Gearing up for a phase III trial with its anti-CD19 chimeric antigen receptor (CAR) T-cell therapy next year, Kite Pharma Inc. upsized its follow-on public offering by 485,000 shares, pricing about 3.4 million shares at $54 each for gross proceeds of about $188.1 million. Read More
Recognizing that new cancer drugs approved for adults are likely to become the off-label standard of care for several pediatric cancers, the FDA's Pediatric Oncology Subcommittee Thursday pondered how to best get the answers needed to advance the science without unduly delaying the approval of new therapies for children. Read More
Bisphosphonates have been used since the early 1990s in two indications. They are most famous as osteoporosis drugs, where even off-patent, Fosamax (alendronate sodium, Merck & Co. Inc.) – only one of several bisphosphonates – raked in more than $700 million in sales in 2013, according to Thomson Reuters Cortellis. Read More
Osteoqc Inc., a new Montreal-based company that will develop therapies for the treatment of bone-related diseases, is leveraging a portfolio of candidates for promoting bone growth developed by Overland Park, Kan.-based Osteogenex Inc. to build a new venture. Read More
Amicus Therapeutics Inc., of Cranbury, N.J., reported that following a successful presubmission meeting with the EMA to discuss the registration of its oral small-molecule chaperone migalastat monotherapy for the treatment of Fabry disease, it has begun preparing a marketing authorization application that it plans to submit to the agency in the middle of 2015 under the centralized procedure. Read More
strong>Lakewood-Amedex Inc., of Sarasota, Fla., said it submitted an investigational new drug application with the FDA to conduct a phase I/IIa study of Nu-3 as a topical antimicrobial treatment for diabetic foot infections. Read More
Sunovion Pharmaceuticals Inc., of Marlborough, Mass., reported results from the first placebo-controlled study of dasotraline for the treatment of adult patients with attention deficit hyperactivity disorder (ADHD) at the American College of Neuropsychopharmacology meeting in Phoenix. Read More
Baxter International Inc., of Deerfield, Ill., filed SEC paperwork in connection with the company's previously disclosed plan to spin off its biopharmaceutical business. Read More
