Regeneron, Sanofi's Dupixent approved for asthma | Genentech's Rituxan gets FDA nod for new indications | Intellia, Regeneron collaborate for gene-editing amyloidosis treatment
October 22, 2018
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Regeneron, Sanofi's Dupixent approved for asthma
Regeneron, Sanofi's Dupixent approved for asthma
(Eric Piermont/AFP/Getty Images)
Regeneron Pharmaceuticals and Sanofi's Dupixent, or dupilumab, was approved by the FDA as an add-on maintenance treatment for patients age 12 and older who have an eosinophilic phenotype or oral corticosteroid-dependent moderate to severe asthma. The drug was previously approved for eczema.
Seeking Alpha (10/20) 
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Learning Smokers’ Triggers ​
It's just lunch for non-smokers, but it's a trigger for those who smoke. The Foundation for a Smoke-Free World is working to understand smokers' needs, in order to give them their best chance at quitting. ​Learn more
Health Care & Policy
Genentech's Rituxan gets FDA nod for new indications
Roche Holding unit Genentech's Rituxan, or rituximab, was granted FDA approval as a treatment for adult patients with two rare forms of vasculitis -- microscopic polyangiitis and granulomatosis with polyangiitis -- who have achieved disease control using induction therapy.
Seeking Alpha (10/19) 
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Intellia, Regeneron collaborate for gene-editing amyloidosis treatment
Intellia Therapeutics has partnered with Regeneron to develop a CRISPR-Cas9 treatment that will allow scientists to alter mutations in patients with transthyretin amyloidosis by delivering the therapy to the liver to decrease TTR levels in order to treat ATTR. Preclinical nonhuman primate data was presented at the European Society of Gene and Cell Therapy's annual meeting.
FierceBiotech (10/19) 
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EU regulators recommend approval of angioedema drug, dengue vaccine
The Committee for Medicinal Products for Human Use of the European Medicines Agency issued several recommendations for approval Friday, including Shire's Takhzyro, or lanadelumab-flyo, for the prevention of recurrent attacks of hereditary angioedema and Sanofi's dengue vaccine Dengvaxia. CHMP backed Sanofi's tetravalent vaccine as a preventive treatment for dengue for people ages 9 to 45 who live in areas where the disease is endemic and who have been previously infected with dengue.
BioCentury (10/19),  FiercePharma (10/19) 
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ViiV files NDA for single pill, 2-drug HIV therapy
ViiV Healthcare, whose majority shares are owned by GlaxoSmithKline, has filed a new drug application for its dolutegravir/lamivudine combo drug to be released as a single pill to treat patients with HIV. ViiV is using its priority review voucher to facilitate the regimen's evaluation by the FDA to obtain a regulatory decision within a six-month period.
PharmaTimes online (UK) (10/19),  Endpoints News (10/19) 
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Prucalopride gets FDA panel backing
Prucalopride gained the endorsement of the FDA's Gastrointestinal Drugs Advisory Committee to treat adult patients with chronic idiopathic constipation. The committee voted 10-0 in favor of the drug.
eMPR (10/19) 
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Company & Financial News
Biotech startup raises $7.1M from funding round
Therapeutic antibodies developer Invenra raised over $7.1 million through an equity funding round, according to a filing submitted to the Securities and Exchange Commission. The financing will support product development, hiring initiatives and facility expansion projects.
Xconomy (10/19) 
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Mezzanine round pulls in $80M for TP Therapeutics
A mezzanine round of funding pulled in $80 million for oncology company TP Therapeutics. The company plans to file an investigational new drug application of TPX0022 for treatment-resistant cancer in the first half of 2019.
BioCentury (10/19) 
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Food & Agriculture
Biotech cotton cultivation approved in Kenya
Kenya President Uhuru Kenyatta has approved the cultivation of biotech cotton with Bacillus thuringiensis soil-borne bacteria in the country. "Cotton farming was once a major source of income and livelihood for many people in this (western) region," Kenyatta said, instructing the ministries of Health, Agriculture, and Industry, Trade and Cooperatives to explore the possibilities of farming biotech cotton.
The Exchange (Kenya/Tanzania) (10/22) 
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Industrial & Environmental
D3MAX facility construction begins in Wis.
Ace Ethanol has started the construction of a facility to convert corn kernel fiber to ethanol in Stanley, Wis. The plant will incorporate D3MAX technology into a corn mill.
AgWired (10/19) 
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The first principle is that you must not fool yourself -- and you are the easiest person to fool.
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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
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