Category: Regulations
-
Cancer Precision Medicine Trial Underway
18 August 2015. A new clinical trial is enrolling participants that tests multiple types of therapies on a number of different cancers based on the genomic make-up of individual patients. The intermediate-stage trial is part of the National Cancer Institute’s Molecular Analysis for Therapy Choice, or NCI-MATCH program. NCI-MATCH seeks to determine if tumors with…
-
Trial Shows Fertility Treatment Boosts IVF Pregnancy Rate
11 August 2015. A clinical study of cellular treatments for women using in-vitro fertilization shows the treatments increased pregnancy rates compared to women receiving standard IVF alone. Findings from the study that tested treatments developed by IVF technology company OvaScience Inc. in Cambridge, Massachusetts are scheduled to be published on 25 August in the Journal…
-
Trial Shows Weekly Growth Hormone Drug Effective, Safe
30 July 2015. Results of an intermediate-stage clinical trial show a drug candidate to treat growth hormone deficiency in children given once a week, works about as well as a current therapy requiring a daily injection. The results were released by Ascendis Pharma A/S, a specialty pharmaceutical company in Copenhagen, Denmark that conducted the trial.…
-
Opioid Overdose Nasal Spray Cleared for FDA Review
29 July 2015. Indivior plc, a pharmaceutical company in the U.K. specializing in addiction therapies, received notice that the U.S. Food and Drug Administration accepted the company’s new drug application and is beginning review of Indivior’s opioid overdose treatment formulated as a nasal spray. The FDA also granted Indivior, in Slough, U.K., priority review status…
-
FDA Clears Trial of Fibrosis Drug for Muscular Dystrophy
24 July 2015. Biotechnology company Fibrogen Inc. says the U.S. Food and Drug Administration approved an application to test its fibrosis drug candidate in patients with Duchenne muscular dystrophy. The company says FDA’s approval was part of a new drug application for its candidate, code-named FG-3019, already in intermediate-stage clinical trials as a therapy for…
-
Dental Implants Found Prone to Fractures
22 July 2015. A review of manufactured dental implants discarded because of bone loss in the jaw of their wearers, indicates more than 6 in 10 of the devices had cracks or similar mechanical defects. The findings from the study by Keren Shemtov-Yona, a dentist and engineering doctoral student at Technion-Israel Institute of Technology in…
-
Trial Shows Engineered T-Cells Act on Multiple Myeloma
21 July 2015. An early-stage clinical trial shows immune system cells from patients with the blood-related cancer multiple myeloma — modified to attack a protein suspected of helping the cancer grow — generated a positive clinical response in most of the participants. The team from University of Pennsylvania cancer center, University of Maryland medical school,…
-
Trial Testing Respiratory Muscle Drug for ALS Patients
14 July 2015. Biopharmaceutical company Cytokinetics is beginning a late-stage clinical trial of a drug designed to slow the decline of respiratory muscle functions in people with amyotrophic lateral sclerosis, or ALS, a neurodegenerative disorder. In addition, Cytokinetics, in South San Francisco, California, received a $1.5 million grant from the ALS Association supporting the trial,…
-
FDA Clears Biotech Cancer Therapies for Early Trials
13 July 2015. Biotechnology company Blueprint Medicines says U.S. Food and Drug Administration accepted new drug applications on its two lead products, clearing the way for trials with humans. The Cambridge, Massachusetts enterprise is developing cancer therapies, with its lead products targeting liver and gastrointestinal tumors. Blueprint develops cancer therapies that limit the actions of…
-
Arcadia Bio, Partners to Produce Stress-Tolerant Soybeans
7 July 2015. Arcadia Biosciences, an agricultural biotechnology company, will develop a new variety of soybeans engineered for greater tolerance of environmental stresses, with partners in Brazil and Argentina, two major soybean growers. Financial details of the collaboration between the Davis, California company and Bioceres S.A. in Rosario, Argentina, and Tropical Melhoramento e Genética Ltda,…