BIO urges FDA to revise draft biologic exclusivity guidelines | Idiopathic pulmonary fibrosis drugs from Roche, Boehringer win FDA approval | FDA clears HPIV test from Quidel
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October 16, 2014
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BIO urges FDA to revise draft biologic exclusivity guidelines
The FDA should revise its draft guidance on determining biologic product exclusivity because it is unnecessarily complicated, lacks clarity and goes beyond its statutory mandate, BIO said in recent comments to the FDA. The group encouraged the agency to clearly indicate in the final guidelines that its interpretation of the Biologics Price Competition and Innovation Act of 2009 includes a presumption of reference product exclusivity that operates by statute. Bloomberg BNA (free content) (10/15)
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Health Care & Policy
Idiopathic pulmonary fibrosis drugs from Roche, Boehringer win FDA approval
The FDA has approved Roche's Esbriet, or pirfenidone, and Boehringer Ingelheim's Ofev, or nintedanib, as treatments for idiopathic pulmonary fibrosis. Esbriet and Ofev are the first drugs approved for the lung disease in the U.S. Reuters (10/15)
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FDA clears HPIV test from Quidel
The FDA has given Quidel 510(k) clearance to market its Lyra Parainfluenza Assay. The real-time polymerase chain reaction based test examines nasopharyngeal and nasal swab samples to identify the presence of human parainfluenza virus types 1, 2, or 3 viral RNA. GenomeWeb Daily News (free registration) (10/15)
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FDA to expedite review of Eisai's lenvatinib for thyroid cancer
Eisai obtained priority-review status from the FDA for its application to market lenvatinib for the treatment of progressive radioiodine-refractory differentiated thyroid cancer. A decision is expected by April 14. The drug is also under clinical development for non-small-cell lung cancer, hepatocellular cancer and other forms of solid tumors. PharmaTimes (U.K.) (10/15)
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Company & Financial News
AbbVie to reconsider $54B merger with Shire
AbbVie said its board of directors will meet next week to discuss whether it should go ahead with its planned $54 billion merger deal with Shire amid the U.S. government's efforts to block tax inversions. Shire said AbbVie should continue the deal, adding that its own board will meet to discuss the situation. The Irish firm said it will get a break fee of $1.64 billion if AbbVie decides to cancel the merger. PharmaTimes (U.K.) (10/15)
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Illumina selects 3 startups for Accelerator funding program
Illumina has selected startup companies Encoded Genomics, EpiBiome and Xcell Biosciences to participate in the inaugural funding cycle of the Illumina Accelerator program. The companies will get a seed investment and business guidance and will be given access to lab space and Illumina's sequencing systems and reagents throughout the six-month funding period. Genetic Engineering & Biotechnology News (10/15)
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Mass. firm developing gout treatment gets $20M funding boost
Selecta Biosciences, a Boston-area biotech firm developing a synthetic vaccine particle technology, said it has raised more than $20 million in its latest equity funding round. The firm's lead product, SEL-212, is designed to treat patients with refractory and tophaceous gout. The Boston Globe (tiered subscription model) (10/15)
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The Latest From BIO ...
Faster & better connections with quality R&D vendors
BIO BizLink is a portal to an unparalleled community of R&D vendors -- including pre-clinical and clinical CROs, CMOs and regulatory consultants -- and a platform to take the administrative hassle out of RFP, vendor, and project management. Sign up for free.
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Industry Deals
Collaboration aims to develop test for early TB diagnosis
Advanced Biological Laboratories has struck a development deal with two universities in Hong Kong for undisclosed terms. Under the deal, the groups will create a next-generation sequencing-based early tuberculosis detection test that works with Advanced Biological's DeepChek system, and validate the test using prospective and retrospective clinical samples. GenomeWeb Daily News (free registration) (10/14)
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Food & Agriculture
Dow AgroSciences' herbicide for biotech corn, soybeans gets EPA's nod
The Environmental Protection Agency has approved Dow AgroSciences' Enlist Duo herbicide, a new version of a weed killer designed to be used with Dow's biotech corn and soybeans. However, the approval allows the new Enlist herbicide to be used only in South Dakota, Wisconsin, Ohio, Iowa, Indiana and Illinois. The Bellingham Herald (Wash.)/The Associated Press (10/15)
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Industrial & Environmental
GranBio considers additional biofuel, biochemical facilities in Brazil
Brazil-based biotechnology company GranBio is planning a second cellulosic ethanol plant, as well as a second biochemical facility. The company's first cellulosic ethanol plant, Bioflex 1, opened last month and can produce 22 million gallons of ethanol from sugarcane waste annually. CEO Bernardo Gradin said the company's biofuel and biochemical plant investments may reach $1.7 billion through 2020. Bloomberg Businessweek (10/14)
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News From BIO
Industrial biotechnology with a French twist!
Over 1,300 leaders in biofuels, biobased products and renewable chemicals will be in Montreal July 19-22, 2015, for BIO World Congress on Industrial Biotechnology. Join industry leaders for great food, excellent wine, high-level networking and a can't-miss program. BIO will accept speaker proposals October 2014-January 2015. Learn more.
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Sr Proposal Development Manager (JBEI)Lawrence Berkeley National LaboratoryBerkeley, California
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SmartQuote
Every great dream begins with a dreamer."
-- Harriet Tubman,
American abolitionist
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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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