Top Stories
Colorcon acquired BASF's Kollicoat IR Coating System product line, including BASF's current customer business and inventory.
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In the largest-ever report of its kind, drugs entering clinical development in Phase I were found to have only a 1 in 10 chance of FDA approval.
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Lagarde will be based out of the company's Boston office and will lead Patheon's global corporate and cross-enterprise operations.
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Industry News
The AAPS Foundation presented five graduate students each with a $10,000 fellowship for their research in the pharmaceutical sciences.
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The United States Geological Survey study detected one or more pharmaceuticals in 59 streams throughout the Southeast United States.
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EXPERT INTERVIEW
Barry Holtz, president, iBio CMO sat down with Pharmaceutical Technology to discuss plant models in biopharmaceutical manufacturing.
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Supplier News
The company will offer a standard serialization solution across 14 locations in Europe and more than 70 product lines.
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W.R. Grace & Co. will sell its chromatography product lines, which includes chromatography instruments, columns, and other related products.
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Bio/Pharma News
Xellia, a generic anti-infective drug manufacturing company, is constructing a laboratory services building at its manufacturing site in Budapest, Hungary.
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Jazz will acquire Celator for approximately $1.5 billion.
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Regulatory News
FDA approved Probuphine, the first buprenorphine implant approved in the United States for the treatment of opioid dependence.
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FDA cited BBT Biotech GMBH for failing to comply with current good manufacturing practice in its German API manufacturing facility.
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VIEWPOINTS
Policies for patient access to life-saving therapies must keep pace with biomedical innovation.
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For the past 25 years, the PDA/FDA Joint Regulatory Conference has provided an exclusive forum in which to hear directly from FDA speakers regarding current Agency efforts that could potentially impact the development of global regulatory strategies. Take advantage of a level of direct exchange with the FDA not found at any other conference.
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QUALITY
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
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STANDARDS & REGULATIONS
In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.
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The ISPE Annual Meeting offers a wide range of industry- and career-advancing opportunities
Network and problem-solve with top pharmaceutical and biopharmaceutical professionals, learn about important industry topics, meet with suppliers, and share best practices with colleagues. This premier event is designed for everyone in the industry from young professionals to senior executives with: the latest trends; a broad spectrum of technical education and unmatched networking opportunities.
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Webcasts
On Demand
Your current contract laboratory and instrument provider may be familiar and comfortable, but, maintaining the status quo doesn't lead to greater rewards. In fact, it often involves putting up with less-than-desired results. Join us in this web seminar to hear how Ajinomoto Althea develops unsurpassed solutions for biopharma companies, and how a team at Thermo Fisher Scientific has challenged the status quo to deliver uncompromised UHPLC.
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Compliance is Key Solutions to Decrease the Likelihood of Receiving a Form 483
LIVE WEBCAST: Thursday, June 23, 2016 at 11:00 am EDT
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On Demand
In this live webinar, experts will showcase how to formulate a peroxide-sensitive drug using a binder that combines high binding strength with no peroxide formation at all.Sponsored by BASF
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Bio/Pharma in China
New Initiatives, New Opportunities
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Events
June 6-8, 2016
June 6-9, 2016
September 12-14, 2016
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REFERENCE BOOKS |
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A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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eBOOKS
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Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.
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