Top Stories
Pfizer will acquire Medivation for approximately $14 billion.
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The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.
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EXPERT INTERVIEW
Angelo Stracquatanio, co-founder of Apprentice Field Suite, spoke with Pharmaceutical Technology about smart glasses and their use in pharmaceutical manufacturing.
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Industry News
Nine public health organizations submitted a letter to US House and Senate committees citing concerns about Section 11 of the FDA and NIH Workforce Authorities Modernization Act.
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The Group is focusing on standardizing data exchanges between the enterprise serialization management function and product packaging lines.
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Have you attended one of Natoli's training seminars yet? Well now is your chance; seats are almost full. Visit Natoli Engineering's headquarters September 20 – 22 and learn first-hand from industry experts. In this four-day Basics of Tablet Manufacturing & Troubleshooting course, you'll receive training on tablet design, tooling options, tool reworking and polishing, and more!  Sign up today! |
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Supplier News
The company is opening two offices in the United States that will offer serialization, automation, and process control services.
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TOPAS Advanced Polymers announces its COC materials are compliant with new USP standard for pharma plastic packaging systems.
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Virtual Pharma Companies – The Future is Now
Once considered a trend, virtual pharmaceutical companies have become a new way of life. Tom Salus discusses the role of the CDMO as a partner to the virtual organization.
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Bio/Pharma News
The joint venture, created through a collaboration with Bayer and CRISPR Therapeutics, will be based in Cambridge, MA.
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Piramal Enterprises has entered into an agreement to acquire 100% stake in Ash Stevens all by cash for a consideration of $42.95 million plus an earn-out consideration capped at $10 million.
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Enabling Formulation of Water-Soluble and Water-Insoluble Molecules Using a Lipophilic Salt Approach
Live Webcast: Tuesday, September 27 at 11:00 EDT.
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Regulatory News
Arbor Pharmaceuticals is voluntarily recalling Cetylev (acetylcysteine) effervescent tablets due to inadequate seal of the blister pack.
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New Trends in Hygienic Diaphragm Valves that Improve Reliability
LIVE WEBCAST: Thursday, September 22, 2016 at 11:00 am EDT.
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MANUFACTURING
The design of Baxter BioPharma Solutions' aseptic filling lines provides a case study in customizing containment systems for multi-product lines.
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Best Practices for Effective Excipient Sourcing and Testing
Live Webinar: Tuesday, September 20, 2016 at 11:00am EDT.
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GMPs
Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.
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OUTSOURCING
CMOs are working hard to improve performance by investigating new technologies for filtration and purification.
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Sustained-Release Formulation: Overcoming Key Challenges Like Alcohol-Induced Dose Dumping
LIVE WEBCAST: Tuesday, September 13, 2016 | 11 am EDT | 10 am CDT | 8 am PDT.
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Webcasts
On Demand
Considerations for preparing for the process transfer, ensuring equipment and materials consistency, and post-transfer activities will be discussed.
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Understanding the Relationship between Critical Quality Attributes and the Microstructure of Topical Semi-Solid Formulations
LIVE WEBCAST: Thursday, September 8, 2016 at 11 am EDT | 10 am CDT | 8 am PDT.
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On Demand
Merger and acquisition (M&A) trends in the contract services and biopharma space are set to continue in the coming years. Although M&A at contract manufacturing organizations (CMOs) can be a stressful time for clients, customers should know that M&As offer various opportunities for continuous improvement and the service providers that go through M&A integration most frequently are likely to be among the best proponents of the process. Learn best practices in approaching integration planning. Find out why change management is vital during acquisitions and learn what you should be communicating during integrations and when you should be talking to the CMO.
Sponsored by AMRI
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Amorphous Dispersion Drug Formulations: A Modern Simulation-Based Approach
LIVE WEBCAST: Wednesday, Sept. 07, 2016 at 11:00 AM EDT.
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Events
September 12-14, 2016
September 18-21, 2016
September 26–28, 2016
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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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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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