FDA approves Neos' ADHD drug | CSL's chronic inflammatory demyelinating polyneuropathy drug OK'd by FDA | FDA to post REMS inquiries
September 18, 2017
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FDA approves Neos' ADHD drug
FDA approves Neos' ADHD drug
The FDA granted approval to Neos Therapeutics' Adzenys ER, which is indicated to treat patients with attention-deficit/hyperactivity disorder.
Seeking Alpha (free registration) (9/15) 
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Health Care & Policy
CSL's chronic inflammatory demyelinating polyneuropathy drug OK'd by FDA
CSL Behring was granted approval by the FDA for its Privigen, or immune globulin intravenous [human] 10% liquid, to improve neuromuscular disability in adult patients with chronic inflammatory demyelinating polyneuropathy. The decision was backed by data from two late-stage studies, in which 73% of patients were responsive to Privigen over 13 weeks of treatment and 61% were responsive over 25 weeks of treatment, both measured by the adjusted score on the Inflammatory Neuropathy Cause and Treatment scale.
eMPR (9/15) 
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FDA to post REMS inquiries
The FDA will publicly release letters the agency sends when generic-drug makers ask the FDA for permission to obtain samples of brand-name drugs for bioequivalence testing. The policy is part of a push to prevent drugmakers from using Risk Evaluation and Mitigation Strategies to withhold samples and prevent generic competition.
Regulatory Focus (9/14) 
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Monoclonal antibody promising against phosphate disease
A late-stage trial found burosumab safe and effective in treating X-linked hypophosphatemia among adults and children, with complete healing of fractures among 44% of patients taking the monoclonal antibody compared with 18% in the placebo group. The studies were presented at the annual meeting of the American Society for Bone and Mineral Research
MedPage Today (free registration) (9/14) 
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Prostate drug meets key goal in late-stage trial
A late-stage trial of Xtandi, from Pfizer and Astellas Pharma, showed the treatment used with an anti-hormone therapy was associated with survival benefits among men with nonmetastatic castration-resistant prostate cancer compared with anti-hormone therapy alone.
Reuters (9/14) 
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Health Canada OKs Amicus' Fabry disease drug
Health Canada gave Amicus Therapeutics approval for its Galafold as a treatment for adult patients with Fabry disease who have an alpha-Gal A mutation determined by an in vitro assay to be amenable. The approval was backed by results from two late-stage trials and one ongoing long-term extension study of the drug.
StreetInsider (9/14) 
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Company & Financial News
Italian gene therapy firm gains $8.4M from funding round
Genenta Science, a gene therapy developer based in Italy, said approximately $8.4 million received from a Series B funding round will support the initiation of its second tumor indication program, while clinical testing for its multiple myeloma candidate will begin in the first portion of 2018.
BioCentury (9/13) 
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Compulsory license for Gilead's hepatitis C drug issued by Malaysia
A compulsory license was issued by the Malaysian government for generic versions of Gilead's Sovaldi, or sofosbuvir, as a treatment for patients with hepatitis C. The license will increase access to and offer a less-expensive version of generic hepatitis C drugs.
Regulatory Focus (9/15) 
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Food & Agriculture
Bayer partners with biotech startup on crop nutrition project
German life sciences, pharmaceutical and chemical company Bayer joined forces with Boston-based biotech startup Ginkgo Bioworks to develop methods for providing nutrition to crops without fertilizer. The companies will focus on using microbes to give crops what they need to grow.
Wired online (9/14),  Reuters (9/13) 
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Hot Topics
Industrial & Environmental
House spending bill would cut EPA's budget by $534M
The House of Representatives passed a $1.2 trillion spending package for fiscal 2018 that includes a $534 million cut in Environmental Protection Agency funding. It's the first time since 2009 that the House has passed a package containing all 12 appropriations bills, although the Senate has not passed any such bills.
Reuters (9/14),  The Hill (9/14) 
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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 bio@smartbrief.com.
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