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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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More than 900 Biologics in Development
America's biopharmaceutical companies are using biological processes to develop 907 medicines and vaccines targeting more than 100 diseases, according to a new report.
Roche and BioLamina Collaborate on Novel Cell Culture Systems
Roche and BioLamina have entered into a research and development agreement to jointly develop new cell culture systems for various applications, including stem cell research. The collaboration will assess laminin-based in vitro cell culture matrices that can offer physiological microenvironments for living cells.

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Life Sciences Guidebook: Best Practices for FDA Compliance Solutions
This guidebook provides you with a basic overview for selecting, implementing and using FDA Compliance and Quality Management solutions. Learn the importance of QMS, best practices for FDA Compliance and Quality systems, and tips and tricks for finding the solution best suited for your company.
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European Patent Filings Up, But Pharma Stays Flat
While the number of patent filings at the European Patent Office in 2012 increased by 5.2% over 2011, pharmaceutical-based patents remained flat, and biotechnology patents dropped slightly.
First Biologic Approved in the EU for Gouty Arthritis
Ilaris (canakinumab), a selective, fully human, monoclonal antibody that inhibits interleukin-1 beta (IL-1 beta), has been approved in the EU for symptomatic pain relief in patients suffering from gouty arthritis whose condition cannot be managed with current treatments.

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Tablet manufacturing problems?
By partnering with Long Island University, Natoli Engineering has developed the Natoli Engineering Institute for Industrial Pharmacy Development and Research. Our mission is to provide customers with unique product solutions to their specific issues based on a combination of science and experience. Learn More! |
Daiichi Sankyo Condemns Falsely-Represented Product
Product sold online in Malaysia and Indonesia infringes on the company's trademark.

AstraZeneca's Crestor Patents Ruled Invalid in Australia
AstraZeneca's three patents protecting Crestor (rosuvastatin) have been ruled invalid by the Federal Court of Australia.
Sequestration: How Big a Hit for FDA, Research, and Pharma? (PharmTech Talk blog)
The greatly feared federal budget sequestration mandate went into effect Mar. 1, 2013, and, initially, the impact was fairly muted. The stock market soared, employment rose and government workers continued on their jobs. Federal agencies, including FDA, launched initiatives to comply with the mandated 5% across-the-board cut in spending (in reality a 9% cut that exceeds $200 million) to minimize the impact on basic operations. That means curbs on training and staff travel, no new hires and a delay in launching new programs.
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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 |
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- Ajinomoto has agreed to acquire the CDMO Althea Technologies for approximately $175 million.
- Catalent Pharma Solutions has announced two joint ventures in China for its Softgel Technologies and Clinical Supply Solutions businesses.
- Galapagos and Roche have agreed to end their alliance in fibrosis.
- 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.
- The Parenteral Drug Association (PDA) announced that three high-level regulators from the US and Europe will speak at the 2013 PDA/FDA Process Validation Workshop, May 20–21, 2013, at the Hyatt Regency in Bethesda, Maryland.
- Read More
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Trends in safe handling of potent compounds in pharmaceutical manufacturing processes
Live Webcast: Wednesday, May 15, 2013 at 11:00 AM EDT. Register Free at www.pharmtech.com/trends |
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A Quality by Design Approach for Stability Testing
Live Webcast: Tuesday, March 26, 2013 from 2:00–3:00 pm EST. Register Free at www.pharmtech.com/stabilitytesting |
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What do you think is the main challenge facing manufacturers seeking to launch a new biosimilar? |
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Safety and interchangeability concerns |
36% |
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Regulatory processes |
28% |
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Legal challenges |
9% |
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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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