Gilead grants Amygdala license to substance abuse candidate | Boehringer's asthma treatment approved by FDA for pediatric use | Liquid formulation of IBSA's thyroid drug wins FDA nod
February 17, 2017
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Gilead grants Amygdala license to substance abuse candidate
Gilead Sciences has granted Amygdala Neurosciences rights to GS-6637, an ALDH2 inhibitor, which is expected to enter midstage trials this year as a potential treatment for alcohol and cocaine dependence. Amygdala will pay undisclosed milestone and royalty fees and gave Gilead an equity stake in the firm.
BioCentury (2/16),  Seeking Alpha (free registration) (2/16) 
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Health Care & Policy
Boehringer's asthma treatment approved by FDA for pediatric use
Boehringer Ingelheim's Spiriva Respimat, or tiotropium bromide, has been approved by the FDA for use as a long-term, once-a-day treatment for asthma in patients at least 6 years old. The drug was initially approved for the same condition for patients 12 years and older.
Pharmacy Times online (2/16) 
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Liquid formulation of IBSA's thyroid drug wins FDA nod
IBSA's Tirosint-SOL, or levothyroxine sodium oral solution, has been approved by the FDA as a liquid formulation to treat hypothyroidism and thyroid stimulating hormone suppression to manage certain forms of thyroid cancer. The firm plans to launch the drug within six months.
eMPR.com (2/15) 
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Alkermes plans to file NDA for antidepressant
A new-drug application for ALKS 5461, or samidorphan and buprenorphine, as an adjunct treatment for major depressive disorder will be submitted by Alkermes to the FDA in the second half of the year. The drug candidate has met the primary endpoint of a late-stage trial.
BioCentury (2/15) 
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Biosimilar cancer drugs being reviewed in Europe
The European Medicines Agency is reviewing approval applications for biosimilar versions of Roche's Rituxan blood cancer drug and Herceptin breast cancer drug.
Reuters (2/15) 
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ViiV releases data on Phase III trial for 2-drug HIV regimen
ViiV Healthcare reports that a combination of its dolutegravir and Janssen's rilpivirine was effective as a maintenance therapy for patients with HIV. The virus remained undetectable in 95% of patients receiving the two-drug combination compared with 96% of those who continued their original regimen.
PharmaTimes (U.K.) (2/15),  MedPage Today (free registration) (2/14) 
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Company & Financial News
Funding round pulls in $41M for Rhythm
A mezzanine financing round has brought in $41 million for Boston-based Rhythm. The firm intends to start late-stage and midstage studies this year for RM-493, or setmelanotide, as a treatment for leptin receptor deficiency obesity, Bardet-Biedl syndrome and several other disorders.
BioCentury (2/16) 
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Researchers in Ireland, England share $740,000 grant to study Huntington's
National University of Ireland Galway and the University of Leicester will share a grant of roughly $740,000 to study potential treatments for Huntington's disease, a neurological disorder. The grant was awarded by the Biotechnology and Biological Sciences Research Council UK and Science Foundation Ireland.
Newstalk (Ireland) (2/14) 
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Food & Agriculture
Expert: Biotech maize may be solution to armyworm problem in Africa
Biotech maize could be an option for South Africa and nearby countries to fight fall armyworms, which plague maize and other staple crops. The pests have grown resistant to many chemical pesticides, writes Lancaster University professor Kenneth Wilson.
Genetic Literacy Project (2/15) 
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Industrial & Environmental
Report: TSCA could spur reform of EPA chemical-review efforts
The Environmental Protection Agency's chemical-review program could receive better marks from the Government Accountability Office if the reformed Toxic Substances Control Act helps improve information-sharing and makes other reforms. "Using both new and previously existing TSCA authorities should enhance the agency's ability to gather new information as necessary to evaluate hazard and exposure risks," a GAO report says.
InsideEPA.com (subscription required) (2/15) 
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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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