Content about Pharmacology

NEW YORK According to a recently published Dow Jones report, state-funded tobacco-prevention programs quickly are becoming the latest casualty of constricting state budgets, prompting concern among public health groups around the nation's progress toward getting adult smokers to quit.

The number of adults who smoke has remained relatively steady since 2004 — 20.6% of the population were smokers in 2009.

SAN DIEGO Two drug makers conducting a late-stage clinical trial of a drug for treating overweight and obese patients said the drug produced significant weight loss in patients with Type 2 diabetes.

Arena Pharmaceuticals and Eisai reported results of the one-year “BLOOM-DM” phase-3 trial of the drug lorcaserin, showing that a significant number of patients lost 5% to 10% of their weight by the end of the trial. Patients taking the drug also showed improvements in blood sugar levels, compared with those taking placebo.

NEW YORK Loss of patent protection for branded drugs and subsequent competition from generics could save the U.S. healthcare system $70 billion or more over the next four years, according to published reports.

Reuters reported IMS Health SVP Murray Aitken as saying at the Reuters Health Summit that generics also would increase their dominance in terms of prescriptions dispensed, increasing from 77% during the first half of this year to perhaps 85% by 2014.

SILVER SPRING, Md. The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of generic drugs, testified Wednesday at a hearing sponsored by the Food and Drug Administration to collect public and industry input on the implementation of the regulatory approval pathway for follow-on biologics included in the healthcare-reform bill.

THOUSAND OAKS, Calif. Amgen's SVP research and development, Joe Miletich, urged members of a Food and Drug Administration panel to establish approval standards for biosimilars that ensure patient safety and follow a science-based approach.

“Put patients first and sound policy will follow,” Miletich said. “Amgen believes biosimilars have a meaningful role to play in the healthcare system. However, dissimilar — unlike generic drugs — are not identical to the innovative biological products.” 

ALEXANDRIA, Va. The National Association of Chain Drug Stores is urging federal health officials to adopt a simpler means of communicating drug safety and efficacy information to patients, and to clear the way for an approval pathway for generic versions of biologically engineered drugs.

NACDS made its priorities known in a letter Monday to Margaret Hamburg, commissioner of the Food and Drug Administration. The letter came from Kevin Nicholson, the group’s VP government affairs and public policy.

WASHINGTON The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent and scientific regulatory structure; and enable innovation and competition when creating regulations governing follow-on biologics, according to testimony released in advance of an FDA hearing by a drug lobbying group.

SILVER SPRING , Md. (Oct. 29) The Food and Drug Administration has approved a new drug for treating schizophrenia, the agency said Thursday.

The FDA announced the approval of Latuda (lurasidone hydrochloride), made by Fort Lee, N.J.-based Sunovion Pharmaceuticals. The drug is approved to treat adults with the disease, a mental illness that causes hallucinations, delusions, paranoia and disordered thinking and behavior.

MOUNTAIN VIEW, Calif. Vivus found itself foiled in its efforts to market a drug for obesity as the Food and Drug Administration turned down its regulatory approval application.

ALEXANDRIA, Va. The charitable arm of the National Association of Chain Drug Stores announced its $1 million contribution to the National Consumers League's medication adherence awareness campaign.