Content about Takeda Pharmaceuticals

April 24, 2013

The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.

BETHESDA, Md. — The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.

December 17, 2012

Japanese drug maker Takeda Pharmaceutical Co. is selling its generics business to India-based Sun Pharmaceutical Industries, Takeda said.

OSAKA, Japan — Japanese drug maker Takeda Pharmaceutical is selling its generics business to India-based Sun Pharmaceutical Industries, Takeda said Monday.

Takeda said it would sell URL Pharma, through U.S. subsidiary Takeda Pharmaceuticals USA, to Sun subsidiary Caraco Pharmaceutical Labs while retaining control of the gout treatment Colcrys (colchicine). Takeda acquired rights to Colcrys when it bought URL Pharma for $800 million in June 2012; financial terms of the current deal with Caraco were not disclosed.

October 2, 2012

Drug makers Takeda Pharmaceutical and H. Lundbeck have applied with the Food and Drug Administration for a new drug to treat depression in adults.

OSAKA, Japan — Drug makers Takeda Pharmaceutical and H. Lundbeck have applied with the Food and Drug Administration for a new drug to treat depression in adults.

Japan-based Takeda and Denmark-based Lundbeck announced the submission of a new drug application for Lu AA21004 (vortioxetine) for major depressive disorder.

September 18, 2012

Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.


NEW YORK — Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.


August 17, 2012

Ranbaxy Labs has launched an authorized generic version of a diabetes drug made by Takeda Pharmaceutical, Ranbaxy said Friday.

PRINCETON, N.J. — Ranbaxy Labs has launched an authorized generic version of a diabetes drug made by Takeda Pharmaceutical, Ranbaxy said Friday.

Ranbaxy announced the launch, through subsidiary Ranbaxy Pharmaceuticals and under an agreement with Takeda, of pioglitazone hydrochloride tablets, an authorized generic version of Takeda's Actos. An authorized generic is a branded drug marketed at a reduced price under its generic name, typically by a third-party company operating under contract with the original branded drug's manufacturer.

July 30, 2012

Drug maker Takeda Pharmaceutical has resubmitted regulatory approval applications for two drugs designed to treat diabetes, the company said.

DEERFIELD, Ill. — Drug maker Takeda Pharmaceutical has resubmitted regulatory approval applications for two drugs designed to treat diabetes, the company said.

Takeda announced the resubmission to the Food and Drug Administration of applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in the Takeda drug Actos.

June 4, 2012

Drug maker Takeda Pharmaceutical has finished its purchase of URL Pharma, the companies said Monday.

DEERFIELD, Ill. — Drug maker Takeda Pharmaceutical has finished its purchase of URL Pharma, the companies said Monday.

Japan-based Takeda announced in April that it would buy URL for $800 million. The acquisition, through local subsidiary Takeda Pharmaceuticals USA, gives Takeda control of the gout drug Colcrys (colchicine). URL will report to Takeda Pharmaceuticals USA president Douglas Cole, and the acquisition is expected to boost 2012 sales by $550 million, Takeda said.

April 26, 2012

The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

DEERFIELD, Ill. — The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

Takeda announced that the FDA issued a complete response letter for its regulatory applications for the Type 2 diabetes drug alogliptin and a combination pill that includes alogliptin and pioglitazone, the active ingredient in the drug Actos.

April 11, 2012

Takeda Pharmaceutical will acquire privately owned drug maker URL Pharma for $800 million, the companies said Wednesday.

DEERFIELD, Ill. — Takeda Pharmaceutical will acquire privately owned drug maker URL Pharma for $800 million, the companies said Wednesday.

Takeda announced that it would acquire Philadelphia-based URL through a U.S. subsidiary for the upfront payment plus future milestone payments. Takeda said it expected the acquisition to contribute "significantly" to its sales and profits starting in fiscal year 2013.

March 6, 2012

Takeda Pharmaceutical's cancer drug unit has started a late-stage clinical trial of a drug for treating a rare form of lymphoma, the company said.

CAMBRIDGE, Mass. — Takeda Pharmaceutical's cancer drug unit has started a late-stage clinical trial of a drug for treating a rare form of lymphoma, the company said.

The unit, Millennium, announced the start of a phase-3 trial to evaluate MLN8237 in patients with relapsed or refractory peripheral T-cell lymphoma, an aggressive non-Hodgkin's lymphoma.

February 17, 2012

The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.


SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.


February 8, 2012

Takeda Pharmaceutical has launched a drug for treating high blood pressure in adults, the company said.

DEERFIELD, Ill. — Takeda Pharmaceutical has launched a drug for treating high blood pressure in adults, the company said.

Takeda announced the availability of Edarbyclor (azilsartan medoxomil and chlorthalidone), a once-daily tablet for the condition, also known as hypertension.

January 9, 2012

Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.

PITTSBURGH — Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.

Mylan said that it was sued by Takeda Pharmaceutical, Watson Pharmaceuticals and Andrx Labs in the U.S. District Court for the Southern District of New York in response to Mylan's filing a regulatory approval application with the Food and Drug Administration for a generic version of Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride) extended-release tablets in the 15-mg/1,000-mg and 30-mg/1,000-mg strengths.

November 28, 2011

A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.

OSAKA, Japan — A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.

The Takeda Global Research and Development Center filed with the Food and Drug Administration for approval of an alogliptin-metformin combination tablet. The company expects the FDA to review the application within the next 10 months.

November 2, 2011

The Food and Drug Administration has approved changes to the labeling of a cancer drug made by Takeda Pharmaceuticals, the drug maker said.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved changes to the labeling of a cancer drug made by Takeda Pharmaceuticals, the drug maker said.

Takeda and Millennium, the Japanese drug maker's cancer-drug subsidiary, announced Tuesday that the FDA approved a supplemental new drug application for the injectable multiple myeloma drug Velcade (bortezomib) that updates its label to include additional data from a clinical study showing that the drug extended patients' survival time.

October 19, 2011

Takeda Pharmaceuticals has started a late-stage clinical trial program for a drug to treat Type 2 diabetes, the drug maker said.

OSAKA, Japan — Takeda Pharmaceuticals has started a late-stage clinical trial program for a drug to treat Type 2 diabetes, the drug maker said.

August 5, 2011

Amylin Pharmaceuticals and Takeda Pharmaceutical have halted development of a treatment for obesity in mid-stage clinical trials, the two companies said.

SAN DIEGO — Amylin Pharmaceuticals and Takeda Pharmaceutical have halted development of a treatment for obesity in mid-stage clinical trials, the two companies said.

The companies said the decision to discontinue development of a therapy that combines pramlintide and metreleptin was based on "a commercial reassessment of the pramlintide/metreleptin program … [that] took into account a revised development plan, as well as evolving dynamics within he obesity therapeutic area."

July 26, 2011

Japanese drug maker Takeda Pharmaceutical is reapplying for approval of two drugs to treat Type 2 diabetes after the Food and Drug Administration turned down its last applications, the company said.

OSAKA, Japan — Japanese drug maker Takeda Pharmaceutical is reapplying for approval of two drugs to treat Type 2 diabetes after the Food and Drug Administration turned down its last applications, the company said.

Takeda announced that it resubmitted its applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in Actos, which the FDA approved in 1999.

The FDA will review the applications over the next six months, the drug maker said.

June 17, 2011

The Food and Drug Administration on Thursday informed the public that continued use of a Type 2 diabetes treatment made by Takeda Pharmaceuticals for more than one year may be associated with an increased risk of bladder cancer.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday informed the public that continued use of a Type 2 diabetes treatment made by Takeda Pharmaceuticals for more than one year may be associated with an increased risk of bladder cancer.

May 12, 2011

Japan-based Takeda Pharmaceutical may acquire Switzerland’s Nycomed for $12 billion, according to published reports.

NEW YORK — Japan-based Takeda Pharmaceutical may acquire Switzerland’s Nycomed for $12 billion, according to published reports.

Reuters reported Thursday that Takeda was in talks to buy Nycomed in order to expand its presence in the European market. Most of Takeda’s business is in Asia and the United States.

Nycomed makes treatments for such diseases as chronic obstructive pulmonary disease, chronic pain, osteoporosis and others.

April 15, 2011

Takeda Pharmaceutical has launched a new treatment for high blood pressure, the company said Friday.

DEERFIELD, Ill. — Takeda Pharmaceutical has launched a new treatment for high blood pressure, the company said Friday.

Takeda announced the launch of Edarbi (azilsartan medoxomil), which the Food and Drug Administration approved on Feb. 25 as a once-daily pill for hypertension.

April 5, 2011

Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

HAYWARD, Calif. — Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

Impax said Tuesday that it had filed an approval application with the Food and Drug Administration for dexlansoprazole delayed-release capsules in the 30-mg and 60-mg strengths. The drug is a version of Takeda’s Dexilant.

March 25, 2011

A drug for Type 2 diabetes made by Takeda Pharmaceutical taken in the morning prevented the disease from developing in nearly three-quarters of patients who were at risk, according to a new study in the New England Journal of Medicine.

SAN ANTONIO — A drug for Type 2 diabetes made by Takeda Pharmaceutical taken in the morning prevented the disease from developing in nearly three-quarters of patients who were at risk, according to a new study in the New England Journal of Medicine.

Researchers enrolled 602 patients through the University of Texas Health Science Center San Antonio and seven other centers and administered Actos (pioglitazone) to them, finding that it prevented Type 2 diabetes in 72% of those whose obesity, ethnicity and other factors put them at risk for the disease.

March 16, 2011

Amylin Pharmaceuticals and Takeda Pharmaceutical have suspended a mid-stage trial of an obesity drug over safety concerns, the two said Wednesday.

SAN DIEGO — Amylin Pharmaceuticals and Takeda Pharmaceutical have suspended a mid-stage trial of an obesity drug over safety concerns, the two said Wednesday.

The drug makers stopped the phase-2 trial of a combination of pramlintide and metreleptin due to problems that arose in two patients related to metreleptin. Amylin said the decision to suspend the trial did not affect its investigations of metreleptin as a treatment of diabetes and hypertriglyceridemia in patients with lipodystrophy.

February 1, 2011

The Food and Drug Administration has turned down an application for an anti-obesity drug.

SAN DIEGO — The Food and Drug Administration has turned down an application for an anti-obesity drug.

Orexigen Therapeutics and Takeda Pharmaceutical said Tuesday that the FDA had issued a complete response letter for their application for Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets.