Specialty Pharmacy

NEW YORK — This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

The Wall Street Journal reported that 21 new drugs were approved through the year, compared with 25 in 2009 and 24 in 2008. The lag came in part due to stricter safety regulations, the newspaper reported.

TITUSVILLE, N.J. — The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.

Tibotec Therapeutics, a subsidiary of J&J, said the FDA approved a 200-mg formulation of Intelence (etravirine) for treating HIV in patients who have taken previous treatments and whose virus has become resistant to antiretroviral drugs.

FLORHAM PARK, N.J. — Former president George W. Bush will deliver the keynote speech at Armada Health Care’s seventh annual Armada Specialty Pharmacy Summit, the specialty pharmacy contracting organization said.

The conference, which will take place May 10 to 13 at the Wynn Hotel in Las Vegas, is considered one of the top conferences in the U.S. drug industry.

NEW YORK — One door closes; another door, well, closes. And that appears to be good news for Teva. Recent news that the Food and Drug Administration has rejected the drug maker's application for a new indication for multiple sclerosis drug Copaxone likely will mean the agency will not be so quick to approve a generic version of the drug without requiring a generic company to perform full clinical trials.

LISLE, Ill. — SXC Health Solutions announced Wednesday that it had completed its acquisition of independent specialty pharmacy provider MedfusionRx in a deal worth $100 million in cash, with an additional $5.5 million subject to the achievement of certain performance targets in fiscal year 2012.

The waiting period under the Hart-Scott-Rodino Act expired Dec. 24.

NEW YORK — More than 25% of children and teens take at least one medication on a daily basis, and nearly 7% are on two or more drugs, the Wall Street Journal reported Tuesday, citing 2009 data from Medco Health Solutions. Drawing additional data from IMS Health, the article noted that prescriptions for hypertension in people under the age of 20 years could reach 5.5 million for 2010 by the time year-end results are tabulated, which would mark a rise of 17% since 2007. 

WHITEHOUSE STATION, N.J. — Merck on Wednesday announced that the Food and Drug Administration has approved Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant] for the prevention of anal cancer in males and females 9 to 26 years of age.

According to the company, Gardasil is the first HPV vaccine on the market available for use in both men and women, and the only one indicated  to help prevent cervical, vaginal, vulvar and anal cancers and pre-cancers, as well as genital warts, caused by certain types of HPV.

FRAZER, Pa. — Cephalon on Thursday appointed Kevin Buchi as CEO and a member of the company's board.