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Podcasts

Webcast:Improving Cell Culture Productivity: Best Practices for Automation and Control
Sponsored by Parker Hannifan

Webcast: Overcoming Formulation Challenges of Parenteral Drugs
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Webcast: Accelerate the Development of Challenging Drug Candidates via Crystal Engineering
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Events

Global Clinical Sourcing and Supply Summit
March 4–5, 2013
Philadelphia, USA

8th Biosimilars Summit
February 5–6, 2013
Washington, USA

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News

Ben Venue Laboratories Enters Consent Decree
Ben Venue Laboratories has entered into a consent decree with FDA over violations of cGMP.
Click Here to Read More

GSK Announces Joint Venture for Pediatric Vaccine
GlaxoSmithKline has formed a joint venture with Indian vaccines company Biological E to research and develop a six-in-one combination pediatric vaccine to help protect children in India and other developing countries from certain infectious diseases.
Click Here to Read More

Actavis Unveils Long-Term Growth Strategy
Actavis unveiled its long-term growth strategy this week and officially re-introduced itself under the Actavis name following the EUR 4.25-billion ($5.4 billion) acquisition of the Actavis Group by Watson Pharmaceuticals in 2012.
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AstraZeneca and Ceram Sign R&D Agreement
AstraZeneca and Ceram Research, a materials development company based in the UK, have signed an agreement whereby Ceram will develop its inorganic-based controlled release technology in a feasibility study for delivering select AstraZeneca compounds.
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Allergan to Acquire MAP Pharmaceuticals
Allergan and MAP Pharmaceuticals have entered into a definite merger agreement under which Allergan will purchase all of MAP’s outstanding shares for the price of $25.00 per share.
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UN pact Scuttles Anti-Vaccine Provision
A new international agreement to reduce mercury contamination of air and water was recently adopted by 140 countries, without a proposal that threatened to limit access to vaccines in much of the world.
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EMA and FDA on Process Validation
Siegfried Schmitt, a principal consultant with PAREXEL, discusses the EMA's guideline on process validation and how it compares with FDA's process validaton guidance.
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Regulatory Roundup
  • ISPE has updated its ISPE GAMP guidance on testing of GXP systems to help companies efficiently test computerized and software-based systems.
  • EMA has published guidance on preparing and reviewing product characteristic summaries.
  • The United States Pharmacopeial Convention (USP) has posted a revision bulletin on <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures.
  • FDA has announced its Vaccines and Related Biological Products Advisory Committee Meeting will be held on Feb. 27, 2013.
  • Read More Regulatory Roundups

IndustryBriefs
  • AAIPharma has expanded its laboratory service offerings, capabilities, and instrumentation at its laboratory technology center in Wilmington, North Carolina.
  • Baxter International has agreed to acquire the investigational hemophilia compound OBI-1 from Inspiration BioPharmaceuticals.
  • Idenix Pharmaceuticals has formed a nonexclusive collaboration with Janssen Pharmaceuticals for the clinical development of all-oral, direct-acting, antiviral Hepatitis C combination therapies.
  • Read More Industry Briefs.
 
Survey
What area do you think will see increased regulatory attention and enforcement in 2013?
 
Foreign APIs 32%
 
 
GMP inspections 19%
     
 
Manufacturing processes 13%
     
 
Counterfeit medicines 28%
     
 
Social media and digital marketing 8%

This week we would like to know...

Which of the following has had the most significant advances in PAT over the last 5 years?

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