Branded

CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new means of administering a cancer drug made by Takeda, the drug maker said.

The FDA approved injection under the skin of Velcade (bortezomib) for multiple myeloma and mantle-cell lymphoma, also known as subcutaneous injection.

Takeda said the approval was based on results of a phase-3 trial conducted on 222 patients who had not received the drug before that showed subcutaneous injection worked as well as intravenous injection.

PRINCETON, N.J. — In an effort to take Type 1 diabetes research to the next level, Novo Nordisk is set to open a research and development center in Seattle.

The center, slated to open this summer, will combine basic research and early proof-of-concept trials under one umbrella, the drug maker said. Additionally, the center will be staffed by approximately 20 researchers who will be supported by corporate functions in the United States and Denmark.

SUPPLIER NEWS — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said. The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl drugs. The new system, which takes effect in March, will allow prescribers and pharmacies to enroll into one system instead of individual systems for each product.

WASHINGTON — Avian flu researchers have agreed to take a 60-day hiatus on testing an H5N1 influenza strain that recently had gained public attention, according to a letter published Friday in the journal Science.

PARSIPPANY, N.J. — A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug's manufacturers said.

Columbia Labs and Watson Pharmaceuticals announced that the FDA's Reproductive Health Drugs Advisory Committee did not recommend approval for progesterone vaginal gel in the 8% strength. The drug is designed to reduce the risk of preterm birth in women with short uterine cervical length in the middle trimester of pregnancy.

PRINCETON, N.J. — Drug maker Bristol-Myers Squibb has donated $6.9 million to a nonprofit group that helps people pay for medical treatments, the company said.

Bristol made the donation to the HealthWell Foundation, which provides financial assistance to eligible people for covering co-insurance, co-payments, healthcare premiums and deductibles for certain treatments. The drug maker's donation is targeted toward underinsured cancer patients.

For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


With the patent cliff and subsequent innovation drought moving closer, generic drug makers are looking to move up the value chain and pursue new sources of revenue, and of all the piles of pay dirt out there, biosimilars represent one of the closest things to an El Dorado, though regulations won’t take their final form for a while.