BARDA to fund development of Regeneron's MERS treatment | FDA fast-tracks treatment for Alzheimer's from AstraZeneca, Lilly | Supernus' sNDA for Trokendi XR gains tentative FDA approval
August 23, 2016
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BARDA to fund development of Regeneron's MERS treatment
The Biomedical Advanced Research and Development Authority entered into an agreement with Regeneron Pharmaceuticals, which will study and manufacture two potential antibody therapies to prevent and treat Middle East respiratory syndrome. Under the terms of the deal, BARDA will provide as much as $8.9 million for packaging and labeling of the antibodies, regulatory submission and a clinical trial conducted by the NIH.
Genetic Engineering & Biotechnology News (8/22) 
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Health Care & Policy
FDA fast-tracks treatment for Alzheimer's from AstraZeneca, Lilly
The FDA has granted fast-track designation to Eli Lilly and Co. and AstraZeneca's AZD3293, an early Alzheimer's disease treatment that inhibits an enzyme involved in the accumulation of beta-amyloid, which causes the disease. The results of a Phase II/III study on the drug are expected by August 2019, and a second late-stage study will begin this quarter.
The Wall Street Journal (tiered subscription model) (8/22),  Seeking Alpha (free registration) (8/22) 
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Supernus' sNDA for Trokendi XR gains tentative FDA approval
The FDA has granted tentative approval to Supernus' supplemental new drug application to expand the label for its epilepsy drug Trokendi XR, or topiramate extended-release capsules, to include migraine prophylaxis in adults. The final approval will be effective only after the drug's pediatric exclusivity ends on March 28, 2017. (8/22) 
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Puma's marketing application for breast cancer drug under EMA review
The European Medicines Agency has accepted for review Puma Biotechnology's marketing authorization application for PB272, or neratinib, as an extended adjunct treatment for HER2-positive early-stage breast cancer in patients who received Herceptin, or trastuzumab, as prior therapy. The drug was submitted for FDA approval in July.
BioCentury (8/22) 
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AstraZeneca gives recommendations on PDUFA VI implementation plan
In a meeting between industry stakeholders and the FDA to discuss PDUFA VI performance and procedural goals, AstraZeneca executive Howard Hutchinson recommended that the agency conduct real-time and face-to-face interaction with drugmakers during pre-IND Type B and Type C meetings. Huchinson also suggested faster issuance of new and updated FDA guidelines regarding the review of combination products.
Regulatory Focus (8/22) 
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Company & Financial News
Arbutus to relocate to Warminster, Pa.
Arbutus Biopharma is moving from the Pennsylvania Biotechnology Center in Bucks County, Pa., to a larger, 35,000-square-foot facility in Warminster, Pa. The growing firm, which is focused on developing treatments for hepatitis B, intends to renovate and build lab space at the new location over the next several months.
The Business Journals (tiered subscription model)/Philadelphia (8/22) 
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Funding round pulls in $5M for Amylyx
Amyotrophic lateral sclerosis treatment developer Amylyx Pharmaceuticals has raised $5 million in a Series A financing round. The firm plans to use the funds to advance its investigational ALS treatment AMX0035, or sodium phenylbutyrate and tauroursodeoxycholic acid, into a midstage trial set to start late this year or early next year.
Xconomy (8/22) 
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Global Developments
EU approves Gilead's HIV PrEP treatment
The European Commission has granted marketing approval to Gilead Sciences' once-daily Truvada, or emtricitabine/tenofovir disoproxil, as pre-exposure prophylaxis for HIV-1 infection in adults for use along with safer-sex practices. The approval was based on positive results from two placebo-controlled trials.
Bidness Etc. (8/22) 
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Food & Agriculture
Bangladesh government to continue biotech crop cultivation
Bangladesh Agriculture Minister Matia Chowdhury, during a program discussing food security in Bangladesh and rice production in Asia, said the government will move forward with the cultivation of biotech crops. Chowdhury said the country has a large population, and the adoption of biotech foods is needed to increase food production and provide food security.
The Daily Star (Bangladesh) (8/21) 
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Industrial & Environmental
Kuwait to build $5.6B biofuel plant
The Kuwait National Petroleum Co. has entered negotiations with international banks and agencies in Japan, Korea, Italy, Britain and Holland to provide financing for a $5.6 billion biofuel plant. KNPC CEO Mohammad Ghazi Al-Mutairi said the company has built 19 gas stations and intends to construct a total of 100. (8/22), (Dubai, United Arab Emirates) (8/21) 
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News From BIO
Savings on environmental waste disposal services
BIO has partnered with Clean Harbors, one of the largest environmental services companies in North America. The new BIO-Clean Harbors program will offer members a full range of hazardous and non-hazardous material management and disposal services at special pricing and deep discounts including 35-40% off list on disposal, 15-20% off list on transportation and materials and 35% off list price on labor charges. In addition, the BIO-Clean Harbors program offers full online tracking, free site visits to assure compliance with state and federal laws, staff training support and much more. Available to BIO or participating state and regional association members at no additional charge.
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