Chinese manufacturers face new device, drug rules | NHS England approves novel therapies for treating tuberculosis | Expert: UK companies need to start planning now for MDR changes
 
August 27, 2015
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Chinese manufacturers face new device, drug rules
New rules from the China Food and Drug Administration will be implemented over the next few months and will affect medical device and drug manufacturers. The rules pertain to unannounced inspections, good manufacturing practice requirements, product classifications and clinical trial records. Clinica (subscription required) (8/25)
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Europe
NHS England approves novel therapies for treating tuberculosis
National Health Service England has added Janssen's Sirturo, or bedaquiline, and Otsuka's Deltyba, or delamanid, to the list of drugs approved to treat pulmonary multidrug-resistant tuberculosis, providing UK patients access to the first novel TB drugs in 50 years. PharmaTimes (U.K.) (8/24)
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Expert: UK companies need to start planning now for MDR changes
Medical device manufacturers need to begin planning now for the upcoming EU Medical Device Regulation changes, said Mike Kreuzer of the Association of British Healthcare Industries. Kreuzer said his organization fears that UK device makers are unaware of the scope of the new rules. Areas of concern for the association include rules for remanufacturing single-use devices, clinical evidence requirements, device reclassification, high-risk device scrutiny, unique device identifiers and hazardous substance rules. Clinica (subscription required) (8/24)
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Takeda's myeloma drug 1 step closer to EU acceptance
The European Medicines Agency has agreed to review the marketing application for Takeda's experimental multiple myeloma drug ixazomib. PharmaTimes (U.K.) (8/24)
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Asia Pacific
Marketing agreement brings Malaysian biosimilars to 5 Asian countries
Inno Bio Ventures of Malaysia entered into a marketing and distribution agreement with Aryogen Biopharma to supply locally manufactured biosimilar products to Vietnam, Laos, Cambodia, Myanmar and the Philippines. The products are Rituximab, Trastuzumab, Etanercept and Factor VII. BioSpectrum Asia (8/26)
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North America
FDA study finds drug ad corrections ineffective
Direct-to-consumer drug ads that correct misleading or omitted information shown in another ad do little to change viewers' perception about risks, an FDA study found. Modern Healthcare (tiered subscription model) (8/25)
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Health experts: Ease or cut restrictions on hepatitis C drugs for Medicaid patients
Experts from the Presidential Advisory Council on HIV/AIDS and the Public Health Service are asking Medicaid to eliminate or relax the restrictions on patient access to hepatitis C treatments because the rules can result in denying or delaying treatment for some Medicaid members. In a letter sent to President Barack Obama, council members called the restrictions "unreasonable and discriminatory." The council also asked the White House to require drugmakers to be transparent about costs associated with development and manufacturing of the treatments. The New York Times (free-article access for SmartBrief readers) (8/25)
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Big Data researchers develop clustering techniques for health studies
Rice University researchers have developed a data analysis system to help clinicians group patients for clinical studies. The tool creates populations, or clusters, of people with similar characteristics. The algorithm is being used by Texas Children's Hospital for a trial involving children with leukemia. Health Data Management (8/24)
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Global
Report predicts worldwide market growth for spine surgery devices
A MedMarket Diligence report examining the worldwide market for spine surgery devices from 2014 to 2021 predicts the segment will see double-digit growth in that period. The boom is attributed to scientific advances that allow every part of the spine to be stabilized, as well as economics, innovation and clinical trends, with spine fusion leading the market. The fastest growth in spine surgery has been seen in the Asia-Pacific and Central/Latin America regions. BeckersSpine.com (8/25)
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Sucampo Pharmaceuticals makes bid to acquire R-Tech Ueno
US-based Sucampo Pharmaceuticals has offered to buy Japan's R-Tech Ueno, a company that manufactures all of Sucampo's drugs. Sachiko Kuno and Ryuji Ueno, founders of Sucampo, already own a controlling stake in R-Tech Ueno. The deal is valued at about $276 million. Bloomberg (8/26)
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DIA News
Take a look inside the new Global Forum
The August issue of Global Forum embraces a more engaging and interactive platform providing even more in-depth and immersive content:
New editors. New content. New format.
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SmartQuote
Any organization, in order to survive and achieve success, must have a sound set of beliefs on which it premises all its policies and actions."
-- Thomas Watson Jr.,
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