FDA to review Ustekinumab
Johnson & Johnson's subsidiary Centocor Inc. said Monday the USFDA will review its application for experimental drug CNTO 1275 for the treatment of psoriasis, a skin disease. Centocor is seeking approval for the late-stage drug, also known as ustekinumab, to treat adults with chronic moderate-to-severe plaque psoriasis, which results from the overproduction of skin cells and causes red, scaly plaques that itch and bleed. Centocor discovered ustekinumab and holds exclusive marketing rights to the product in the United States. Janssen-Cilag International NV has exclusive marketing rights in countries outside of the United States.
Setback for Akela Pharma
Akela Pharma Inc said on Monday it received a letter from the USFDA saying that its six-month inhalation toxicology studies for its lead product were deemed invalid due to GLP (Good Laboratory Practice) deviations.
The drug developer said no toxicological reasons were cited and is evaluating several alternative remedies. It said it is confident that the submission for regulatory approval will not be delayed by more than six months.
Fentanyl Taifun is Akela's lead product for the treatment of breakthrough cancer pain and is a formulation of pain reliever Fentanyl delivered using the company's Taifun dry powder inhaler platform.
Late last year, Akela said it would not go ahead with a planned 5.3 million share public offering in the United States, citing unfavorable market conditions for small and microcap companies.
The company said it was still exploring finance options and still intended to list its shares on a U.S. exchange.
Akela Pharma Inc said on Monday it received a letter from the USFDA saying that its six-month inhalation toxicology studies for its lead product were deemed invalid due to GLP (Good Laboratory Practice) deviations.
The drug developer said no toxicological reasons were cited and is evaluating several alternative remedies. It said it is confident that the submission for regulatory approval will not be delayed by more than six months.
Fentanyl Taifun is Akela's lead product for the treatment of breakthrough cancer pain and is a formulation of pain reliever Fentanyl delivered using the company's Taifun dry powder inhaler platform.
Late last year, Akela said it would not go ahead with a planned 5.3 million share public offering in the United States, citing unfavorable market conditions for small and microcap companies.
The company said it was still exploring finance options and still intended to list its shares on a U.S. exchange.
