Branded

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.

PRINCETON — Sandoz has introduced an authorized generic version of a herpes treatment made by parent company Novartis, the company said Thursday.

Sandoz announced the launch of famciclovir tablets, an authorized generic of Famvir, used to treat genital herpes and cold sores in patients with healthy immune systems, and to treat shingles and herpes simplex infections of the skin and mucosa in patients with HIV.

Authorized generics are branded drugs sold under their generic chemical names at a reduced price, often through third-party companies.

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.

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.

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.

BETHESDA, Md. — Most patients that suffer from gastroesophageal reflux disease or persistent heartburn symptoms rarely speak with a healthcare provider about their condition, according to a new study conducted on behalf of the American Gastroenterological Association, in partnership with drug maker Takeda.

JACKSONVILLE, Fla., and DEERFIELD, Ill. — The American Association of Clinical Endocrinologists has teamed up with drug maker Takeda to develop an online resource that will be reviewed and evaluated by top medical experts.

AACE and Takeda will offer a compendium of existing reliable resources specific to Type 2 diabetes, divided into various categories (e.g., management, lifestyle and tools) and reviewed by experts to help healthcare professionals guide their patients and caregivers as they attempt to cut through the clutter of the many resources available.

FRAZER, Pa. — Cephalon plans to acquire a privately owned company developing treatments for cancer, Cephalon said Monday.

The Frazer, Pa.-based drug maker said it would pay $225 million upfront for Malvern, Pa.-based Gemin X, and Gemin X stockholders would be eligible to receive up to $300 million in milestone payments related to products under development.

Gemin X specializes in cancer treatments that target and kill cancer cells. Its lead product is GX15-070 (obatoclax), currently in phase-2b clinical development as a treatment for small cell lung cancer.