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20 May 2014

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Featured Topics

Quality-Technical Agreements Siegfried Schmitt, principal consultant at PAREXEL, discusses the importance of quality-technical agreements. More...

EU Steps Up Inspection Efforts The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures. More...

Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process Considerations USP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs. More...

Top Stories
FDA and EMA Join Forces on Treatment of Gaucher Disease in Children FDA and EMA release a draft joint proposal on the development of new drugs to treat Gaucher disease in children. More...

EMA Opens Registration for European Network of Paediatric Research Workshop EMA opens registration for it's sixth annual workshop on pediatric drug research and development. More...

Boehringer Ingelheim to Make Clinical Trial Data Available Boehringer Ingelheim announced that it is working on a program to make clinical trial data and other related documents more widely accessible for approved products and drug-development programs that have been terminated. More...

EMA and European Chemicals Agency Strengthen Collaboration EMA and ECHA sign agreement to share information and work together on risk assessments. More...

FDA Releases Draft Guidance on Biosimilarity Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics. More...

FDA Releases Q&A on ANDAs and Stability Testing FDA clarifies stability data recommendations for abbreviated new drug applications. More...

Industry News

Novasep Commissions Plant Extension for Highly Potent APIs New manufacturing capacity at the Le Mans, France facility is being used to scale up antibody drug conjugates. More...

Merck Sells Ophthalmology Business in Japan to Santen Pharmaceutical Santen will purchase Merck's ophthalmology products business in Japan and key markets in Europe and Asia Pacific. More...

Eurofins to Acquire ViraCor-IBT Laboratories Eurofins Scientific will acquire ViraCor-IBT Laboratories for $255 million. More...

KBI Biopharma Acquires Merck's Biologics Operations KBI Biopharma acquires Merck's microbial process development and manufacturing operations in Colorado. More...

Shire Acquires Lumena Pharmaceuticals Shire expands rare disease portfolio with acquisition of Lumena Pharmaceuticals. More...

Webcasts
Life Cycle Management Opportunities In Softgel Technologies: Regulatory and Technological Aspects Wednesday, May 21, 2014 at 11:00 AM EDT Sponsored by: Patheon

Effective Viral Contamination Testing Programs for Biologics Product Manufacturing Tuesday, May 27, 2014 at 11:00 AM CET Sponsored by: SGS Life Science Services

Delivering Biologics with a Difference Thursday June 5, 2014 at 11:00 AM EDT Sponsored by: Baxter Biopharma Solutions

More Webcasts

Product Profiles

LB Bohle

With the Bohle Uni Cone BUC ^® process, L.B. Bohle can protect a new development method for precise coating of particles as a utility model right now. Read more

Shimadzu

Nexera X2 – X-ceptional insights
Ultra-high sensitivity, expanded flexibility, increased stability and robustness - the Nexera X2 UHPLC system targets routine analysis and applications in highly regulated environments demanding complex system setups. Read more

What impact do mega-mergers of biopharmaceutical companies have on the development of new drugs?

Reference Library

Pharmaceutical Technology Outsourcing Guide
Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations. ... Click here

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