ZaBeCor gets green flag from FDA for asthma drug trials
NEW YORK The Food and Drug Administration has given biotech ZaBeCor Pharmaceuticals permission to begin clinical trials of a drug for treating asthma.
The company plans to begin phase 1 testing of the drug Excellair, which targets proteins involved with inflammatory diseases such as asthma.
The drug is based on research from the University of Pennsylvania School of Medicine.
FDA approves Mylan’s generic drug for treating epilepsy
ROCKVILLE, Md. The Food and Drug Administration has approved Mylan’s levetiracetam tablets, FDA records show.
The tablets, a generic version of UCB’s epilepsy drug Keppra, will be available in 250 mg, 500 mg and 750 mg dosages.
The agency’s records indicate an approval date of Nov. 4 and that Mylan’s is the first generic version of Keppra.
Study shows Gardasil is effective in prevention of HPV in males
ATLANTA A vaccine used to prevent genital warts in girls and women works in boys and men, too.
A study of Gardasil funded by its manufacturer, Merck, has shown that the vaccine is effective in preventing infection human papillomavirus in boys and men as well as in girls and women. The study took place in 20 countries among 4,000 boys and men aged 16 to 26, including more than 1,000 in the United States.
Regulatory agencies in 40 countries have approved Gardasil for use in males, but not the Food and Drug Administration, which has approved it only for females aged 9 to 26 because of the lack of evidence of efficacy in males.
Now, however, Merck plans to ask the FDA to extend approval to males. As yet, there is no evidence that the vaccine prevents HPV-related cancers in males.