More contamination troubles for Genzyme Nov 14, 2009
Fabrazyme treats Fabry disease, which prevents the body from breaking down oils and fats that build up in the eyes and kidneys. Particles are believed to have been found in less than 1 percent of the Genzyme drugs based on product lots examined, according to a statement from the Food and Drug Administration. (Boston Globe)
Inventive Approach May Improve Enzyme Replacement Therapy For Fabry Disease Oct 25, 2009
The research, published by Cell Press on October 22nd in the American Journal of Human Genetics, describes a new and highly promising candidate for enzyme replacement therapy (ERT) for Fabry disease ... Fabry disease is a rare genetic disorder caused by a deficiency in alpha-galactosidase-A (GLA), an enzyme that breaks down fatty substances called glycolipids ... "The modified NAGA is highly promising as a new enzyme for ERT for Fabry disease, and such structure-based designing of modified... (Science Daily)
Genzyme expects shortages of two drugs to end by 2010 Sep 24, 2009
Genzyme started rationing Cerezyme, used for Gaucher disease, and Fabrazyme, for Fabry disease, after discovering the virus ... Gaucher and Fabry disease are inherited disorders caused by low levels of certain enzymes needed to break down fatty substances. (Boston Globe)
Genzyme struggles to recover from virus Sep 21, 2009
The rationing program continues for Cerezyme, which treats Gaucher disease, and Fabrazyme, a treatment for Fabry disease. Both diseases are enzyme deficiencies. (Boston Globe)
Analyst Picks and Pans: Fannie Mae, Freddie Mac, Genzyme Sep 1, 2009
Fabrazyme treats an inherited disorder known as Fabry disease, which is caused by the buildup of a particular type of fat in the body's cells. Meanwhile, European regulators have now inspected the Allston plant. (BusinessWeek)
Inspectors find major flaw at Genzyme plant Sep 1, 2009
The shutdown of the 13-year-old plant caused a shortage of Cerezyme, a drug to treat Gaucher disease, and of Fabrazyme, for Fabry disease. Genzyme is the world s leading supplier of treatments for the disorders. (Boston Globe)
Let the race begin Aug 21, 2009
Genzyme s drug to treat patients suffering from Fabry disease won that intense competition. A new round of competition is about to begin. (Boston Globe)
Genzyme closes drug plant due to virus Aug 14, 2009
Genzyme has previously said that it is currently not making enough of the drugs Cerezyme for Gaucher s disease and Fabrazyme for Fabry disease, to meet projected global demand. The company is unsure how the virus will affect the Cerezyme production but expects Fabrazyme supply constraints to occur for a limited period beginning in September. (Boston Business Journal, MA)
Genzyme guidance falls amid plant delays Aug 14, 2009
The Allston facility primarily produces Cerezyme for the treatment of Gaucher s disease and Fabrazyme, used to treat Fabry disease. For the three months ended June 30, Genzyme booked $1. (Boston Business Journal, MA)
FDA seeks contingency details from Genzyme Aug 13, 2009
Fabrazyme treats Fabry disease, in which a missing or faulty enzyme prevents the body from breaking down oils, waxes, and fatty acids that build up in the eyes and kidneys as well as the nervous and cardiovascular systems. Myozyme treats Pompe disease, which interferes with muscle development and causes severe respiratory problems. (Boston Globe)
FDA to Genzyme: plant not OK Aug 2, 2009
The facility produces the drug Fabrazyme, to treat Fabry disease, and Cerezyme, to treat Gaucher s disease. Genzyme officials say they will work with the FDA to schedule the re-inspection as soon as possible. (Boston Business Journal, MA)
Genzyme says FDA will reinspect Allston plant Aug 1, 2009
The plant produces the drugs Cerezyme to treat Gaucher disease and Fabrazyme to treat Fabry disease, both enzyme deficiency disorders. We are reinspecting as part of our normal procedures, FDA spokeswoman Karen Riley said in a statement yesterday. (Boston Globe)
Genzyme patients not negatively affected by production halt, they say Jul 10, 2009
The plant manufactures Cerezyme, a drug for Gaucher disease, and Fabrazyme, which treats Fabry disease ... At Massachusetts General Hospital in Boston, Dr. Katherine Sims, who does clinical work with Gaucher and Fabry diseases, said Genzyme has done a good job of communicating with physicians and patients about the supply disruption. (Boston Globe)
FDA moves to speed access to Gaucher drugs Jul 7, 2009
Cambridge-based Genzyme, which makes Cerezyme, the world s leading treatment for Gaucher disease, recently said it would shut down its plant in Allston after a virus halted production of Cerezyme and Fabrazyme, its treatment for Fabry disease, another rare condition. Protalix said the FDA has asked the company to consider submitting a treatment protocol that would allow use of its treatment, prGCD, under an expanded access program. (Boston Globe)
Genzyme drugs could be rationed for longer Jun 26, 2009
Cerezyme treats Gaucher disease, while Fabrazyme treats Fabry disease. The company said it hopes to resume full operations at the plant by the end of July, but because of the shutdown, doses will be temporarily rationed for many of the approximately 8,000 patients worldwide who use one of the drugs. (Boston Globe)
After a virus invades, Genzyme scrubs down Jun 25, 2009
Cerezyme treats Gaucher disease, while Fabrazyme treats Fabry disease. Both conditions cause waste to build up in the body, swelling organs. (Boston Globe)
Genzyme sees outside vendor as source of plant contamination Jun 20, 2009
The conditions, Gaucher disease and Fabry disease, cause waste to build up in parts of the body, swelling organs and causing a litany of problems. The treatments, which are given intravenously about every two weeks, are extremely expensive - about $200,000 a year per patient. (Boston Globe)
Framingham Genzyme operations OK despite Allston closing Jun 19, 2009
Fabrazyme treats an inherited disorder called Fabry disease, caused by the build-up of a particular type of fat in the body's cells. Cerezyme treats Gaucher disease, an enzyme disorder that can result in liver and neurological problems. (Framingham TAB, MA)
Genzyme plight leaves patients uneasy Jun 18, 2009
Fabrazyme treats another rare disorder called Fabry disease ... Fabry disease prevents the body from breaking down oils, waxes, and fatty acids, leading to problems with eating, an enlarged heart, and kidney problems ... Jack Johnson, who has Fabry disease, says he hasn t heard much concern about the shutdown from other patients. (Boston Globe)
Genzyme Shuts Down Facility After Detecting Virus Jun 17, 2009
Fabrazyme treats an inherited disorder known as Fabry disease, which is caused by the buildup of a particular type of fat in the body's cells. Cerezyme treats Gaucher disease, an enzyme disorder that can result in liver and neurological problems. (ABC News -- Wire)
Virus shuts Genzyme plant,holds up drugs for 8,000 Jun 17, 2009
Fabrazyme treats Fabry disease, in which a missing or faulty enzyme prevents the body from breaking down oils, waxes, and fatty acids that build up in the eyes and kidneys, as well as the nervous and cardiovascular systems ... Still, Jack Johnson, 46, who has Fabry disease, said any disruption in the drug supply could be disturbing to patients, there s no question about that. (Boston Globe)
Genzyme acquires rights to Campath Apr 1, 2009
the Cambridge biotechnology giant best known for targeting rare genetic disorders like Pompe disease and Fabry disease, is increasing its investment in drugs to treat broader diseases such as cancer and multiple sclerosis. The company said it struck a multimillion dollar deal yesterday with Bayer HealthCare to acquire most of Bayer's rights to Campath, a cancer drug in advanced clinical trials to treat multiple sclerosis. (Boston Globe)
Amicus Therapeutics Presents Positive Results From Phase 2 Extension Study of Amigal(TM) for Fabry Disease at ACMG 2009 Annual Meeting Mar 30, 2009
CRANBURY, N.J., March 28 /PRNewswire-FirstCall/ -- Amicus Therapeutics (Nasdaq: ) announced today positive results from its ongoing Phase 2 extension study of its investigational drug, Amigal(TM) (migalastat HCL) for Fabry disease ... Fabry disease is a lysosomal storage disorder caused by inherited genetic mutations in the GLA gene, which result in deficient activity of the enzyme alpha-galactosidase A (a-Gal A) ... Deficient a-Gal A activity leads to lysosomal accumulation of... (PR Newswire)
