Content about Astellas Pharma

October 17, 2013

Nearly two dozen women with heart disease will educate their communities about heart disease in women.

WASHINGTON — Nearly two dozen women with heart disease will educate their communities about heart disease in women.

September 25, 2013

Teva Pharmaceutical Industries has become the first to launch a generic drug for treating certain heart patients, the company said.

JERUSALEM — Teva Pharmaceutical Industries has become the first to launch a generic drug for treating certain heart patients, the company said.

Teva announced the launch of adenosine injection, a generic version of Astellas Pharma's Adenoscan. The drug is used in combination with thallium-201 in patients undergoing myocardial perfusion scintigraphy who are unable to exercise adequately.

August 22, 2013

Astellas Pharma has introduced a new drug for preventing the body from rejecting transplanted organs, the company said.

NORTHBROOK, Ill. — Astellas Pharma has introduced a new drug for preventing the body from rejecting transplanted organs, the company said Thursday.

The drug maker announced the availability of Astagraf XL (tacrolimus) extended-release capsules in pharmacies. The drug is designed for use in kidney transplant patients with Genenetech's CellCept (mycophenolate mofetil) and corticosteroids, with or without induction of Novartis' Simulect (basiliximab).

August 19, 2013

Specialty pharmacy CareMed Pharmaceutical Services has been added to a limited-distribution network for a cancer drug sold by Genentech and Astellas Pharma, the company said.

LAKE SUCCESS, N.Y. — Specialty pharmacy CareMed Pharmaceutical Services has been added to a limited-distribution network for a cancer drug sold by Genentech and Astellas Pharma, the company said.

CareMed said it had been selected to supply the drug, Tarceva (erlotinib). The two drug makers stopped distributing the drug, a once-daily treatment for advanced lung cancer, through retail pharmacies at the beginning of July.

July 22, 2013

The Food and Drug Administration has approved a drug made by Japanese drug maker Astellas for preventing the body from rejecting transplanted organs, the company said.

NORTHBROOK, Ill. — The Food and Drug Administration has approved a drug made by Japanese drug maker Astellas for preventing the body from rejecting transplanted organs, the company said.

Astellas announced through a U.S. subsidiary that the FDA had approved Astagraf XLTM (tacrolimus) extended-release capsules for preventing rejection of transplanted kidneys, for use with Genentech's CellCept (mycophenolate mofetil) and corticosteroids, with or without Simulect (basiliximab), a biotech drug made by Swiss drug maker Novartis.

July 2, 2013

A cancer drug made by Genentech and Astellas is no longer available through ordinary retail channels and is now available only through a limited-distribution network.

NEW YORK — A cancer drug made by Genentech and Astellas is no longer available through ordinary retail channels and is now available only through a limited-distribution network.

Cancer-focused specialty pharmacy Onco360 said that effective Monday, the drug Tarceva (erlotinib) would no longer be available through retail pharmacies and that had joined a limited-distribution network that the drug makers had set up for the drug. Tarceva is used for treating advanced non-small cell lung cancer and pancreatic cancer.

June 26, 2013

The Food and Drug Administration has approved a drug made by Astellas Pharma for treating fungal infections in children.

NORTHBROOK, Ill. — The Food and Drug Administration has approved a drug made by Astellas Pharma for treating fungal infections in children.

May 15, 2013

The Food and Drug Administration has approved a drug for a type of lung cancer.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug for a type of lung cancer.

Roche subsidiary Genentech and the U.S. subsidiary of Japan's Astellas Pharma announced the approval of Tarceva (erlotinib) for advanced non-small cell lung cancer whose tumors have mutations that activate the epidermal growth factor receptor. The FDA also approved a test to detect the mutation.

The drug was already approved for advanced NSCLC that did not exhibit the mutation.

 

December 10, 2012

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

October 22, 2012

The U.S. subsidiary of Japanese drug maker Astellas Pharma has made a drug for overactive bladder available in U.S. pharmacies, the company said.

NORTHBROOK, Ill. — The U.S. subsidiary of Japanese drug maker Astellas Pharma has made a drug for overactive bladder available in U.S. pharmacies, the company said.

Astellas Pharma US announced the availability of Myrbetriq (mirabegron) extended-release tablets. The drug is used to treat OAB with symptoms of urge urinary incontinence, urgency and urinary frequency. The Food and Drug Administration approved the drug on June 28, 2012.

September 26, 2012

The U.S. subsidiary of Japanese drug maker Astellas is seeking approval from the Food and Drug Administration for a drug to prevent rejection of transplanted organs.

NORTHBROOK, Ill. — The U.S. subsidiary of Japanese drug maker Astellas is seeking approval from the Food and Drug Administration for a drug to prevent rejection of transplanted organs.

Astellas Pharma US said it applied with the FDA for approval of tacrolimus extended-release capsules to prevent rejection of transplanted kidneys in adults and transplanted livers in men. The drug was approved in Europe in 2007 under the name Advagraf and under the name Graceptor in Japan in 2008; the drug has been approved in 69 countries so far.

September 4, 2012

The Food and Drug Administration has approved a new drug made by Astellas Pharma U.S. and Medivation for treating prostate cancer, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Astellas Pharma U.S. and Medivation for treating prostate cancer, the agency said Friday.

The FDA announced the approval of Xtandi (enzalutamide) for castration-resistant prostate cancer that has spread or recurred despite medical or surgical therapy to minimize testosterone.

August 13, 2012

An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

EAST HANOVER, N.J. — An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

A phase-3 study published in the American Journal of Transplantation found that patients taking RAD001 (everolimus) with a reduced dose of Astellas' Prograf (tacrolimus) experienced equal efficacy and superior kidney function to patients taking Prograf alone.

June 28, 2012

The Food and Drug Administration has approved a new drug for treating overactive bladder made by Astellas Pharma, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating overactive bladder made by Astellas Pharma, the agency said Thursday.

The FDA announced the approval of Myrbetriq (mirabegron), which works by relaxing the bladder muscle while the organ is filling. In patients with overactive bladder, the muscle can't be controlled, squeezes too often or squeezes without warning. Symptoms of overactive bladder include the need to urinate too often, the need to urinate immediately and incontinence. The condition affects about 33 million Americans.

April 6, 2012

A panel of Food and Drug Administration experts has recommended approval for a drug made by Astellas Pharma for overactive bladder.

DEERFIELD, Ill. — A panel of Food and Drug Administration experts has recommended approval for a drug made by Astellas Pharma for overactive bladder.

The drug maker announced that the FDA Reproductive Health Drugs Advisory Committee voted 7-4 with one abstention that its assessment of the risks and benefits of the drug YM178 (mirabegron) supported the drug's approval.

The FDA is not required to follow the recommendations of advisory committees, but usually does. The agency is expected to decide whether or not to approve the drug by June 29.

April 2, 2012

Two drug makers have finalized the design of a late-stage clinical trial for a vaccine against a common virus that can cause complications later in life.

SAN DIEGO — Two drug makers have finalized the design of a late-stage clinical trial for a vaccine against a common virus that can cause complications later in life.

Vical and Astellas Pharma announced Monday that they had finalized the general design of a phase-3 trial of TransVax, a vaccine against cytomegalovirus, or CMV, for transplant recipients.

March 16, 2012

Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

WASHINGTON — Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

January 27, 2011

Swiss drug maker Novartis posted sales of $14.2 billion for fourth quarter 2010 and $50.6 billion for the year as a whole, according to an earnings report released Thursday.

BASEL, Switzerland — Swiss drug maker Novartis posted sales of $14.2 billion for fourth quarter 2010 and $50.6 billion for the year as a whole, according to an earnings report released Thursday.

That compared with sales of $12.9 billion and $44.3 billion during fourth quarter 2009 and 2009 as a whole, respectively. Profits for the year were nearly $10 billion, an 18% increase from $8.4 billion in 2009, though profits for the quarter decreased by 2%, from fourth quarter 2009’s $2.32 billion to $2.27 billion in fourth quarter 2010.

December 16, 2010

An investigational treatment for irritable bowel syndrome could become a blockbuster by the end of the decade, according to a report by Decision Resources.

BURLINGTON, Mass. — An investigational treatment for irritable bowel syndrome could become a blockbuster by the end of the decade, according to a report by Decision Resources.

The report, which the healthcare market research firm said it would publish later this month, found that linaclotide — made by Ironwood Pharmaceuticals, Forest Labs, Almirall and Astellas Pharma — would emerge as the market leader for IBS and achieve sales of $1.1 billion in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan by 2019.

November 11, 2010

The president and CEO of Agensys, a subsidiary of Japanese drug maker Astellas, will retire,...

TOKYO The president and CEO of Agensys, a subsidiary of Japanese drug maker Astellas, will retire, Astellas said Tuesday.

 

Donald Rice founded Agensys as UroGenesys in Santa Monica, Calif., in 1996 for the development of biotech drugs for treating cancer. Astellas acquired Agensys in December 2007.

 

Former Allergan SVP, head of global drug development and chief medical officer Sef Kurstjens will replace Rice as president and CEO of Agensys.

September 20, 2010

The Food and Drug Administration has approved a generic treatment for organ transplant patients....

PITTSBURGH The Food and Drug Administration has approved a generic treatment for organ transplant patients.

 

Mylan announced Tuesday the approval of tacrolimus capsules in the 0.5-mg, 1-mg and 5-mg strengths, and said it plans to launch the drug immediately. The drug is used to prevent rejection of transplanted organs.

 

 

July 5, 2010

The Food and Drug Administration has approved a drug made by Watson Pharmaceuticals for treating...

June 7, 2010

Japanese drug maker Astellas Pharma has completed its acquisition of OSI Pharmaceuticals, Astellas said Tuesday....

May 20, 2010

Dr. Reddy’s Labs has launched a treatment for organ transplant patients, the Indian generic drug...

May 16, 2010

Japanese drug maker Astellas Pharma will acquire U.S.-based OSI Pharmaceuticals for $4 billion, the two...