Researchers in Brazil are developing sugarcane that can produce more sucrose by identifying the genes that stimulate the activity. The scientists applied ethephon and an ethylene inhibitor on sugarcane before maturation, which led to a 60% increase in sucrose production with ethephon, and scientists determined which genes responded to ethylene during the ripening process.
Otsuka Pharmaceutical and Akebia Therapeutics have expanded their existing US licensing deal for Akebia's chronic kidney disease candidate vadadustat to give Otsuka exclusive rights to the drug in Canada, China, the Middle East, Europe and Australia. In exchange, Otsuka will make a $73 million upfront payment to Akebia and provide research and development funding, and potential milestone fees and royalties.
Conditional marketing authorization has been granted by the European Commission to Shire's Natpar, or rhPTH[1-84], a full-length recombinant human parathyroid hormone used as an adjunctive treatment for chronic hypoparathyroidism in adults whose serum calcium levels are insufficiently managed with calcium and vitamin D. The approval was based on late-stage trial data.
Xenon Pharmaceuticals will expand its neurology pipeline by acquiring 1st Order Pharmaceuticals' potassium channel modulator XEN1101. Xenon is expected to submit an investigational new drug application later this year for XEN1101 as a treatment for drug-resistant focal or partial-onset seizures in adults with epilepsy.
As part of a revision of their 2015 agreement, Novartis will commercialize its migraine candidate erenumab, or AMG 334, in Canada while Amgen will co-market the drug in the US. Amgen retains exclusive marketing rights in Japan, while Novartis maintains marketing rights in all other countries as part of the original deal.
The FDA has approved Silvergate's Xatmep, or methotrexate, oral solution indicated for treatment of acute lymphoblastic leukemia as part of multiphase combination chemotherapy maintenance in pediatric patients. Xatmep is also approved for the management of polyarticular juvenile idiopathic arthritis in patients who cannot use first-line therapies because they did not respond adequately to or cannot tolerate the treatment.
Flex Pharma's investigational new drug application for FLX-787 has received FDA approval for a midstage trial involving patients with amyotrophic lateral sclerosis. The company is also exploring use of the drug for treatment of the Charcot-Marie-Tooth group of neuropathies.
Alnylam Pharmaceuticals and The Medicines Co. announced the FDA approved a late-stage clinical trial for inclisiran that will include patients with familial hypercholesterolemia and atherosclerotic cardiovascular disease. The filing of a new-drug application is anticipated by the end of 2019.
New real-world data presented by Biogen at the American Academy of Neurology meeting suggests early treatment with Tysabri, or natalizumab, and Tecfidera, or dimethyl fumarate, may benefit people with relapsing multiple sclerosis.
The European Medicines Agency has granted priority medicines designation to uniQure's AMT-060, an investigational gene therapy for patients with hemophilia B. The designation was based on early-stage trial data showing patients with severe disease were nearly cured of spontaneous bleeding episodes with up to a year of follow-up, and they experienced significantly increased levels of Factor IX and substantially reduced need for Factor IX replacement.
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