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The Digital Pharma Marketing Course
November 27, 2011–November 28, 2011
Brussels, Belgium
CPhI India
November 30, 2011–December 2, 2011
Mumbai, India
BioManufacturing World China 2011
November 30, 2011–December 1, 2011
Shanghai, China
Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
November 30, 2011–December 2, 2011
King-of-Prussia, Pennsylvania
4th West Coast Forum on Clinical Supply Chain Management
December 6, 2011–December 7, 2011
Burlingame, California

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FDA Notifies Genentech of Violations at Avastin Plant
On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company’s South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations. 
GlaxoSmithKline Agrees in Principle to $3-Billion Settlement with the US Government
GlaxoSmithKline (GSK) has come to a tentative agreement with the US government to conclude ongoing investigations relating to sales and marketing practices. The settlement is still subject to negotiation, but GSK expects to pay around $3 billion, which is covered by existing legal provisions. The final amount and terms of the settlement are expected to be finalized in 2012. 
SOCMA Lends Support for Measures Addressing Nontariff Barriers
The Society of Chemical Manufacturers and Affiliates issued a statement to support a recently introduced bill intended to help the federal government deal with market-access barriers more effectively. 
EMA Eyes Ophthalmic Medicines
Seeking to review the regulatory and scientific challenges in developing ophthalmic medicines, EMA brought together eye-disease experts from Europe, Asia, and the US for a two-day workshop. 
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Software manages information in a centralized enterprise system
Honeywell’s vendor-neutral process-control suite allows plant operators to centrally monitor and control process-control systems. It is designed to avoid the information silos that can be created by Advanced Process Control (APC) systems.
The suite contains Honeywell’s Loop Scout software, which gives control engineers the ability to identify and correct poorly performing control loops. In addition, the Control Performance Monitor detects, identifies, diagnoses, and remedies regulatory and APC asset issues throughout the plant.
The Honeywell Process Solutions suite can work with various APC technologies and processing facilities, thus contributing to consistent performance benchmarking across the enterprise and ensuring that proper corrective action is taken if necessary.
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AMAG Pharmaceuticals, a biopharmaceutical company, has announced leadership changes, including the departure of the company’s president and CEO, Brian J. G. Pereira, and the implementation of a broad restructuring plan to reduce operating expenses.
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Ancor Capital Partners, a private-equity firm, has acquired WellSpring Pharmaceutical, a CMO and manufacturer and marketer of specialty prescription over-the-counter (OTC) products.
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Bosch Packaging Technology has announced plans to build a second production facility in Chengdu, China. The investment amounts to EUR 17 million ($23.1 million), and includes an agreement concerning the use of a 66,000-m2 site (710,418 ft2).
The new location’s land area is twice the size of Bosch’s existing location in Hangzhou, China. The company will start operations in Chengdu at the beginning of next year in a leased production hall. Construction work for the new plant is set to start in 2014. A year later, the first expansion phase will be completed when a building of 13,500 m2 (145,313 ft2) of floor space will be ready for occupation. The production area will occupy 7200 m2 (77,500 ft2) of the total floor space. The new facility will enable Bosch to serve the pharmaceutical, food, and confectionery sectors with packaging machines of medium output capacity.
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Eli Lilly and Company and the biopharmaceutical company Amylin Pharmaceuticals have terminated their alliance for Byetta (exenatide), a diabetes drug, and plan to resolve the outstanding litigation between the companies. As part of the agreement, the parties will transition full responsibility for the worldwide development and commercialization of exenatide to Amylin, beginning in the United States (US) on Nov. 30, 2011, and progressing to all markets by the end of 2013. Under the terms of the new global agreement, Amylin will make a one-time, upfront payment to Lilly of $250 million. Amylin will also agree to make future revenue-sharing payments to Lilly in an amount equal to 15% of global net sales of exenatide products until Amylin has made aggregate payments to Lilly of $1.2 billion plus accrued interest. Amylin will issue a secured note in the amount of $1.2 billion to Lilly under which any revenue-sharing payments made to Lilly will reduce amounts outstanding under the note. If Amylin’s investigational, once-weekly version of exenatide, Bydureon (exenatide extended-release for injectable suspension), has not received FDA approval prior to June 30, 2014, Amylin’s revenue sharing obligations will terminate, and Amylin shall thereafter pay Lilly 8% of global net sales of exenatide products. Amylin will also pay a $150-million milestone to Lilly contingent upon FDA approval of a once monthly suspension version of exenatide that is currently in Phase II. The companies have also agreed that the maturity date for the $165-million line of credit that Amylin drew from Lilly earlier in the year will be extended from the second quarter of 2014 to the second quarter of 2016.
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In other news, Lilly has entered into a collaboration agreement with AMRI. AMRI plans to hire over 40 synthetic chemists by the third quarter of 2012 to support Lilly’s drug-discovery programs. The chemists will work onsite at Lilly’s headquarters in Indianapolis, Indiana, where they will support the medicinal chemistry department. This collaboration will further accelerate Lilly’s drug-discovery efforts by maximizing real-time exchange of scientific information. AMRI expects to recruit the majority of the synthetic chemists who will be affiliated with this collaboration from Indiana and surrounding states. The term of the collaboration is six years, extendable by mutual agreement of both parties.
Evonik Industries, a specialty- and fine-chemicals company, agreed to acquire the pharmaceuticals business of SurModics, a producer of bio-resorbable polymers, on Nov. 1, 2011. The acquisition is subject to customary closing conditions and regulatory approval.
Hawaii Biotech (HBI), a biotechnology company, has acquired an exclusive license to tick-borne encephalitis virus, malaria vaccine technology, and a nonexclusive license to recombinant protein-expression technology from Merck, through a subsidiary. These technologies were previously developed by HBI and acquired by Merck as part of a larger transaction in 2010.
MedImmune, the biologics arm of AstraZeneca, has announced that the company’s expansion project at its Frederick, Maryland, manufacturing center won the International Society for Pharmaceutical Engineering’s (ISPE) overall 2011 Facility of the Year Award. This is the first time MedImmune has won the award. The annual Facility of the Year Awards, sponsored by the ISPE and INTERPHEX, recognizes projects using new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.
PerkinElmer has completed its acquisition of Caliper Life Sciences, an imaging and detection services provider for life-sciences research, diagnostics, and environmental markets. In September 2011, PerkinElmer announced its intent to acquire Caliper for $10.50 per share, for a total net purchase price of approximately $600 million in cash.
The Procter & Gamble Company and Teva Pharmaceutical Industries have entered into a consumer healthcare partnership and joint venture (JV). The JV, to be named PGT Healthcare, will be headquartered in Geneva, Switzerland, and will operate in markets primarily outside of North America. The partnership between P&G and Teva will also develop new brands for the North American market. PGT Healthcare will focus on development and commercialization of branded OTC medicines. The JV will bring together each company’s complementary capabilities and existing OTC medicines. The partnership will start from a base of approximately $1.3 billion in annual sales and is targeted to grow to $4 billion in annual sales toward the end of the decade, according to the companies.
West Pharmaceutical Services, an injectable drug service provider, and the CDMO Vetter have agreed to provide customers with the ability to source filled Daikyo Crystal Zenith syringes. Investments have been made at Vetter’s facilities in Germany and at its new Chicago facility. Capabilities will initially exist for early-phase clinical filling in Germany. Options for commercial-scale filling will be available.
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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DCAT has announced its 2011–2012 board of directors. Joan Connolly, principal with Connovan Consulting, has been named president, taking over from Bob Kanuga, who is now vice-president of external manufacturing with Merck & Co. A complete list of the board members may be found here.
The Johnson & Johnson subsidiary SterilMed has appointed Mike Gustafson as the company’s president. Gustafson will succeed Brian Sullivan, who intends to retire from the company following a transition period.
The CDMO Patheon announced that Eric Evans, executive vice-president and chief financial officer (CFO), has resigned from the company. His duties will be managed by the company’s finance and operations teams until a new CFO is appointed.
The biotechnology company Threshold Pharmaceuticals has appointed Nipun Davar as vice-president of pharmaceutical development and manufacturing. In this position, Davar will lead all activities related to formulation development and manufacturing of TH-302, Threshold’s Phase III clinical-stage, hypoxia-targeted cancer therapeutic.
The US Pharmacopeia (USP) has made several appointments to its executive team. Praveen Tyle has joined USP as the organization’s chief science officer. In addition, Scott Henderson was named chief information officer, and Angela G. Long has been appointed as chief of global alliances and organizational affairs, and V. Srini Srinivasan as chief international sites and standards officer.
Viamet Pharmaceuticals, a drug-development services provider, has named Marc S. Rudoltz to the newly created position of chief medical officer. Rudoltz will oversee the development of the company’s novel therapies for oncology and infectious disease. Rudoltz was previously senior global clinical leader at Novartis Oncology.
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Solid-Dosage Innovation
What is driving manufacturers to reformulate or reinvent currently marketed solid dose pharmaceutical products?
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View the poll archive. |
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