 |
GAO Says FDA Should Ramp Up Its Rate of Foreign Inspections
Although the US Food and Drug Administration increased the number of foreign drug inspections it conducted during fiscal years 2007 to 2009, the agency still conducted fewer foreign inspections than domestic inspections each year, according to a new report from the US Government Accountability Office. 
Pfizer Recalls Additional Lots of Lipitor
Pfizer recalled two additional lots—approximately 38,000 bottles—of Lipitor (atorvastatin calcium) 40 mg tablets distributed in the United States due to an uncharacteristic odor in the product bottles.
Industry Needs New Approach To Manage Growing Supply-Chain Complexity
The growth in pharmaceutical outsourcing is creating a more complex and risky supply-chain environment, according to a report issued by PricewaterhouseCoopers and others last week.
|
|
|
 Tank cleaner fits in 2-in. connection
Responding to clients’ requests, Gamajet (Exton, PA) has introduced its NanoJet rotary-impingement cleaner, which fits through a 2-in. triclover inlet connection. The device is made according to a sanitary design and is appropriate for small pharmaceutical process tanks and mixing vessels. The NanoJet cleaner is intended to optimize mechanical force, thus minimizing the effect of cleaning solution, temperature, and time on cleaning efficiency. The device is fluid-driven and uses no external motor, thus simplifying maintenance and enhancing control. Users do not need external air sources or oil lubrication to operate the cleaner.
The NanoJet machine scours the inside of a tank in a 360° pattern. The cleaner is designed to minimize leakage and maximize the flow exiting the nozzles. Increasing the flow from the nozzle enhances the fluid’s impact on the tank wall. Because of its structure, the NanoJet can generate three to five times the impact of other tank cleaners, according to the company.
|
|
|
Advertisement:
Bioanalysis World Tour: Join Waters on our Bioanalysis World Tour. Events are scheduled in various locations – from Switzerland to Japan, Louisiana to China, Switzerland to India. Learn how Waters system solutions redefine the bioanalytical lab. Oasis and Ostro SPE products provide the fastest, easiest, and cleanest sample preparation available. ACQUITY UPLC has changed separation science forever. MassLynx MS Software provides an intuitive interface. And now, Xevo TQ-S offers unmatched MS sensitivity.  Find out more.
|
 |
|
ABITEC (Columbus, OH), a provider of lipidic based bioenhancement excipient products, and Mutchler Pharmaceutical Ingredients (Harrington Park, NJ), formed a comarketing and distribution partnership for ABITEC's Captex, Capmul, Acconon, Sterotex BBS-C and Hydro-Kote lipid-based pharmaceutical-grade excipients to enhance solubilization, emulsification, permeation, and bioavailability of poorly water-soluble active pharmaceutical ingredients.
ATMI (Danbury, CT), a provider of semiconductor materials, materials-development science, and high-purity materials handling and delivery solutions, acquired the biotechnology firm Artelis (Brussels), a company focused on the biotechnology industry's scale-up needs and producer of bioprocesses and technologies for cell-culture research and manufacturing scale-up. The acquisition complements ATMI's offerings in ultra-pure single-use films, bioreactors, and mixing systems for characterizing, developing, and manufacturing biopharmaceuticals.
Advertisement:
Ropack, a leader in packaging solutions for the pharmaceutical, biopharmaceutical and nutraceutical industries, now provides the technology and expertise for stickpack packaging of solid oral dosage in a low relative humidity and temperature-controlled environment. Stickpacks – slim, tube-shaped packets the size of a stick of gum – offer impressive benefits: fill accuracy, portability, product differentiation, reduction in paper and foil usage, product differentiation and ideal sample option
 Read more...
|
Baxter International (Deerfield, IL) agreed to divest its US generic injectables business to Hikma Pharmaceuticals (Amman, Jordan) for approximately $112 million. Hikma will acquire Baxter's high-volume, generic injectable products in vials and ampules, which are sold primarily in the United States including chronic pain, anti-infective and anti-emetic products. Hikma also gains the Cherry Hill, New Jersey, manufacturing facility, and the Memphis (Southpoint), Tennessee, warehouse and distribution center. Approximately 750 employees will transfer as part of the arrangement.
The US Food and Drug Administration issued a Warning Letter to Bristol-Myers Squibb (New York) for “significant violations” of current good manufacturing practice regulations for pharmaceutical products. Deficiencies listed in the letter include a lack of written procedures designed to prevent microbiological contamination of sterile drug products and a failure to thoroughly investigate the failure of a batch. FDA said it could withhold approval of requests for export certificates or of pending drug applications until the violations in the letter are corrected.
GlaxoSmithKline (London) and Amicus Therapeutics (Cranbury, NJ) formed an agreement to develop and commercialize Amigal (migalastat HCl), currently in Phase III development for the treatment of Fabry disease, a rare inherited disorder. Under the terms of the agreement, Amicus will receive an upfront payment of $30 million and may receive up to $170 million in milestone payments, plus royalties on product sales. In addition, as part of the collaboration, GSK is purchasing 6.9 million shares of Amicus common stock at a price of $4.56 per share, which represents a total value of this equity investment of $31 million and a 19.9% ownership position for GSK in Amicus. The total cash upfront to Amicus from GSK is approximately $60 million.
In other GSK news, the company said it finalized a previously reported agreement in principle with the US Attorney’s Office for the District of Massachusetts and the US Department of Justice regarding the investigation of the company’s former manufacturing facility in Cidra, Puerto Rico. In July, GSK disclosed a $750-million charge to its second-quarter 2010 earnings in connection with the agreement in principle, and no additional charge to the company’s earnings will be recorded. This settlement resolves issues stemming from a 2002 warning letter at a plant in Cidra, Puerto Rico, which was closed in 2009 due to declining demand for the medicines made there. GSK no longer owns the facility. Cheryl Eckard, a whistleblower who exposed contamination problems at the facility, was awarded $96 million, according to a Guardian article. Eckard was a global quality assurance manager who lost her job at GSK after repeatedly complaining to management about the manufacturing problems at the Cidra plant. She later contacted FDA about the plant’s issues.
Advertisement:
Management of Water/Cleaning Validation , From inspections of the water used in drug manufacture to cleaning validation, Shimadzu’s TOC analyzers are ideal for the management of the total amount of organic carbon in drug manufacturing processes. Multiple oxidation methods (combustion catalytic and wet chemical) are available, and they can be used with the swab direct combustion method when combined with a solid sample combustion unit
 Learn more. |
Johnson & Johnson (J&J, New Brunswick, NJ) and Crucell (Leiden, The Netherlands) provided an update on the preparations for a public offer. The companies said they are making progress, and that J&J is working with Crucell to understand the circumstances surrounding Crucell’s announcement of manufacturing issues in its Shingal facility in Korea. In addition, J&J filed a first draft of the offer document with the Netherlands Authority for the Financial Markets for review and approval, and the US Securities and Exchange Commission will also have an opportunity to review and comment on the offer document. Crucell plans to hold an initial informational extraordinary general meeting of shareholders on Dec. 10, 2010 to discuss the offer. The companies have also filed tax documents and antitrust notifications with various international regulatory agencies.
Novartis (Basel) will add 300 new jobs and invest $600 million during the next five years to expand its global research headquarters campus on Massachusetts Avenue in Cambridge, Massachusetts. The company plans to expand its current campus by more than 400,000 ft2, including laboratory, office, and retail space. Construction is expected to begin in 2011.
Pharmaceutical company Nycomed (Zurich) acquired a majority stake in Guangdong Techpool Bio-Pharma (Guangzhou, China), a biopharmaceutical company focused on biologic drugs derived from natural sources. Nycomed acquired 51.34% of the shares of Techpool.
Advertisement:
Vetter Secondary Podcast , The market for parenteral drugs has been growing for years, and competition in the sector is fierce. The focus on patient- and user-friendliness is intensifying. In response, Germany-based contract manufacturer Vetter built its state-of-the-art Vetter Secondary Packaging facility. Listen to find out more information
 Listen |
sanofi aventis (Paris) agreed to acquire BMP Sunstone (Beijing), a Chinese consumer healthcare company. sanofi acquired all outstanding shares of BMP Sunstone for $10 per share, or a total of approximately $520.6 million, and the acquisition is to be structured as a merger of BMP Sunstone and a wholly owned subsidiary of sanofi-aventis.
SGS (Geneva, Switzerland), a provider of inspection, verification, testing, and certification services, acquired M-Scan (Reading, UK), a group of chemical analysis laboratories focused on advanced chemical and biochemical testing as well as high-end good laboratory practice/good manufacturing practice contract analytical services, consultancy, and training based on mass spectrometry and chromatography. M-Scan's laboratories provide analytical services such as protein/glycoprotein analysis, pharmaceutical analysis, extractables/leachables, and bioanalysis to support drug development.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
|
|
|
|
|
Donald B. Rice will retire from Agensys (Santa Monica, CA), a biotechnology company and affiliate of Astellas Pharma (Tokyo). Sef Kurstjens was appointed as the new CEO and president.
AVI BioPharma (Bothell, WA), a developer of RNA-based therapeutics, appointed Graham Johnson as senior vice-president of preclinical development and research, Patrick Iversen as senior vice-president of research and innovation, and Ryszard Kole as senior vice-president and an AVI distinguished scientist.
Bausch + Lomb (Rochester, NY), an eye health company, named Mariano García-Valiño to the newly created role of corporate vice-president and president of its Latin America business. García-Valiño was previously a partner with Advent International, a global private-equity firm, where he focused on investment opportunities in the Latin American healthcare industry.
Advertisement:
Beamalloy , Reduce sticking and filming during solid dose tablet production by improving and maintaining the finish on tablet tooling with Beamalloy precision coatings. The coatings are designed to reduce sticking, wear, and corrosion, and can be applied to punches, dies, and tamping pins made from all popular steels without affecting dimensional tolerances or original cup surface finish
 Read more... |
Catalent Pharma Solutions (Somerset, NJ) appointed Mark Bridgewater global account director. Bridgewater, based in Switzerland, will be responsible for developing the company’s sales strategy for key global customer accounts.
The Drug, Chemical and Associated Technologies Association (DCAT) announced that Bob Kanuga, executive director of external manufacturing operations for Merck & Co. (Whitehouse Station, NJ), was elected president of the organization. The following people were elected as DCAT officers: Joan Connolly, associate vice-president of clinical supplies and logistics at ImClone Systems, a subsidiary of Eli Lilly (Indianapolis); J. Tyson Popp, vice-president of research and development at West Pharmaceutical Services (Lionville, PA); and Lyra Myers, senior procurement manager of CGMP procurement at Genentech (South San Francisco, CA).
Elan (Dublin) directors Jack Schuler and Vaughn Bryson resigned from the board effective Oct. 29, 2010, in accordance with their previously announced intention and their related agreements with Elan.
Biopharmaceutical company Idenix Pharmaceuticals (Cambridge, MA) named Ronald C. Renaud, Jr. president, CEO, and a member of its board of directors of the company. Renaud has served as the company's CFO and treasurer since June 2007 and chief business officer since June 2010. Jean-Pierre Sommadossi resigned as president, CEO, and chair of the board to pursue other interests in the biotechnology field.
Medivir (Stockholm), a specialty pharmaceutical company focused on infectious diseases, appointed Charlotte Edenius to the new position of vice-president of research and development projects.
Kevin T. Rigby, vice-president of public affairs and communications at Novartis Pharmaceuticals Corporation (East Hanover, NJ), was elected chair of the National Pharmaceutical Council’s (NPC) board of directors for 2010-2011. Rigby has served on NPC’s board since 2007, most recently as vice-chair, and has been active on the organization’s communications and strategic coordinating committees. NPC also elected Robert A. McMahon, president of US commercial operations at Merck & Co. (Whitehouse Station, NJ), to serve as its vice-chair, and Rich Fante, US president of AstraZeneca (London), as treasurer.
|
|
|
This week, the US Food and Drug Administration held a two-day public hearing to gain public input on how to implement and regulate the follow-on biologics pathway that was cleared via President Obama’s Biologics Price Competition and Innovation Act of 2009, which falls under the 2010 approved healthcare reform legislation. Members from the agency’s biologics and drug evaluation and research centers (the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research), as well as the Office of Compliance, were on the panel. Representatives from the major industry trade associations, the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and the Generic Pharmaceutical Association (GPhA), gave presentations, as did other members of industry and healthcare. The transcript of the hearing will be available here. See the related PharmTech Talk blog post, Biosimilars Hearing Begins Today.
|
|
|
