Can-Fite BioPharma Ltd has announced that it has opened Investigational New Drug application (IND) with the United States Food and Drug Administration (US FDA). The IND is for Can-Fite’s lead compound, CF101, for the treatment of patients with psoriasis. This is the third US IND for CF101, and the fourth for Can-Fite. The planned randomized, double-blind, controlled trial will compare 2 dose levels of CF101 to placebo.

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The FDA has approved Novo Nordisk’s new Diabetes drug Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in adults. Victoza, also known as Liraglutide, was launched in European markets in 2009 and has gained regulatory approval in Japan last week. Victoza belongs to a class of medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists, which help the pancreas make more insulin after eating a meal.

Endo Pharmaceuticals has announced that it received a complete response letter from the FDA regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone. Low testosterone is also known as hypogonadism. In the complete response letter, the FDA has requested information from Endo to address the agency’s concerns regarding very rare but serious adverse events, including post-injection anaphylactic reaction and pulmonary oil microembolism.

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The FDA granted traditional approval for INTELENCE® (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). INTELENCE is the only NNRTI specifically indicated for use in treatment-experienced adults who are experiencing virologic failure with HIV-1 strains resistant to an NNRTI and other antiretroviral (ARV) agents. The traditional approval is based on 48-week data from two Phase 3 studies known as DUET-1 and DUET-2.

Organon has announced the launch in India of its vaginal ring that contains the same hormones found in the oral pill, but is to be self-inserted only once-a-month for contraceptive action. The ring was approved by the US Food and Drug Administration in 2001. The Central Drugs Control Standards Organisation (CDSCO) in New Delhi approved the contraceptive ring for marketing in India in 2005.

CSL Behring has announced that the FDA has granted marketing approval for Berinert® C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE).  Berinert is the first therapy approved for this indication in the U.S. The approval is based on the results of the phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), which studied the efficacy and safety of C1-inhibitor concentrate.

Generex Biotechnology Corporation has been granted price approval by the US Food and Drug Administration approval for the use of Generex Oral-lyn(TM) under the FDA’s Treatment Investigational New Drug (IND) program. Generex was previously granted the FDA approval for the use of Generex Oral-lyn(TM) in patients with Type 1 or Type 2 diabetes mellitus under the FDA’s “Treatment IND” rules.

The prescription drug Avandia (rosiglitazone), marketed as a treatment for Type II diabetes, causes an increase in liver problems, heart problems and bone density problems resulting in fractures. It has been linked to cases of death due to liver failure and heart failure. Patients who have a history of certain medical conditions, such as heart disease, heart attack, high blood pressure, smoking and stroke, and those taking medications including diuretics, steroids, seizure medication and thyroid medication are more prone to experiencing serious side effects while taking Avandia.

Daiichi Sankyo Inc’s supplemental new drug application (sNDA) for Welchol has ben approved by the FDA. Welchol is to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol in boys and postmenarchal girls, aged between 10 and 17 years suffering from heterozygous familial hypercholesterolemia. The drug can be used alone or in combination with a statin after failing an adequate trial of diet therapy.

Wockhardt received the tentative approval from the FDA for marketing Tamsulosin Hydrochloride capsules for the treatment of prostate related problems. The drug will be available in 0.4 mg strengths. Tamsulosin is the generic name for the brand Flomax, marketed by the drug firm Boehringer Ingelheim, and the patent for the drug is scheduled to expire on 2010. Wockhardt will launch the drug after the patent expiry date. According to research firm IMS, the total market for Tamsulosin capsules in the US is about $1.6 billion per annum.