Roche seeks to block approval of Avastin biosimilar in India | Parkinson's treatment introduced in UK | French investigators fault study's response to adverse events
May 24, 2016
DIA Global SmartBrief
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Roche seeks to block approval of Avastin biosimilar in India
Roche argued at the Delhi High Court that approving a biosimilar version of its cancer drug Avastin, or bevacizumab, from Hetero Drugs would be a misuse of proprietary data and could harm the company's reputation. Roche is challenging the recommendation process used by a panel of the Drugs Controller General of India.
The Economic Times (India) (5/21) 
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10 Questions to ask before choosing a cloud-based ERP solution
How do you know if a cloud-based solution suits your business? And more importantly, how do you find the right match? This whitepaper features 10 important questions you should ask to identify the best cloud-based ERP for your company. Click here to read the white paper.
Parkinson's treatment introduced in UK
Zambon and Newron Pharmaceuticals launched Parkinson's treatment Xadago, or safinamide, in the UK. European regulators approved the drug more than a year ago, and it is already available in Germany, Switzerland, Spain, Italy, Belgium, Denmark and Sweden.
PharmaTimes (U.K.) (5/23) 
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French investigators fault study's response to adverse events
A report by French investigators found flaws in Biotrial's implementation of a Phase I trial in which one participant died and another five were admitted to hospitals. Biotrial and Portuguese drugmaker Bial did not inform regulators promptly when a subject was hospitalized and did not conduct enhanced patient monitoring when study was ended, according to the report. (5/25) 
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Asia Pacific
IMA warns against using APIs from Indian drugmaker
The Italian Medicines Agency has expressed concerns about active pharmaceutical ingredients made by Indian drugmaker Krebs Biochemicals, saying the manufacturing facility deviated from good manufacturing practices in 24 instances and that APIs made there pose a "critical risk" to public health. The IMA recommended retesting all imported batches and prohibiting supplies unless there is a shortage risk and no alternative suppliers. (5/23) 
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North America
Novo Nordisk's trials on diabetes drug questioned by FDA
An FDA preliminary review released ahead of a May 24 advisory committee meeting expressed doubts about the study findings and practical use of Novo Nordisk's diabetes drug IDegLira, or insulin degludec liraglutide. According to the reviewers, the clinical trials had limitations that made the interpretation of results difficult.
Reuters (5/20),  BioCentury (5/20) 
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First US procedure using meniscus implant recorded by Active Implants
A patient at Salt Lake Regional Medical Center in Utah was the first in the US to undergo meniscus replacement using Active Implants' NUsurface Meniscus Implant. The procedure was performed as part of a trial evaluating the effectiveness and safety of the implant in treating deteriorating meniscus cartilage. (5/20) 
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J&J robot-assisted surgery unit to move into product design
Johnson & Johnson officials told investors last week that the company's robot-assisted surgery unit, Verb Surgical, will likely transition from concept development to product design before the year closes. Verb's device is meant to facilitate surgical procedures that can reach inaccessible areas of a patient's body, said Michael del Prado, chairman of Johnson & Johnson subsidiary Ethicon. (Boston) (5/20) 
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New guidelines recommend Novartis' heart failure drug
Novartis' Entresto, or sacubitril/valsartan, received a Class I recommendation for treatment of heart failure in newly issued guidelines from the American College of Cardiology, the American Heart Association and the European Society of Cardiology. According to the guidelines, patients who can tolerate standard treatments and have sufficient blood pressure should be given Entresto instead of ACE inhibitors and angiotensin II receptor blockers.
Reuters (5/21),  RTT News (5/21) 
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Avalon, GSK establish cancer immunotherapy firm
PDI Therapeutics, a cancer immunotherapy developer, has been established by Avalon Ventures under an expanded build-to-buy collaboration with GlaxoSmithKline. PDI is entitled to receive Series A financing from Avalon and research and development support from GSK valued at a total of $10 million. The company is the eighth firm launched through Avalon's and GSK's alliance.
BioCentury (5/20) 
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