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EAG Laboratories adds to environmental testing capabilities

(Image: iStock/pattonmania)

25-Oct-2016 - EAG Laboratories has added 33,000-square-feet to its Easton, Maryland facility, with space for dedicated laboratories and equipment to support GLP-compliant ecotoxicology, environmental fate, metabolism, and other testing services.

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Aduro told to halt cancer vaccine trial enrollment after listeria found in patient sample

25-Oct-2016 - The US FDA has told Aduro Biotech not to enrol subjects in trials of its listeria-based immunotherapies after one study subject tested positive for the bacteria.

Biotrial says Le Figaro coverage of BIA 10-2474 trial is "smear campaign"

24-Oct-2016 - Biotrial has accused French newspaper Le Figaro of leading a “smear campaign” through its coverage of the Phase I trial in which one man died and five others were hospitalised in January. 

Laxachem Organics ban not linked to B. cepacia outbreak says US FDA

24-Oct-2016 - APIs made by Laxachem Organics pvt ltd were not the source of bacteria in Pharmatech laxatives linked to a spate of Burkholderia cepacia infections according to the US FDA.

Teva's troubled Godollo plant earns firm US FDA warning letter

20-Oct-2016 - The US FDA has warned Teva Pharmaceutical Industries about its facility in Godollo, Hungary over ongoing concerns about manufacturing operations.

Second Form 483 for Montana Compounding Pharmacy in two years

19-Oct-2016 - US FDA inspectors found vermin in drug production areas at a manufacturing facility operated by Montana Compounding Pharmacy.

US FDA publishes Akorn Pharmaceuticals' Form 483

19-Oct-2016 - The US FDA has identified quality control problems at a sterile drug manufacturing facility operated by Akorn Pharmaceuticals.

Regeneron and Teva to bar OA patients from fasinumab trials after US study halt

18-Oct-2016 - Advanced osteoarthritis patients will be barred from taking part in fasinumab trials after a sufferer enrolled in a Phase IIb study developed joint disease.

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