Content about AstraZeneca

February 23, 2011

The makers behind a popular Type 2 diabetes treatment have included data from two clinical studies in an update to the drug's prescribing information.

PRINCETON, N.J., and WILMINGTON, Del. — The makers behind a popular Type 2 diabetes treatment have included data from two clinical studies in an update to the drug's prescribing information.

Bristol-Myers Squibb and AstraZeneca said the Food and Drug Administration approved the labeling update for Onglyza (saxagliptin), which now includes efficacy and safety information about the drug's effects on patients with renal impairment or end-stage renal disease.

January 31, 2011

Nearly half a million people participated in AstraZeneca's prescription savings programs.

WILMINGTON, Del. — Nearly half a million people participated in AstraZeneca's prescription savings programs.

The drug maker reported that it provided $947 million in savings last year to the more than 545,000 patients in the United States who participated. Participation in the AZ&Me prescription savings programs has increased steadily over the past three years, up 7% over 2009 and 19% over 2008, AstraZeneca said.

January 17, 2011

A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

LONDON — A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

The drug maker recently announced that the Food and Drug Administration asked AstraZeneca to submit a Risk Evaluation and Mitigation Strategy, which accordingly extended the Prescription Drug User Fee Act from Jan. 7 to April 7.

AstraZeneca will continue to work closely with the FDA to support the review of vandetanib, a drug for treating patients with advanced medullary thyroid cancer.

January 11, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug to treat Type 2 diabetes made by Merck, the drug maker said Tuesday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug to treat Type 2 diabetes made by Merck, the drug maker said Tuesday.

Merck announced the acceptance of its application for extended-release Janumet, which combines in a single pill the active ingredient sitagliptin with extended-release metformin, a drug commonly prescribed for Type 2 diabetes.

January 7, 2011

A new oral treatment for Type 2 diabetes hit the shelves Friday.

PRINCETON, N.J. — A new oral treatment for Type 2 diabetes hit the shelves Friday.

Bristol-Myers Squibb and AstraZeneca announced the availability of Kombiglyze XR (saxagliptin and metformin hydrochloride), which the companies called the only once-daily treatment for diabetes that combined metformin with a DPP-4 inhibitor, the drug class to which saxagliptin belongs.

The drug is designed for use alongside diet and exercise to improve glycemic control in adults with Type 2 diabetes.

December 21, 2010

An Anglo-Swedish drug maker said it is discontinuing further development of a drug that is designed to prevent a respiratory virus that infects the lungs and breathing passages.

LONDON — An Anglo-Swedish drug maker said it is discontinuing further development of a drug that is designed to prevent a respiratory virus that infects the lungs and breathing passages.

AstraZeneca has requested the withdrawal of its pending biological license application for motavizumab from the Food and Drug Administration. Motavizumab is an investigational monoclonal antibody that could prevent serious respiratory syncytial virus disease.

AstraZeneca said it will incur a financial impairment charge of $445 million in fourth quarter 2010.

December 21, 2010

A judge recently blocked AstraZeneca from attempting to impede the development of generic versions of its popular cholesterol drug, according to published reports.

NEW YORK — A judge recently blocked AstraZeneca from attempting to impede the development of generic versions of its popular cholesterol drug, according to published reports.

December 17, 2010

The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

WILMINGTON, Del. — The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

The agency sent AstraZeneca a complete response letter requesting additional analyses of data from a clinical study of Brilinta (ticagrelor), but did not request additional studies. The drug is designed to treat acute coronary syndromes.

A complete response letter means that the FDA has completed its review of a drug application, but issues remain that preclude final approval.

December 9, 2010

An investigational treatment for lung cancer made by Boehringer Ingelheim Pharmaceuticals extended patients’ survival by more than four months, according to results of a late-stage clinical trial announced Thursday.

RIDGEFIELD, Conn. — An investigational treatment for lung cancer made by Boehringer Ingelheim Pharmaceuticals extended patients’ survival by more than four months, according to results of a late-stage clinical trial announced Thursday.

BI said the phase 2b/3 “LUX-Lung 1” trial of BIBW 2992 (afatinib) showed a fourfold increase in survival among advanced non-small cell lung cancer patients taking the drug versus those taking placebo, whose survival was extended by one month.

December 2, 2010

A growing drug-treated population will cause the Type 2 diabetes drug market in China to increase to $2.5 billion by 2014 ...

BURLINGTON, Mass. — A growing drug-treated population will cause the Type 2 diabetes drug market in China to increase to $2.5 billion by 2014, according to a new report by Decision Resources.

The Type 2 diabetes market in China totaled $1.4 billion in 2009, Decision Resources said.

November 22, 2010

WOODCLIFF LAKE, N.J. Par Pharmaceutical has begun shipments of a generic treatment for asthma, the drug maker said Monday.

Par announced that it started shipping zafirlukast tablets in the 10-mg and 20-mg strengths. The drug is a generic version of AstraZeneca’s Accolate.

Accolate has sales of $50 million in the United States per year, according to IMS Health.

November 21, 2010

Indian generic drug maker Dr. Reddy’s Labs has launched a version of an asthma drug...

HYDERABAD, India Indian generic drug maker Dr. Reddy’s Labs has launched a version of an asthma drug for the U.S. market, the company said.

Dr. Reddy’s announced the launch of zafirlukast tablets in the 10-mg and 20-mg strengths. The drug is a version of AstraZeneca’s Accolate, which had sales of $50 million during the 12-month period ended in August, according to IMS Health.

October 27, 2010

Many Type 2 diabetes patients who use the drug Onglyza (saxagliptin) switched to that drug...

BURLINGTON, Mass. Many Type 2 diabetes patients who use the drug Onglyza (saxagliptin) switched to that drug from Merck’s Januvia (sitagliptin) and Janumet (sitagliptin and metformin), according to a new report by market research firm Decision Resources.

 

October 13, 2010

AstraZeneca is launching a new campaign focused on depression, the Anglo-Swedish drug maker said Thursday....

WILMINGTON, Del. AstraZeneca is launching a new campaign focused on depression, the Anglo-Swedish drug maker said Thursday.

 

The campaign, “Take on Depression,” consists of a Facebook page and Twitter feed designed to provide information on bipolar depression and major depressive disorder.

 

 

October 5, 2010

AstraZeneca will provide medications free of charge to qualifying patients in Sacramento, Calif., through its...

WILMINGTON, Del. AstraZeneca will provide medications free of charge to qualifying patients in Sacramento, Calif., through its prescription savings program, the Anglo-Swedish drug maker said Wednesday.

 

September 29, 2010

The Food and Drug Administration has given tentative approval to a generic cholesterol drug made...

MUMBAI, India The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Sun Pharmaceutical Industries.

Sun announced Wednesday the tentative approval of rosuvastatin calcium tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths.

September 26, 2010

Supermarket chain Stater Bros. is marking National Breast Cancer Awareness Month in October by giving...

SAN BERNARDINO, Calif, Supermarket chain Stater Bros. is marking National Breast Cancer Awareness Month in October by giving away a drug used to treat the disease.

 

The chain announced Monday that it would provide 30-day supplies of the drug tamoxifen for free to patients with valid prescriptions at all of its 28 stores.

 

 

September 23, 2010

An investigational diabetes drug works as well as a generic already on the market, according...

STOCKHOLM An investigational diabetes drug works as well as a generic already on the market, according to results of a late-stage clinical trial announced Friday by AstraZeneca and Bristol-Myers Squibb.

 

September 22, 2010

The Food and Drug Administration has accepted AstraZeneca’s regulatory application for an investigational cancer drug,...

LONDON The Food and Drug Administration has accepted AstraZeneca’s regulatory application for an investigational cancer drug, the Anglo-Swedish drug maker said Thursday.

 

AstraZeneca announced the FDA’s acceptance of its application for vandetanib, a drug for treating patients with advanced medullary thyroid cancer. The agency gave the drug priority review status and expected to take action on it in January.

 

 

September 14, 2010

The Food and Drug Administration has extended the amount of review time for an AstraZeneca...

WILMINGTON, Del. The Food and Drug Administration has extended the amount of review time for an AstraZeneca drug, AstraZeneca said Wednesday.

 

The FDA extended the date of completion for its review from Thursday to Dec. 16 for the drug Brilinta (ticagrelor), a drug used to treat acute coronary syndromes.

 

 

The drug also is under review in nine other areas, including Canada, Brazil and the European Union.

 

September 12, 2010

The Food and Drug Administration has approved a new dosage of an AstraZeneca drug for...

WILMINGTON, Del. The Food and Drug Administration has approved a new dosage of an AstraZeneca drug for treating breast cancer, AstraZeneca said Friday.

 

The Anglo-Swedish drug maker announced the approval of the 500-mg dose of the injected drug Faslodex (fulvestrant) for treating breast cancer that has spread to other parts of the body –– also known as metastasis –– in postmenopausal women after they have received anti-estrogen therapy. The new dosage replaces the previous 250-mg dose of the drug.

 

September 6, 2010

With September marked as National Cholesterol Education Month, drug maker AstraZeneca is using the occasion...

WILMINGTON, Del. With September marked as National Cholesterol Education Month, drug maker AstraZeneca is using the occasion to push lifestyles that promote low cholesterol, the Anglo-Swedish company said.

 

AstraZeneca, which markets the cholesterol-lowering drug Crestor (rosuvastatin calcium), is pushing such habits as a healthy diet and exercise as ways to keep cholesterol down. According to the American Heart Association, 102 million Americans ages 20 years and older have borderline-high or high cholesterol.

 

 

August 29, 2010

AstraZeneca's biologics unit has received a second complete response letter from the Food and Drug...

August 8, 2010

Anglo-Swedish drug maker AstraZeneca has settled 17,500 product liability cases involving one of its drugs,...

July 15, 2010

It’s been said many times that the people you know are as important as what...

WHAT IT MEANS AND WHY IT'S IMPORTANT It’s been said many times that the people you know are as important as what you know. In the case of Billy Tauzin, former president and CEO of the Pharmaceutical Research and Manufacturers of America, this adage was especially true, considering his former career as a member of Congress.

(THE NEWS: PhRMA names new president, CEO. For the full story, click here)