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update - comment from Unite

GSK says UK manufacturing cuts not Brexit related

GSK has announced a shakeup of its UK network, shelving plans for Ulverston biopharma plant, mooting the sale of its cephalosporin antibiotics business and pledging to invest in HIV and respiratory drug capacity.

The serialisation stragglers: industry concern for complacency

The US Food and Drug Administration’s (FDA) decision to delay serialisation regulations shows drug companies and contract manufacturers are still unprepared, say industry representatives.

WHO prequalifies Mylan's India unit to supply TB drug API

The WHO has prequalified Indian-based Mylan Laboratories Ltd to supply the tuberculosis drug ingredient protionamide.

Update - comments from EMA and EFPIA

EU to probe if drug firms' pre-submission meetings sway EMA approval decisions

Drug firms’ pre-submission meetings with the EMA may influence agency approval decisions according to European Ombudsman Emily O' Reilly who has launched an investigation 

US FDA reaffirms hold on oral Proellex trials prompting Repros rethink

The US FDA has told Repros Therapeutics Inc. a new trial is needed to prove oral Proellex is safe, prompting the firm to consider refocusing on a vaginally-delivered formulation of the endometriosis candidate.

US FDA warns opthalmic supplier Tubilux about Italian plant

The US FDA has called on Tubilux Pharma SPA to identify potential contamination sources at its eye medicine production plant in Italy in a warning letter this week.

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