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Podcasts

Webcast: Accelerate the Development of Challenging Drug Candidates via Crystal Engineering
Sponsored by Catalent (On Demand)

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

Webcast: Overcoming Formulation Challenges of Parenteral Drugs
Sponsored by Croda (On Demand)

MORE WEBCASTS

Events

DCAT Week 2013
March 11–14, 2013
Washington, USA

Pittcon Conference & Expo
March 17–21, 2013
Philadelphia, USA

More events


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Optimizing Quality by Design in Bulk Powders & Solid Dosage
Live Webcast: Thursday March 21, 10:00 - 11:00 AM EST
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News

INTERPHEX 2013 Announces Conference Program
INTERPHEX 2013, to be held Apr. 23–25, 2013, at the Javits Center in New York, will highlight pharmaceutical regulation QA/QC, product development, facility, process design, manufacturing, packaging, and supply chain programs.
Click Here to Read More

Sanofi's Six-In-One Pediatric Vaccine Recommended for European Approval
EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi’s six-in-one pediatric vaccine for marketing authorization.
Click Here to Read More

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European Commission Authorizes First Therapy for Alcohol Dependence
The European Commission has granted H. Lundbeck A/S marketing authorization for Selincro (nalmefene) for the reduction of alcohol consumption in adult patients with alcohol dependence.
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Capsugel Acquires Encap Drug Delivery
Capsugel's acquisition of Encap Drug Delivery expands its lipid expertise and adds an FDA-inspected commercial manufacturing facility.
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Tablet manufacturing problems?
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Mylan Acquires Generic Injectables Unit From Strides Arcolab
Mylan announced that it has signed an agreement to acquire the generic injectables unit Agila Specialties from Strides Arcolab for $1.6 billion in cash.
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The Drop in Drug Spending
Sales of traditional drugs fell for the first time according to Express Scripts’ annual Drug Trend Report. The decline is being attributed to patent expirations, causing a greater use of generic drugs and increased competition. According to the report, the higher cost of specialty medications offset the overall decline. Express Scripts’ report anticipates these trends to continue.
Click Here to Read More


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Dow Pharmaceutical Sciences
Dermatologicals are unique. This NEW Dow 1-Day workshop will provide insightful answers to questions regarding formulation development or optimization, preclinical and clinical requirements, and regulatory strategies that are difficult to find.
Speakers include Dow's Founder, Gordon Dow, one of the world's preeminent topical formulators. Dr. Jeffrey Sugarman will provide unique insights into a dermatologist's perspective on the relationship between skin disease and topical product development. Read More

Company Notes
  • BioLamina and Roche have formed an R&D agreement to jointly develop new cell culture systems for various applications, including stem cell research.
  • DBV Technologies, a new standard in the treatment of allergies, announced today that it entered into a strategic manufacturing agreement with Sanofi to produce Viaskin’s API, such as peanut protein extract. Per the agreement, Sanofi will act as DBV’s CMO. In this context, Sanofi will scale-up and validate the production process of Viaskin’s API and full supply at commercial scale.
  • FDA expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.
  • Phenomenex has launched a redesigned website, featuring industry-specific gateways function as complete digital consultants, helping users find answers by providing customized content and newsletters along with product selection and method development tools.
  • Franz B. Humer, chairman of the board of directors of the Roche Group, announced at the company’s Mar. 5, 2013, annual general meeting that he will not stand for re-election to the Board in 2014. The company will nominate a successor for the chairmanship in autumn 2013.
  • Read More Industry Briefs

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Survey
What do you think is the main challenge facing manufacturers seeking to launch a new biosimilar?
 
Safety and interchangeability concerns 36%
 
 
Regulatory processes 28%
     
 
Legal challenges 9%
     
 
Complex manufacturing processes 27%

This week we would like to know...

How do you think the reputation of the pharmaceutical industry has changed in recent years?

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