Goodwin teams up with Minn. foundation to develop opioid addiction vaccines | FDA grants orphan status to ChemoCentryx's kidney disease drug | Actinium gets EMA nod for AML drug
March 23, 2017
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Goodwin teams up with Minn. foundation to develop opioid addiction vaccines
Goodwin Biotechnology and the Minneapolis Medical Research Foundation have entered into a collaboration to develop Goodwin's two opioid addiction vaccines. A three-year grant from the National Institute on Drug Abuse will fund the research. (3/22) 
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Health Care & Policy
FDA grants orphan status to ChemoCentryx's kidney disease drug
ChemoCentryx's avacopan has received orphan drug status from the FDA as a treatment for the severe kidney disease C3 glomerulopathy. A study on avacopan's efficacy is expected to begin next quarter.
Seeking Alpha (free registration) (3/22) 
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Actinium gets EMA nod for AML drug
The European Medicines Agency has provided positive guidance for Actinium Pharmaceuticals' Iomab-B for treatment of acute myeloid leukemia. The agency said the company's data from a late-stage study of the drug was sufficient for filing a marketing authorization application.
Seeking Alpha (free registration) (3/21) 
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FDA gives positive regulatory guidance for Pain Therapeutics' Remoxy ER
The FDA has asked Pain Therapeutics to conduct two additional studies of Remoxy ER, or extended-release oxycodone capsules CII, before refiling the new-drug application for Remoxy ER. The studies, which are expected to be completed this year, include a clinical abuse potential study via the intranasal route of abuse and a nonclinical abuse potential study using household solvents.
Seeking Alpha (free registration) (3/21) 
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Neurocrine reports positive results of late-stage trial for Ingrezza
Neurocrine Biosciences' Ingrezza, or valbenazine, has met the primary endpoint of a late-stage study in which the drug showed a statistically valid difference from baseline in the AIMS scale than placebo in the treatment of tardive dyskinesia. The FDA's PDUFA date for Ingrezza's marketing application is April 11.
Seeking Alpha (free registration) (3/21) 
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Anafranil generic introduced by Upsher-Smith
A generic version of Mallinckrodt Pharmaceuticals' Anafranil, or clomipramine hydrochloride, capsule has been launched by Upsher-Smith Laboratories as clomipramine hydrochloride capsules USP, 25 mg, 50 mg and 75 mg.
Drug Store News (3/22) 
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Company & Financial News
$100M public stock offering to boost La Jolla's drug development pipeline
La Jolla Pharmaceutical, a developer of drugs for hereditary blood diseases, is seeking to raise $100 million through a public offering of stock. The funds will be used to finance clinical trials for drugs, including a regulatory hormone for iron metabolism as well as a medication for rare genetic diseases and bacterial infections.
The San Diego Union-Tribune (tiered subscription model) (3/21) 
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Industry Deals
H-Immune to collaborate with Pierre Fabre to develop antibodies against cancer
H-Immune, an immunotherapy startup, and Pierre Fabre agreed to collaborate on the development of antibody candidates against cancer. Under the terms of the deal, Pierre Fabre will gain access to H-Immune's In Vitro Immunization technology for use in three immuno-oncology discovery programs and will pay H-Immune research and development funding and potential milestone fees.
Genetic Engineering & Biotechnology News (3/21) 
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Food & Agriculture
First biotech potatoes to be planted in Canada
Farmers in Canada are preparing to plant J.R. Simplot's Russet Burbank, Ranger Russet, Atlantic and Snowden biotech potato varieties this spring. Health Canada and the Canadian Food Inspection Agency approved the potatoes last spring, which was too late for cultivation for commercial production in 2016, Simplot spokesman Doug Cole said.
Genetic Literacy Project (3/22), (Canada) (3/14) 
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Industrial & Environmental
Ethanol, biodiesel terminal to expand in Texas
Vopak Americas plans to add 10 tanks at Vopak Terminal Deer Park in Texas as part of the company's Deer Park Brownfield Expansion project. The expansion will increase capacity for storing, receiving and exporting biodiesel and ethanol products. (3/22) 
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The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at
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