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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 — Some people liked President Barack Obama's State of the Union address Tuesday night, and some people didn't, and the response from the drug industry was no less mixed.

The Generic Pharmaceutical Association called for measures to lower healthcare costs, including ensuring that generic pharmaceuticals and biosimilars reach patients' hands quickly and also avoiding measures intended to provide savings that the GPhA said would raise prescription drug costs, though the grow didn't specify what those measures were.

MCLEAN, Va. — Unexpected toxicities from prescription drugs that emerge years after regulatory approval may be due to poor medication adherence in clinical trials, according to a new study.

While much attention on medication adherence has focused on patients not taking the already approved drugs prescribed to them or not taking them properly, the new study, released Tuesday by Consumer Health Information, found problems with adherence in clinical trials as well.

JERUSALEM — Teva Pharmaceutical Industries has added a University of California at Los Angeles medical professor to its board of directors, the Israeli drug maker said.

Teva announced the appointment of Arie Belldegrun, who is a director at the UCLA Institute of Urology Oncology and professor and chair of urologic oncology at the David Geffen School of Medicine. The company appointed Belldegrun at its Feb. 5 meeting to fill a vacancy, and Belldegrun's term will extend the drug maker's 2013 annual shareholder meeting.

BAGSVÆRD, Denmark — The Food and Drug Administration declined to approve two insulin products made by Danish drug maker Novo Nordisk, the company said Sunday.

Novo Nordisk said it received complete response letters from the FDA for Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart). The FDA issues a complete response letter when it has finished reviewing an application for a drug, but determines that the application can't be approved in its current form.

SILVER SPRING, Md. — A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration reported Friday. 

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Celgene for treating the cancer multiple myeloma, the agency said Friday.

The FDA announced the approval of Pomalyst (pomalidomide) for patients whose disease has progressed after treatment with other cancer drugs.

ATLANTA — For the week ended Feb. 2, influenza activity remained elevated in the United States but decreased in most areas, the Centers for Disease Control and Prevention reported Friday. According to CDC's activity level map, it appears most incidence is concentrated across the central United States, including Texas, Oklahoma, Kansas and Missouri. 

TEMECULA, Calif. — While this season's flu epidemic maintains its strength across the West Coast, one vaccine distributor announced Wednesday they still have vaccine on hand. 

"FFF is prepared to respond to the unpredictable nature of flu season. And our secure supply chain can always be counted on to deliver safe products — even in times of limited supply," stated Patrick Schmidt, CEO FFF Enterprises. "We purchase direct from manufacturers and sell only to licensed hospitals, pharmacies and clinics."

STAMFORD, Conn. — An insomnia drug made by Purdue Pharma "significantly" reduced the time it took patients to return to sleep after they'd woke up in the middle of the night, according to a new study.

The placebo-controlled study, published in the journal Sleep, tested the drug Intermezzo (zolpidem tartrate) sublingual tablets on 295 adults with primary insomnia and difficulty returning to sleep after waking up in the middle of the night. Purdue said Intermezzo was the only drug approved by the Food and Drug Administration for treating such patients.

LAKE MARY, Fla. — CueScript on Tuesday launched an innovative platform that delivers on-demand prescription-specific videos and other value-added services designed to engage patients, improve health literacy and improve medication adherence.