Medivir, Cancer Research Technology sign cancer drug development deal | Sanofi holds firm on diabetes drug pricing | Malaysia offers fast-track medical device registration process

April 16, 2015
DIA Global SmartBrief
News on diagnostic and therapeutic innovations and regulatory science

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India considers action against EMA over suspended drug sales
India's Ministry of Commerce and Industry might file a complaint with the World Trade Organization against the European Medicines Agency, which suspended sales of hundreds of drugs whose approvals were based on studies by GVK Biosciences. An EMA investigation found evidence that some clinical trial data had been manipulated, but a panel of experts commissioned by the Indian government found no manipulation of data, according to GVK. India has asked the EMA to reconsider the suspensions. Reuters (4/15)
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An Investigation on Medicare Advantage Dual Eligible Member-Level Performance on CMS Five-Star Quality Measures
The new Dual's study provides insights into how clinical, sociodemographic and community resource characteristics impact health outcomes and Medicare Advantage (MA) plan Five-Star ratings. Learn more.
Medivir, Cancer Research Technology sign cancer drug development deal
Medivir and Cancer Research Technology entered into a collaboration for the research and development of cancer drugs that target ADAM8, a protein that is associated with cancer progression. Under terms of the deal, Medivir will gain worldwide rights to develop, produce and market drugs arising from the partnership. Cancer Research Technology is entitled to an undisclosed upfront payment, milestone fees and sales royalties. PharmaTimes (U.K.) (4/13)
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Sanofi holds firm on diabetes drug pricing
Sanofi executives say the company will not offer additional discounts in the U.S. for its diabetes drug Toujeo. Sanofi's blockbuster Lantus has lost patent protection, and the company wants to convert patients to the new drug. Bloomberg (4/13)
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What You Can Learn From Some of 2014's Top Innovators
Ready to get inspired for 2015? The experiences of these 6 innovative leaders can help you chart a smarter, more successful way forward with your business. Read the featured article.

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Malaysia offers fast-track medical device registration process
The Malaysian Medical Device Authority will accelerate registration of all Class A devices through June 30. Fast-track registration is also available for Class A, B, C and D devices already registered in the U.S., Australia, Canada, Europe or Japan. Full certification of fast-tracked devices must be obtained by June 30, 2020. Emergo (4/13)
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Australia looks to EMA for drug quality guidelines
Australia's Therapeutic Goods Administration is seeking public comment on a proposal to adopt 10 European Medicines Agency guidelines to replace portions of its own standards. The guidelines cover pharmaceutical quality, biosimilars, clinical safety and efficacy, and nonclinical standards. If adopted, the guidelines would be effective by the end of July or sooner. (4/13)
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Combating Identity Theft in a Mobile, Social World
Mobile connectivity threats extend from consumers to the business environment. But who is really responsible for securing sensitive information? Smart business leaders are becoming proactive on the matter. Learn how to get protected in this white paper. Download the white paper now.

North America
J&J unit, Ichor Medical collaborate on hepatitis B drug-device combo
San Diego-based Ichor Medical Systems has entered into a licensing and development deal with Janssen Pharmaceuticals, a unit of Johnson & Johnson. The deal calls for the use of Ichor's electroporation system, the TriGrid device, to deliver a DNA-based vaccine aimed at hepatitis B. Ichor will receive $85 million from Janssen, including milestone fees, research and development support and an upfront payment. (Boston) (4/13)
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Specialty drugs drive spending growth in the U.S.
Annual spending on drugs rose 13% last year in the U.S., the largest percentage increase since 2001, driven primarily by high-priced specialty drugs for cancer and hepatitis C, according to a report from the IMS Institute for Healthcare Informatics. Spending on new hepatitis C drugs accounted for nearly half of the $24.5 billion spent on new drugs last year in the U.S. HealthDay News (4/14), Reuters (4/14)
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Nanotech-based breath test shows promise in predicting stomach cancer
A testing method based on nanotechnology was able to detect slight changes in specific compounds found in exhaled breath that could signal early signs of stomach cancer, according to a small Israeli study in the journal Gut. The test shows promise as a noninvasive tool for screening people at greater risk of the cancer, once the findings are confirmed in larger studies, researchers said. HealthDay News (4/14)
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Pfizer, Mylan reach patent settlement on Viagra
Mylan will launch a generic version of Pfizer's erectile dysfunction drug Viagra in the U.S. in December 2017 or before if certain conditions are met. The drug's patent expires in 2020. Zacks/Analyst Blog (4/14), Reuters (4/13)
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AstraZeneca secures research partnership with PatientsLikeMe
A five-year research partnership between PatientsLikeMe and AstraZeneca is designed to harness patient-generated data for pharmaceutical research. The deal gives AstraZeneca access to PatientsLikeMe's database for research that will initially focus on cancer, diabetes, lupus and respiratory disease. (4/13)
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DIA News
DIA China 7th Annual Meeting
Experience one of the world's most essential and vibrant markets at our DIA China 7th Annual Meeting: Innovation and Convergence -- Building a Sustainable R&D Ecosystem, DIA's largest multidisciplinary educational and networking event in Asia, presented at Shanghai International Convention Center (SHICC) on May 24-27. Today is your last day to save through the early registration discount. Scheduled highlights of this year's program include:
  • This year's CFDA Town Hall will give leading regulators the opportunity to communicate with the audience on hot topics related to drug review and approval system reform
  • Breakthrough Therapies in Diabetes Diseases session
  • Chronic HCV Management session
  • Generic Drug Forum
  • Special Forum: R&D Ecosystem
Online registration is quick and easy. Sign up to join us today!
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Have patience. All things are difficult before they become easy."
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