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The article discusses the growing participation of patients to clinical research. It was observed that patients look for faster drug development, better recruitment for clinical research, and actions from regulatory settings. Highlighted are the cases of biotechnology firm Genzyme on the exclusive license of patent for Fabrazyme and of John and Aileen Crowley who raised funds for nonprofits supporting research into their children's Pompe disease. However, there is a concern on conflicts of interest for the relationships of advocates and the industry.

The article reports on the signing of a $1.9 billion agreement between Genzyme and Isis Pharmaceuticals in the U.S. According to the author, the agreement is to in-license the cholesterol-lowering antisense drug mipomersen. He added that Genzyme will pay $325 million up front for the powerful drug mipomersen, an antisense treatment that slashes cholesterol levels. Moreover, mipomersen is a second-generation antisense phosphorothioate oligonucleotide inhibitor that is thought to act by binding mRNA encoding apolipoprotein B-100.

Presents news briefs related to pharmaceutical industry in the U.S. as of September 2003. Financial performance of Amgen Pharmaceuticals in second quarter of 2003; Acquisition of SangStat Medical Corp. by pharmaceutical company Genzyme Corp.; Information about follow-on offerings in biotechnology sector in the month of July.

Five hypothetical mergers could change the industry and provide a model for its future. [ABSTRACT FROM AUTHOR]

The article reports on the approval of the Cerdelga, the first oral therapy to treat type I Gaucher's disease, by the U.S. Food and Drug Administration (FDA) in August 2014. The drug was made by Cambridge, Massachusetts-based Genzyme Corp., a Sanofi-Aventis SA company. Mark Clark, a biotech analyst at Deutsche Bank AG in London, England, states analysts do not expect a market sweep, despite the drug's convenience and comparable efficacy.

The article focuses on development of RNA interference (RNAi) therapeutics by the global biopharmaceutical companies. It informs the equity investment of 700 million dollars of Genzyme in Alnylam Pharmaceuticals for commercialization of RNAi therapeutics. It mentions the launch of venture-backed startups by Solstice Biologics.

The article discusses the buyout by Sanofi-aventis of Paris, France of Massachusetts-based Genzyme. The takeover negotiations started in late July 2010 when Sanofi presented a 17.5 billion U.S. dollars offer to Genzyme management which was rejected due to Sanofi's failure to recognize Genzyme's MS compound Lemtrada. Both parties finally agreed to 74 U.S. dollars per share and additional 14 U.S. dollars through the "contingent value right" (CVR). It cites Sanofi chief executive officer Chris Viehbacher emphasis on having a U.S. biotech presence.

The article offers information about the velaglucerase alfa, glucocerebrosidase (VPRIV) developed by Shire and was approved by the European Medicines Agency and the U.S. Food and Drug Administration. The gene-activation technology is used for the firm's enzyme replacement therapies, Replagal for treating Fabry disease and VPRIV for Gaucher disease The intellectual property case between Genzyme and Amgen for its erythropoietin is discussed.

The article reports on the acceleration of approval of products of competing biotechnology manufacturers and the sale of stock by investors at Genzyme as the company faces viral contamination problem at its plant in Allston, Massachusetts. With the problem facing Genzyme, the U.S. Food and Drug Administration approved products from Genzyme's competitors including the velaglucerase alfa and Replagal from Shire and the Uplyso taliglucerase alfa from Protalix Biotheraeutics for treatment of Gaucher's and Fabry's diseases. Genzyme, in response, has taken steps to upgrade its manufacturing processes and speed the construction and European approval process for its manufacturing facility in Geel, Belgium. It has implemented changes to operating procedures and focused on manufacturing quality.

The article reports on the decision of Genzyme to continue supporting Osiris in pursuing the use of its Prochymal mesenchymal stem cell (MSC) therapy in cardiac and autoimmune diseases. The results of the third and fourth clinical trials in the phase 3 studies for Prochymal in severe refractory graft-versus-host disease (GvHD) were said to be disappointing. Based on the article, the trials of Prochymal in Crohn's disease and in chronic obstructive pulmonary (COPD) were also discontinued because the placebo groups did better than expected. Randy Mills of Osiris comments on the results of the clinical trials.

The article discusses business dealings between Genzyme of Cambridge, MA and Osiris Technologies of Columbia, MD regarding mesenchymal stem cell (MSC) technology. Genzyme purchased rights from Osiris to sell its MSC treatments in all countries except for the United States and Canada. Drugs that are close to U.S. Food and Drug Administration (FDA) approval and commercialization are Prochymal and Chondrogen. Treatments are discussed for graft-versus-host disease, Crohn's disease, knee cartilage regeneration, acute radiation sickness, osteoarthritis, cardiovascular disease, diabetes, and chronic obstructive pulmonary disease (COPD). Also discussed are a contract with the U.S. Department of Defense, MSC drug manufacture, and clinical trail results.

The article offers news briefs on biotechnology. The Innovative Medicines Initiatives, a $2.9 billion plan to renew the competitiveness of Europe's pharma industry, is open for proposals. Genzyme will pay $325 million up front to develop and sell Isis' mipomersen, as part of a collaboration that has a $1.9 billion potential. The National Institutes of Health received a budget increased for 2008.

The article reports that Nuvelo Inc. is in the process of conducting phase 3 trials on its blood-clot buster enzyme therapy. The results are expected early next year. If the company successfully launches alfimeprase in the U.S. market, it will mark a new era in enzyme therapy. Genzyme Corp. and BioMarin Pharmaceuticals Inc. have earlier developed similar recombinant enzyme therapies.

The article reports on global developments related to biotechnology. The announcement of the U.S. Food and Drug Administration to crate phase O, or exploratory clinical trials, to speed up the development of new medicines. The plan of National Research and Technology to launch the BioInkubator, Hungary's first biotechnology incubator. The initiative of the European Medicines Agency that will promote drug development by small pharmaceutical companies. Genzyme Corp. has acquired the rights to gene therapy technology developed by Avigen.

In July, 2003, biotech companies Biogen Inc., Genzyme Corp. and Abbott Bioresearch Center filed a joint lawsuit against Columbia University, New York City in an attempt to invalidate a gene-splicing technology patent held by Columbia. The complaint accuses the university of an illegitimate effort to create a "patent monopoly," placing hundreds of millions of dollars in potential royalties and license fees at stake. The patent in question, number 6,455,275 issued by the U.S. Patent and Trademark Office in 2002, is the fourth in a string of so-called Axel patents, named for one of its inventors. Many observers of the litigation say the case, extremely unusual within the world of technology transfer, was initiated because of the large sums of money the patent has generated.

Reports on impact of false Internet postings on the financial status of biotechnology companies in the United States. Corporate profile of Ridgefield, New Jersey-based Biomatrix Inc.; Company history of Cambridge, Massachusetts-based Genzyme Corp.

Reports on the acquisition of a biotechnology company Cell Genesys Inc. in Foster City, California by another biotechnology company Genzyme Corp. in Cambridge, Massachusetts in October 1999 for 350 million dollars. Benefits of the deal to both the companies; Number of patents gained by Genzyme; Research projects on gene therapy that are being handled by Genzyme.

The article presents information on the biopharmaceutical company Shire's decision to withdraw its US marketing application for Replagal, an enzyme-replacement therapy for the treatment of Fabry's disease. It reports that Shire's decision to withdraw its application from the US Food and Drug Administration (FDA) came in context of Genzyme Corp's decision to resume the shipment of its own product, Fabrazyme, the only treatment approved in the U.S. for the treatment of Fabry's disease.

The article discusses the response of Genzyme on the tender offer made by Sanofi-aventis for 69 U.S. dollars per share.

This article reports on the move by biotechnology firm Genzyme to resolve manufacturing issues that have affected supplies of its biologics to treat Gaucher's disease and Fabry's diseases. The company sent patient communities letters detailing the company's plans for supply of the drugs. The impact of the issue on a takeover bid by Sanofi-Aventis for Genzyme is discussed.

In this article the author comments on the cases of Genzyme and Genentech, two U.S. biotechnology companies that took opposite approaches when faced with a competitive threat. He discusses the effort made by Genzyme to acquire competitor Novazyme Pharmaceuticals when the company was in financial trouble. He also examines the competition between Genentech and Tanox over an anti-immunoglobulin solution.

The article reports on the partnership formed by Massachusetts-based Genzyme with the Tianjin International Joint Academy of Biotechnology and Medicine in China.

The article reports that the U.S. Food and Drug Administration has drafted a decree that requires biotechnology firm Genzyme to pay 175 million U.S. dollars for disgorgement of previous profits.

The article reports that the state of recruitment in the life science industry has improved in the third quarter of 2009. Amgen, Pfizer and Celgene were among the companies that reported increase in profit in the quarter. Based on the article, the hiring at the 25 largest biotechnology companies has also increased, with Amgen and Genzyme having the highest number of job openings. While the number of full-time employees (FTEs) at Monsanto, Genzyme and Actelion has rose, the largest drop in employees were said to be at PerkinElmer and Amgen.

This article reports on the move of Genzyme to temporary shut down its plant in Allston, Massachusetts, in 2009. The company made the move due to a bioreactor contamination with Vesivirus 2117. It claims that the virus does not cause human infections, but impairs growth of the biologics-producing Chinese hamster ovary (CHO) cells.

This article reports on the decision of the U.S. Food & Drug Administration (FDA) to approve the production of the drug Myozyme (alglucosidase alfa) by Genzyme in 2009. The FDA approved the drug for the treatment of Pompe disease. However, the agency balked at the plan citing concerns about bioequivalence in the drug.

The article reports on the deal between Genzyme and Bayer to market Fludara-branded fludarabine for B-cell chronic lymphocyte leukemia (B-CLL), Leukine-branded sargramostim hematopoietic growth factor and Campath-branded alemtuzumab for B-CLL. Part of the deal also stipulates that Genzyme will pay Bayer up to $500 million based on annual revenues, while Bayer will continue supporting Genzyme in its development of Campath, which is being tested against multiple sclerosis (MS). According to Brian Abrahams, analyst with Oppenheimer, the deal would alter accounting and delineate development responsibilities.

This article discusses the U.S. Food and Drug Administration's rejection of Genzyme's application to produce Myozyme in its 2000-liter-scale facility under the same approval it has for its 160-liter-scale. The rejection is important because of the demand for the drug by those affected with Pompe disease and because of the negative effects it could have on the generics industry.

Reports on the termination of the merger between biotechnology companies Genzyme General and Cell Genesys Inc. Factors that led to the termination of the merger; Plans of Genzyme General to acquire Cell Genesis in November 1999;Reasons for the opposition of the board of directors of Cell Genesis in December 1999.