Content about Branded

April 5, 2011

Drug maker Merck is looking to boost its eye care portfolio by acquiring a company focused on developing and commercializing ophthalmic products. The deal carries a cash value of about $430 million.

WHITEHOUSE STATION, N.J. — Drug maker Merck is looking to boost its eye care portfolio by acquiring a company focused on developing and commercializing ophthalmic products. The deal carries a cash value of about $430 million.

April 5, 2011

The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

RIDGEFIELD, Conn. — The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

The FDA approved Viramune XR (nevirapine), a single-pill, once-daily, extended-release formulation of nevirapine for use in combination with other antiretroviral drugs.

April 4, 2011

Daiichi Sankyo's SVP commercial operations has taken on a new role at the company.

PARSIPPANY, N.J. — Daiichi Sankyo's SVP commercial operations has taken on a new role at the company.

The drug maker said that John Gargiulo would become president and CEO, effective Monday, following the retirement of current leader Joseph Pieroni.

Gargiulo has been with Daiichi Sankyo since its inception in 1996. In addition to his role at the company, he currently serves on the board of directors of the Pharmaceutical Research and Manufacturers Association, as well as the National Pharmaceutical Council.

April 4, 2011

A topical medication for treating low testosterone in men now is available, drug maker Eli Lilly said.

INDIANAPOLIS — A topical medication for treating low testosterone in men now is available, drug maker Eli Lilly said.

Lilly announced the availability of Axiron (testosterone), a topical solution designed for application under the arm.

The Food and Drug Administration approved Axiron in November, making it the only testosterone replacement therapy applied to the underarm.

April 4, 2011

Pfizer will sell its Capsugel business to Kohlberg Kravis Roberts & Co. for nearly $2.4 billion, the drug maker said Monday.

PEAPACK, N.J. — Pfizer will sell its Capsugel business to Kohlberg Kravis Roberts & Co. for nearly $2.4 billion, the drug maker said Monday.

Capsugel, which develops hard capsules and drug-delivery systems, generated about $750 million in sales last year. The company will maintain its New Jersey headquarters after the sale is complete.

April 4, 2011

A drug used to treat pain in cancer patients now is available in the United States.

BEDMINSTER, N.J. — A drug used to treat pain in cancer patients now is available in the United States.

ProStrakan Group announced Monday the launch of Abstral (fentanyl) sublingual tablets. The tablets, which disintegrate rapidly and are placed under the tongue, treat breakthrough pain, common in one-half to two-thirds of people with cancer-related pain.

The drug, an opioid and controlled substance, only is available through a Food and Drug Administration-mandated REMS program. The FDA approved the drug in January.

April 4, 2011

French drug maker Sanofi-Aventis may get a name change soon, according to a published report.

NEW YORK — French drug maker Sanofi-Aventis may get a name change soon, according to a published report.

Bloomberg reported that the drug maker had scheduled a vote at its May 6 stockholders meeting to shorten the name to “Sanofi.” The article paraphrased a spokesman as saying that the current name is difficult for people in some countries to pronounce.

The Sanofi-Aventis name came into being following the 2004 acquisition of Aventis by Sanofi-Synthelabo.

April 4, 2011

Sanofi-Aventis said it completed its exchange offer for drug maker Genzyme, which expired just before midnight April 1.

PARIS — Sanofi-Aventis said it completed its exchange offer for drug maker Genzyme, which expired just before midnight April 1.

All 224,528,469 shares of Genzyme common stock were validly tendered, which is represented by 84.6% of common stock and 77% of shares on a diluted basis.

Last month, the board of directors of Genzyme unanimously recommended that shareholders accept French drug maker Sanofi-Aventis’ $74-per-share buyout offer.

March 31, 2011

Usually, when the Food and Drug Administration approves a commercial version of a drug, it prohibits compounding pharmacies from producing it, but it’s making an exception in the case of a drug used to prevent premature births.

SILVER SPRING, Md. — Usually, when the Food and Drug Administration approves a commercial version of a drug, it prohibits compounding pharmacies from producing it, but it’s making an exception in the case of a drug used to prevent premature births.

March 31, 2011

A drug used to treat diabetes also may prevent it, according to a new study published in the journal Experimental Biology and Medicine.

CLEVELAND — A drug used to treat diabetes also may prevent it, according to a new study published in the journal Experimental Biology and Medicine.

Researchers at Case Western Reserve University took specially bred obese, prediabetic rats and gave them either Merck’s Januvia (sitagliptin), placebo or glyburide, an older diabetes drug. Both of the diabetes drugs lowered blood-glucose levels after the rats had eaten, but only Junuvia raised the total output of insulin by the pancreas while lowering levels of glucagon.

March 30, 2011

A biopharmaceutical company that specializes in diabetes treatments has appointed a new board chairman.

DANBURY, Conn. — A biopharmaceutical company that specializes in diabetes treatments has appointed a new board chairman.

Biodel said that effective immediately, Brian Pereira, who has served on the drug maker's board since 2007, will become chairman. Current chairman Charles Sanders, who served as chairman since March 2010 after joining the board in August 2006, will continue to serve as a board member, Biodel said.

March 30, 2011

Dr. Reddy’s Labs will assume ownership of a penicillin manufacturing site in Bristol, Tenn., from GlaxoSmithKline.

HYDERABAD, India — Dr. Reddy’s Labs will assume ownership of a penicillin manufacturing site in Bristol, Tenn., from GlaxoSmithKline.

The generic drug maker said it completed the acquisition of the facility and related product portfolio, including Augmentin and Amoxil brands. GSK will retain the existing rights for the aforementioned brands outside the United States.

Further financial terms and conditions of the transaction are not being disclosed.

March 30, 2011

Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

The buyout offer, equal to $73 per share, includes a 29% premium over Cephalon’s stock price. Valeant noted it had made previous offers, but was “disappointed by Cephalon’s unwillingness to engage in discussions in a timely manner.”

March 29, 2011

For many patients, the inability to pay for drugs is enough of a problem, but what if the drugs they need aren’t available at all?

NEW YORK — For many patients, the inability to pay for drugs is enough of a problem, but what if the drugs they need aren’t available at all?

According to a new report by the Premier Healthcare Alliance, more than 240 drugs were hard to find or entirely unavailable, while more than 400 generic versions of branded drugs were backordered for more than five days. Premier said shortages had more than tripled since 2005, with the frequency and effects rising to critical levels and affecting all segments of health care.

March 28, 2011

The Food and Drug Administration has approved a topical treatment for genital warts made by Graceway Pharmaceuticals, the drug maker said Monday.

BRISTOL, Tenn. — The Food and Drug Administration has approved a topical treatment for genital warts made by Graceway Pharmaceuticals, the drug maker said Monday.

The FDA approved Zyclara (imiquimod) cream in the 3.75% strength for patients ages 12 years and older. According to clinical trial data, the cream effectively cleared genital warts, and of patients who achieved complete clearance, only a small percentage had a recurrence 12 weeks after treatment.

March 28, 2011

Looking to further communicate the important role pharmacy plays in the healthcare delivery system, the National Association of Chain Drug Stores president and CEO Steve Anderson ran an opinion column in a "Medication Non-Adherence" supplement published Monday by Mediaplanet and distributed in The Washington Post.

ALEXANDRIA, Va. — Looking to further communicate the important role pharmacy plays in the healthcare delivery system, the National Association of Chain Drug Stores president and CEO Steve Anderson ran an opinion column in a "Medication Non-Adherence" supplement published Monday by Mediaplanet and distributed in The Washington Post.

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 25, 2011

"Dispense-as-written" prescriptions are exacerbating medication nonadherence and costing the U.S. healthcare system billions of dollars, according to a new study by researchers at Harvard University, Brigham and Women's Hospital, and CVS Caremark.

WOONSOCKET, R.I. — "Dispense-as-written" prescriptions are exacerbating medication nonadherence and costing the U.S. healthcare system billions of dollars, according to a new study by researchers at Harvard University, Brigham and Women's Hospital, and CVS Caremark.

March 25, 2011

A pill developed by AstraZeneca and Pozen that combines a nonsteroidal anti-inflammatory drug with a proton-pump inhibitor was well-tolerated in patients with osteoarthritis, according to a new study.

NATIONAL HARBOR, Md. — A pill developed by AstraZeneca and Pozen that combines a nonsteroidal anti-inflammatory drug with a proton-pump inhibitor was well-tolerated in patients with osteoarthritis, according to a new study.

AstraZeneca announced results of PN400-304, a 12-month study of Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets in patients with osteoarthritis who need daily treatment with NSAIDs but are at risk of NSAID-related gastric ulcers. Vimovo is designed to reduce pain while reducing gastric ulcer risk.

March 25, 2011

The Food and Drug Administration has approved a vaccine for shingles in older patients.

SILVER SPRING, Md. — The Food and Drug Administration has approved a vaccine for shingles in older patients.

The agency said Thursday that it had approved Merck’s Zostavax (zoster vaccine live) vaccine in patients ages 50 to 59 years. The vaccine already is approved for those ages 60 years and older.

Shingles, caused by the varicella-zoster virus, the same virus that causes chickenpox, affects about 200,000 people in the United States ages 50 to 59 years each year.

March 24, 2011

Bristol-Myers Squibb said its late-stage clinical trial for a cancer treatment, which currently is under review by the Food and Drug Administration, achieved its primary endpoint.

PRINCETON, N.J. — Bristol-Myers Squibb said its late-stage clinical trial for a cancer treatment, which currently is under review by the Food and Drug Administration, achieved its primary endpoint.

The company said its phase-3 trial for investigational compound ipilimumab, designed for previously untreated patients that were diagnosed with metastatic melanoma, improved overall survival. The study compared the combination of ipilimumab 10 mg/kg and chemotherapy (dacarbazine) with chemotherapy alone.

March 24, 2011

The Food and Drug Administration has extended its regulatory review period for Novartis' new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.

BASEL, Switzerland — The Food and Drug Administration has extended its regulatory review period for Novartis' new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.

March 24, 2011

Four-in-5 menthol smokers would quit if the Food and Drug Administration banned mentholated cigarettes, according to a survey conducted this month with sponsorship from GlaxoSmithKline Consumer Healthcare.

PARSIPPANY, N.J. — Four-in-5 menthol smokers would quit if the Food and Drug Administration banned mentholated cigarettes, according to a survey conducted this month with sponsorship from GlaxoSmithKline Consumer Healthcare.

The survey found that smokers of menthol cigarettes — who are disproportionately African-American — feel “twice-addicted” to the menthol and the tobacco, while 74% of them said the menthol made inhalation easier, and 40% said menthol flavoring was the only reason they smoked.

March 24, 2011

GlaxoSmithKline withdrew all regulatory approval applications for a drug designed to cut men's risk of developing prostate cancer.

LONDON — GlaxoSmithKline withdrew all regulatory approval applications for a drug designed to cut men's risk of developing prostate cancer.

The drug maker announced it no longer would pursue global approval for Avodart (dutasteride) and would work with regulatory agencies to remove the indication from the product’s license.

March 24, 2011

Novo Nordisk said new data showed that its basal insulin analog is just as effective as human basal insulin in Type 1 diabetes patients ages 2 to 5 years.

COPENHAGEN — Novo Nordisk said new data showed that its basal insulin analog is just as effective as human basal insulin in Type 1 diabetes patients ages 2 to 5 years.