Shire accepts AbbVie's $55B takeover bid | Pulmonary fibrosis drug from InterMune secures FDA breakthrough designation | FDA grants another QIDP designation to antifungal agent isavuconazole
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July 21, 2014
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Shire accepts AbbVie's $55B takeover bid
U.K. drugmaker Shire has accepted AbbVie's takeover offer for about $55 billion in a deal that will allow the U.S. firm to reduce its reliance on arthritis treatment Humira and slash its corporate tax rate by relocating to the U.K. The firms plan to establish a new company that will be incorporated on Jersey and tax-domiciled in Britain. The acquisition is expected to be finalized in the fourth quarter. Reuters (7/19), (U.K.) (7/18), ABC News/The Associated Press (7/18)
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Health Care & Policy
Pulmonary fibrosis drug from InterMune secures FDA breakthrough designation
The FDA has granted breakthrough therapy status to InterMune's pirfenidone as a treatment for idiopathic pulmonary fibrosis. The drug, which is already being sold in Europe under the brand name Esbriet, also holds U.S. priority review status for the same indication. PharmaTimes (U.K.) (7/18)
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FDA grants another QIDP designation to antifungal agent isavuconazole
Astellas Pharma and Basilea Pharmaceutica International's antifungal agent isavuconazole received qualified infectious disease product designation from the FDA as a treatment for invasive candidiasis. The designation makes isavuconazole eligible for priority review and provides Astellas with an additional five years of market exclusivity upon approval of the drug. Isavuconazole also holds QIDP status for invasive aspergillosis and mucormycosis. Healio (free registration)/Infectious Disease News (7/18)
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GSK's melanoma drug combo prolongs survival in Phase III trial
GlaxoSmithKline said a late-stage trial of its combination therapy that consists of Mekinist, or trametinib, and Tafinlar, or dabrafenib, was halted early after a data-monitoring panel found that the drug significantly improved survival in patients with BRAF V600-positive metastatic melanoma. The firm will likely use the data to support a marketing application resubmission in Europe. PharmaTimes (U.K.) (7/17)
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Amgen drug performs well in chronic-kidney-disease trial
A late-stage trial showed that Amgen's experimental drug AMG 416 was significantly more effective than placebo in reducing parathyroid hormone levels in chronic-kidney-disease patients who require dialysis. The drug also improved patients' serum phosphorus and calcium concentration levels compared with placebo, meeting the secondary goals of the study. NewsDaily/Reuters (7/17)
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ViaCyte to begin stem cell therapy trial for type 1 diabetes
ViaCyte has filed an application to start a Phase I/II clinical trial of its embryonic stem cell therapy for type 1 diabetes, which will evaluate the safety and efficacy of the product in humans. The stem cells are grown to replace insulin-producing cells, packaged in a semi-permeable device and implanted into the patient. The work is funded by the California Institute for Regenerative Medicine. San Diego Union-Tribune (7/17)
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Company & Financial News
Foundation awards $4.7M for prostate cancer test development
The Movember Foundation has awarded $4.7 million to a team of Canadian scientists to support the development of molecular diagnostic tests that could be used to guide the treatment of prostate cancer. Specifically, the team will design an assay that could pinpoint men who are at risk for aggressive prostate cancer and formulate customized treatments for early cancers. GenomeWeb Daily News (free registration) (7/17)
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Funding round brings in $1.5M for DesignMedix
DesignMedix secured $1.5 million in its second angel funding round. Proceeds from the round will go toward the development of the firm's experimental drugs against drug resistance, which include antibacterial and malaria treatments. American City Business Journals/Portland, Ore./Healthcare Inc. Northwest blog (7/18)
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Food & Agriculture
New technology could end malaria by changing mosquito DNA
Altering mosquito DNA may be the answer to curbing the ongoing spread of malaria, according to a pair of papers published in Science and eLife, respectively. The authors describe technology known as Crispr, which could allow scientists to alter mosquito DNA, either to make the insects resistant to the malaria parasite or to engineer mosquitoes to become infertile, eliminating their population altogether. Since this technology has such wide-ranging effects, however, researchers are urging discussion before putting Crispr into use. The New York Times (tiered subscription model) (7/17)
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Hot Topics
Industrial & Environmental
10 biomass research projects receive $12.6M from feds
Ten innovative research projects focusing on plant feedstocks for bioenergy and bioproduct applications have received a total of $12.6 million in funding from a joint program by the departments of Agriculture and Energy. "Biofuels and bio-based products offer the potential of homegrown American resources that can reduce our dependence on imported oil and also cut carbon emissions," said Energy Secretary Ernest Moniz. (7/17)
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News From BIO
Announcing the BIO Latin America Conference!
BIO and Biominas have partnered to co-host the first annual BIO Latin America, the industry’s must-attend conference for innovation and collaboration in Latin America’s rapidly-growing biotechnology sector. Join high-level executives, academics and investors in Rio de Janeiro, September 9-11, to discuss trends, navigate industry challenges, attend company presentations, conduct 1x1 partnering meetings and learn about investment opportunities within this emerging market. Register now.
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