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Top Headlines

'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.

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

FDA offers draft guidance on quality metrics used to assess drug manufacturing

New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that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

EMD Millipore and celares team to offer PEGylation to biologic makers

Attaching PEG-chains to biological molecules can increase bioavailability and speed up development of protein-based therapies and biosimilars, says EMD Millipore which has inked a deal with PEGylation firm celares.

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.

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.

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