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European Filing & Registration Procedures
July 23, 2012–July 24, 2012
King of Prussia, Pennsylvania
Pharmaceutical Technology Presents Bio/Pharmaceutical Manufacturing Outsourcing
July 24, 2012–July 25, 2012
Philadelphia, Pennsylvania
Orphan Drug Summit
July 24, 2012–July 26, 2012
London, United Kingdom
REACH and CLP USA
August 1, 2012–August 2, 2012
Raleigh, North Carolina
Antibody-Drug Conjugates, Bispecifics & Empowered Antibodies
August 6, 2012–August 8, 2012
San Francisco, California

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Congress Passes Generic Drug Act
On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry’s history.

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The FDA has taken the next step in increasing efficiency of electronic regulatory reporting through the implementation of the eMDR Electronic Submissions Gateway. Learn the benefits and best practices of using the FDA's eMDR program to meet specific business needs, and the future of eMDR for Life Science organizations. Read More |
FDA Introduces New Safety Measures for Opioid Medications
FDA approved a risk evaluation and mitigation strategy for extended-release and long-acting opioid medications.

ISPE Issues Guidance for Packaging, Labeling, and Warehousing Facilities
ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.

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Portable particle counter is easy to transport
The Kanomax Model 3910 50LPM Portable Particle Counter can simultaneously measure six particle sizes in tasks such as cleanroom verification, clean bench verification, filter testing, and facility certification. The model is designed to be small and light to alleviate transportation and management in the field. This model has an increased, 50-L/min flow rate, which increases testing speed. The unit has a stainless-steel enclosure and is compliant with ISO 21501-4 and 21 CFR Part 11. The instrument features an intuitive, LCD touch screen and preprogrammed standards, and stores up to 10,000 measurements. An optional Climomaster probe measures air velocity, temperature, and humidity.
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Pharmaceutical Technology Presents Bio/Pharmaceutical Manufacturing Outsourcing
Build Strategic Partnerships • Improve Technology Transfer • Mitigate Risk
July 24-25, 2012 Philadelphia, PA
In this focused, interactive forum, bio/pharmaceutical executives come together with contract manufacturing organizations to discuss strategies for effective operations, quality oversight and risk mitigation. Join your colleagues to hear the latest regulatory trends, learn best sourcing practices and identify business opportunities in the outsourcing arena.
Register by June19th at http://www.cbinet.com/outsourcing and save $300 with priority code: AMS592 |
Amgen has completed its acquisition of KAI Pharmaceuticals, a privately held company based in South San Francisco, California. The acquisition was initially announced Apr. 10, 2012, and includes KAI’s lead product candidate KAI-4169, a novel agent being studied initially for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Read More
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Technical Advantages for High Purity Extra Granular Sodium Bicarbonate
Are you looking for an opportunity to reduce costs with less fillers and tableting agents? Learn how to select the grade which best meets your needs to maximize utilization and performance. Find Out More |
Renaissance Acquisition Holdings, a portfolio company of RoundTable Healthcare Partners, an operating-oriented private-equity firm focused exclusively on the healthcare industry, has acquired the CDMO DPT Laboratories. DPT’s headquarters and staff will continue to be located in San Antonio, Texas, and its management team will remain in place. As a result of the transaction, DFB Pharmaceuticals, based in San Antonio and Fort Worth, Texas, will maintain a meaningful interest in the combined business and will provide oversight and counsel through representation on Renaissance’s board of directors. Read More
Seven pharmaceutical companies (Abbott, AstraZeneca, Bayer, Eli Lilly, GlaxoSmithKline, Merck & Co., and Sanofi) and four research institutions (the Infectious Disease Research Institute; the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health; Texas A&M University; and Weill Cornell Medical College), working with the Bill & Melinda Gates Foundation, have launched a partnership that aims to expedite the discovery of new treatments for tuberculosis (TB). The partnership, known as the TB Drug Accelerator (TBDA), will target the discovery of new TB drugs by collaborating on early-stage research. The long-term goal of the TBDA is to create a TB drug regimen that cures patients in only one month. Existing drugs, all at least 50 years old, require six months to cure the disease—a lengthy process that contributes to 20–30% of patients dropping out before completion. Aided by nearly $20 million from the Gates Foundation, the partners launched the TBDA in April 2012, and have begun the first round of screening for new TB drug candidates. The TBDA aims to develop five new preclinical drug candidates with treatment-shortening potential within five years and proof-of-concept for a one-month, three-drug regimen within 10 years. Read More
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Realize Effective Pharmaceuticals
Reliable solutions enable pharmaceutical scientists to innovate in disease research, accelerate drug discovery and have greater confidence throughout development and manufacturing. Agilent solutions in genomics research, automation, separation and detection technologies along with workflow driven software solutions helps deliver the answers to bring effective therapeutics to market.
Learn about pharmaceutical purification, purity, and impurity analyses at www.agilent.com/lifesciences/realizepharma |
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More
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Maximize GC Headspace Productivity
Develop reliable testing for residual solvents with the Agilent 7697A Headspace Sampler injection system and maximize your precision, accuracy and throughput. Agilent’s method translation tools allow for conversion from other headspace samplers to deliver unparalleled confidence in your analytical results. See the animated demo |
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
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CBI's Biopharmaceutical Forum on Clinical and Commercial Global Supply Chain Excellence
Ensure End-to-End Integrity and Adapt to Fit Regulatory, Market and Operational Needs
July 24-25, 2012 * New Brunswick, NJ * Hyatt Regency New Brunswick
This conference brings together the clinical and commercial supply teams for thought sharing on intersecting issues while still addressing unique challenges during tracked (clinical/commercial) sessions. Hear organizational strategies and learn how industry peers are managing the diverse supply chain network including cross functional-teams, suppliers, global/virtual teams etc.
Register by July 24th at http://www.cbinet.com/supplychain and save $300 with priority code: HCJ494 |
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Biosimilar Developers Face a Reference-Product Dilemma |
by: Fiona Greer
Does global development have to entail multiple comparability studies?
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Coming soon: Pharm Tech’s August issue features a case-study analysis of resolving challenges in achieving desired product yields, enantioselectivity, purity, and reaction efficiency in API synthesis. |
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Get a Working Knowledge of All Aspects for Effective Packaging
Attend CfPA’s training course July 26-27 for an intensive look at how all types of packaging are developed, manufactured, tested, filled, transported, stored and used. Emphasis placed on the characteristics of packaging materials which can influence the packed product; protection, compatibility, safety, compliance, design, performance on the filling and closing lines, distribution, marketing and use. Read More |
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Know Before You Go—2012 Conference Previews
Visit our Show & Exhibition Gateway 2012 to see which companies are exhibiting at upcoming industry conferences.
Find company backgrounds, new product releases, booth materials, and more.
PharmTech's online
Gateway is your guide to the season's leading shows.
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Unlocking the Power of New Softgel Technology for Multiple API Formulations
Live Webcast: Thursday, July 26, 2012 at 11:00 am EDT
Register Free at http://www.pharmtech.com/apiformulations |
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