AstraZeneca to collaborate with Allergan on combination antibiotic | German firm develops rapid Dx test for Zika virus | Merck partners with Cancer Research Technology on drug development
February 2, 2016
DIA Global SmartBrief
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AstraZeneca to collaborate with Allergan on combination antibiotic
AstraZeneca will work with Allergan on the development and marketing of a fixed-dose antibiotic compound for use against metallo-beta-lactamase-producing Gram-negative bacterial infections. Under the terms of the deal, AstraZeneca will have marketing rights to the compound, which combines aztreonam and avibactam, in all countries except the US and Canada. Financial terms of the deal were not disclosed. Genetic Engineering & Biotechnology News (1/29), Seeking Alpha (free registration) (1/29)
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German firm develops rapid Dx test for Zika virus
A rapid Zika virus diagnostic assay has been developed by German biotechnology firm Genekam. Researchers said the assay, which can also measure the amount of Zika pathogens in the blood, can only be used in specialized health facilities and laboratories. The test has already been deployed in Brazil for immediate use. (Venezuela) (1/31)
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Merck partners with Cancer Research Technology on drug development
Merck will work with Cancer Research Technology on the development of drugs that inhibit protein arginine methyltransferase 5 for use against cancer and blood disorders. Under the terms of the agreement, Merck will get the development and marketing rights to drugs arising from the collaboration and will give CRT a $15 million upfront payment and as much as $500 million in milestone fees plus sales royalties. PharmaTimes (U.K.) (1/28)
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Biogen building $1.4B facility in Switzerland
Massachusetts-based Biogen is building a $1.4 billion manufacturing facility in Luterbach, Switzerland, that will employ about 400 and triple the company's biologics capacity. Biogen previously announced that it will spend $2.5 billion on Alzheimer's research and development. (1/30)
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Asia Pacific
Wockhardt gets FDA warning over data integrity problems
The FDA said in a January report that India-based pharmaceutical firm Wockhardt removed information from machines and didn't record the outcomes of 22 failed tests. According to the report, a batch of an unapproved Wockhardt treatment was placed in an "approved material" area, and some drugs didn't have expiration dates on their labels. The company is not allowed to ship drugs from its Shendra plant to the US until it has put plans in place to address the data integrity issues and has assured the FDA that the problems are solved. Wockhardt is among several other Indian companies that have been questioned by the FDA in recent months over data integrity issues. Reuters (1/28)
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IPCA Laboratories gets FDA warning for manufacturing violations
A warning letter has been issued by the FDA to IPCA Laboratories over quality violations found at its drug-ingredients plant and finished-drug facilities in India. The company is not allowed to ship drugs from the plants to the US until it has resolved the problems. IPCA is working to fix the issues and is keeping the FDA informed about the steps it is taking. Reuters (2/1)
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$28M in funding secured by Adagene
Chinese drug developer Adagene raised $28 million to support its work in mono-specific and bi-specific antibody therapeutics. BioSpectrum Asia (2/1)
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North America
Congress looks for ways to improve medtech monitoring
U.S. Capitol In Washington
(Stefan Zaklin/Getty Images)
Sen. Patty Murray, D-Wash., is calling for a new monitoring system for medical devices that would draw on insurance claims information and resemble how prescription drugs are tracked. Murray's is the latest effort in Congress to reform the FDA's surveillance system for medical devices after a superbug outbreak last year was traced to tainted medical scopes. "The FDA has extensive postmarket authorities -- including requirements for quality systems, adverse-event reporting, mandatory recalls, corrections and removals -- to help ensure the safety and effectiveness of medical technologies once they are on the market," according to JC Scott, AdvaMed's senior executive vice president of government affairs. The Washington Post (tiered subscription model) (1/31)
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WHO: Zika virus a global health emergency
Close-up of mosquitoes
(FEMA/Getty Images)
The World Health Organization has designated the mosquito-borne Zika virus a global public health emergency. An international coordinated response is necessary to curb the spread of the virus and find a vaccine, said WHO Director-General Margaret Chan, who added that travel restrictions weren't needed. Reuters (2/1)
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DIA News
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