Content about Pharmaceutical sciences

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said Friday.

The FDA announced the approval of Genentech's Kadcyla (ado-trastuzumab emtansine) for HER2-positive breast cancer that has spread to other parts of the body. HER2 is a protein involved in the growth of normal cells but found in increased amounts in some kinds of cancer cells, which contributes to cancer cell growth and survival. Genentech is the U.S. subsidiary of Swiss drug maker Roche.

WASHINGTON — Patients around the country "strongly" oppose laws that have been proposed to change popular OTC drugs to prescription-only, according to a new survey.

The survey, conducted online by Harris Interactive on behalf of the Asthma and Allergy Foundation of America, polled 2,020 adults in January who had asthma, allergies, cold, cough or flu in the past 12 months and who had purchased OTC drugs for at least one condition during that time.

RALEIGH, N.C. — Kerr Drug has rolled out the PDX Enterprise Pharmacy System chainwide, the retail pharmacy chain said.

Kerr said the system would help it focus on "the future of pharmacy," with increased prescription volume and higher patient care requirements.

HYDERABAD, India — The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.

Aurobindo announced the approval of pioglitazone tablets in the 15 mg, 30 mg and 45 mg strengths, in addition to the earlier tentative approval it received for pioglitazone and metformin hydrochloride tablets in the 15 mg/500 mg and 15 mg/850 mg strengths.

SILVER SPRING, Md. — The Food and Drug Administration and the Federal Trade Commission last week issued a number of warning letters to distributors of "unapproved medicines," noting that because each of the products identified claimed to prevent or treat the cold or flu, they need to be registered and approved by the FDA. And because none of the ingredients listed are in fact monographed OTC cough, cold or flu symptom relievers, those products would additionally need to be filed as "new drugs."

Eighty-eight members of the House of Representatives fired off a letter Monday to postmaster general and CEO of the U.S. Postal Service Patrick Donahoe urging the agency not to eliminate Saturday delivery of mail, saying it would impede the ability of people who depend on mail-order pharmacies to receive their medications.

SILVER SPRING, Md. — U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla. The products may be unsafe because they contain an undisclosed active pharmaceutical ingredient.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.

The drug maker said Thursday that its experimental drug E7080 (lenvatinib) had received orphan drug designation from the FDA for follicular, medullary, anapestic and metastatic or locally advanced papillary thyroid cancer.

SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.

The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.

The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.

RARITAN, N.J. — The Food and Drug Administration has given a special designation to a cancer drug under development by Johnson & Johnson and Pharmacyclics, the companies said.

J&J subsidiary Janssen Research & Development and Pharmacyclics announced that the FDA had given breakthrough therapy designations to the experimental drug ibrutinib as a standalone therapy for relapsed or refractory mantle cell lymphoma in patients who have received prior therapy and for Waldenstrom's macroglobulinemia.

WASHINGTON — More than seven dozen members of the House of Representatives are urging the U.S. Postal Service to continue delivering medications to all Americans six days a week.

LONDON — Walgreens and Alliance Boots will generate $130 billion or more in combined sales, Greg Wasson, Walgreens president and CEO, told analysts Wednesday. Walgreens and Alliance Boots offered analysts a firsthand look at the Alliance Boots operation here, beginning with a store tour and then leading into presentations.