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2011 AAPS National Biotechnology Conference
May 16–May 18, 2011
San Francisco, CA
Sterile Pharmaceutical Dosage Forms: Basic Principles
June 1–June 2, 2011
Bethesda, MD
Lyophilization Technology - Practical Application of the Scientific Principles
June 13–June 15, 2011
Los Angeles, CA
Chemspec Europe 2011
June 15–June 16, 2011
Geneva, Switzerland
10th Annual Biological Production Forum 2011
June 20–June 22, 2011
Frankfurt, Germany
IVT’s 2nd Annual ACE
June 21–June 23, 2011
Philadelphia, PA
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FTC Finds 60% Increase in Pay-to-Delay Deals
In fiscal year 2010, the number of patent settlements in which the manufacturers of branded products paid makers of generic drugs to postpone the introduction of their products reached its highest level ever, according to the Federal Trade Commission. 
FDA Issues Guidance on Bioequivalence Studies
FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications.
Alkermes Snaps up Elan Drug Technologies
Alkermes purchased Elan’s Elan Drug Technologies (EDT) unit in a cash and stock transaction worth approximately $960 million. The two companies will be merged into a new holding company in Ireland under the name Alkermes.
PhRMA Comments on USTR Report on Pharmaceutical Trade Practices
The Office of the United States Trade Representative issued a report as part of its annual review of the global state of intellectual-property rights protection and enforcement.
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 Glove boxes provide operator protection
Labconco’s Protector high-efficiency particulate air and ultralow particulate air filtered glove boxes provide a high level of containment or isolation. The company tests its glove boxes with helium to ensure the absence of leaks greater than 1 x 10-6 cc/s.
In addition, operators can clean Protector glove boxes quickly, thus reducing the time it takes to change between potent materials. After 5 min. of glove box air-volume dilution at 85 fpm, a perimeter scan detected an average tracer-gas level of 0.05 ppm, according to Bob Applequist, a product manager at Labconco. The glove boxes’ design thus helps ensure user protection.
The units’ liquid crystal microprocessor display enables the real-time monitoring of air-volume dilution rates in cubic feet/min and air changes/min. The display also measures the main chamber’s static pressure in inches of water. An audible and visible alarm trips when airflow or pressure is below selectable air-pressure limits.
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It’s all about Aptuit service. Our customers say they respect our commitment to resolving challenging issues. They will work with us again because of our ability to accomplish goals in aggressive timelines while staying on budget. They are voicing their positive response to our recent breakthrough systems, and providing even greater global service efficiencies. Across the entire drug development continuum, it’s all about Aptuit service.
 http://www.aptuit.com/ItsAllAboutTheService/service.htm
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Almac, a contract development and manufacturing organization, launched selectAZyme, an offering of biocatalysts, including reductases, transaminases, hydrolases, and nitrilases. The offering also includes metabolite synthesis for oxidative and glycosylated products.
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Modular Cleanrooms to Your Specs
Terra Universal designs, builds and equips  modular cleanrooms, available in hardwall/softwall plastic and stainless steel designs. All-steel support frames require no external bracing. Double-wall pharmaceutical BioSafe designs feature pre-engineered panels for simple installation and rounded, easy-clean surfaces for aseptic environments from ISO 4 to ISO 8. Terra also offers gowning room furniture, hoods, glove boxes, workstations, chairs and more. |
American Regent, a supplier of injectable products, resumed the shipment of its product line on May 5, 2011. On Apr. 21, 2011, Luitpold Pharmaceuticals, American Regent’s parent company, temporarily suspended distribution of all drug products manufactured at its Shirley, New York, facility. The suspension followed an FDA inspection and follow-up meeting on Apr. 14, 2011.
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The company formed by the merger of specialty-pharmaceutical firms Axcan and Eurand was named Aptalis Pharma. The merger was completed in February 2011.
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Optimum FTIR Performance, Sensitivity, and Reliability
Shimadzu’s IRAffinity-1 FTIR is ideal for high-precision infrared analysis in a multitude of pharmaceutical applications, from identification of foreign matter to analysis of contaminants. It features best-in-class sensitivity, long-term stability, increased reliability with self-diagnosis and continuous monitoring during operation, protection from humidity with a triple protection interferometer, and analysis support programs.  Learn more. |
INC Research, a contract research organization (CRO) agreed to acquire CRO Kendle for $232 million. Kendle’s board of directors approved the transaction, which is expected to close in the third quarter of 2011, subject to approval by Kendle’s shareholders, customary closing conditions, and regulatory approval.
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Reports from the Waters Bioanalysis World Tour:
Our recent special event series has been creating a lot of buzz among bioanalysts, with engaging discussions on topics from microsampling to peptide bioanalysis. Read reports written by the Bioanalysis Journal, watch our on-demand webinars, and look for future symposia dates at  www.waters.com/biotour |
Iroko Pharmaceuticals, a pharmaceutical services company, selected Aptuit as a contract manufacturing partner to produce Phase III supplies of low-dose nanotechnology formulations of multiple nonsteroidal anti-inflammatory drugs. Aptuit will also make batch material to satisfy requirements for product registrations.
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CBI’s 9th Product Complaints for Bio/Pharmaceuticals and Medical Devices — June 14–16, 2011, Arlington, VA
Create your own agenda at the QA/QC event of the year. Hear from the FDA and quality leaders from Abbott, Alcon Labs, American Medical Systems, Baxter Healthcare Corp., Becton Dickinson, GE Healthcare, Janssen Supply Group, LLC, Merck & Co., Inc. Philips Healthcare, Shire and more. Be the next to benefit.
Register today at  www.cbinet.com/productcomplaints |
The CRO Parexel instituted a restructuring plan in its early-phase program, which is scheduled to begin in the fourth quarter of fiscal year 2011. The amount of the restructuring is estimated at $15 million, of which approximately $4 million is expected to be recorded in the fourth quarter.
Precis Engineering is providing mechanical, electrical, plumbing, process engineering, and commissioning services for Morphotek's new $80-million, 60,000-ft2 manufacturing pilot plant currently under construction in Exton, Pennsylvania. The Morphotek facility will house a biologics plant, laboratories, a cGMP cell-culture core area, warehouse storage, and offices to support the company's production of biologics for early-stage clinical trials. The facility is scheduled to be completed in the spring 2011, and operations are slated to begin in 2012. Morphotek a biopharmaceutical subsidiary of Eisai.
sanofi-aventis changed its name to Sanofi. The name change was voted into effect by shareholders at the company’s annual shareholder meeting on May 6, 2011.
Contract manufacturing organization SCM Pharma secured a sterile filling and packaging project with Molteni Therapeutics, an Italian specialty-pharmaceutical company. The project involves a drug substance being developed for the topical treatment of infected skin lesions using photodynamic therapy.
FDA issued the specialty-pharmaceutical company Warner-Chilcott a Warning Letter in response to a video about Atelvia (risedronate sodium) delayed-release tablets that its sales team had posted on YouTube. FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) received a complaint about the video, which is titled “Brooke Stacey SA, TX Atelvia.” In the Warning Letter, the agency said that the video “makes representations about the use of Atelvia, but fails to present any risks associated with [the drug’s use] and fails to disclose the drug’s indication. The video also presents dosing claims for Atelvia that omit material facts and that are misleading.” Warner-Chilcott is required to confirm receipt of FDA’s letter by May 19.
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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Almac appointed Todd Kole as vice-president of clinical project services and as a member of the executive leadership team.
CMC Biologics, a contract biopharmaceutical manufacturer, hired Claes Glassell as its CEO.
Contract service provider Penn Pharma named Mark Dean-Netscher as chief operating officer. He will be responsible for overseeing the operation of the company’s special and global contract manufacturing and development services.
Pfizer CentreSource appointed Cristin B. Grove as director of global contract manufacturing. She most recently served as business development manager for Pfizer Global Supply.
Pharmaceutical Research and Manufacturers of America has named Rod Hunter as senior vice-president of international advocacy, effective June 10, 2011. Hunter will report to Chip Davis, executive vice-president of advocacy.
Valerie Palumbo joined contract research organization PharmaNet Development as senior vice-president of corporate quality assurance.
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FDA issued last week a final guidance for industry about over-the-counter (OTC) liquid drug products packaged with cups, droppers, syringes, and spoons to measure and dispense the doses of medication. Titled Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products, the guidance describes how manufacturers can use dosage delivery devices and devices to help minimize the risk of unintentional overdose of OTC products. Read PharmTech’s blog about the guidance.
FDA is asking for input on the development of a user-fee program for biosimilar and interchangeable biological product applications. According to a Federal Register notice, the Biologics Price Competition and Innovation Act of 2009, a provision of the Affordable Care Act, which creates an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to, or interchangeable with an FDA-licensed biological product, directs the agency to develop recommendations for a related user-fee program for fiscal years 2013 through 2017. The recommendations must be presented to Congress by January 15, 2012.
On May 5, FDA published the minutes of public and industry meetings held in February 2011, about the renewal of PDUFA.
FDA also issued a procedural notice about how CDER responds to requests for waivers of postmarketing safety reporting requirements for NDAs, ANDAs, and BLAs. The document explains how CDER reviews and responds to such requests.
USP and FDA are expanding their partnership for another three years to focus on developing USP written and physical reference standards for the quality, identity, purity, and strength of medicines. The new agreement, according to a USP announcement, furthers annual collaborative testing between USP and FDA laboratories of roughly 40 chemical reference standards, primarily for controlled substances. The agreement also promotes joint work to modernize tests and assays in USP’s standards and to further develop test methods for hand-held instruments that law enforcement inspectors can use to screen drugs in the field for adulteration, contamination, and authenticity, says the announcement.
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Continuous Processing
Does your company apply continuous processing in any projects in your manufacturing operations?
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View the poll archive. |
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