Jet lag treatment receives complete response letter
FRAZER, Pa. The Food and Drug Administration declined to approve a Cephalon drug as a treatment for jet lag, the drug maker announced Monday.
Cephalon said it received a complete response letter from the FDA for Nuvigil (armodafinil) tablets. The company had been seeking approval for the drug, already approved for sleep apnea, as a treatment for excessive sleepiness associated with jet lag, particularly resulting from eastbound travel.
The FDA issues complete response letters when it has finished reviewing a drug, but issues remain that preclude the drug’s approval. Cephalon chief medical officer Lesley Russell said in a statement that the agency had raised questions about a subjective assessment of clinical efficacy called the patient global impression of severity, or PGI-S.
GSK offers free vaccines to uninsured adults
RESEARCH TRIANGLE PARK, N.C. GlaxoSmithKline is offering its vaccines free of charge to low-income adults, the British drug maker announced Monday.
The GSK Vaccines Access Program offers adult vaccines for diseases such as hepatitis, tetanus and human papillomavirus for adults ages 19 years and older who lack health insurance coverage for vaccines.
“Vaccines are one of the most effective ways we can prevent and fight disease, and subsequently drive down the cost of health care in the United States,” GSK president for North America Pharmaceuticals Deirdre Connelly said. “Unfortunately, vaccines are severely underutilized by American adults.”
Children up through the age of 18 years are eligible to receive free vaccines under a separate program, Vaccines for Children, which receives federal funding.
NBA Cares takes vaccination awareness program to Detroit
DETROIT The charitable arm of the NBA is expanding its education program about adolescent vaccinations to Detroit.
Detroit Pistons forward Jonas Jerebko and NBA Legend Bob Lanier teamed up with NBA Cares and the Society for Adolescent Medicine to bring Vaccines for Teens to the Metro Detroit community. Vaccines for Teens is a national multimedia campaign designed to educate teens and their parents about the importance of vaccination against serious and potentially life-threatening diseases.
To tip off the campaign locally, Jerebko and Lanier appeared at the Arts and Technology Academy in Pontiac, Mich., to urge parents of preteens and teens to discuss adolescent vaccinations with their family physicians.
Teens are at risk for influenza disease, both seasonal and the influenza A (H1N1) virus, as well as for other serious infectious diseases such as meningococcal disease (including meningitis) and whooping cough (pertussis). The basketball superstar and local community leaders agree it is more important than ever to help protect preteens and teens in the Metro Detroit area from the potentially life-threatening complications of these diseases.
“Vaccination can help teens grow into healthy adults, and is beneficial for the students at Arts and Technology Academy of Pontiac and for teens throughout the Metro Detroit area,” said Jerebko. “In basketball, the best offense is a good defense, and the same holds true for protecting teen health.”