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July 14, 2011

A new study conducted by Bayer HealthCare suggests that an investigational treatment for acne may be suitable for patients with dark complexions whose acne includes a condition that causes irregular discoloration of the skin known as postinflammatory hyperpigmentation, or PIH.

BERLIN — A new study conducted by Bayer HealthCare suggests that an investigational treatment for acne may be suitable for patients with dark complexions whose acne includes a condition that causes irregular discoloration of the skin known as postinflammatory hyperpigmentation, or PIH.

July 14, 2011

Eli Lilly & Co. and Disney are collaborating to produce a dedicated lifestyle website and publications for families affected by Type 1 diabetes, the two companies said Thursday.

INDIANAPOLIS — Eli Lilly & Co. and Disney are collaborating to produce a dedicated lifestyle website and publications for families affected by Type 1 diabetes, the two companies said Thursday.

July 14, 2011

A team comprised of scientists from drug maker Merck and several U.S. universities will look for ways to eradicate HIV, Merck said.

WHITEHOUSE STATION, N.J. — A team comprised of scientists from drug maker Merck and several U.S. universities will look for ways to eradicate HIV, Merck said.

July 14, 2011

French drug maker Sanofi has sold its skin care business to Canada’s Valeant Pharmaceuticals International, Sanofi said.

PARIS — French drug maker Sanofi has sold its skin care business to Canada’s Valeant Pharmaceuticals International, Sanofi said.

Sanofi said the $425 million sale of its dermatology business, Dermik, would allow it to focus on its core businesses. Valeant’s business is much more focused on dermatology, as well as neurology, than Sanofi’s is.

July 14, 2011

OSAKA, Japan — Two diabetes drugs made by Takeda Pharmaceutical Co. have been pulled from the market in France due to evidence that their use may increase the risk of bladder cancer, Takeda said.

Takeda said its French subsidiary, Laboratoires Takeda, would withdraw Actos (pioglitazone) and Competact (pioglitazone and metformin). In addition, Takeda said it was cooperating with the European Medicines Agency in a pan-European of pioglitazone. Competact is marketed in the United States under the brand name Actoplus Met.

July 13, 2011

Taking drugs for treating HIV might reduce the risk of infection among heterosexual couples, according to two new studies conducted in Africa.

NEW YORK — Taking drugs for treating HIV might reduce the risk of infection among heterosexual couples, according to two new studies conducted in Africa.

One study, funded by the Bill & Melinda Gates Foundation and conducted among 4,758 couples in Kenya and Uganda, found that when taken daily, Gilead’s Viread (tenofovir) reduced the rates of infection by at least 62% compared with placebo. Truvada (tenofovir and emtricitabine), another drug made by Gilead, reduced infection risk by 73%.

July 11, 2011

Upsher-Smith Labs has launched a topical medication for itching and inflammation of the skin resulting from such conditions as psoriasis and atopic dermatitis, the company said Monday.

MAPLE GROVE, Minn. — Upsher-Smith Labs has launched a topical medication for itching and inflammation of the skin resulting from such conditions as psoriasis and atopic dermatitis, the company said Monday.

Upsher-Smith announced the launch of Trianex (triamcinolone acetonide) ointment, which the company described as a prescription topical corticosteroid that offers the feel of a cream and the strength of an ointment.

July 8, 2011

Novo Nordisk could be outpacing Eli Lilly and Amylin Pharmaceuticals in the diabetes wars, according to an analysis by healthcare market research firm Decision Resources.

BURLINGTON, Mass. — Novo Nordisk could be outpacing Eli Lilly and Amylin Pharmaceuticals in the diabetes wars, according to an analysis by healthcare market research firm Decision Resources.

July 8, 2011

Danish drug maker Novo Nordisk will work with advocacy group Children with Diabetes to distribute materials to children newly diagnosed with Type 1 diabetes, the two said Thursday.

ORLANDO, Fla. — Danish drug maker Novo Nordisk will work with advocacy group Children with Diabetes to distribute materials to children newly diagnosed with Type 1 diabetes, the two said Thursday.

The approximately 7,000 kits, designed to help them learn to live with the condition, include a booklet, savings offers and patient-support videos, and were created based on feedback from CWD members with Type 1 diabetes. Patients can order the kits through their doctors.

July 7, 2011

Merck KGaA division Merck Serono has appointed Belen Garijo as COO and Annalisa Jenkins as global head of drug development and medical, effective Sept. 5.

DARMSTADT, Germany — Merck KGaA division Merck Serono has appointed Belen Garijo as COO and Annalisa Jenkins as global head of drug development and medical, effective Sept. 5.

The company, which operates under the name "EMD" in the United States and is a separate company from U.S.-based Merck, said Garijo and Jenkins will be based in Geneva and will report to president Stefan Oschmann.

Garijo previously worked for Sanofi, where he was SVP global operations for the European region, while Jenkins was SVP global medical for Bristol-Myers Squibb.

July 6, 2011

A once-monthly formulation of a drug made by Amylin Pharmaceuticals, Eli Lilly and Alkermes improved glucose control in patients with Type 2 diabetes, according to results of a mid-stage clinical trial presented at the American Diabetes Association’s 71st Scientific Sessions.

SAN DIEGO — A once-monthly formulation of a drug made by Amylin Pharmaceuticals, Eli Lilly and Alkermes improved glucose control in patients with Type 2 diabetes, according to results of a mid-stage clinical trial presented at the American Diabetes Association’s 71st Scientific Sessions.

The three companies said once-monthly injections of the drug exenatide improved blood-sugar control and produced modest weight loss in the 121-patient phase-2 study.

July 6, 2011

Patients with Type 1 diabetes using an insulin product made by MannKind expressed a better opinion about insulin therapy than those taking the standard treatment, according to a study presented at the American Diabetes Association’s 71st Scientific Sessions.

SAN DIEGO — Patients with Type 1 diabetes using an insulin product made by MannKind expressed a better opinion about insulin therapy than those taking the standard treatment, according to a study presented at the American Diabetes Association’s 71st Scientific Sessions.

MannKind said that patients taking the investigational inhaled insulin Afrezza (insulin human [rDNA origin]) with basal insulin came to view insulin therapy more positively during the 16-week study than those taking Eli Lilly’s injected Humalog (insulin lispro [rDNA origin]) with basal insulin.

July 5, 2011

APP Pharmaceuticals has received regulatory approval for the treatment of a complication related to hypothyroidism.

SCHAUMBURG, Ill. — APP Pharmaceuticals has received regulatory approval for the treatment of a complication related to hypothyroidism.

APP said that its levothyroxine sodium for injection will be marketed in single-dose 100-mcg, 200-mcg and 500-mcg vials. The drug is designed to treat myxedema coma, a life-threatening complication of hypothyroidism.

July 5, 2011

Eli Lilly's SVP global quality has joined the drug maker's executive committee, effective July 1.

INDIANAPOLIS — Eli Lilly's SVP global quality has joined the drug maker's executive committee, effective July 1.

Fionnuala Walsh, who joined Lilly in 1988, will continue in her current role at Lilly, where she ensures the company maintains high-quality standards across its worldwide operations.

Walsh reports to company chairman, president and CEO John Lechleiter.

July 5, 2011

The Food and Drug Administration has approved a drug made by Archimedes Pharma for treating breakthrough pain in cancer patients, Archimedes said last week.

BEDMINSTER, N.J. — The Food and Drug Administration has approved a drug made by Archimedes Pharma for treating breakthrough pain in cancer patients, Archimedes said last week.

Archimedes announced the approval of Lazanda (fentanyl) nasal spray for cancer patients who have acquired a tolerance to opioid drugs. Breakthrough pain is an intense, sudden pain that is unpredictable and often debilitating and occurs despite otherwise appropriate pain therapy.

July 5, 2011

The Food and Drug Administration has approved a drug made by Novartis for treating chronic obstructive pulmonary disease, the FDA said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Novartis for treating chronic obstructive pulmonary disease, the FDA said Friday.

The FDA approved Arcapta Neohaler (indacaterol inhalation powder) for long-term, once-daily maintenance of bronchodilator treatment of airflow obstruction in people with COPD, including chronic bronchitis and emphysema.

COPD, which often results from cigarette smoking, is the fourth-leading cause of death in the United States, according to the Centers for Disease Control and Prevention.

July 5, 2011

As part of a strategic assessment, generic drug maker Par Pharmaceutical is set to restructure its branded division.

WOODCLIFF LAKE, N.J. — As part of a strategic assessment, generic drug maker Par Pharmaceutical is set to restructure its branded division.

The company said last week that its restructuring of Strativa Pharmaceuticals will result in a reduced workforce, prompting one-time noncash charges in the second quarter in addition to severance costs, although Par said the restructuring will generate expense savings in the $8 to $12 million range for the remainder of the year.

July 5, 2011

Pfizer defended a drug used for smoking cessation Monday following reports of a Canadian study that found it raised the risk of heart problems.

NEW YORK — Pfizer defended a drug used for smoking cessation Monday following reports of a Canadian study that found it raised the risk of heart problems.

The 8,216-patient study of Chantix (varenicline), published in the Canadian Medical Association Journal, found that of the 4,908 patients who received Chantix, 52 had an increased risk of serious heart problems, with similar risks appearing in 27-of-the-3,308 patients who took placebo.

July 5, 2011

Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

DUBLIN — Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

Shire said it has filed lawsuits in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals and Sandoz. Amneal and Sandoz recently filed abbreviated new drug applications with the Food and Drug Administration to market generic Vyvanse (lisdexamfetamine), an ADHD drug.

July 5, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said Friday.

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said Friday.

Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.

June 30, 2011

Innovation took center stage Thursday as Eli Lilly laid out its future growth strategies at a meeting with investors.

NEW YORK — Innovation took center stage Thursday as Eli Lilly laid out its future growth strategies at a meeting with investors.

At its “Bridging to the Future” meeting, Lilly said it had 70 drugs in its research and development pipeline, including 33 in phases 2 and 3. The company said it expects at least 10 new drugs to enter phase 3 this year, including drugs in such areas as cancer, diabetes and neuroscience, as well as new therapeutic areas, such as autoimmune disorders.

June 30, 2011

Drug maker UCB and Harvard University have entered a research alliance that is designed to advance ongoing Harvard research projects along the drug development pathway.

BOSTON and BRUSSELS — Drug maker UCB and Harvard University have entered a research alliance that is designed to advance ongoing Harvard research projects along the drug development pathway.

UCB said it will bring its expertise in antibody generation and medicinal chemistry into the alliance and will provide up to $6 million over two years to fund specific innovative research projects led by Harvard scientists. The collaboration focuses on the central nervous system and immunology, UCB said.

June 30, 2011

Canadian drug maker Valeant Pharmaceuticals International will acquire rights to topical drugs for eczema and cold sores from Swedish drug maker Meda.

MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals International will acquire rights to topical drugs for eczema and cold sores from Swedish drug maker Meda.

Valeant said it would buy rights for the eczema drug Elidel (pimecrolimus) and the cold sore drug Xerese (acyclovir and hydrocortisone) for the United States, Canada and Mexico. Valeant said, however, that Xerese has not yet received regulatory approval in Canada.

June 29, 2011

Adding an investigational drug for Type 2 diabetes to the common generic drug metformin helped control blood sugar in patients who could not control their blood sugar with metformin alone, according to results of a late-stage clinical study.

SAN DIEGO — Adding an investigational drug for Type 2 diabetes to the common generic drug metformin helped control blood sugar in patients who could not control their blood sugar with metformin alone, according to results of a late-stage clinical study.

June 29, 2011

A topical drug made by Eli Lilly restored testosterone to normal levels in men with abnormally low testosterone, according to results of a late-stage clinical trial.

INDIANAPOLIS — A topical drug made by Eli Lilly restored testosterone to normal levels in men with abnormally low testosterone, according to results of a late-stage clinical trial.

Lilly announced results of a phase-3 trial of Axiron (testosterone) topical solution, a treatment for the condition, also known as hypogonadism. Study results also showed that the drug improved symptoms associated with it.

Hypogonadism results from damage or disease of the testicles, hypothalamus or pituitary glands that inhibits production of testosterone.