Content about JERUSALEM

August 8, 2011

The Food and Drug Administration has accepted an approval application for a drug made by Teva Pharmaceutical Industries for treating allergies, Teva said.

JERUSALEM — The Food and Drug Administration has accepted an approval application for a drug made by Teva Pharmaceutical Industries for treating allergies, Teva said.

The Israeli drug maker said the FDA accepted its application for BDP Nasal HFA (beclomethasone dipropionate hydrofluoroalkane) for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis. The drug is a nasal aerosol corticosteroid.

July 29, 2011

Teva Pharmaceuticals has launched an authorized generic version of a contraceptive made by Duramed Pharmaceuticals, Teva said.

JERUSALEM — Teva Pharmaceuticals has launched an authorized generic version of a contraceptive made by Duramed Pharmaceuticals, Teva said.

Teva announced the launch of Camrese, an authorized generic of Duramed’s Seasonique (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets).

The launch of Teva’s authorized generic follows the launch of Watson Pharmaceuticals’ generic version of the drug, which it is marketing under the name Amethia.

June 14, 2011

Before they can move ahead with their deal, drug makers Teva and Cephalon must provide the Federal Trade Commission with additional information related to Teva's pending acquisition of Cephalon.

JERUSALEM and FRAZER, Pa. — Before they can move ahead with their deal, drug makers Teva and Cephalon must provide the Federal Trade Commission with additional information related to Teva's pending acquisition of Cephalon.

June 2, 2011

The Food and Drug Administration has approved a generic drug for Alzheimer’s disease made by Teva Pharmaceutical Industries.

JERUSALEM — The Food and Drug Administration has approved a generic drug for Alzheimer’s disease made by Teva Pharmaceutical Industries.

The FDA approved Teva’s donepezil hydrochloride tablets in the 5-mg and 10-mg strengths.

The drug is a generic version of Aricept, made by Pfizer and Eisai. Branded and generic versions of the drug had sales of about $2.3 billion during the 12-month period ended in March, according to IMS Health.

May 2, 2011

Cephalon has another suitor in the form of the world’s largest generic drug company.

JERUSALEM — Cephalon has another suitor in the form of the world’s largest generic drug company.

Teva Pharmaceutical Industries said Monday that it would buy Frazer, Pa.-based Cephalon for $6.8 billion, undercutting efforts by Valeant Pharmaceuticals International, which had offered $5.7 billion in March.

The boards of both companies have agreed to the acquisition, equal to $81.50 per share. Cephalon previously had turned down Valeant’s offer, prompting the Mississauga, Ontario-based company to take its case directly to Cephalon’s shareholders.

April 12, 2011

An investigational drug made by Teva Pharmaceutical Industries and Active Biotech for multiple sclerosis reduced disease relapses and prevented the progression of disability, according to late-stage clinical trial results announced Monday.

JERUSALEM — An investigational drug made by Teva Pharmaceutical Industries and Active Biotech for multiple sclerosis reduced disease relapses and prevented the progression of disability, according to late-stage clinical trial results announced Monday.

March 1, 2011

Teva on Tuesday said that a trial date has been set for its ongoing patent infringement litigation against several drug makers.

JERUSALEM — Teva on Tuesday said that a trial date has been set for its ongoing patent infringement litigation against several drug makers.

Teva said the U.S. District Court for the Southern District of New York will commence proceedings Sept. 7. Teva's litigation is against Momenta Pharmaceuticals/Sandoz and Mylan Pharmaceuticals/Mylan/Natco Pharma regarding their purported generic versions of Copaxone (glatiramer acetate injection).

February 9, 2011

An investigational drug made by Teva Pharmaceutical Industries for treating allergies is safe and effective, according to results of a late-stage clinical trial announced Wednesday.

JERUSALEM — An investigational drug made by Teva Pharmaceutical Industries for treating allergies is safe and effective, according to results of a late-stage clinical trial announced Wednesday.

Teva said the phase-3 trial of the nasally inhaled drug Qnaze (beclomethasone dipropionate) showed that it significantly relieved symptoms of seasonal and perennial allergic rhinitis compared with placebo while demonstrating a similar safety profile.

February 8, 2011

Drug maker Teva on Tuesday said its North American sales during the fourth quarter ended Dec. 31 drove the drug maker's financial well-being.

JERUSALEM — Drug maker Teva on Tuesday said its North American sales during the fourth quarter ended Dec. 31 drove the drug maker's financial well-being.

January 26, 2011

Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.

JERUSALEM — Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.

Teva and APP launched gemcitabine hydrochloride injfection in 200-mg and 1-g single-dose vials. The drug is a version of Eli Lilly’s Gemzar, which had sales of about $785 million in the United States in 2010, according to IMS Health. The drug is used to treat cancers of the lungs, pancreas, breasts and ovaries.

January 25, 2011

Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

JERUSALEM — Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

December 13, 2010

Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.

JERUSALEM — Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.

Teva said its petition, concerning the drug Copaxone (glatiramer acetate), is based on what it called the inability to establish acceptable “sameness” due to the active ingredient’s complexity.

December 2, 2010

Oramed Pharmaceuticals, a developer of oral drug delivery solutions, has published an article in the Journal of Diabetes Science and Technology’s November issue describing evaluation of the company’s glucagon-like peptide (GLP-1) analog formulation (ORMD-0901) in regulating glucose excursions in animal models.

JERUSALEM — Oramed Pharmaceuticals, a developer of oral drug delivery solutions, has published an article in the Journal of Diabetes Science and Technology’s November issue describing evaluation of the company’s glucagon-like peptide (GLP-1) analog formulation (ORMD-0901) in regulating glucose excursions in animal models.

November 15, 2010

An investigative treatment for allergies made by Teva Pharmaceutical Industries appears to work, according to...

JERUSALEM — An investigative treatment for allergies made by Teva Pharmaceutical Industries appears to work, according to results of a late-stage clinical trial released Monday.

 

Teva said phase-3 data from a study of Qnaze HFA (beclomethasone dipropionate), designed to be inhaled through the nose, was effective in treating patients with seasonal allergic rhinitis, while safety results were similar to those for placebo. Data from the study were presented at the annual meeting of the American College of Allergy, Asthma & Immunology in Phoenix.

October 17, 2010

The Food and Drug Administration granted approval for Teva's abbreviated new drug application to market...

JERUSALEM The Food and Drug Administration granted approval for Teva's abbreviated new drug application to market a generic version of a drug designed to treat peptic ulcers.

The generic drug maker said that its drug, lansoprazole, is a generic version of Takeda’s Prevacid SoluTab. Annual sales of the branded product were approximately $453 million in the United States, according to IMS sales data.

Sandoz, the generics division of Swiss drug maker Novartis, also announced the launch of its own version of Prevacid SoluTab.

September 30, 2010

Teva Pharmaceutical Industries and Active Biotech announced promising results from a mid-stage trial of laquinimod,...

September 29, 2010

The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker...

JERUSALEM The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker said Thursday.

 

Teva said it received a complete response letter from the FDA concerning Neutroval (filgrastim), for neutropenia in patients receiving chemotherapy for cancer. The FDA issues complete response letters when it needs additional information before it can approve a drug.

 

 

Neutroval is a biosimilar of Amgen’s Neupogen and is marketed in Europe under the name TevaGrastim.

 

September 21, 2010

Teva filed a complaint against a generic drug maker this week, asserting four patents for...

JERUSALEM Teva filed a complaint against a generic drug maker this week, asserting four patents for its multiple sclerosis drug are being infringed.

September 14, 2010

Oramed Pharmaceuticals has seen promising results from a clinical trial of an oral insulin for...

JERUSALEM Oramed Pharmaceuticals has seen promising results from a clinical trial of an oral insulin for diabetes, the Israeli drug maker said.

 

The company said its exploratory clinical trial of the oral insulin capsule ORMD-0801 was successful. The company is developing the capsule as a treatment for patients with uncontrolled Type 1 diabetes. The company also is developing the oral insulin as a treatment for Type 2 diabetes.

 

 

August 9, 2010

Israeli drug maker Teva Pharmaceutical Industries has finished its $5 billion acquisition of German generic...

August 2, 2010

Teva Pharmaceutical Industries got closer to finishing its $5 billion acquisition of German drug maker...