Top Stories
The deal to acquire Allergan's generic-drug business is valued at $40.5 billion.
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FDA approved the drug for a more narrow indication in the US than did EMA for Repatha, Praluent's fiercest competitor.
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Agilent CrossLab –From Insight to Outcome
Laboratories today face complex scientific and business challenges that require key insights into laboratory operations. Agilent CrossLab Enterprise Solutions provide these insights by leveraging laboratory operations data to help you dramatically improve scientific and business outcomes across your local, regional or global laboratory enterprise. Agilent CrossLab Enterprise Solutions -- focused on your organization’s goals.
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QUALITY METRICS
FDA's quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.
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The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.
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Industry News
EMA gives GSK's malaria candidate vaccine a positive opinion for the prevention of malaria in young children in sub-Saharan Africa.
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Manufacturers are producing new drugs and vaccines and clinical supplies faster and more efficiently through the development of standards and common practices for single-use technology systems.
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Supplier News
Investment at Capsugel's Edinburgh, Scotland facility will expand the company's liquid- and semi-solid-fill capsule manufacturing capacity.
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SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.
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Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins
Live Webinar: Thursday, July 30th 2015 at 8:00 am PDT | 11:00 am EDT
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
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Bio/Pharma News
MedImmune will provide funding and in-kind contributions to support University of Sheffield research projects to address key challenges in cell engineering.
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Biogen will take ownership of Eisai's Research Triangle Park manufacturing campus and will manufacture both oral solid-dose and parenteral drugs for Eisai.
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Regulatory News
FDA warns an Arkansas compounding company that it is in violation of the FDCA.
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The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.
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Webinar Aug. 12th: Using Raman Spectroscopy & LIBS for Automated Particle Identification
Gain insight into the value of using Raman/LIBS for automated particle identification as a fast and effective method for understanding the composition of foreign particles, in addition to learning about some of the most commonly found sources of foreign particulate and witness case study examples of automated particle identification.
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OUTSOURCING
While all market signs are pointing up, memories of past setbacks may discourage CDMOs from expanding capacity.
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VIEWPOINTS
The bio/pharma industry enjoys success, but it cannot ignore patient access to medications.
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Webcasts
On Demand
As global requirements for pharma supply chain safety become more stringent, pharmaceutical manufacturers need to be more proactive in monitoring supply chain partners to ensure security and quality. In this program, an expert shares best practices that will prevent liability and noncompliance, improve quality and boost supply chain efficiency.
Sponsored by: Spectrum Chemical Mfg. Corp.
On Demand
Weighing is one of the most common activities carried out in the laboratory. In most cases, weighing is the critical first step in the preparation of a substance or sample for further analysis or processing. If the weighing result is unreliable, it can have a profound effect on the quality of the final results. However, many factors that can influence the accuracy of a weighing are often overlooked. Learn how to improve the reliability of weighing and have more confidence in the weighing results generated.
Sponsored by: Mettler Toledo
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on pharmtech tv
Collaborative Success Strategies for Biopharma Companies
Addressing Drug Quality: Aging Facilities
The Human Element in Pharma Manufacturing
Working with CMOs and CDMOs
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Events
August 12–13, 2015 | Philadelphia, PA
August 18–20, 2015 | Philadelphia, PA
September 7–9, 2015 | Seoul, Korea
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REFERENCE BOOKS
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Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
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eBOOKS
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This eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms.
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