Aldara (imiquimod) is a synthetic agent with immune response modifying activity. As an immune response modifier (IRM), imiquimod stimulates cytokine production, especially interferon production, and exhibits antitumor activity, particularly against cutaneous cancers. Imiquimod's proapoptotic activity appears to be related to Bcl-2 overexpression in susceptible tumor cells. Check for active clinical trials or closed clinical trials using this agent.
Meda has reached an agreement with Valeant to terminate the companies' joint ventures in Canada, Mexico and Australia in the second quarter of 2014. In all three countries own Meda affiliates have been established.
A research team from the Institute for Cancer Research at the MedUni Vienna has decoded a previously unknown mechanism of the active ingredient imiquimod in tumour defense. They have been able to prove that imiquimod transforms plasmacytoid dendritic cells (pDCs) into "tumour-killers" which can fight the tumour independently from other immune cells. This discovery could be an important step on the way to a more efficient treatment for cancer.
Graceway Pharmaceuticals, LLC announced today that the Food and Drug Administration (FDA) has approved Zyclara Cream, 2.5% for the treatment of actinic keratoses, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses.
Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Imiquimod Cream, 5%.
Graceway Pharmaceuticals announced today that the Food and Drug Administration has approved Zyclara Cream for the treatment of external genital and perianal warts in patients 12 years of age and older.
Scratching deep beneath the surface, a team of researchers from the University of California, San Diego School of Medicine and three South Korean institutions have identified two distinct neuronal signaling pathways activated by a topical cream used to treat a variety of skin diseases. One pathway produces the therapeutic benefit; the other induces severe itching as a side effect.
Tamir Biotechnology, Inc. announced today that scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID) reported test results confirming two of our lead compounds showed excellent in vitro antiviral activity and no cellular toxicity at dose levels tested for Human Papillomavirus (HPV).
Perrigo Company today announced results for its first quarter ended September 25, 2010.
Results from a randomized, double-blinded, placebo-controlled, multicentred study just published in the Journal of Drugs in Dermatology shows that treating Actinic Keratoses (AK) with imiquimod 3.75% (Zyclara®) following cryotherapy was more effective than cryotherapy alone in reducing total AK lesion count and achieving complete clearance of AK.
Perrigo Company announced it received FDA approval from the U.S. Food and Drug Administration to manufacture and market Imiquimod Cream, 5%. Perrigo will vertically integrate this product with their own API.
Results from a randomized study with Zyclara following cryotherapy in the treatment of actinic keratoses (AK) demonstrated Zyclara complemented the effectiveness of cryosurgery in reducing total AK count and achieving complete clearance of AK, according to data presented at the American Academy of Dermatology Summer Academy Meeting 2010 (Summer AAD), August 4 - 8.
Results from a Phase III program evaluating imiquimod 3.75% and 2.5% creams for the treatment of EGW, applied once daily for up to 8 weeks, demonstrated that both were well-tolerated and more efficacious than placebo, according to data presented at the annual Human Papillomavirus Conference in Montreal, July 3 - 8. Investigators found that efficacy was greatest for imiquimod 3.75% with an enhanced safety profile.
“We have very good experience with Aldara in Europe and we look forward to provide AK patients with a new product with improved tolerability that builds on the efficacy of imiquimod”
Watson Pharmaceuticals, Inc. today reported a 28 percent increase in net revenue for the first quarter ended March 31, 2010 to $856.5 million, compared to $667.4 million in the first quarter 2009. On an adjusted cash basis, net income increased 25 percent to $100.3 million or $0.81 per share, compared to $80.2 million or $0.69 per share in the first quarter 2009. GAAP earnings for the first quarter 2010 were $0.57 per share, compared to $0.43 per share in the prior year period.
After a strong Q4 in 2009, net sales decreased 14% in Q1 to SEK 2,943 million (3,437). Mainly currency effects but also increased competition for Astelin and Optivar reduced sales by more than SEK 400 million, compared with the same period last year.
Graceway® Pharmaceuticals announced today that the Food and Drug Administration has approved the New Drug Application for Zyclara™, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses.
The Journal of the American Academy of Dermatology (JAAD) has published Phase III data evaluating the safety and efficacy of imiquimod cream at two doses - 2.5% and 3.75% - administered daily on a 2-week treatment cycle. The study demonstrates that both formulations were superior to placebo, and that imiquimod 3.75% on a daily 2-week treatment cycle is superior to imiquimod 2.5% in treating actinic keratosis (AK) on a large surface area - the face or balding scalp.
The Journal of the American Academy of Dermatology has published Phase III data evaluating the safety and efficacy of imiquimod cream at two doses – 2.5% and 3.75% – administered daily on either 2-week or 3-week treatment cycles.
E. Fougera & Co., a leading specialty pharmaceutical manufacturer, today announced it has received first generic approval from the FDA for Imiquimod Cream 5% (Rx). Fougera's Imiquimod Cream 5% is rated AB, generically equivalent to Aldara® by Graceway Pharmaceuticals and substitutable for all indications. According to industry data, U.S. sales of the brand named product in 2009 exceed $360 million.
“The Meda Group expects to achieve sales of about SEK 13,000 million and an EBITDA of about SEK 4,200 million for full-year 2009.”