Dr. Reddy's, Integra LifeSciences reach exclusive distribution deal | EC approves 2 Humira biosimilars | Pfizer's meningococcal vaccine receives positive opinion from EMA panel
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March 28, 2017
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Dr. Reddy's, Integra LifeSciences reach exclusive distribution deal
Dr. Reddy's Laboratories has agreed to exclusively distribute and market Integra LifeSciences' DuraGen Plus and Suturable DuraGen Dural Regenerative Matrices in India for use in patients undergoing neurosurgery. Duraplasty Solutions, part of the DuraGen line of products, facilitates repair of the dura mater.
Business Standard (India) (tiered subscription model) (3/27),  Reuters (3/27) 
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Reimagine the life science patient experience
The life science industry is undergoing rapid transformation, driven by consumer empowerment, clinical innovation and outcomes-driven health care policy. In this changing landscape, medical device and pharmaceutical companies are striving to connect with patients and deliver the best possible experience before, during and after therapy. Learn more.
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Europe
EC approves 2 Humira biosimilars
The European Commission has issued marketing authorizations for two Humira biosimilars from Amgen. Amgevita, or adalimumab, is approved for all Humira indications, while Solymbic, or adalimumab, is approved for all but polyarticular juvenile idiopathic arthritis.
Regulatory Focus (3/24) 
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Pfizer's meningococcal vaccine receives positive opinion from EMA panel
Pfizer's meningococcal group B vaccine Trumenba has been recommended by the European Medicines Agency's Committee for Medicinal Products for Human Use as a preventive vaccine against invasive meningococcal disease caused by Neisseria meningitidis serogroup B in patients ages 10 years and above.
Seeking Alpha (free registration) (3/24) 
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Asia Pacific
Australian study seeks to develop new test to eradicate malaria
Monash University biospectroscopists from Australia are conducting an experimental trial to develop a new test that will detect the presence of malaria in the blood of villagers in impoverished, remote areas of Papua New Guinea. The kit consists of a portable spectrometer, a blood centrifuge, a laptop and a small battery and has the capacity to identify multiple malaria strains and identify asymptomatic carriers.
ABC (Australia) (3/24) 
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North America
GOP's ACA replacement plan pulled from House
The American Health Care Act, an Affordable Care Act replacement plan that included a provision on repealing the medical device tax, has been pulled by House Republicans from consideration after they failed to secure enough votes to pass it. The medical device tax was temporarily suspended in 2015 and will resume in January.
Medtech Insight (free registration) (3/24) 
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Participants sought for FDA device center's staff training program
The FDA's Center for Devices and Radiological Health is calling on medical device companies, incubators, accelerators and other stakeholders to join its Experiential Learning Program, which seeks to provide its staff with better understanding of medical devices and the challenges affecting the device development life cycle. The center is accepting applications for participation in the training program until April 30.
Regulatory Focus (3/24) 
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Other News
Latin America
Venezuela seeks pharmaceutical help from UN
Venezuelan President Nicolas Maduro has asked the United Nations for help to ease a serious shortage of medications in the country caused by its economic crisis. Approximately 85% of drugs are unavailable to citizens, according to the Venezuelan Pharmaceuticals Federation.
Reuters (3/25) 
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Global
AstraZeneca gains approval in China for lung cancer pill
Regulators in China approved AstraZeneca's Tagrisso, an oral drug for lung cancer patients with certain genetic mutations. The drug is a potential blockbuster, and approval represents a "significant opportunity" for the drugmaker, AstraZeneca's Sean Bohen said in a statement.
Reuters (3/27) 
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DIA News
DIA CMC Workshop, April 24-26, Rockville, Md.
Co-sponsored with the American Association of Pharmaceutical Scientists, DIA's CMC Workshop offers an opportunity to discuss in depth new regulatory, technical and GMP/Quality processes, innovative products, and global perceptive to help you start resolving CMC challenges. Featuring three parallel tracks, the workshop includes four plenary sessions on accelerated programs, innovative technologies with a focus on continuous manufacturing, life cycle management using ICHQ12 and the global regulators update. Download our new eBook for content resources and in-depth detail about the DIA CMC Workshop.
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