Any notions that the pace of dealmaking would ease off in 2014 after the record number of M&A and licensing transactions that were completed last year, will be quickly dispelled following the release of the Thomson Reuters Recap half-year analysis. Read More
Isis Pharmaceuticals Inc. advanced another candidate from its rare drug portfolio into phase III development, initiating a pivotal study of the antisense drug ISIS-SMNRx in infants with spinal muscular atrophy (SMA), the most common genetic cause of infant mortality. Read More
WASHINGTON – The FDA reported July 31 that it has released a final guidance for companion diagnostics (CDx), tests developed to help doctors determine whether a patient is likely to benefit from a particular drug. Read More
In recent years, it has become increasingly clear that misfolded proteins can cause damage not just in the cell where they originally misfold. Since scientists first discovered that prion proteins can be infectious, traveling from cell to cell and even organism to organism to organism – causing Scrapie in sheep, mad cow disease in cows and Creutzfeldt-Jacob disease in humans – the list of misfolded proteins that can spread reads like a who's who of neurodegenerative disease: Alzheimer's and Parkinson's disease, amyotrophic lateral sclerosis (ALS) and frontotemporal lobe dementia. Read More
With an inhibitor of the Trk family of receptor tyrosine kinases in phase I, Loxo Oncology Inc. priced an upsized initial public offering (IPO) of about 5.2 million shares at $13 each, raising about $67.6 million for an effort to come up with a best-in-class compound. Read More
HONG KONG – A leading Indian biosimilars maker reported a slight decline in biopharma sales in the quarter ending June 30, affected by the chaotic situation in the Middle East. Read More
Arena Pharmaceuticals Inc., of San Diego, said partner Eisai Inc., of Woodcliff Lake, N.J., reported net sales of obesity drug Belviq (lorcaserin HCl) totaling $9.9 million for the second quarter, resulting in revenue to Arena of $3.5 million. Read More
Prothena Corp. plc, of Dublin, said the first patient with Parkinson's disease (PD) was dosed in a multiple ascending-dose phase I trial of the anti-alpha-synuclein antibody PRX002. Read More
Alimera Sciences Inc., of Atlanta, said the Danish Health and Medicines Authority has granted marketing authorization to Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies. Read More
Pfizer Inc., of New York, and Roche AG, of Basel, Switzerland, joined the Addplan DF Consortium, which aims to develop methodologies and execution technologies for improving dose-selection, which remains a major barrier to resolving high failure rates in phase III trials. Read More
Researchers from Drexel University have developed a vaccine against the bacterium Clostridium difficile, which causes intestinal disease. It is often acquired in hospitals, kills tens of thousands of Americans annually and can become a cause of chronic diarrhea. Read More