Content about Genzyme

March 11, 2014

Prasco Laboratories announced on Tuesday that it has started shipping the generic version of Hectorol (doxercalciferol) 0.5-, 1.0- and 2.5-mcg capsules, each in 50-count bottles under the Prasco label.

CINCINNATI — Prasco Laboratories announced on Tuesday that it has started shipping the generic version of Hectorol (doxercalciferol) 0.5-, 1.0- and 2.5-mcg capsules, each in 50-count bottles under the Prasco label.

Prasco entered into a distribution and supply agreement with Genzyme, a Sanofi company, for doxercalciferol capsules, the generic version of Hectorol 0.5-, 1.0- and 2.5-mcg capsules.
 

February 6, 2014

Sandoz announced the launch of doxercalciferol injection vials, the first generic version of Genzyme’s Hectorol.

PRINCETON, N.J. — Sandoz announced the launch of doxercalciferol injection vials, the first generic version of Genzyme’s Hectorol. Doxercalciferol injection vials are used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

“Sandoz is pleased to be the first company to market a high quality, affordable generic version of this important product to dialysis patients in the US,” Peter Goldschmidt, President of Sandoz, said.  

December 30, 2013

The Food and Drug Administration has declined to approve a drug made by Genzyme Corp. for certain forms of multiple sclerosis, the company said Monday.

CAMBRIDGE, Mass. — The Food and Drug Administration has declined to approve a drug made by Genzyme Corp. for certain forms of multiple sclerosis, the company said Monday.

March 22, 2013

Disease relapse rates and worsening of disability were low among patients taking a drug made by Genzyme for multiple sclerosis, the company said.

CAMBRIDGE, Mass. — Disease relapse rates and worsening of disability were low among patients taking a drug made by Genzyme for multiple sclerosis, the company said.

Genzyme, a division of French drug maker Sanofi, announced results of an extension study of the drug Lemtrada (alemtuzumab). The study was a follow-up to two other late-stage clinical studies of the drug, finding that relapse rates and sustained accumulation of disability remained low among patients who had previously received the drug.

January 30, 2013

The Food and Drug Administration has approved a new drug for treating a rare cholesterol disorder, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare cholesterol disorder, the agency said.

The FDA announced the approval of Kynamro (mipomersen sodium), made by Genzyme for the treatment of homozygous familial hypercholesterolemia, or HoFH. Kynamro has been approved as an orphan drug, a designation the FDA gives to drugs that treat diseases affecting fewer than 200,000 people.

January 28, 2013

The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.

CAMBRIDGE, Mass. — The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.

Genzyme, a division of French drug maker Sanofi, said the FDA accepted its application seeking approval for Lemtrada (alemtuzumab) for relapsing MS. The company expects the agency to decide whether to approve the drug in the second half of this year.

October 2, 2012

An experimental drug for treating a rare genetic disease appears effective, according to a late-stage clinical trial.

CAMBRIDGE, Mass. — An experimental drug for treating a rare genetic disease appears effective, according to a late-stage clinical trial.

September 13, 2012

The Food and Drug Administration has approved a new drug for multiple sclerosis.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new drug for multiple sclerosis.

Sanofi subsidiary Genzyme announced that the FDA had approved Aubagio (teriflunomide) as a once-daily, oral treatment for patients with relapsing MS.

September 4, 2012

Generic drug maker Impax Labs has settled with a subsidiary of Sanofi regarding generic versions of two drugs for dialysis patients, Impax said Tuesday.

HAYWARD, Calif. — Generic drug maker Impax Labs has settled with a subsidiary of Sanofi regarding generic versions of two drugs for dialysis patients, Impax said Tuesday.

Impax announced a settlement with Genzyme concerning generic versions of Renvela (sevelamer carbonate) 800 mg tablets and 2.4 g and 0.8 g oral suspension and Renagel (sevelamer hydrochloride) tablets in the 400 mg and 800 mg strengths.

August 27, 2012

Genzyme announced it has received a refuse-to-file letter from the Food and Drug Administration in response to the drug maker's supplemental biologics license application for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis.

CAMBRIDGE, Mass. — Genzyme announced it has received a refuse-to-file letter from the Food and Drug Administration in response to the drug maker's supplemental biologics license application for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis.

July 31, 2012

Abon Pharmaceuticals is challenging the patent protection on an injected drug used to treat leukemia in children and adolescents, the company said Tuesday.

NORTHVALE, N.J. — Abon Pharmaceuticals is challenging the patent protection on an injected drug used to treat leukemia in children and adolescents, the company said Tuesday.

Abon said it filed with the Food and Drug Administration for regulatory approval of clofarabine in the 1 mg-per-mL strength. The drug is a generic version of Genzyme's Clolar, used to treat relapsed or refractory acute lymphoblastic leukemia in patients ages one to 21 years, who already have undergone at least two regimens.

June 12, 2012

A Sanofi company is seeking regulatory approval from the Food and Drug Administration for a drug designed to treat relapsing multiple sclerosis.

CAMBRIDGE, Mass. — A Sanofi company is seeking regulatory approval from the Food and Drug Administration for a drug designed to treat relapsing multiple sclerosis.

May 3, 2012

Drug makers could strike big with new treatments for rare diseases, according to a new report by a market research firm.

NEW YORK — Drug makers could strike big with new treatments for rare diseases, according to a new report by a market research firm.

April 20, 2012

Drug maker Genzyme plans to present data from trial programs of two multiple sclerosis drugs at the American Academy of Neurology's annual meeting in New Orleans, which starts this Saturday and lasts until next Saturday.

CAMBRIDGE, Mass. — Drug maker Genzyme plans to present data from trial programs of two multiple sclerosis drugs at the American Academy of Neurology's annual meeting in New Orleans, which starts this Saturday and lasts until next Saturday.

Genzyme, owned by French drug maker Sanofi, will present results of 12 trials of the experimental drugs alemtuzumab and teriflunomide, including the phase-3 "CARE-MS II" trial, which compares alemtuzumab with Rebif (interferon beta-1a), made by Pfizer and Merck KGaA.

January 24, 2012

The Food and Drug Administration has approved a new manufacturing plant that will be operated by drug maker Genzyme.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new manufacturing plant that will be operated by drug maker Genzyme.

Genzyme said the plant, located in Framingham, Mass., will help the company continue the production of Fabrazyme (agalsidase beta), a Fabry disease treatment, so that patients can be return to the full dosing levels (1 mg/kg).

December 21, 2011

An orally administered drug made by Genzyme for treating multiple sclerosis did not appear superior to a biotech drug already on the market, according to results of a late-stage clinical trial.

CAMBRIDGE, Mass. — An orally administered drug made by Genzyme for treating multiple sclerosis did not appear superior to a biotech drug already on the market, according to results of a late-stage clinical trial.

Genzyme, owned by French drug maker Sanofi, compared the once-daily drug teriflunomide with Rebif (interferon beta-1a), made by Pfizer and Merck KGaA, in patients with relapsing MS in the 324-patient "TENERE" trial. Merck KGaA, based in Germany, operates under the name EMD Serono in the United States to avoid confusion with U.S.-based Merck & Co.

November 14, 2011

A late-stage clinical trial of a drug under development as a treatment for multiple sclerosis has shown "successful" results.

CAMBRIDGE, Mass. — A late-stage clinical trial of a drug under development as a treatment for multiple sclerosis has shown "successful" results.

Genzyme, acquired earlier this year by French drug maker Sanofi, announced results of the phase-3 "CARE-MS II" trial of Lemtrada (alemtuzumab), saying the drug "significantly reduced" worsening of disability and relapse in patients with MS, compared with Rebif (interferon beta-1a), made by Pfizer and German drug maker Merck KGaA, a separate company from U.S.-based Merck.

November 10, 2011

Genzyme has named leaders of two units that are part of the core focus of the drug maker's business.

CAMBRIDGE, Mass. — Genzyme has named leaders of two units that are part of the core focus of the drug maker's business.

Bill Sibold, former chief commercial officer at Avanir Pharmaceuticals, was appointed to serve as head of the multiple sclerosis business, while Rogério Vivaldi, who most recently served as president of Genzyme’s renal and endocrinology business, now is the head of the rare diseases business.

Both Sibold and Vivaldi will report to Genzyme president and CEO David Meeker, who recently became part of the company's executive team.

October 25, 2011

Sanofi has appointed David Meeker as CEO of Genzyme, the French drug maker said.

PARIS — Sanofi has appointed David Meeker as CEO of Genzyme, the French drug maker said.

Sanofi bought the Cambridge, Mass.-based biotech manufacturer for $20.1 billion earlier this year.

"After working closely with David over the past six months, I am confident that he is the best person to lead Genzyme," Sanofi CEO Christopher Viehbacher said. "David's commitment to employees, physicians and patients has been a key success factor in the successful integration of Genzyme as part of the Sanofi Group."

October 11, 2011

A drug maker that focuses on treatments for hemophilia has named a new CEO.

LAGUNA NIGUEL, Calif. — A drug maker that focuses on treatments for hemophilia has named a new CEO.

Inspiration Biopharmaceuticals announced Tuesday the appointment of John Butler as chief executive officer. Butler replaces Michael Griffith, who is taking the role of chief scientific officer while retaining the title of president.

September 15, 2011

GlaxoSmithKline and Amicus Therapeutics have started a late-stage clinical trial for a drug to treat a rare genetic disorder, the companies said.

CRANBURY, N.J. — GlaxoSmithKline and Amicus Therapeutics have started a late-stage clinical trial for a drug to treat a rare genetic disorder, the companies said.

GSK and Amicus announced the start of a second phase-3 trial of Amigal (migalastat hydrochloride) for Fabry disease, a rare lysosomal storage disorder that affects between 5,000 and 10,000 people worldwide. The market for Fabry disease has long been dominated by Genzyme, a subsidiary of French drug maker Sanofi that makes the biologic drug Fabrazyme (agalsidase beta).

June 30, 2011

Impax Labs has agreed not to market a generic version of a drug designed to reduce blood sugar and cholesterol in tablet form until 2015.

HAYWARD, Calif. — Impax Labs has agreed not to market a generic version of a drug designed to reduce blood sugar and cholesterol in tablet form until 2015.

April 11, 2011

Genzyme now officially is a wholly owned subsidiary of Sanofi-Aventis.

PARIS — Genzyme now officially is a wholly owned subsidiary of Sanofi-Aventis.

The Paris-based drug maker said that the closing followed the completion of the exchange offer for drug maker Genzyme last week. As its subsidiary, Genzyme will become a new platform in Sanofi's sustainable growth strategy and expand the company's presence in biotechnology, Sanofi said. Genzyme will continue to operate out of its Cambridge, Mass., headquarters, and will be led by Sanofi CEO Christopher Viehbacher for several months.

April 4, 2011

Sanofi-Aventis said it completed its exchange offer for drug maker Genzyme, which expired just before midnight April 1.

PARIS — Sanofi-Aventis said it completed its exchange offer for drug maker Genzyme, which expired just before midnight April 1.

All 224,528,469 shares of Genzyme common stock were validly tendered, which is represented by 84.6% of common stock and 77% of shares on a diluted basis.

Last month, the board of directors of Genzyme unanimously recommended that shareholders accept French drug maker Sanofi-Aventis’ $74-per-share buyout offer.

March 7, 2011

The board of directors of Genzyme unanimously recommended that shareholders accept French drug maker Sanofi-Aventis’ $74-per-share buyout offer, Genzyme said Monday.

CAMBRIDGE, Mass. — The board of directors of Genzyme unanimously recommended that shareholders accept French drug maker Sanofi-Aventis’ $74-per-share buyout offer, Genzyme said Monday.

Genzyme recently accepted Sanofi’s $20.1 billion offer for the Cambridge, Mass.-based biotech company. Sanofi had sought to buy the company since last July, when it offered $18.5 billion, or $69 per share.