AbbVie, Genentech's CLL, SLL therapy wins FDA full approval | FDA approves Alembic's major depressive disorder tablets | Eagle wins orphan status exclusivity in court for blood cancer drug
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June 11, 2018
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AbbVie, Genentech's CLL, SLL therapy wins FDA full approval
AbbVie and development partner Roche Holding unit Genentech's venetoclax was granted full approval by the FDA as a treatment for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with or without 17p deletion who had at least one prior line of treatment.
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Health Care & Policy
FDA approves Alembic's major depressive disorder tablets
The FDA has approved Indian drugmaker Alembic Pharmaceuticals' abbreviated new drug application for major depressive disorder drug bupropion hydrochloride tablets USP, 75 mg and 100 mg. The drug is therapeutically equivalent to GlaxoSmithKline's Wellbutrin, its reference drug.
PharmaBiz (India) (6/11) 
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Eagle wins orphan status exclusivity in court for blood cancer drug
Eagle wins orphan status exclusivity in court for blood cancer drug
(Joe Raedle/Getty Images)
A court awarded seven-year orphan drug status exclusivity to Eagle Pharmaceuticals' blood cancer drug Bendeka, or bendamustine hydrochloride. The FDA was sued by Eagle after the agency said there was no evidence of clinical superiority of the drug and did not give it orphan drug-related exclusivity.
Seeking Alpha (6/8) 
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AZ's Tagrisso gets EU nod as first-line NSCLC therapy
The European Commission has approved AstraZeneca's Tagrisso, or osimertinib, as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer that expresses EGFR mutations. The decision was supported with data from a late-stage FLAURA study, in which the drug achieved the primary endpoint of improving progression-free survival as compared to standard of care in the first-line setting.
BioCentury (6/8) 
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CytoDyn reports on data for PRO 140 to treat multidrug-resistant HIV-1
PRO 140, the investigational humanized monoclonal antibody developed by CytoDyn, attained its primary endpoint in a pivotal trial that tested the candidate on 50 patients with multidrug-resistant HIV-1 in combination with antiretroviral treatment, with participants achieving a 97% mean viral load reduction from baseline one week after receiving a single injection, according to a presentation made at the conference of the American Society for Microbiology. Based on the favorable results, CytoDyn plans to file for a biological license application for PRO 140 in a combination therapy indication.
Healio (free registration)/Infectious Disease News (6/9) 
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Company & Financial News
Editas, Broad Institute enter sponsored research agreement
Editas Medicine will collaborate with the Broad Institute in a sponsored research agreement that involves the use of certain CRISPR-Cas9 technology to advance genome-editing research and the development of drugs to treat or prevent human diseases. Editas will make two upfront payments totaling $12.5 million linked to its market cap, with the total value not to exceed $125 million.
Seeking Alpha (6/8) 
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Cell therapy developer Autolus aims to raise $125M in IPO
An initial public offering was filed by cell therapy developer Autolus, with the potential to raise $125 million. The company is currently testing four programmed T-cell therapies, comprising early-stage AUTO1 for adults with acute lymphoblastic leukemia; Phase I/II AUTO2 for multiple myeloma; Phase I/II AUTO3 for diffuse large B-cell lymphoma and pediatric ALL; and early-stage AUTO6, indicated to treat neuroblastoma.
BioCentury (6/8) 
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Food & Agriculture
Biotech salmon to be grown in Ind.
Massachusetts-based AquaBounty Technologies plans to grow its biotech salmon in Albany, Ind. The company's salmon is developed to grow faster than fish raised in fresh water.
WMOT-FM (Murfreesboro, Tenn.) (6/8) 
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Industrial & Environmental
French farmers urge government to curb palm oil import
The French government was urged by farmers to curb Total's plans of importing palm oil for use in the production of biofuel. Five refinery sites and oil depots have been blockaded by farmers who grow local oilseed crops such as rapeseed, with plans for an additional 13 site blockades today.
Reuters (6/10),  TeleSurTV (Venezuela)/Reuters (6/11) 
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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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