Fresh from a special protocol assessment agreement with the FDA, Cell Therapeutics Inc. has snagged a lucrative licensing deal with Baxter International Inc. for its Janus kinase (JAK) inhibitor, pacritinib. The potential $172 million deal gives Baxter exclusive commercialization rights for all indications for pacritinib outside the U.S. The two companies will jointly commercialize the drug within the U.S. Read More
Likely breathing easier ahead of Tuesday’s FDA advisory committee meeting is Biomarin Pharmaceutical Inc., with Vimizim (elosulfase alfa) slated to undergo scrutiny as an enzyme replacement therapy (ERT) for mucopolysaccharidosis Type IVA, also called Morquio A syndrome. Read More
LONDON – Shield Therapeutics Ltd. is awaiting FDA permission for a Phase III trial of its oral iron replacement, ST10, for treating anemia in patients with chronic kidney disease (CKD) who are not on dialysis. Read More
With sequestration all but wiping out the 6 percent increase the FDA received in drug user fees for fiscal 2013, the agency is struggling to keep up with a medical revolution spurred by scientific advances and the potential of personalized medicine, Janet Woodcock, director of the agency’s drug review center, told a House subcommittee Friday. Read More
After reducing its initial public offering (IPO) from a range of $16 to $19 down to $12, Relypsa Inc. dropped the price again, to $11 , before the company’s shares began trading Friday on Nasdaq under the ticker “RLYP.” But that move seemed to sit well with investors, with the stock opening at $12.47. Read More
By disrupting the interaction between glucokinase and its regulatory protein, scientists at Amgen Inc. have managed to specifically affect high blood sugar levels in mouse models of diabetes, while having no effect on animals with normal blood sugar. Read More
• Cadence Pharmaceuticals Inc., of San Diego, said the U.S. District Court for the District of Delaware has ruled in favor of Cadence in the company’s patent infringement lawsuit against Exela Pharma Sciences LLC, of Lenoir, N.C., regarding Ofirmev (intravenous acetaminophen). Read More
• Opko Health Inc., of Miami, completed patient recruitment for its Phase III trial of Rayaldy, a vitamin D prohormone treatment, for secondary hyperparathyroidism, Stage 3 or 4 chronic kidney disease and vitamin D insufficiency. Read More
• Valeant Pharmaceuticals International Inc., of Laval, Quebec, said the FDA approved Luzu (luliconazole) cream, 1 percent, for the topical treatment of athlete’s foot (interdigital tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis), caused by Trichophyton rubrum and Epidermophyton floccosum, in patients 18 and older. Read More
Counterintuitive as it sounds, bacteria can poison themselves to inhibit their own growth. And researchers from the Massachusetts Institute of Technology have identified one way in which they do so, in the hopes of ultimately developing antibiotics that could do the same thing. Read More
