Top Stories
The committee suggests there may be a connection between the Zika virus and other neurological disorders in some affected areas.
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With a new name formed from the legacy company names, Alcami offers development services, analytical testing, and API and finished drug development and manufacturing.
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INTERPHEX 2016 KEYNOTE SERIES: BIOPROCESSING CHALLENGES
Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series discussion on bioprocessing challenges at INTERPHEX 2016.
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Industry News
The group is inviting additional industry stakeholders to participate in the technology roadmapping process to address complexity of the current industry structure, which the group says has held back innovation.
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The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.
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Supplier News
Hovione will operate a commercial-scale continuous manufacturing facility in New Jersey as part of an agreement with Vertex Pharmaceuticals.
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The investment includes facility upgrades and expansion of development capabilities.
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Bio/Pharma News
GW Pharmaceuticals released Phase III trial results on Epidiolex, which was shown to decrease monthly convulsive seizures in children by 39%.
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The EC approved the merger on March 10, 2016 on the condition that Teva and Allergan divest certain assets in Europe.
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Regulatory News
Both agencies warn of increased rates of serious adverse events, including death, during clinical trials of Zydelig (idelalisib).
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The five-year Medicare initiative seeks to change the way in which drugs are reimbursed under Medicare Part B.
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FEATURED TOPICS |
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PEER-REVIEWED RESEARCH
The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a critical quality attributes is large enough to make a practically meaningful impact.
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OUTSOURCING
The pharma outsourcing market starts 2016 with expansions, acquisitions, and new offerings.
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Natoli Engineering Company, Inc., maintains a large selection of replacement parts for nearly every tablet press on the market ready for immediate delivery worldwide. By stocking replacement parts, up to 50% less cost than the original equipment manufacturers, Natoli is able to provide the highest quality parts at exceptional prices, faster than anyone else in the industry with next-day service!
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KEYNOTE SERIES AT INTERPHEX 2016
At INTERPHEX 2016, Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series addressing leading bio/pharma industry issues.
Oral solid-dosage forms are the leading drug delivery method, but new development and manufacturing technologies are offering new options for patients. Experts will discuss advances in drop-on-demand manufacturing, polymer thin films for drug delivery, and manufacturing of minitablets.
Tuesday, April 26, 1–3:30 pm
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How will consolidation in the bio/pharmaceutical and contract services market, a changing financial market, and an active political and regulatory year shape the fortunes of the contract services market? In his annual presentation, industry expert Jim Miller will offer his perspectives on the contract services landscape for the next few years.
Wednesday, April 27, 10:30 am – 11:30 am
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Aging facilities and equipment, inadequate operator training, a lack of quality control, tighter regulatory enforcement, and business decisions to eliminate unprofitable product lines contribute to ongoing shortages vital drug products. In this session, industry thought leaders will identify triggers for drug shortages, methods to avoid production line shutdowns and update facilities, and innovative industry efforts to fulfill demand for needed therapies.
Wednesday, April 27, 1:30 – 3:15 pm
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Sterile injectables have been in extremely short supply, and industry efforts have been focusing on root causes involving infrastructure, quality, and efficiency. Experts involved in this work discuss recent initiatives, and offer insights into what must be done to prevent injectables shortages in the future.
Wednesday, April 27, 3:30 – 4:30 pm
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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
LIVE WEBCAST: Wednesday, March 23, 2016 at 8 am PDT / 10 am CDT / 11 am EDT
Join this informative webinar to learn how to foster relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny.
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Webcasts
On Demand
Learn basics of water activity and the role it plays in the chemical stability, microbial content, and physical properties of pharmaceutical products. Hear experts discuss compendial and regulatory requirements for water-activity determination, and practical applications of water activity in marketed pharmaceuticals.
Sponsored by Decagon Devices
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On Demand
Spray-dried dispersion technology is a proven approach to improve the dissolution rate and bioavailability of low solubility compounds, and helps to bring new medicines to market. Attend this webinar to learn the fundamentals of spray-dried dispersion formulation selection, process development, stability, scale-up, and performance considerations.
Sponsored by Bend Research
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Engineering the Mechanical properties of Amorphous Spray-Dried dispersions
On Demand
Capsugel Dosage Form Solutions will present a webinar discussing the aspect of engineering spray-dried dispersion properties, with a particular emphasis on the impact of atomization and drying rate on powder mechanical properties.
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on pharmtech tv
The Transition from Paper Records to Electronic Batch Records
Trends in Drug Formulation
HPAPI Manufacturing
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Events
April 26-28, 2016
June 6-8, 2016
May 18-19, 2016
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Best Practices for Effective Product Transfer
On Demand
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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REFERENCE BOOKS |
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A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
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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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