FDA grants tentative approval to Teva's generic mifepristone | Keytruda, Inlyta combo shows benefits for kidney cancer patients | Allergan to seek US approval for migraine drug
October 19, 2018
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FDA grants tentative approval to Teva's generic mifepristone
Teva Pharmaceutical Industries' generic version of mifepristone was granted tentative approval from the FDA. The drug is the active ingredient in Corcept Therapeutics's Korlym.
Seeking Alpha (10/18) 
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23rd Annual Drug & Med Device Litigation Conference
Widely regarded as the go-to conference for the pharma and med device products liability community, ACI's Drug & Med Device Litigation event, taking place Nov 28-30, 2018 in NYC, is the only event to showcase a faculty of 20+ In house counsel, 10+ judges and 20+ leading law firms. Limited comp passes are available to qualified in-house counsel. Learn more >>
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Health Care & Policy
Keytruda, Inlyta combo shows benefits for kidney cancer patients
Statistically meaningful improvements in overall survival and disease progression were seen in patients with kidney cancer treated with a combination of Merck's Keytruda, or pembrolizumab, and Pfizer's Inlyta, or axitinib. The combination treatment met the main goals of the late-stage trial as compared with kidney cancer drug Sutent, or sunitinib malate, also from Pfizer.
Specialty Pharmacy Times (10/18) 
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Allergan to seek US approval for migraine drug
Dublin, Ireland-based Allergan plans to submit a marketing application for its migraine therapy ubrogepant to the US early next year. Allergan recently finished two safety studies in which more patients treated with 50-mg and 100-mg doses of the drug experienced relief from pain and bothersome migraine-associated symptoms two hours after the initial dose, compared with those receiving placebo.
PharmaTimes online (UK) (10/18) 
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Rocket Pharma provides update on Fanconi anemia study in Spain
Rocket Pharmaceuticals unveiled updated long-term results from a Phase I/II study being conducted in Spain to assess its gene therapy candidate RP-L102, indicated for patients with Fanconi Anemia, a rare, inherited hematologic disorder. The data were presented at the meeting of the European Society of Gene and Cell Therapy, which showed durable engraftment in four patients based on follow-up data for 12 months.
Seeking Alpha (10/18) 
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Pain crises in sickle cell patients diminished with crizanlizumab
Based on post hoc analysis from its midstage SUSTAIN study, Novartis reported that nearly 36% of sickle cell patients treated with crizanlizumab, or SEG101, did not experience post-treatment pain crises, compared with 16.9% of patients given a placebo. Findings were published in the American Journal of Hematology.
Sickle Cell Anemia News (10/18) 
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Chinese biopharma initiates Phase I study for AML candidate
An early-stage study was launched in China by Hutchison China MediTech, or Chi-Med, to assess the preliminary efficacy, safety and pharmacokinetics of its experimental drug HMPL-523, combined with azacitidine, as a treatment for elderly acute myeloid leukemia patients who have not been previously treated or who are ineligible to undergo standard induction therapy. The study's primary endpoint includes overall response rate as well as adverse events.
Seeking Alpha (10/18) 
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Company & Financial News
AbbVie to license Morphic's antifibrotic integrins
AbbVie and Morphic Therapeutic will work together to develop the latter's antifibrotic integrins to block transforming growth factor β activation through various undisclosed targets. Under the deal, Morphic will receive $100 million up front plus potential licensing fees down the road from AbbVie for global development and marketing rights to the potential products of the research.
BioCentury (10/18) 
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Novartis to pay $2.1B for drugmaker Endocyte
Swiss pharmaceutical company Novartis plans to buy US-based cancer-drug developer Endocyte for $2.1 billion. Earlier this year, Novartis bought gene therapy company AveXis for $8.7 billion.
BloombergQuint (India) (10/18),  The Wall Street Journal (tiered subscription model) (10/18) 
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Food & Agriculture
Biotech mosquito with smaller body size developed using CRISPR-Cas9
Scientists from University of California, Riverside used CRISPR-Cas9 technology to develop biotech mosquitoes that have decreased body size. Researchers shortened the mosquitoes' lifespan by altering their DNA sequences and modifying their gene function to postpone development.
University of California, Riverside (10/17) 
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Industrial & Environmental
Brazilian ethanol producer awarded $13M funding by BNDES
Ethanol producing company Companhia Agricola Usina Jacarezinho received $13 million from the Brazilian Development Bank. The grant is expected to help the company improve its sugar processing capacity.
Renewables Now (Bulgaria) (tiered subscription model) (10/19) 
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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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