Janssen Pharmaceutica NV, of Beerse, Belgium, part of Johnson & Johnson, reported results from the PROSIPAL (Prevention of Relapse With Oral Antipsychotics Versus Injectable Paliperidone Palmitate) study at the European Congress of Psychiatry in Munich, showing Xeplion (paliperidone palmitate), a once-weekly, long-acting therapy, significantly lengthened the time to relapse during the two-year treatment phase, as well as significantly lowered relapse rates in people with schizophrenia, compared to treatment as usual with the investigators’ choice of oral antipsychotic treatment. Read More
Advanced Accelerator Applications, of Saint-Genis-Pouilly, France, said it received FDA and EMA orphan drug designation status for its radiopharmaceutical, Gallium-68 DOTATATE for use as a diagnostic agent for the management of gastroentero-pancreatic neuroendocrine tumors (GEP-NETs). Read More
Boston Therapeutics Inc., of Manchester, N.H., said it received institutional review board approval to start a phase II study of BTI-320 (formerly PAZ320), a nonsystemic chewable complex carbohydrate-based compound, in the U.S. Read More
Biolinerx Ltd., of Jerusalem, priced an underwritten public offering of 8.4 million American depositary shares (ADS), each representing 10 ordinary shares, at $2.50 per ADS, seeking to raise $21 million. Read More
The FDA finalized guidances on biologic license applications (BLAs) and investigational new drug applications (INDs) for minimally manipulated, unrelated allogeneic placental/umbilical cord blood for patients with hematopoietic disorders. Read More
LONDON – People carrying one copy of a rare mutant gene are at 65 percent lower risk of developing type 2 diabetes, a genomewide association study has found. The work suggests that it may be possible one day to develop therapies that target the protein encoded by the gene in question, which is known to play a role in insulin secretion. Read More
STOCKHOLM – Stockholm’s transition to a 21st century location for discovery science and drug development is under way in earnest, as two separate research partnerships between Astrazeneca plc and the Karolinska Institute start to gather momentum, while a preclinical drug development “toolbox,” aimed at academic researchers, will put out a call for its first projects in the coming months. Read More
With a wholly owned drug for Parkinson’s disease (PD) at the phase III stage, Adamas Pharmaceuticals Inc. said Forest Laboratories Inc. – its partner for a combo Alzheimer’s disease (AD) therapy – submitted a new drug application (NDA) to the FDA for the once-daily capsule MDX-8704 to treat AD-related dementia. Read More
Shares of Oxygen Biotherapeutics Inc. (NASDAQ:OXBT) climbed as much as 35 percent Tuesday after the company reported the FDA lifted the clinical hold on Oxycyte, clearing the path for the company to resume U.S. studies. Read More
Although the Department of Health and Human Services (HHS) would, as a whole, see its revenue decrease slightly under the president’s nearly $4 trillion budget, the FDA and National Institutes of Health (NIH) could be in line for healthy increases. Read More
