Roche Acquires Seragon Pharmaceuticals; FDA Urged to Preserve Biosimilar Naming Conventions

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Analytical Challenges and Case Studies in Method Development for Fixed-Dose Combinations
Thursday, July 17, 2014 at 11:00 AM EDT
Sponsored by: Patheon

Optimizing Microbial Quality Control Testing
On Demand
Sponsored by: Rapid Micro Biosystems

Meeting Regulatory and Technical Requirements for Organic Impurity Analysis
On Demand
Sponsored by: SGS Life Science Services

More Webcasts

Facility Design, Innovation and Qualification
July 29-31, 2014
Philadelphia, PA

IVT's Annual Microbiology Week
August 5-7, 2014
Philadelphia, PA

MES 2014
August 14-15, 2014
Philadelphia, PA USA

Cleaning Validation and Critical Cleaning Processes
August 19-21, 2014
San Diego, CA USA

July 10, 2014

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Potential Benefits Drive Interest in Continuous Manufacturing
Players across the biologics value chain are attracted by the advantages of continuous biopharmaceutical manufacturing.

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Accuracy in the palm of your hand: HM70 Temp & RH Handheld
The HM70 Hand-Held is ideal for “sanity-checking” critical environments that fluctuate.

Temperature range: -70 to +180 °C, RH 0 to 100%
Optional probes for dewpoint and CO2
Optional sensor preheat and chemical purge

Optimizing the Sterilization of Liquids in Sealed Containers
An alternate sterilization process for liquids in containers—cycles controlled by differential pressure—maintains the pressure in the chamber at a level that prevents the rigid containers from exploding and the non-rigid containers from becoming deformed.

Determining Cross-Contamination Risks in Multiproduct Biopharmaceutical Facilities
A global contract manufacturer of biologics discusses the increasing impact of health-based exposure limits in assessing cross-contamination risks.

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The Risk and Compliance Paradigm: Risk Management's Impact on QMS
Risk Management is everywhere, and is not some lofty strategic element that is limited to top floor suits making enterprise-wide decisions. Risk Management is becoming an integral part of the compliance process. There are many ways to look at Risk, and each industry has developed different risk based tools to suit their specific business needs.
Get a glimpse at how compliance industries are utilizing risk as a core benchmarking metric for decision-making in the enterprise.Read more.

Roche to Acquire Seragon Pharmaceuticals
Genentech's $1.7 billion acquisition of Seargon Pharmaceutical includes portfolio of investigational next-generation oral selective estrogen receptor degraders.

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NATOLI Tablet Press Manufacturing and Refurbishing
Need a new R&D, medium to high-production tablet press? Contact “The Global Leader” in the tablet compression industry. NATOLI Engineering also refurbishes tablet press with results that often exceed the efficiency and functionality of the original.

Learn more about NATOLI’s renowned experience in building and refurbishing tablet presses. All NATOLI Tablet Presses are Made in the U.S.A.

FDA Urged to Preserve Biosimilar Naming Conventions
Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

Merck Collaborates with Bionomics on Alzheimer's Treatments
Merck funds Bionomics with $20 million to progress therapies for cognitive impairment caused by central nervous system disorders.

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Life Cycle Management Opportunities in Softgel Technologies
On Demand Webcast
To Register Free:

www.pharmtech.com/opportunities

EMD Serono and Mersana to Develop Next-Generation Antibody-Drug Conjugates
The collaboration will use Mersana Therapeutics Fleximer technology for antibody-drug conjugates.

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Lyophilization Cycle Design and Scale Up – Practical Methodologies for Developing Cycles
On Demand Webcast
To Register Free:

www.pharmtech.com/cycles

Hospira Acquires Orchid's API Manufacturing and R&D Facilities
Hospira acquires assets from Orchid Chemicals & Pharmaceuticals for $218 million.

Catalent Marks 40 Years in Japan with New Investments and Country Leader
Catalent appoints a new country leader and expands facilities.

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Using Engineered Particles in Capsules for Rapid-to-Clinic Dry Powder Inhalation Applications
On Demand Webcast
To Register Free:

www.pharmtech.com/drypowder

FDA Approves Drug for Non-Hodgkin Lymphoma
The FDA approved Beleodaq for the treatment of patients with peripheral T-cell lymphoma.

Biotage Launches Accelerated Chromatographic Isolation
Biotage has launched a purification technology, Accelerated Chromatographic Isolation (ACI), which converts simple flash purification into a faster and more economical way to isolate pure compounds.

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Analytical Challenges and Case Studies in Method Development for Fixed-Dose Combinations
Thursday, July 17, 2014 at 11:00 AM EDT
To Register Free:

www.pharmtech.com/method_development

Bioprocessing and Sterile Manufacturing
View technical articles on the development and manufacturing of parenteral and biologic drugs, including continuous manufacturing, monitoring, sterilization procedures, modular manufacturing, and more.

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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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