Biopharmx Corp., of Menlo Park, Calif., priced an underwritten public offering comprising class A units and class B units. The class A units, priced at 35 cents each, consist of one share of common stock and one seven-year warrant to purchase 0.75 of a share of common stock with an exercise price of 35 cents. Read More
Protalix Biotherapeutics Inc., of Carmiel, Israel, said the Brazilian regulator ANVISA granted approval for alfataliglicerase as a long-term enzyme replacement therapy (ERT) for children, 4 and older, with a confirmed diagnosis of type I Gaucher disease. The ERT was approved for adults in March 2013. Gaucher disease is a rare lysosomal storage disorder, with about 700 patients treated in Brazil. Read More
With one year to go on the first GDUFA, the FDA finalized a guidance that seeks to answer questions about the user fee agreement that went into effect in 2012 for generic drugs. Read More
PERTH, Australia – Although industry rated Australia's Therapeutics Goods Administration (TGA) high when it comes to performing its role ethically and with integrity, the agency has a ways to go when it comes to communicating with its stakeholders, a recent survey suggests. Read More
Reading or hearing about precision medicine can be reminiscent of Dan Ariely's snappy summary of big data analysis, which he said is "like teenage sex: Everyone talks about it, nobody really knows how to do it; everyone thinks everyone else is doing it, so everyone claims they are doing it." Read More
TOKYO – New drug approvals in Japan dropped to a five-year low in 2015, according to the latest report from the PMDA. While reviews are getting faster for standard products, reviews for priority products have grown increasingly longer. Read More
Privately held Arog Pharmaceuticals Inc. won orphan drug status in Europe for crenolanib to treat acute myeloid leukemia (AML) and soft-tissue sarcoma. An orally available benzimidazole, crenolanib is a type I kinase inhibitor that goes after the signaling of wild-type and mutant isoforms of class III receptor tyrosine kinases FLT3 and platelet-derived growth factor receptor (PDGFR) alpha/beta. Read More
DUBLIN – Zealand Pharma A/S has attained the most significant milestone in its 18-year history, the FDA approval of Sanofi SA's type 2 diabetes combo product, Soliqua 100/33 (insulin glargine and lixisenatide injection, or Lixilan), which adds Zealand's glucagon-like peptide receptor agonist Adlyxin (lixisenatide) to the big pharma firm's basal insulin in a fixed-dose pen. Read More
Neurotrope Inc., of New York, said it started dosing the final patient in the randomized, double-blind, placebo-controlled phase II study testing bryostatin in moderate to severe Alzheimer's disease. Read More
