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Webcast: Overcoming Formulation Challenges of Parenteral Drugs
October 30, 2012—Sponsored by Croda

Webcast: Best Practices for Achieving Product Quality in Sterile Manufacturing
November 6, 2012—Sponsored by Baxter

Webcast: API Development: Risk and Control of Genotoxic Impurities
November 8, 2012—Sponsored by Neuland

Webcast: Application of QWBA and Short-Lived Isotopes in the Drug Development Paradigm
November 29, 2012—Sponsored by MPI Research

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European Pharmaceutical Pricing & Reimbursement
October 29, 2012–October 30, 2012
London, United Kingdom

The New FDA/EU Approach to Process Validation
October 30, 2012–October 31, 2012
Barcelona, Spain

Virus and TSE Safety Made Simple
October 30, 2012–October 31, 2012
Heidelberg, Germany

Innovation Excellence Workshop
October 30, 2012–October 31, 2012
Berlin, Germany

PDA Pharmaceutical Quality System (ICH Q10) Conference
November 5, 2012–November 6, 2012
Tokyo, Japan

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News

Watson Receives Clearance for Actavis Acquisition
Watson Pharmaceuticals has received clearance from the Federal Trade Commission for its acquisition of generic-drug manufacturer Actavis.
Click Here to Read More

Ben Venue Resumes Limited Production
Ben Venue Laboratories has resumed production on a limited number of manufacturing lines in the company’s Bedford, Ohio, facilities.
Click Here to Read More

Dr. Reddy's Announces Plans to Acquire OctoPlus for EUR 27 Million ($35.7 Million)
Dr. Reddy's is planning to acquire the specialty injectable company OctoPlus for approximately EUR 27.4 million ($35.7 million) in cash to strengthen its technological capabilities in drug delivery.
Click Here to Read More


Product Spotlight

Software enables efficient electronic batch recording

Rockwell Software PharmaSuite contains a comprehensive set of functions that address the most common applications, such as dispensing, quality, and electronic batch recording. The software tracks material, equipment, and personnel involved in the manufacturing process and maintains a complete electronic batch record. Rockwell Software PharmaSuite is based on S88 and S95 standards which allows for better integration with other enterprise systems involved in manufacturing operations. Its object-oriented design enables a user-friendly functionality to build and modify applications, and systematically deploy them across multiple sites.


Company Notes

AstraZeneca and Ironwood Pharmaceuticals have agreed to codevelop and cocommercialize Ironwood’s linaclotide in China. Linaclotide is a guanylate cyclase-C (GC-C) agonist approved by FDA, in August 2012, for treating irritable bowel syndrome with constipation and chronic idiopathic constipation. The companies are jointly responsible for strategic oversight of the development and commercialization of linaclotide in China. AstraZeneca will have primary responsibility for the local operational execution. Under the collaboration, AstraZeneca will make an upfront payment of $25 million to Ironwood and will share the net profits and losses associated with linaclotide in China, with AstraZeneca carrying 55% until a certain specified milestone is achieved, moving to a 50/50 split thereafter. Ironwood will also be eligible for $125 million in additional commercial milestone payments, contingent on the achievement of certain sales targets. Read More

Advertisement:
Handheld Raman Accelerates Raw Material Release
Enwave Optronics introduces the NEW ASSUPx Handheld Raman Analyzer for raw material verification. Most materials are measured and evaluated within 15 seconds. The ASSUPx is fully 21 CFR Part 11 compliant for GMP requirements. It is an ideal choice for pharmaceutical, industrial chemicals and applications requiring high speed, reliable Raman analysis.
Enwave Optronics, Inc.
http://www.enwaveopt.com/EZRaman-H.htm

Catalent Pharma Solutions has launched the Catalent Applied Drug Delivery Institute to promote innovation, knowledge-sharing, and collaboration between industry leaders, academic experts, customers and regulators to enhance understanding of available, emerging, and future drug-delivery technologies and improve patient care. As part of its mission, the Catalent Applied Drug Delivery Institute will serve as a link between industry and academia by providing guidance, counsel, and resources on major issues pertaining to drug development, delivery, and formulation. The Institute will develop programs that facilitate mutually beneficial collaborations, increase communication, and shed light on regulatory issues affecting drug developers and researchers. It also will pursue a multitiered approach of seed funding, strategic counsel, and educational programs to advance the adoption of emerging technologies. Catalent announced the launch of the institute at the 2012 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in Chicago earlier this month. Read More

Advertisement:
Caron's Photostability Chambers ideal for forced degradation
Caron's Photostability chambers feature a benchtop size and are designed in accordance with ICH Q1B guidelines. Uniform light distribution and high intensity levels allow for quick response forced degradation testing and confirmatory studies. To learn more and to download our white paper "Using Photostability Chambers to Meet the Requirements of Drug Testing in Accordance with ICH, Q1B" visit www.caronproducts.com/photostability

Pfizer has announced its intention to acquire NextWave Pharmaceuticals, a privately held specialty pharmaceutical company focused on the development and commercialization of products for the treatment of attention deficit/hyperactivity disorder (ADHD) and related central nervous system disorders. NextWave is the developer of Quillivant XRTM (methylphenidate hydrochloride) for extended-release oral suspension, CII, a once-daily liquid medication approved in the US for the treatment of ADHD. NextWave holds exclusive North American commercialization rights to Quillivant XR. Quillivant XR received approval from the FDA on Sept. 27, 2012, and is expected to be available in pharmacies in the US in January 2013. 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 more at www.agilent.com/lifesciences/realizepharma

The biotechnology company Seattle Genetics has expanded its antibody-drug conjugate (ADC) collaboration with Abbott. Under the expanded deal, Abbott will pay an upfront fee of $25 million for rights to use Seattle Genetics’ auristatin-based ADC technology with antibodies to additional oncology targets. In addition, Seattle Genetics may receive up to $220 million in potential milestone payments per additional target upon achieving predetermined development and commercial objectives, as well as mid-to-high single-digit royalties on worldwide net sales of any resulting products under the multitarget collaboration. Read More

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Agilent ICP-MS/ICP-OES
Reliable solutions for regulated pharmaceutical laboratories
Complying with new elemental impurity limits as defined by draft USP methods <232>/<233> could pose a significant challenge. You need to choose qualified hardware and software, ensure verification, and maintain electronic records. But there is a simple answer – Request a free copy of our primer on Elemental Impurity Analysis to learn more.

A roundup of additional 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]


Regulatory Roundup

Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, announced on Oct. 24, 2012, in an FDA blog, the launch of the Coalition for Accelerating Standards and Therapies (CFAST), a partnership between FDA, the Clinical Data Interchange Standards Consortium (CDISC), and the Critical Path Institute (C-Path). The partnership intends to bring clinical data experts together to “develop data standards tailored to individual diseases and therapeutic areas” and provide opportunities to transform data from drug studies on specific diseases to get new therapies to patients quicker.

Advertisement:
Best Practices for Achieving Product Quality in Sterile Manufacturing
Live Webcast: Tuesday, November 6, 2012 at 11:00am–12:00pm EST
Register Free at www.pharmtech.com/achieving

“Standardized data elements that are common to all clinical trials, such as age and gender, have been established using CDISC terminology. However, data elements that are unique for a particular disease or therapeutic area still need to be developed so that the data from multiple trials can be more easily grouped for reporting and analysis,” said Woodcock. “We believe that CFAST will provide an important resource for drug development and research that will result in enhancements in the evaluation of safe and innovative therapies for the public.”

Advertisement:
API Development: Risk Evaluation and Control of Genotoxic Impurities
Live Webcast: Thursday, November 8, 2012 at 10:00am EST
Register Free at www.pharmtech.com/genotoxic

FDA Commissioner Margaret A. Hamburg, MD, issued a statement on Oct. 24, 2012, in response to the fungal meningitis outbreak, stressing the importance of the partnership between federal, state, and local authorities in dealing with public health issues. "The FDA has been working closely with the CDC and public health officials in Massachusetts and other states to investigate the scope and cause of the outbreak. In fact, both agencies have been working hand-in-hand with our colleagues in every state affected by this outbreak," said Hamburg.

Advertisement:
Overcoming Formulation Challenges of Parenteral Drugs
Live Webcast: Tuesday, October 30, 2012 from 11:00 AM EST to 12:00 PM EDT
Register Free at www.pharmtech.com/parenteral

PharmTech, the magazine
Current Issue cover
Integration of Less-Formal Risk Assessment Tools into Change Control
by: Kelly Waldron, Marissa Gray
Managing risk in biopharmaceutical operations is of utmost importance for patient protection.
Click Here to Read More

Coming soon: Pharm Tech’s November issue will explore mean kinetic relative humidity and its relationship with moisture-sensitive pharmaceuticals.


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