oral NINLARO capsules plus lenalidomide and dexamethasone versus placebo plus lenalidomide-dexamethasone in patients with relapsed and/or...
By a News Reporter-Staff News Editor at Drug Week AbbVie, a global biopharmaceutical company, announced new real-world data showing 96 percent of genotype 1 patients and 100 percent of genotype 4 patients achieved sustained virologic response at 12 weeks post-treatment. "Real-world studies complement randomized controlled trials and help to furt
Dr Edwin Moses, CEO of Ablynx, commented: "We are very pleased that Novartis will soon begin clinical development of this novel Nanobody against a GPCR. About the collaboration between Novartis and Ablynx. In December 2005, Ablynx and Novartis entered into an agreement to discover and develop novel Nanobody-based therapeutics against a number of di
Stefano Buono, AAA s CEO, commented, 2015 was a pivotal year for AAA. We also submitted an NDA and MAA in the U.S. and Europe, respectively, for Somakit, which could be the ideal in-vivo companion diagnostic for Lutathera.. With our Lutathera filing now complete and submitted to the FDA and the EMA and the anticipated Somakit approval in b
"In the first quarter we advanced our checkpoint antibodies by gaining FDA clearance for the Investigational New Drug applications for our CTLA-4 antagonist antibody AGEN1884, and for our GITR agonist antibody partnered with Incyte, INCAGN1876," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "Earlier this week, we commenced a Phase 1 trial
Allergan plc, a leading global pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use has adopted a Positive Opinion for the Marketing Authorisation of ENZEPI in the European Union. 1 ENZEPI is a pancreatic enzyme replacement therapy for patients with exocrine pancreatic insufficiency due to cystic f
By a News Reporter-Staff News Editor at Drug Week Allergan plc, a leading global pharmaceutical company committed to developing new treatment options for infectious diseases, announced that new data from its anti-infective portfolio will be featured in 20 abstracts during the upcoming European Congress of Clinical Microbiology and Infectious...
-Aquinox Pharmaceuticals, Inc., a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, announced today that David Main, Aquinox President& CEO, will present a corporate overview at the upcoming 2016 Annual Bloom Burton& Co. Healthcare Investor Conference in...
LONDON- British drug maker AstraZeneca plc said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2 g/0. 5 g powder. CAZ AVI is being jointly developed by AstraZeneca and Allergan plc to treat a broad range of Gram-ne
FOSTER CITY- Gilead Sciences Inc. said Friday that the Committee for Medicinal Products for Human Use or CHMP, the scientific committee of the European Medicines Agency or EMA, has adopted a positive opinion on the company's Marketing Authorization Application or MAA for Odefsey, an investigational single tablet regimen for the treatment of HIV-1..
Data from University of California Provide New Insights into Clinical Trials and Studies. By a News Reporter-Staff News Editor at Health& Medicine Week Researchers detail new data in Clinical Research. Our news journalists obtained a quote from the research from the University of California, "Patients were randomized to point-of-care ultrasound,.
Gilead Sciences, Inc. today announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company s Marketing Authorization Application for Odefsey , an investigational single tablet regimen for the treatment of HIV-1 infection in adults and..
AbbVie, a global biopharmaceutical company, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion in favor of the use of IMBRUVICA for the treatment of adult patients with previously-untreated chronic lymphocytic leukemia in the European Union. IMBRUVICA is jointly...
Coalition Duchenne, a Newport Beach, California based charity committed to raising awareness for Duchenne muscular dystrophy, and funding for Duchenne research, participated in the April 25 U.S. Food and Drug Administration advisory committee hearing on the efficacy of the Sarepta Therapeutic's novel Duchenne drug eteplirsen. The meeting at the Mar
ACADIA Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced that the U.S. Food and Drug Administration has approved NUPLAZID for the treatment of hallucinations and delusions associated with...
For U.S. media only Bayer announced today that the U.S. Food and Drug Administration has approved Gadavist injection for use with magnetic resonance angiography to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients. 1 The FDA approval is based on the results of two, multi-center, Phase 3, open-la
DelMar Pharmaceuticals announced today that the FDA Office of Orphan Products Development has granted orphan drug designation for its lead product candidate, VAL-083, in the treatment of ovarian cancer. The investigational drug candidate previously received an orphan designation for glioma and medulloblastoma in the United States and glioma in Euro
-Flexion Therapeutics, Inc. today reported it has enrolled the first patient in a clinical trial to assess the effects of its lead drug candidate, Zilretta, on blood glucose levels in approximately 36 adults with osteoarthritis of the knee who also have Type 2 diabetes. This clinical trial in patients with OA of the knee will assess whether Zilrett
Novartis drug Afinitor recommended by CHMP for European Union approval to treat select GI and lung neuroendocrine tumors. Novartis International AG/ Novartis drug Afinitor recommended by CHMP for European Union approval to treat select GI and lung neuroendocrine tumors. Processed and transmitted by NASDAQ OMX Corporate Solutions.
EVENT: Health and Human Services Department; Food and Drug Administration holds a workshop entitled "Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices," focusing on the specific analytical and clinical study designs and considerations for validation and use of.