Specialty Pharmacy

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.

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.

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.

LOS ANGELES — A group of physicians is urging the Food and Drug Administration not to approve a drug made by Gilead Sciences for the prevention of HIV infection.

Fifty-five physicians signed a letter spearheaded by the AIDS Healthcare Foundation citing concerns about the use of Gilead’s Truvada (tenofovir disoproxil fumarate and emtricitabine) for “pre-exposure prophylaxis,” or PrEP. Concerns included the risk of a decrease in condom use and a lack of information showing proper use in “real world” situations.

ALLEGAN, Mich. — Perrigo on Wednesday announced that its closing date to complete the acquisition of Paddock Labs — a generic pharmaceutical and specialty over-the-counter products manufacturer — has been delayed by an extended Federal Trade Commission review.

FLINT, Mich. — Just about everybody seems satisfied with Diplomat Specialty Pharmacy’s services, according to the company’s 2011 patient satisfaction survey.

Diplomat mailed the survey to 1,545 customers in May, of whom 463 responded. Of those respondents, 90% said Diplomat exceeded their expectations; 98% said it met their expectations; and 99% said they were satisfied overall with the specialty pharmacy provider.

Diplomat president and CEO Phil Hagerman said the results affirmed the provider’s patient-focused model.

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.

MONMOUTH JUNCTION, N.J. — A specialty pharmaceutical company has appointed a new VP human resources.

Cheryl Patnick, who has more than 20 years of experience in human resources and mergers/acquisitions, will lead and manage Tris Pharma's human resource activities, the company said Wednesday.