Top Stories
The latest revisions to the international pharmacopoeia standards for glass pharmaceutical packaging have emphasized the importance of assessing delamination propensity.
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AstraZeneca will add ZS Pharma’s leading ion-channel candidate to its pipeline.
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Industry News
Even though rising production and use of generic pharmaceuticals is saving billions for the nation’s healthcare system, policy makers continue to slap the industry with policies it claims will limit product development and sales.
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Biotech boom, niche markets, smaller batch sizes and high potency manufacturing are among the key trends shaping the pharmaceutical industry of the 21st century.
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Supplier News
Under the terms of the agreement, Daewoong will annually purchase minimum API quantities of erdosteine of approximately EUR 25 million from Edmond Pharma, a Recipharm Group company.
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BASF’s new multi-product amines plant in Ludwigshafen, Germany meets growing demand for amines in various applications, including pharmaceuticals.
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Bio/Pharma News
South Africa’s Biovac Institute launched a public-private partnership with Pfizer to enable local manufacturing of Prevenar 13, a vaccine against pneumonia-causing bacteria.
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At least 70 patents for Humira will protect the legacy product from biosimilar competitors, according to information presented during the company’s third-quarter earnings call.
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Regulatory News
The European agency presents guidelines for conducting post-authorization efficacy studies.
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The Life Sciences Guidebook
In a market where high-demand causes organizations to seek software systems that will fit into their complex business infrastructure, the pressure to find the right system often causes angst to many. Learn some key elements to spotting a good FDA Compliance solution, techniques for achieving GMP Compliance, and how to ensure that Quality and Compliance are met in the Life Science industry.
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FORMULATION
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The global supply chain for bovine and porcine heparin and regulatory considerations are examined.
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Equipment Showcase
The NP-400 is an economical, heavy-duty, medium output rotary tablet press designed, engineered and manufactured in the United States. Capable of running 24/7, the NP-400 can produce up to 180,000 tablets per hour. This single footprint press continuously monitors tablet pre-compression, main compression forces and tablet ejection force. Tablet take off force, press temperature and humidity monitoring are also available.
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Webcasts
On Demand
Risk Management Plans have become a cornerstone in the pharmacovigilance of new drugs. It was introduced to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. In this webinar, EtQ and HighPoint Solutions will cover the regulations around the European Medicines Agency’s Risk Management Plan and also the FDA's Risk Evaluation and Mitigation Strategy.
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LIVE WEBCAST: Wednesday, January 20, 2016 at 11:00am EST
Understanding all aspects of the product transfer process is critical to a successful transfer and delivery of a quality product. During this one-hour webinar, regulatory and pharma experts will discuss the critical elements and processes needed for an effective, compliant product transfer process and successful end results.
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On Demand
Ion exchange resins have long been in the formulator’s toolkit, but only recently have they been used as excipients. Learn the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more.
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Addressing Pharma Industry Issues
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Addressing Drug Quality: Aging Facilities
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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 features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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