2 Indian drugmakers recall drugs from US market | Scottish regulator endorses 6 new drugs | Incyte, Eli Lilly's rheumatoid arthritis drug gets EU nod
February 16, 2017
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2 Indian drugmakers recall drugs from US market
Dr. Reddy's is recalling Olanzapine tablets, for the treatment of schizophrenia and bipolar disorder, and Aurobindo Pharma is withdrawing injectable Pantoprazole sodium, used to treat gastroesophageal reflux, after receiving FDA warning letters. Both are voluntary Class III recalls, indicating negative health consequences are unlikely.
The Economic Times (India) (2/15) 
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Europe
Scottish regulator endorses 6 new drugs
The Scottish Medicines Consortium has recommended six drugs for National Health Service use in Scotland to treat cancer, chronic migraine, high cholesterol and iron deficiency. The drugs include: AstraZeneca's Tagrisso, Novartis' Afinitor, Servier Laboratories' Lonsurf, Allergan's Botox, Amgen's Repatha and Pharmacosmos' Diafer.
PharmaTimes (U.K.) (2/14) 
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Incyte, Eli Lilly's rheumatoid arthritis drug gets EU nod
The European Commission has approved the use of Incyte and Eli Lilly and Co.'s Olumiant, or baricitinib, as a treatment for moderate to severe rheumatoid arthritis in adults who are intolerant to or have an inadequate response to disease-modifying anti-rheumatic drugs. The drug is expected to be launched this year.
BioCentury (2/13),  Seeking Alpha (free registration) (2/13) 
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Study finds antibiotic intake prior to cancer immunotherapy reduces its efficacy
Researchers from the Gustave Roussy Cancer Institute in France found that disease progression was more rapid among the 80 study patients with metastatic renal cell carcinoma who took antibiotics within a month before their scheduled cancer immunotherapy session compared with those who didn't. The findings were presented at a presscast prior to the Genitourinary Cancers Symposium being held in Florida.
Medscape (free registration) (2/13) 
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Asia Pacific
China records spike in bird flu deaths
China records spike in bird flu deaths
(AFP/Getty Images)
Chinese authorities said 79 people died of H7N9 bird flu in January, roughly four times higher than in the same time period in previous years.
Reuters (2/15) 
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Inovio signs deal with ApolloBio to develop HPV vaccine in China
China-based ApolloBio has gained exclusive rights to develop Inovio Pharmaceuticals' VGX-3100, a late-stage vaccine candidate designed to prevent and treat precancerous infections and dysplasias related to human papillomavirus, in China, Taiwan, Hong Kong and Macao. Under the collaboration and licensing deal, Inovio will receive a $3 million upfront payment and is eligible for a $12 million near-tern payment and $20 million in regulatory milestones, along with sales royalties.
Genetic Engineering & Biotechnology News (2/13),  BioCentury (2/13) 
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India caps coronary stent prices
An order has been issued by India's National Pharmaceutical Pricing Authority capping prices of bare-metal coronary stents at approximately $109 per unit and of metallic drug-eluting stents and bioresorbable vascular scaffold or biodegradable stents at approximately $442 per unit effective immediately.
Medtech Insight (free registration) (2/14) 
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North America
HHS urged by senators to allow Canadian drug imports amid drug price hikes
HHS urged by senators to allow Canadian drug imports amid drug price hikes
(Nicholas Kamm/AFP/Getty Images)
A letter was sent to HHS Secretary Tom Price by Sens. Chuck Grassley, R-Iowa, John McCain, R-Ariz., and Amy Klobuchar, D-Minn., requesting immediate approval for Canadian import of prescription drugs in response to price hikes. The senators noted that Price has the authority to allow imports under four circumstances, including a "significant and unexplained increase in price," such as the recently approved Duchenne muscular dystrophy treatment that was set to be priced over 50 times its cost in Canada.
Regulatory Focus (2/14),  BioCentury (2/14) 
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Global
Global cervical total disc replacement device market poised for growth
A Persistence Market Research report predicts the worldwide market for cervical total disc replacement devices will reach $1.75 billion by 2021 with a 23.1% compound annual growth rate due to the expanding aging population and the increasing incidence of chronic diseases. Among the key market players are Medtronic, DePuy Synthes, NuVasive and Globus Medical.
BeckersSpine.com (2/14) 
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DIA News
Advertising and Promotion Regulatory Affairs Conference
Feb. 23-24, Washington, D.C.
DIA's Advertising and Promotion Regulatory Affairs Conference dives deep into the latest best practices, how to avoid potential legal implications, mobile app considerations, ad promo submissions and how to handle FDA inspections. Whether you are new to the field or have years of experience, you can't afford to miss this opportunity to prepare yourself for what's coming! Learn the five keys to building the bridge with FDA on advertising and promotion challenges. View the infographic.
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DIA events coming up next!
Stay up to date with what's happening at DIA in 2017. Download the DIA Events and Training Calendar to see where and when DIA will be hosting conferences, meetings, short courses and training opportunities for you and your team. DIA brings together industry, academia, regulators and patient representatives all in one place. Take advantage of options like exhibits, sponsorship and advertising opportunities. Download the DIA 2017 Media and Sponsorship Kit to explore the options or create your own.
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