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August 6, 2007
Bayer HealthCare and Nektar Therapeutics have agreed to develop and commercialize NKTR-061 (inhaled amikacin). NKTR-061 is under development for adjunctive treatment of Gram-negative pneumonias that often lead to significant morbidity and mortality.…
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August 3, 2007
Thomas B. Smith, M.D. has been named vice president, medical affairs, Kendle. Dr. Smith will develop and lead the company's new global medical affairs organization, aimed at enhancing delivery of Phase II-IV services worldwide. This team of medical d…
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August 3, 2007
Regeneron Pharmaceuticals and Bayer HealthCare AG initiated a Phase III study of the VEGF Trap-Eye in the neovascular form of age-related macular degeneration (wet AMD). The study will compare the VEGF Trap-Eye and ranibizumab, Genentech's Lucentis,…
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August 3, 2007
Dr. Jur Strobos has been appointed chief medical officer of InNexus Biotechnology, Inc. Dr. Strobos has extensive experience as director of policy research in the office of the Commissioner of the FDA and has a background in drug law, medical product…
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August 2, 2007
Genzyme Corp. met its primary and secondary endpoints in a second Phase III trial of Mozobil in multiple myeloma (MM) similar to the recent trial in non-Hodgkin's lymphoma. The combined results of these two trials—in which patients with two typ…
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August 2, 2007
AMRI
2Q Revenues: $49.4 million (+8%)
2Q Earnings: $4.6 million (loss of $353,000 in 2Q2006)*
YTD Revenues: $97.7 million (+10%)
YTD Earnings: $7.8 million (earnings were $1.5 million YTD2006)
Comments: Contract revenue in the q…
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August 1, 2007
Johnson & Johnson is restructuring and plans to reduce its global work force by 4% or approximately 4,820 jobs, in an effort to counter losses as a result of falling sales of its heart stents due to safety concerns and impending patent expiration…
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August 1, 2007
Abraxis BioScience, Inc. has acquired a sterile injectable manufacturing facility in Phoenix, AZ, from Watson Pharmaceuticals, Inc. This facility currently manufactures products for both Watson and third parties and is capable of manufacturing lyophi…
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August 1, 2007
MDS Pharma Services is expanding its Development & Regulatory Services (DRS) business in Europe and will now offer full-service DRS consulting services to support development of new drugs and biopharmaceutical products for clients in Europe. The…
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July 31, 2007
Laureate Pharma, Inc. has entered into a cGMP contract manufacturing agreement with Enobia Pharma, a biotechnology company developing an enzyme replacement therapy for the treatment of hypophosphatasia. Under the agreement, Laureate will produce Enob…
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July 31, 2007
Robert M. Haggerty has been appointed to the newly created position of vice president of quality, Hyaluron Contract Manufacturing (HCM). Mr. Haggerty will be responsible for overseeing quality and regulatory compliance at the company’s Burlingt…
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July 31, 2007
PPD, Inc. plans to expand its operations in Bellshill, Lanarkshire, in an effort to meet the increasing demand for its drug development services. The company expects to invest as much as $30 million to expand its offices in this location during the n…
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July 30, 2007
OSG Norwich Pharmaceuticals, a CMO based in Norwich, NY, has been acquired by AFI Partners, a NYC-based private equity group. The company, which was owned by Outsourcing Services Group, will now be known as Norwich Pharmaceuticals, Inc., and operatio…
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July 30, 2007
ImClone Systems and Bristol-Myers Squibb have amended the terms of their Erbitux agreement regarding the development and promotion in North America. Under this amendment, the companies have expanded the investment in the ongoing clinical development…
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July 30, 2007
Akorn, Inc. and Hyaluron Contract Manufacturing (HCM) have signed a development and supply agreement for two ANDA injectable suspension products.
One of the products is an injectable sustained release pharmaceutical, which will be available in b…
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