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March 26, 2012

A drug under development by Forest Labs and Pierre Fabre has been shown to reduce symptoms of major depressive disorder, the companies said.

SUPPLIER NEWS — A drug under development by Forest Labs and Pierre Fabre has been shown to reduce symptoms of major depressive disorder, the companies said. New York-based Forest and Paris-based Pierre Fabre announced results of a phase-3 trial of levomilnacipran, saying the drug showed reductions in symptoms as early as one week after treatment was started. The companies expect results of another phase-3 trial of the drug this spring.


 

March 22, 2012

The Food and Drug Administration's director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing.

SILVER SPRING, Md. — The Food and Drug Administration's director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing held here.

March 21, 2012

A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

PHILADELPHIA — A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

GSK announced that the FDA Oncologic Drugs Advisory Committee voted 11-2 that clinical trial data indicated a favorable risk-benefit profile of the drug Votrient (pazopanib) in patients with advanced soft-tissue sarcoma who have received chemotherapy. The drug is already approved for treating the kidney cancer renal cell carcinoma.

March 21, 2012

An investigational Type 2 diabetes drug may improve glycemic control among patients that are unable to improve their blood sugar with high doses of insulin alone, according to a new study.

NEW YORK — An investigational Type 2 diabetes drug may improve glycemic control among patients that are unable to improve their blood sugar with high doses of insulin alone, according to a new study.

March 21, 2012

Israel-based Teva Pharmaceutical Industries is switching stock exchanges, the company said.

JERUSALEM — Israel-based Teva Pharmaceutical Industries is switching stock exchanges, the company said.

The world's largest generic drug manufacturer — and increasingly a player in branded and specialty drugs — announced Wednesday that it would transfer the listing of its shares from the Nasdaq to the New York Stock Exchange, with plans to start trading on the NYSE on May 30 under its current ticker symbol, "TEVA."

March 20, 2012

Novartis has launched a new treatment for chronic obstructive pulmonary disease, the drug maker said Monday.

EAST HANOVER, N.J. — Novartis has launched a new treatment for chronic obstructive pulmonary disease, the drug maker said Monday.

Novartis Pharmaceuticals, the U.S. division of the Swiss drug manufacturer, announced the launch of Arcapta Neohaler (indacaterol inhalation powder) in the 75-mcg strength. The Food and Drug Administration approved the drug last July.

March 19, 2012

Women take mental health drugs at a much higher rate than men, according to a new study by one of the country's largest pharmacy benefit managers.

WASHINGTON — Women take mental health drugs at a much higher rate than men, according to a new study by one of the country's largest pharmacy benefit managers.

Medco Health Solutions released results of the study Monday, showing that 25% of women use psychotropic drugs, compared with 15% of men. The study was based on the pharmacy claims of more than 2 million Americans and measured the use of drugs for treating depression, anxiety, attention deficit hyperactivity disorder and psychotic disorders between 2001 and 2010.

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.

March 15, 2012

Abbott is set to enroll patients into two late-stage clinical trials designed to evaluate the safety and efficacy of one of its drugs as a treatment for a difficult-to-treat chronic inflammatory skin disease.

ABBOTT PARK, Ill. — Abbott is set to enroll patients into two late-stage clinical trials designed to evaluate the safety and efficacy of one of its drugs as a treatment for a difficult-to-treat chronic inflammatory skin disease.

March 15, 2012

The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

WAYNE, N.J. — The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

Bayer HealthCare Pharmaceuticals announced Wednesday the approval of Natazia (estradiol valerate and estradiol valerate and dienogest) tablets for heavy menstrual bleeding not caused by any conditions of the uterus. The drug was originally approved as an oral contraceptive in May 2010.

March 15, 2012

The Food and Drug Administration approved an effervescent tablet for treating osteoporosis.

FREIENBACH, Switzerland — The Food and Drug Administration approved an effervescent tablet for treating osteoporosis.

EffRx Pharmaceuticals announced the FDA approval of Binosto (alendronate sodium), a strawberry-flavored tablet designed to dissolve in water that the company called the first treatment of its kind. The drug is designed to treat osteoporosis in menopausal women and increase bone mass in men with osteoporosis. EffRx expects to launch Binosto in third quarter 2012.

March 15, 2012

A drug under investigation by Teva Pharmaceutical Industries and Active Biotech reduced symptoms and progression of disease in patients with multiple sclerosis, according to results of a late-stage clinical trial.

JERUSALEM — A drug under investigation by Teva Pharmaceutical Industries and Active Biotech reduced symptoms and progression of disease in patients with multiple sclerosis, according to results of a late-stage clinical trial.

Teva and Active announced the publication of results of the phase-3 "Allegro" study of oral laquinimod in the March 15 issue of the New England Journal of Medicine. The study was conducted in 24 countries and enrolled 1,106 patients with MS who received 0.6 mg of laquinimod per day or placebo.

March 14, 2012

Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

CHADDS FORD, Pa. — Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

March 14, 2012

Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.

NEW YORK — Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.

Forest and Johnson & Johnson subsidiary Janssen Pharmaceutica NV have sued Glenmark, Hetero USA, Torrent Pharmaceuticals and Watson Labs in response to their filing regulatory approval applications with the Food and Drug Administration for generic versions of Bystolic (nebivolol).

March 14, 2012

Pharmaceutical wholesaler H.D. Smith has appointed Bill Williams as CFO, the company said Wednesday.

SPRINGFIELD, Ill. — Pharmaceutical wholesaler H.D. Smith has appointed Bill Williams as CFO, the company said Wednesday.

Williams, who has worked at such companies as Kraft Foods, Allied Signal and Martin Brower Co., most recently worked as a partner in Tatum LLC's Chicago office.

March 12, 2012

One of pharmacy's top awards is getting some support from a German drug maker. Boehringer Ingelheim announced that it became a premier supporter of the American Pharmacists Association's Bowl of Hygeia Award.

RIDGEFIELD, Conn. — One of pharmacy's top awards is getting some support from a German drug maker. Boehringer Ingelheim announced that it became a premier supporter of the American Pharmacists Association's Bowl of Hygeia Award.

March 12, 2012

Drug maker Watson Pharmaceuticals has started a late-stage trial of a drug made to treat benign tumors of the uterus, the company said Monday.

PARSIPPANY, N.J. — Drug maker Watson Pharmaceuticals has started a late-stage trial of a drug made to treat benign tumors of the uterus, the company said Monday.

Watson announced the initiation of a phase-3 trial of Esmya (ulitristal acetate) in women who have anemia due to uterine leimyomas, also known as uterine fibroids, which causes benign solid tumors that can lead to excessive menstrual bleeding, anemia and pain and may require surgery. Watson is developing the drug under a licensing agreement with Gedeon Richter.

March 9, 2012

A Food and Drug Administration panel will meet Monday to discuss a class of drugs designed to treat chronic painful conditions that currently are under development and the safety issues possibly related to the drugs.

WASHINGTON — A Food and Drug Administration panel will meet Monday to discuss a class of drugs designed to treat chronic painful conditions that currently are under development and the safety issues possibly related to the drugs.

March 8, 2012

The market for drugs to treat diabetes — especially Type 2 diabetes — has shown quite a bit of activity lately.

The market for drugs to treat diabetes — especially Type 2 diabetes — has shown quite a bit of activity lately. At the end of January, the Food and Drug Administration approved Bydureon (exenatide), a once-weekly version of the drug Byetta, which was originally developed by Alkermes and subsequently developed further under an alliance between Amylin Pharmaceuticals and Eli Lilly that the two companies formed in 2002. In November 2011, however, Amylin and Lilly terminated their alliance in the wake of an announced diabetes drug partnership between Lilly and Boehringer Ingelheim.

March 8, 2012

The Food and Drug Administration is looking at the possibility of selling certain prescription drugs over the counter under specific circumstances, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration is looking at the possibility of selling certain prescription drugs over the counter under specific circumstances, the agency said.

March 7, 2012

A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said Wednesday.

INDIANAPOLIS — A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said Wednesday.

The two companies announced the availability of Jentadueto (linagliptin and metformin hydrochloride). The Food and Drug Administration approved the drug on Jan. 30.

March 7, 2012

Prices for generic drugs may be dropping, but increases in branded and specialty drug prices have offset those decreases, according to a new study.

WASHINGTON — Prices for generic drugs may be dropping, but increases in branded and specialty drug prices have offset those decreases, according to a new study.

The study, conducted by AARP's Public Policy Institute, found that the cumulative change in drug prices from 2005 to 2009 was almost double the rate of inflation. As a result, the average annual cost of drug therapy continued to rise.

March 7, 2012

The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

Eisai said the FDA delivered it a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about an regulatory application that preclude approval, usually due to insufficient clinical trial data.

March 7, 2012

A drug under development by Forest Labs and Pierre Fabre "significantly" reduced symptoms of major depressive disorder, the companies said Wednesday.

NEW YORK — A drug under development by Forest Labs and Pierre Fabre "significantly" reduced symptoms of major depressive disorder, the companies said Wednesday.

New York-based Forest and Paris-based Pierre Fabre announced results of a phase-3 trial of levomilnacipran, saying the drug showed reductions in symptoms as early as one week after treatment was started. The companies expect results of another phase-3 trial of the drug this spring.

March 7, 2012

Drug maker Shire will conduct two post-marketing trials to compare its treatment for attention deficit hyperactivity disorder with a competing drug, the company said Tuesday.

PHILADELPHIA — Drug maker Shire will conduct two post-marketing trials to compare its treatment for attention deficit hyperactivity disorder with a competing drug, the company said Tuesday.

Shire announced that it would start two phase-4 trials comparing its drug, Vyvanse (lisdexamfetamine dimesylate), with Alza's Concerta (methylphenidate hydrochloride).