As expected, the FDA approved Gilead Sciences Inc.’s Sovaldi (sofosbuvir) 400-mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for chronic hepatitis C virus, as part of a combination antiviral treatment regimen. Read More
The FDA approved Xiaflex (collagenase clostridium histolyticum) for Peyronie’s disease, making it the first approved therapy for the condition, which is characterized by abnormal tissue in the penis, causing a curvature deformity of at least 30 degrees upon erection. Read More
Positive Phase III data with Breo Ellipta in asthma reported by Theravance Inc. and partner Glaxosmithkline plc (GSK) could let them join two major competitors in the field, but with a once-a-day rather than twice-a-day, therapy, which is already approved for chronic obstructive pulmonary disorder (COPD). Read More
Marking the completion of one of European biotech’s major comeback stories in recent years, Newron Pharmaceuticals SpA and its partner Zambon SpA submitted a marketing authorization application (MAA) for safinamide in Parkinson’s disease to the European Medicines Agency and are on track for a potential approval during 2014. Read More
The area of complex carbohydrate chemistry offers broad potential in drug development, with carbohydrates playing key roles in cell function and major disease pathologies. But it’s that first word, “complex,” that has kept less intrepid drug developers away. Read More
LONDON – Physicians will soon attempt to treat patients with liver diseases caused by single-gene defects, by performing highly specific gene therapy on single liver stem cells, then growing up the genetically engineered cells and transplanting them back into the liver via an injection in the portal vein. Read More
Orexigen Therapeutics Inc., of San Diego, said it closed its offering of $115 million aggregate principal amount of convertible senior notes due 2020, including $15 million aggregate principal amount of the notes issued in connection with the exercise by initial purchases of their option to purchase additional notes. Read More
Genmab A/S, of Copenhagen, said it reached a new milestone in its Duobody technology collaboration with Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, triggering a $4 million milestone. Read More
Moberg Pharma AB, of Stockholm, signed a deal to acquire three over-the-counter brands in the U.S. from Bayer Healthcare LLC, of Deerfield, Ill. Read More
Sangamo Biosciences Inc., of Richmond, Calif., presented data from all dose cohorts in ongoing clinical trials (SB-728-1101 and SB-728-902 Cohort 5) of SB-728-T, which is being developed for the functional control of HIV/AIDS. Read More
Scientists from Emory University have shown that the yellow fever vaccine, one of the most successful vaccines of all time that has been used by more than half a billion people, works partly by stimulating a nutrient sensor that activates autophagy. The authors used a systems biology approach to look at changes in gene expression following vaccine administration. Read More
