Manufacturing and Production

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EMA picture

EMA and FDA move closer on inspections

December 12, 2011 Manufacturing and Production EMA, FDA

The EMA and US FDA has taken a step closer to mutual recognition of manufacturing site inspections, launching a three-year …

SHL receives great response at the 2011 PDA in Basel

December 12, 2011 Manufacturing and Production autoinjector, pda, pen injector, prefilled syringe, shl group

SHL successfully wrapped up this year’s exhibition at the PDA’s ” The Universe of Pre-filled Syringes and Injection Devices” 2011 …

Dechra Pharmaceuticals PLC FDA Approval for manufacturing at Dales Pharmaceuticals

December 9, 2011 Manufacturing and Production, Research and Development FDA Approval

Dechra® Pharmaceuticals PLCFDA APPROVAL FOR MANUFACTURING AT DALES® PHARMACEUTICALS  Dales Pharmaceuticals (‘Dales’ or the ‘Company’), based in Skipton, North Yorkshire, UK, …
Novartis' facility in North Carolina

Novartis warned over standards at generics sites

December 9, 2011 Manufacturing and Production CGMP Failures, FDA compliance, Novartis, Sandoz

The FDA has warned Novartis that three North American production facilities operated by its generics subsidiary Sandoz are failing to …

Dr Rajeev Venkayya to head Takeda’s new vaccine business

December 9, 2011 Business Services, Manufacturing and Production, Research and Development, Sales and Marketing Takeda

Takeda will establish a new vaccine business division in January next year and will appoint Dr Rajeev Venkayya as its …

Deepak Khanna becomes new ABPI president-elect

December 8, 2011 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing ABPI, Deepak Khanna

Deepak Khanna, senior vice president and UK managing director of Merck, Sharp and Dohme has been named as president-elect of …

Biogen and Samsung invest $300m on joint biosimilars venture

December 8, 2011 Manufacturing and Production Biogen, Samsung, biosimilars

Biogen Idec and Samsung will invest $300 million in a joint venture to develop biosimilars. Both firms will contribute a …

New EU Cosmetics Regulation

December 7, 2011 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

The European Cosmetics Directive has been recast and the new legislation takes the form of Regulation 1223/2009.  As a Regulation, …
Lonza picture

Lonza to make Elan’s Alzheimer’s candidate

December 7, 2011 Manufacturing and Production Abbott, Elan, Lonza

Elan has awarded a manufacturing contract to Lonza to supply the active pharmaceutical ingredient (API) for its small-molecule candidate Alzheimer’s …

Contract research news in brief

December 7, 2011 Manufacturing and Production Almac, GVK Biosciences and PreClinOmics/AIT, PPD, Quintiles

Our round-up of news from the contract research sector includes PPD’s sales to a private equity consortium, new clinical supply …

Catalent Announces plans to increase Biologic Development and Manufacturing Capabilities

December 7, 2011 Manufacturing and Production

SOMERSET, NJ, December 7, 2011 — Catalent Pharma Solutions, a leading provider of drug and biologic development services, delivery technologies …

Health Protection Agency welcomes the Approval of ERWINAZE™ Biologics License Application for Treatment of Acute Lymphoblastic Leukemia

December 7, 2011 Manufacturing and Production

Salisbury, UK – 18th November 2011 –the Health Protection Agency (HPA) today welcomed the news that the U.S. Food and …

GlaxoSmithKline moves closer to green power goals

December 6, 2011 Manufacturing and Production GSK, manufacturing

GlaxoSmithKline took a step closer to becoming a generator of electricity in a bid to offset the high energy demands …

Pharma manufacturing news in brief

December 6, 2011 Manufacturing and Production GSK, Hospira, PharmaS, UPS, Uquifa, Vivimed

India’s Vivimed buys Spanish API maker, Hospira tries to spend its way out of manufacturing woes, plus updates from PharmaS, …

SciGen sells Israeli vaccines plant to FDS

December 6, 2011 Manufacturing and Production FDS, SciGen

UK drugmaker FDS Pharma has bought a manufacturing facility in Israel operated by Singapore biopharmaceutical concern SciGen. FDS Pharma has …
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