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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).

March 6, 2012

The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.

WAYNE, N.J. — The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.

Bayer HealthCare Pharmaceuticals said the FDA approved a lower-dose formulation of Angeliq (drospirenone and estradiol) tablets, used to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The new formulation contains 0.25-mg drospirenone and 0.5-mg estradiol, while the previously approved formulation contained 0.5-mg drospirenone and 1-mg estradiol.

March 6, 2012

The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

Merck said the agency issued a complete response letter for its regulatory approval application for a drug that would combine the cholesterol drug Zetia (ezetimibe) with atorvastatin, the active ingredient in Pfizer's Lipitor. A complete response letter means that the FDA cannot approve a drug application in its current form.

March 5, 2012

Alkermes has appointed a new chief commercial officer.

DUBLIN — Alkermes has appointed a new chief commercial officer.

Mark Stejbach, who brings 25 years of experience in biotech and pharmaceutical marketing, sales, managed care and finance to his new role, will be responsible for Alkermes' commercial activities, including marketing and sales of Vivitrol and developing and executing commercial strategies for Alkermes' late-stage pipeline assets, namely ALKS 9070 (for schizophrenia), ALKS 37 (for opioid-induced constipation) and ALKS 5461 (for treatment-resistant depression).

March 5, 2012

Cardinal Health can continue distributing controlled medications from a distribution center in Florida, according to published reports.

NEW YORK — Cardinal Health can continue distributing controlled medications from a distribution center in Florida, according to published reports.

On Friday, the U.S. Court of Appeals for the District of Columbia Circuit put a stay on the Drug Enforcement Administration's order that had blocked Cardinal from shipping controlled substances from the Lakeland, Fla., center. The stay will last until the middle of the month, when Cardinal has to file its emergency motion, and the DEA has to file its response, according to the reports.

March 5, 2012

A drug under development by Teva Pharmaceutical Industries appears safe and effective in treating allergies, according to results of a late-stage clinical trial released Monday.

JERUSALEM — A drug under development by Teva Pharmaceutical Industries appears safe and effective in treating allergies, according to results of a late-stage clinical trial released Monday.

Teva said a 529-patient phase-3 trial of Qnasl (beclomethasone dipropionate) nasal aerosol showed the drug produced a "significant" improvement in patients with seasonal and perennial allergies. Patients received either 320 mcg of Qnasl or a placebo.

March 2, 2012

The Centers for Disease Control and Prevention on Friday issued its latest update on the influenza season to date, or rather the lack thereof. For the week ended Feb. 25, visits for influenza-like illnesses have yet to crack the national baseline of 2.4% this season.

ATLANTA — The Centers for Disease Control and Prevention on Friday issued its latest update on the influenza season to date, or rather the lack thereof. For the week ended Feb. 25, visits for influenza-like illnesses have yet to crack the national baseline of 2.4% this season.

Over the past two seasons, 2009/2010 and 2010/2011, reports of ILI activity reached levels approaching 8% and 5%, respectively, after crossing over that 2.4% threshold — an indicator that the flu season is well under way.

March 2, 2012

An organization representing independent retail pharmacies is criticizing a new ad by a pharmacy benefit manager industry group, calling the ad "irresponsible."

ALEXANDRIA, Va. — An organization representing independent retail pharmacies is criticizing a new ad by a pharmacy benefit manager industry group, calling the ad "irresponsible."

March 1, 2012

Endo's parent company is looking to change its name and will integrate four of its operating units, the drug maker said Thursday.

CHADDS FORD, Pa. — Endo's parent company is looking to change its name and will integrate four of its operating units, the drug maker said Thursday.

Endo said the company, currently called Endo Pharmaceutical Holdings, would ask shareholders to approve changing the name to Endo Health Solutions at its annual shareholder meeting in May.

March 1, 2012

The Food and Drug Administration has approved what it called the first flu vaccine to prevent four strains of the influenza virus.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the first flu vaccine to prevent four strains of the influenza virus.

March 1, 2012

The Food and Drug Administration has approved two new drugs for pancreatic disorders, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved two new drugs for pancreatic disorders, the agency said Thursday.

The FDA announced the approval of Aptalis Pharma's Ultresa and Viokase, both generically known as pancrelipase. Ultresa is a delayed-release capsule for children and adults with cystic fibrosis, which affects the lungs and other organs, while Viokase is meant for use with a proton-pump inhibitor in adults who can't digest food because of pancreatitis or surgical removal of the pancreas.

March 1, 2012

An investigational diabetes therapy made by Takeda helped lower HbA1C levels among patients with Type 2 diabetes, the drug maker said.

DEERFIELD, Ill. — An investigational diabetes therapy made by Takeda helped lower HbA1C levels among patients with Type 2 diabetes, the drug maker said.

February 29, 2012

A federal district court has turned down a request by Cardinal Health for an injunction against the Drug Enforcement Administration's suspension of the company's license to ship painkiller drugs from one of its distribution centers, the company said Wednesday.

COLUMBUS, Ohio — A federal court has turned down Cardinal Health's request for an injunction against the Drug Enforcement Administration's suspension of the its ability to ship controlled medications from one of its distribution centers, the company said Wednesday.

Reggie Walton, a judge for the U.S. District Court for the District of Columbia, ruled against Cardinal's request to enjoin the DEA from preventing the company from shipping controlled substances from the distribution center, in Lakeland, Fla.

February 28, 2012

The Food and Drug Administration on Tuesday announced it will hold a public hearing on March 22 and 23 to discuss how technology can expand which drug products can be switched from prescription to over-the-counter status.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced it will hold a public hearing on March 22 and 23 to discuss how technology can expand which drug products can be switched from prescription to over-the-counter status.

February 28, 2012

The Food and Drug Administration has given priority review to a regulatory application from Johnson & Johnson for a drug designed to reduce the risk of complications from internal blood clots.

RARITAN, N.J. — The Food and Drug Administration has given priority review to a regulatory application from Johnson & Johnson for a drug designed to reduce the risk of complications from internal blood clots.

J&J's Janssen Research & Development division announced that the FDA had given the designation to Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of certain types of heart attacks in patients with acute coronary syndrome, which 1.2 million Americans are diagnosed with every year.