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Global ManuCHEM Strategies 2012
February 13, 2012—February 14, 2012
Berlin, Germany
Informex
February 14, 2012—February 17, 2012
New Orleans, LA, USA
Pharmapack
February 15, 2012—February 16, 2012
Paris, France
Cancer Biologics
February 21, 2012—February 23, 2012
San Francisco, CA, USA
World Generic Medicines Congress Europe 2012
February 28, 2012—March 2, 2012
London, United Kingdom 
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FDA Commissioner Testifies for PDUFA Reauthorization
Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to support the fifth authorization of the Prescription Drug User Fee Act, also known as PDUFA V. She also outlined a series of recommendations, sent to Congress in January 2012, to include in PDUFA V.
Pfizer Contraceptive Pill Packaging Error Leads to Recall
Following a packaging error affecting birth-control pills, Pfizer has issued a one-million pack recall and warned women in the US who have been taking the medication during the last several months to consult with their physicians.
EMA to Implement Pharmacovigilance
The European Medicines Agency (EMA) has published an implementation plan for Europe's new pharmacovigilance legislation, which comes into force in July with the aim of improving the safety and risk–benefit monitoring of drugs. The new legislation will represent the biggest change in the legal framework of the industry since EMA was first established in 1995.
GlaxoSmithKline Tracks R&D Performance
GlaxoSmithKline released its fourth quarter and full year 2011 earnings report, which showed its return on R&D to be 12%—up from 11% in 2010, and closing in on the company's goal of a 14% return.
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 Image analyzer features particle characterization
The ShapeSizer image analyzer from Whitehouse Scientific can characterize particles in the size range of 1–5000 µm. The analyzer integrates a charge-coupled device camera with its software system, which is designed to provide a cost-effective solution for a variety of industrial particulate applications where size and shape are important parameters.
Some key features of the ShapeSizer include automatic cluster recognition and elimination, a particle-separation and editing facility, and a sieve calibration option. In addition, it contains a Miles-Lantuejoul option to maximize its field of view without eliminating particles. |
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AstraZeneca has announced a restructuring program intended to deliver an estimated $1.6 billion in annual benefits by the end of 2014, at an estimated total cost of $2.1 billion. AstraZeneca expects that this restructuring program will affect approximately 7300 positions. Final estimates for program costs, benefits, and headcount impact in all areas of the business are subject to completion of applicable consultation processes. Approximate position reductions in specific departments are as follows: selling, general, and administrative: 3750; R&D: 2200, and operations: 1350. Read More
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Pharmaceutical starches from Grain Processing Corporation (GPC) range from basic unmodified starches for tableting to very specialized, innovative starches for unique applications. Spress® Pregelatinized Corn Starches NF perform as binders, disintegrants and lubricants for granulations, direct-compression tablets, capsules, dry blends and roller compaction. PURE-COTE® film-forming starches are designed for coating applications, oral thin films, capsules and any applications where clear, flexible films are required.  Read More
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BASi, a provider of drug-discovery and development services, has opened a discovery center at its corporate headquarters in the Purdue Research Park in West Lafayette, Indiana The purpose-built facility is designed to provide pharmaceutical and biotechnology companies with the information to evaluate new compounds in early-stage development. The facility has 4800-ft2 of dedicated research space and environmental systems to maintain and monitor laboratory conditions. Read More
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Walker Barrier Systems custom designs & manufacturers Isolators, Restricted Access Barrier (RAB's), and Downflow Booths to provide both product & personnel protection for containment, aseptic, and sterility test applications. Walker Barrier Systems also provides aftermarket support for all isolator and downflow booth needs. See us at ISPE Tampa, PDA Annual and InterPhex or visit our website at  www.walkerbarrier.com
for information |
Catalent Pharma Solutions has completed the expansion of its facility in Aprilia, Italy. This expansion features complete turnkey services, from product conceptualization, formulation, development, production, and packaging for prescription and over-the-counter products. The expansion also enhances Catalent's European quality and analytical capabilities. Read More
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Today's product lifecycle is moving at a speed like never before. With more and more businesses rushing their products to market in order to keep up with this pace, bringing visibility to quality becomes a challenge. Learn how Risk Management provides the framework for handling adverse events in a systematic way—from design, to post-market events, to tracking and trending risk across the enterprise.  Read More |
Merck KGaA and the biotechnology company Threshold Pharmaceuticals have agreed to codevelop and commercialize TH-302, Threshold's small-molecule hypoxia-targeted drug for treating advanced pancreatic cancer and first-line advanced soft tissue sarcoma, which is in Phase III development. Under the terms of the agreement, Merck will receive co-development rights, and exclusive global commercialization rights and will provide Threshold an option to cocommercialize the therapeutic in the United States. In exchange, Threshold will receive an upfront payment of EUR 19 million ($25 million) and could receive up to EUR 26.5 million ($35 million) in additional development milestones during 2012. Threshold is also eligible to receive a EUR 15-million ($20 million) milestone payment based on positive results from its randomized Phase II trial in pancreatic cancer. The deal is subject to customary closing conditions and regulatory approval. Read More
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 Podcast - Process Validation for Sterile Manufacturing
Join William (JR) Humbert, the Validation Manager at Cook Pharmica, as he discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices, and the impact the guidance has for biotechnology and pharmaceutical companies performing sterile manufacturing process validation. |
Industry Briefs:
A roundup of other company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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FDA issued last week a series of questions and answers regarding the regulation and approval process of positron emission tomography (PET) drugs. The agency published regulations on cGMP standards for PET drug manufacturers in late 2009. The Q&A guidance aims to respond to follow-up questions from the industry. Addressed are application extensions, inspections, CTD filings, the use of synthesizers, IND sponsors, trials, and more.
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Social Media
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View the poll archive. |
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