Top Stories
The number of novel drugs approved in 2016 by FDA's CDER department was half the number approved the previous year; many of the complete response letters issued in 2016 were a result of preapproval inspection.
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J&J's Innovation Global announced the company has entered into 15 new collaborations.
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PODCAST
B&W Tek's director of Market and Customer Development, Katherine A. Bakeev, PhD, discusses analysis of pharmaceutical raw materials and the benefits of using handheld Raman spectrometers.
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The 2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conference, Feb. 21-22, presents the first opportunity to address the FDA's revised draft guidance on quality metrics. Through plenary sessions and panel discussions, industry and regulatory experts will explore what has changed in the FDA's newest guidance, the benefits to industry and patients, and potential challenges to implementation across various segments of the pharmaceutical industry.
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Industry News
A study of 53 cancer drugs found that new treatments extended patient life an average of 3.43 months when compared with treatments available in 2003.
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According to a Deloitte report, the industry's return on its research investment has been steadily slipping for the past six years. The conclusion? Fundamental change may no longer be a given, but a necessity for the industry.
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Supplier News
Catalent announces a development agreement with JOT to evaluate softgel options for a resveratrol drug candidate.
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GEA's ConsiGma continuous tableting line combined with Siemens' automation and Sipat data management systems enables continuous manufacturing.
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See machinery in action. Discover packaging innovations. Learn about breakthroughs and best practices. For pharma and medical device manufacturing professionals, PACK EXPO East and the Healthcare Packaging and Processing Conference have it all! Head to Philadelphia next month for solutions from 400+ exhibitors—including 200+ pharma industry suppliers—and get answers to critical issues from 30 education sessions.  Register today at packexpoeast.com |
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Bio/Pharma News
Takeda will acquire ARIAD Pharmaceuticals for approximately $5.2 billion.
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A judge ruled that Regeneron's mAb be removed from the market after Amgen alleged that the marketing of Praluent hurt its reputation as innovator of this class of drugs.
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Regulatory News
The European Pharmacopoeia Commission adopted a chapter on chemical imaging for analytical development, quality control, and manufacturing.
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The company was cited by FDA for violations of sterile processing GMPs.
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PARTICIPATE! Need your input for BioPlan's 14th Annual Global Biopharmaceutical Manufacturing Study -
BioPlan will donate $10 (up to $2,000) on your behalf to global health charities - Be the first to receive a FREE Aggregated Summary of this year's results AND receive our UPDATED 15 Top Trends in Biopharmaceutical Manufacturing White Paper.
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QUALITY
Understanding of endotoxin assays and a range of detection technologies are essential for effective testing.
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PEER-REVIEWED RESEARCH
The Uniformity of Dosage Units test is used to evaluate content uniformity or weight variation or dosage forms such as tablets and capsules. The author introduces two different acceptance value limits (n = 10 and 30) in this article.
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Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers.
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FILL/FINISH
Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?
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Events
February 1–2, 2017
February 27–March 2, 2017
March 5–9, 2017
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REFERENCE BOOKS |
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A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
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eBOOKS
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Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain. |
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