Manufacturing and Production

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IDT Biologika expands investment in German manufacturing capacity

March 28, 2011 Manufacturing and Production Germany, IDT Biologika, vaccines

IDT Biologika has said it plans to invest around 85 million euros in new production facilities and equipment in Germany …

Setback on road to recovery for Genzyme’s Allston facility

March 28, 2011 Manufacturing and Production Genzyme

Genzyme has been forced to discard one lot of its Fabry disease treatment Fabrazyme (agalsidase beta) manufactured at its troubled …

Pharma manufacturing news in brief

March 22, 2011 Manufacturing and Production American Regent, Berkshire Hathaway, Cytovance, Intercell, Solagran, West Pharmaceutical Services, morphosys, pharma contract manufacturing

Lubrizol bought for $9.7 billion by Berkshire Hathaway, plus the latest pharma manufacturing and quality news. Berkshire Hathaway, run by …

Dendreon wins green light for Provenge production

March 22, 2011 Manufacturing and Production Cancer, Dendreon, FDA, Provenge, pharma manufacturing, prostate cancer vaccine, sipuleucel-T

US oncology specialist Dendreon has been boosted by the approval of additional production capacity for its therapeutic prostate cancer vaccine …

Lonza wins two biomanufacturing contracts

March 22, 2011 Manufacturing and Production Athera Biotechnologies, ENB-0040, Enobia Pharma, Lonza, PC-mAb, asfotase alfa, contract manufacturing, pharma, pharmaceuticals

Lonza has been awarded two contracts for biological drug candidates in quick succession, including a new deal that will make …

FDA and EMA join forces on quality-by-design

March 22, 2011 Manufacturing and Production EMA, FDA, QbD, Quality by Design, pharmaceutical marketing applications

The FDA has teamed up with the EMA on a new pilot programme that will allow parallel evaluation of marketing …

Novartis gets FDA warning letter for Puerto Rico plant

March 21, 2011 Manufacturing and Production Ciba Vision, FDA manufacturing inspections, Novartis, SoftPerm contact lenses, manufacturing compliance, pharma manufacturing

A manufacturing facility operated by Novartis subsidiary Ciba Vision in Puerto Rico has been cited for manufacturing quality violations and …

New Regulatory & Pharmacovigilance training webinars available

March 15, 2011 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

Wainwright Associates have designed a multitude of courses on general and specific regulatory & pharmacovigilance topics including:• Analytical Validation• Appeals, Hearings and …

J&J charged with US manufacturing violations

March 15, 2011 Manufacturing and Production J&J, JJ, Johnson and Johnson, McNeil Consumer Healthcare, McNeil Fort Washington, McNeil recall, Motrin recall, manufacturing compliance, pharma manufacturing, recalls

Johnson & Johnson subsidiary McNeil Consumer Healthcare has been officially charged with manufacturing and distributing drugs in violation of federal …

Daiichi recalls contaminated paediatric vaccines

March 15, 2011 Manufacturing and Production ActHIB, Daiichi Sankyo, manufacturing compliance, padiatric vaccine recall, recalls, vaccines

Japanese drugmaker Daiichi Sankyo has recalled around 1.3 million doses of the paediatric vaccine ActHIB, manufactured by Sanofi-Aventis, because of …

Bayer-helmed oncology biomarker project launched

March 14, 2011 Manufacturing and Production, Research and Development AstraZeneca, Bayer, Janssen, Max Planck Institute, Merck, OncoTrack, Pfizer, Roche, biomarkers, oncology

A project to develop the next generation of oncology biomarkers has been launched in Berlin. The pharma industry and European …

Pfizer sells Irish manufacturing facility to Amgen

March 14, 2011 Manufacturing and Production Amgen, Dun Laoghaire, Ireland, Pfizer, pharma manufacturing, pharma manufacturing in Ireland

Amgen has come to the rescue of 280 workers whose jobs were threatened by the closure of a manufacturing facility …

Eisai confirms 20% cut in US workforce

March 8, 2011 Manufacturing and Production, Research and Development, Sales and Marketing Aricept, Eisai, Halaven, US, donepezil, eribulin, pharma job cuts

Eisai’s planned job cuts will fall heaviest on its US operations, where 20% of the workforce will be let go …
Merck & Co workers protest job cuts

Merck says sale of Oss facility would be too expensive

March 8, 2011 Manufacturing and Production, Research and Development Holland, Merck & Co, Oss, Oss pharma research, Pantarhei Bioscience

The debate around the closure of Merck & Co’s R&D and manufacturing unit in Oss, the Netherlands, rumbles on, with …
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