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Headlines > February 2012

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FDA sends warning letter to APP after insects found in vials

29-Feb-2012 - The US FDA has sent APP Pharmaceuticals a warning letter after insects were found in production areas and finished products.

Find alternative excipients for vegetarians, researchers urge

29-Feb-2012 - Researchers are calling for alternative excipients for vegetarians who are unwittingly consuming animal fats when physicians prescribe meds containing gelatin.

Lilly's new Ireland plant is prep for pipeline products

29-Feb-2012 - Eli Lilly says plans for a new €330m ($444m) manufacturing facility in Ireland are in preparation for the launch of a range of its pipeline molecules.

EXCLUSIVE

Create painless devices for quicker regulatory approval, says BD

28-Feb-2012 - Reduced-pain injection systems are the key to gaining regulatory approval for new products, according to BD.

EMA calls for companies to trace their heparin to slaughterhouses

28-Feb-2012 - Marketing applications for heparin should cover traceability from slaughterhouses and other details of sourcing porcine mucosa, the EMA said.

News in brief

Rousselot announces gelatine price increases

28-Feb-2012 - Ingredients manufacturer Rousselot has announced a price increase on its gelatine portfolio to balance out spiralling raw material costs.

Almost 30% of biopharma CEOs insourced work in ’11; survey

28-Feb-2012 - Almost 30 per cent of biopharma companies have insourced previously outsourced work in the past year, a PwC survey of CEOs found.

People on the move: jobs in pharma

27-Feb-2012 - in-PharmaTechnologist presents its weekly round-up of the latest appointments within the pharmaceutical industry, including news from Biomatters, Seattle Genetics, and Permeon.

Grindeks posts jump in API sales after expanding range by 50%

27-Feb-2012 - API sales at Latvia-based Grindeks jumped last year as it benefited from expanding its portfolio by 50 per cent.

News in brief

Glenmark recalling birth control pills after packaging error

27-Feb-2012 - Glenmark is recalling incorrectly packaged birth control pills from the US, less than one month after Pfizer took similar actions.

Sole suppliers must alert FDA to CMO production interruptions

27-Feb-2012 - Sole suppliers that outsource manufacture must alert the FDA of interruptions at their CMOs, the Agency wrote in draft drug shortages guidance.

FDA posts guidance on Phase I CMC for live biotherapeutics

27-Feb-2012 - The US FDA has published final guidance on the CMC data needed to support early phase trials of live biotherapeutics.

News in brief

FDA issues import alerts against 22 Chinese heparin suppliers

23-Feb-2012 - The US FDA has issued import alerts against 22 Chinese heparin suppliers it claims ship adulterated product.

IPEC wants feedback on proposed 2015 Chinese Pharmacopoeia revision – Today!

23-Feb-2012 - IPEC Americas has issued an urgent call for drug industry feedback on China Pharmacopoeia Committee plans to expand the number of excipients listed in the 2015 edition of the Chinese Pharmacopoeia.

Unilife launches Autoinfuser range publically

23-Feb-2012 - Unilife is expanding its large dose delivery platform in a bid to meet a “growing industry need” for at-home drug administration in bigger scale.

FDA guidance aims to stop drug shortages using supply alerts

23-Feb-2012 - The US FDA has published draft guidance on drug shortages to clarify when and how manufacturers should report possible supply disruptions.

Freeman sets up US subsidiary and plans to establish service lab

22-Feb-2012 - Freeman Technology says growing Pharma demand for analytical data prompted the formation of US subsidiary and it behind its plans for a new laboratory.

update

BASF hikes EOA prices again

22-Feb-2012 - BASF has increased its European prices for ethanolamines (EOA) for the third time in as many months.

EXCLUSIVE

Bespak hunting development deals for nasal spray tech

22-Feb-2012 - Bespak is on the hunt for more development contracts for its new nasal delivery platform.

FDA allows temporary import of Sun’s Doxil alt to ease shortage

22-Feb-2012 - The US FDA is allowing Sun Pharma to import a version of Doxil to ease the drug shortage created by manufacturing failings at Ben Venue.

GE Healthcare launches bioprocess training courses in Singapore

21-Feb-2012 - GE Healthcare has launched a new suite of bioprocess training courses in collaboration with a leading Singapore academic institution.

Exclusive interview

Aptar Pharma says new eDevices will speed up regulatory approval

21-Feb-2012 - Aptar Pharma says its new eDevices can help companies gain quicker regulatory approval for their nasal drug products without having to re-do clinical trials.

Abbott's extends in Sligo ready for its new API line

21-Feb-2012 - Abbott Laboratories will pump €85m ($113m) into the expansion of its API production plant in Sligo, Ireland, in preparation of the launch of its pipeline products.

News in brief

Pfizer and Mylan settle drug delivery patent case with Sanofi

21-Feb-2012 - Pfizer and Mylan have settled patent litigation with Sanofi over a pre-filled drug delivery device used to treat allergic reactions.

Job cuts a factor in calculating GMP compliance risk; PIC/S

21-Feb-2012 - Regulators should consider the impact of job cuts at manufacturing sites when drafting a risk-based GMP inspection plan, PIC/S said.

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