Breaking News on Global Pharmaceutical Technology & Manufacturing

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Ashland opens Nanjing excipient plant citing growing local demand in light of new quality regulations

Ashland has opened a pharmaceutical excipients plant in Nanjing, China in a bid to capture growing local demand for modern formulation technologies.

Inovio's DNA vaccine trial on hold over delivery device shelf life concerns

The US FDA has placed a Phase III trial of Inovio’s candidate DNA cancer vaccine VGX-3100 on clinical hold over concerns about its delivery device.

Patheon contracted to make second drug by age-related diseases firm Biophytis

Patheon will make a candidate AMD treatment under a contract with French biotech Biophytis.

Everstone Capital buys stake in Rubicon Research citing delivery techs and ANDAs

Everstone Capital has acquired a 70% stake in drug delivery tech firm Rubicon Research Pvt for $33m (€30m).

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

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.

Lannett compiling evidence to block FDA efforts to pull generic Concerta ANDA

Lannett is confident it can prove the extended release tech in its Concerta generic is equivalent to the original after the US FDA said it will seek withdrawal of firms ANDA.

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

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. 

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

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

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