Regulatory and Washington

SILVER SPRING, M.D. — The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.

According to several published reports, FDA commissioner Margaret Hamburg recently told a group of scientific advisers that the agency is considering allowing makers of drugs having a societal benefit to conduct faster clinical trials with a smaller group of patients than is now required.

 SILVER SPRING, Md. — The Food and Drug Administration took the Family Smoking Prevention and Tobacco Control Act of 2009 one step closer to being considered by the Supreme Court earlier this week. The FDA recently petitioned the D.C. Circuit Court of Appeals to revisit the court's August decision that ruled in favor of the tobacco industry and precluded the FDA from mandating that graphic images depicting the consequences of smoking be placed on all cigarette packaging. 

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a new use for a drug made by Roche division Genentech.

The drug maker said Friday that the FDA had approved Actemra (tocilizumab) for adults with moderately to severely active rheumatoid arthritis who have not responded adequately to one or more disease-modifying antirheumatic drugs. The drug was already approved for systemic juvenile idiopathic arthritis.

PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Sandoz for treating symptoms of various skin diseases.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval of desoximetasone ointment in the 0.25% strength. The drug is a generic version of Taro Pharmaceutical Industries' Topicort and, according to Sandoz, is the first Fougera dermatology product Sandoz has launched since its $1.5 billion acquisition of the company in May 2012.

SUMMIT, N.J. — The Food and Drug Administration has approved an injected drug for lung cancer made by Celgene, the company said Friday.

Celgene announced the approval of Abraxane (paclitaxel) protein-bound particles for injectable suspension, for the first-line treatment of non-small cell lung cancer that has advanced locally or spread to other parts of the body, in combination with carboplatin, for patients who are not candidates for curative surgery or radiation therapy.

BENSALEM, Pa. — Thirteen million more Americans had health insurance in June 2012 than 18 months earlier, according to a new report by BusinessOne Technologies, a healthcare technology and data company.

For branded drug makers, the pharmaceutical patent cliff has never loomed higher or steeper. The exposure of so many of the world’s biggest-selling medicines to generic competition for the first time is redefining the pricing model for many of the most widely prescribed classes of pharmaceuticals — reducing costs for health plans, payers and patients; scrambling drug makers’ balance sheets; and potentially boosting both drug utilization and adherence rates as reduced out-of-pocket costs induce more patients to fill their prescriptions.


CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new drug for multiple sclerosis.

Sanofi subsidiary Genzyme announced that the FDA had approved Aubagio (teriflunomide) as a once-daily, oral treatment for patients with relapsing MS.