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Senate Committee OK’s extra $40m to FDA but refuses Obama’s $146m plan

The Senate Committee on Appropriations has approved $2.6bn in funding to the US FDA for FY2016.

The Senate Committee on Appropriations approved a modest increase to FDA funding

'Rough notes' and backdated signatures land Indian API maker US FDA warning

Issues with batch production records at an Indian facility have landed API maker Mahendra Chemicals with a US FDA warning letter.

FDA offers draft guidance on quality metrics used to assess drug manufacturing

New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that they use to make drugs and biologics.

Hikma buys B-I generics subsidiary, strengthens position in US market

Hikma says its $2.65bn acquisition of Roxane Laboratories will make it the sixth largest firm in the US generics space.

US FDA finalises analytical procedures and methods validation guidance

Pharma firms may need to carry-out an analytical method comparability study as part of the life cycle management of a drug, according to final US FDA guidelines.


Senior changes at Sanofi-Merck JV, Novo Nordisk, ABPI, and MedImmune

New faces in pharma in our weekly column.

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