FDA approves Adcetris for classical Hodgkin lymphoma | EU expands indications for Sobi's Kineret | Ohara halves price of generic leukemia drug
April 12, 2018
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FDA approves Adcetris for classical Hodgkin lymphoma
Adcetris, or brentuximab vedotin, received FDA approval for use with chemotherapy in treatment-naive patients with stage III or IV classical Hodgkin lymphoma. The therapy combines an anti-C30 antibody with monomethyl auristatin E to target lymphoma cells.
Cancer Network (4/10) 
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Health Care & Policy
EU expands indications for Sobi's Kineret
European regulators expanded treatment indications for Sobi's Kineret, or anakinra, to treat the rare auto-inflammatory disorder Still's disease. This move was supported by clinical research showing remission in the majority of pediatric and adult patients taking the drug.
PharmaTimes online (UK) (4/11) 
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Ohara halves price of generic leukemia drug
Ohara Pharmaceutical halved the price of its generic version of Glivec in Japan in a bid to make medications more affordable for patients with chronic myelocytic leukemia. Currently, 17 pharmaceutical companies offer a generic version of Glivec, but market penetration is low because of high prices.
The Japan News by The Yomiuri Shimbun (4/11) 
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Lung drug gains orphan status
Reviva Therapeutics' drug candidate RP5063, a treatment for idiopathic pulmonary fibrosis, received orphan drug status from the FDA. Preclinical studies indicated the drug has potential for stabilization and improvement of lung function.
Rare Disease Report (4/10) 
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NIA proposes focusing on biomarkers, not symptoms, in Alzheimer's research
Alzheimer's disease research should focus on biologic and physical markers of the disease instead of on symptoms, according to new research guidelines from the National Institute on Aging. The proposed framework, published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association, is in line with protocols for other disease research and present an opportunity to develop prevention strategies, experts said.
HealthDay News (4/10) 
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New therapies recommended by Scottish regulator for NHS funding
The Scottish Medicines Consortium approved for National Health Service use Shire's Revestive, or teduglutide, for pediatric onset short bowel syndrome in children ages 1 to 17, and Sanofi's Kevzara, or sarilumab, for adults with rheumatoid arthritis who do not respond to or are intolerant of standard therapies. The regulator also endorsed two hepatitis C-targeting drugs: Gilead's Vosevi, or sofosbuvir/velpatasvir/voxilaprevir, which is indicated to treat certain adult patients with hepatitis C, and Gilead's Epclusa, or sofosbuvir-velpatasvir, for patients with hepatitis C genotype 1 or 4 infection.
PharmaTimes online (UK) (4/10) 
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Company & Financial News
$160M biomanufacturing plant planned in R.I.
California-based biotech firm Amgen is planning to build a $160 million biomanufacturing plant in Rhode Island. It's unclear when construction will start, but a state board already has approved about $9.5 million in tax credits for the project.
WPRI-TV (Providence, R.I.) (4/10) 
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Parexel, Japanese university to offer joint program in clinical research
Parexel and Meiji Pharmaceutical University announced a plan to help expand the biopharmaceutical workforce in Japan by launching a joint program for clinical research and clinical trial management at the Tokyo school. The four-week undergraduate curriculum will be preceded by a series of two-week pilot programs, with the full curriculum being offered beginning in November 2019.
OutsourcingPharma (4/10) 
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Food & Agriculture
Bill Gates: CRISPR, gene editing could improve agriculture
Bill Gates says CRISPR technology and gene editing could benefit food production and fight diseases such as malaria. The technologies could be used to make more productive animals and produce crops that can withstand harsher growing conditions, says Gates, whose Bill and Melinda Gates Foundation backs gene editing.
Quartz (4/11) 
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Industrial & Environmental
Canadian students create human waste-derived bioplastic ingredient
A team of undergraduate students from the University of Calgary in Canada has developed a bioplastic ingredient made from human waste that can be used for 3D printing in space. The students used genetically engineered E. coli bacteria to convert human waste into bioplastics.
3DPrint (4/10) 
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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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