Aduro to purchase BioNovion for $32.5M | Keryx's hyperphosphatemia treatment approved in Europe | Asthma treatment from GlaxoSmithKline gets EMA panel backing
September 25, 2015
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Aduro to purchase BioNovion for $32.5M
Aduro Biotech agreed to pay about $32.5 million to acquire BioNovion Holding, a firm that is developing monoclonal antibodies and checkpoint inhibitors to treat cancer. Under the terms of the agreement, Adura will pay about $16 million in cash and $16 million in stock. The agreement also calls for Aduro to pay regulatory milestone fees to BioNovion shareholders. American City Business Journals/San Francisco (9/24)
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Health Care & Policy
Keryx's hyperphosphatemia treatment approved in Europe
Keryx Biopharmaceuticals' Fexeric, or ferric citrate coordination complex, has been cleared by European regulators as a treatment for hyperphosphatemia in chronic kidney disease patients who are on dialysis or who are considered pre-dialysis. The approval was granted based on data from two studies, including a late-stage trial that showed Fexeric was effective in lowering patients' serum phosphorus levels. European Pharmaceutical Review (U.K.) (9/24)
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Asthma treatment from GlaxoSmithKline gets EMA panel backing
GlaxoSmithKline's injectable Nucala, or mepolizumab, has been endorsed for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use as a treatment for severe refractory eosinophilic asthma patients who have a poor response to traditional inhalers. A final decision from the European Commission is expected by the end of this year. Reuters (9/24), Seeking Alpha (free registration) (9/24)
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Gilead's chronic lymphocytic leukemia drug receives NICE backing
Final draft guidance has been issued by the National Institute for Health and Care Excellence endorsing the use of Gilead Sciences' Zydelig, or idelalisib, in combination with rituximab, as a first-line treatment for chronic lymphocytic leukemia patients with a 17p deletion or TP53 mutation and as a second-line therapy for previously treated patients who relapse within 24 months. PharmaTimes (U.K.) (9/24)
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Generic acid reflux drug from Aurobindo wins FDA approval
The FDA has approved Aurobindo Pharma's generic version of AstraZeneca's delayed-release Prilosec, or omeprazole, capsules. The drug, which will be marketed in 10-, 20- and 40-milligram strengths, is indicated for gastroesophogeal reflux disease, as maintenance therapy to heal erosive esophagitis and as a short-term therapy for duodenal and gastric ulcers. Drug Store News (9/24)
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Late-stage trial promising for Avastin biosimilar
In a Phase III trial, Amgen and Allergan's biosimilar ABP 215 performed as well as its reference drug, Roche Holding's Avastin, or bevacizumab, in treating non-small cell lung cancer. The trial showed clinical equivalence between the two in objective response rate and safety. PharmaTimes (U.K.) (9/24)
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Company & Financial News
Bioceres targets $81M in IPO
An initial public offering has been filed by Bioceres with the goal of securing as much as $81 million. The Argentina-based firm specializes in the development of crop productivity traits for biotech seeds. Capital (9/24)
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Developer of blood disease therapy turns to crowdfunding
HemoGenyx, the Buffalo, N.Y.-based developer of an investigative cellular therapy for blood diseases and bone marrow failure, is seeking to raise $200,000 through crowdfunding. The firm plans to use the money to support preclinical studies and regulatory applications. HemoGenyx recently received orphan drug status from the FDA for the use of adult hemogenic endothelial cells in the treatment of severe aplastic anemia. American City Business Journals/Buffalo, N.Y. (9/23)
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The Latest From BIO ...
Registration is open for the 2015 BIO Latin America Conference!
BIO Latin America, happening Oct. 14-16 in Rio de Janeiro, delivers expert-led panel discussions on the latest market and investment opportunities and key policy trends affecting the region, company presentations, and partnering opportunities. Register today.
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Food & Agriculture
Scotland could appear to be "anti-science" because of biotech ban, experts say
An academic institution in Scotland said the government's decision to prohibit biotech crops, which was made without considering scientific evidence, could create an impression that the country is "anti-science." The biotech ban could "damage [Scotland's] ability to attract and retain innovative researchers and disadvantage the growth of important Scottish businesses," the Royal Society of Edinburgh said in an official advice paper. The society also called for a "rational and respectful debate" to address the issue. The Independent (London) (tiered subscription model) (9/24)
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Industrial & Environmental
Study: World biofuels capacity to reach 61 billion gallons annually by 2018
Global biofuels capacity will reach 61 billion gallons annually by 2018, with ethanol and biodiesel making up 96% of that amount, according to a study performed by Lux Research. The study indicates that ethanol and biodiesel will reach capacities of 40 billion gallons per year and 19 billion gallons per year. North and South America will boast a 64% share of the global capacity, says Lux Research. (9/23)
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News From BIO
FDA/Sponsor Interactions During Drug Development: Preliminary Data
BIO is conducting a first-of-its-kind survey on FDA/Sponsor Interactions During Drug Development. Earlier this year, BIO held an exclusive webinar to reveal the preliminary data from this survey. You can view select slides from the webinar. Survey participants have full data access -- you can sign up to receive exclusive insights from our upcoming spring data pull by visiting We have been able to glean some high-level insights from the preliminary data set presented during the webinar, but we need more participation for this survey to affect positive change at the FDA. In-depth company feedback will enable BIO to provide real-time information to the FDA and will inform BIO's policy priorities. Companies are encouraged to share their insights by signing up. If you have any questions, please contact Charles Crain.
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