FDA advisory committee approves Pfizer’s HIV treatment
NEW YORK A Food and Drug Administration advisory committee has recommended approval for an HIV drug as a first-line treatment for the disease.
Drug maker Pfizer announced Thursday that the FDA’s Antiviral Drugs Advisory Committee had voted 10 to 4 to recommend the approval for Selzentry (maraviroc) in combination with other drugs in adult patients who have not taken drugs for HIV before. The drug is already approved as a treatment for HIV patients who have not responded to other therapies.
“Pfizer is pleased that the committee has recognized the effectiveness and safety profile of maraviroc in patients who are starting HIV therapy,” Pfizer executive director and disease area leader for antiviral drugs Howard Mayer said in a statement.
Results of a clinical trial indicated that the drug, when combined with GlaxoSmithKline’s Combivir (zidovudine and lamivudine) was as effective as Bristol-Myers Squibb’s Sustiva (efavirenz) combined with Combivir in reducing viral load. In terms of safety, patients taking Selzentry and Combivir experienced less than half of the adverse side effects as those in the Sustiva group.
An FDA advisory committee’s recommendation does not guarantee final approval of a drug, but the FDA takes it into account when making a final decision.
GSK to supply more than 400 million doses of swine flu vaccine
LONDON GlaxoSmithKline has contracts to supply more than 400 million doses of vaccine for the H1N1 swine flu, the British drug maker announced.
GSK said Tuesday that it had received orders for 149 million additional doses of the vaccine, bringing the total to 440 million. The company plans to ship initial supplies of the vaccine this week and into the first half of 2010.
Doses of the vaccine have been percolating into various parts of the United States over the last several days, and Health and Human Services secretary Kathleen Sebelius recently said that Americans “must” get the vaccine. To date, the pandemic H1N1 flu has killed about 600 people in this country.
Published reports: Violent criminals, organized crime turning to Medicare fraud
NEW YORK Violent criminals, including those involved in organized crime, are turning to Medicare fraud as a way of making money, according to published reports.
The Associated Press reported Tuesday that lighter sentences and easy money were leading many criminals to move from drug dealing to healthcare fraud, which can earn them $25,000 a day but a 10-year prison sentence if convicted.
Crimes have included sending Medicare fraudulent bills for drugs and medical equipment with invoices containing Social Security and Medicare numbers bought from homeless people on Los Angeles’ Skid Row. Most of the activity has occurred in Los Angeles, Miami, Detroit and Houston.