Pharmaceutical Product Guide

Can-Fite BioPharma Announces Opening Of CF101 Dermatology IND With Phase 2/3 Psoriasis Protocol

Kimberly Obrien — Fri, 11 Jun 2010 09:15:33 +0000

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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Diabetes drug Victoza Gets FDA Approval

Kimberly Obrien — Fri, 29 Jan 2010 04:56:02 +0000

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.

Development Of ADX10059 Ended For Long-Term Use

Kimberly Obrien — Fri, 22 Jan 2010 05:22:05 +0000

Addex Pharmaceuticals announced that based on preliminary review of the unblinded data from study 206, it has terminated development of ADX10059 for chronic indications, including long term treatment of gastroesophageal reflux disease and migraine prophylaxis. In study 206 the incidence of alanine transaminase (ALT) levels greater than five times the upper limit of normal ( > 5xULN) levels was 6% (16 of 257 patients); however, bilirubin remained normal in all but one patient.

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Aerocrine: US Expert Panel Recommends The Use Of Fractional Exhaled Nitric Oxide (FENO) In The Diagnosis And Management Of Asthma

Kimberly Obrien — Fri, 15 Jan 2010 05:09:09 +0000

Aerocrine AB announced that a group of prominent clinicians and researchers, all leaders in the field of asthma in the US, has issued a consensus paper recommending that inflammation monitoring using exhaled nitric oxide should be part of the routine clinical management of asthma in conjunction with other conventional methods. The points of clinical consensus were arrived at during a closed meeting held at National Jewish Health in Denver, Colorado.

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Early Trial Shows Drug Can Curb Ewing’s Sarcoma Growth

Kimberly Obrien — Fri, 08 Jan 2010 13:34:42 +0000

An early study of the drug figitumumab has found that in some patients it can curb the growth of Ewing’s sarcoma – a cancer which affects mainly teenage boys. The study was conduted by The Institute of Cancer Research and The Royal Marsden Hospital, and funded by Pfizer, who developed the drug. The promising results have led to the drug’s progression to a Phase II trial in patients with Ewing’s sarcoma.

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Chinese medicine firm employs Cambridge University to research remedies

Kimberly Obrien — Wed, 30 Dec 2009 12:25:27 +0000

Hutchison Chi-Med has signed up the University of Cambridge to investigate the potential healing and anti-aging properties of a number of the group’s herbal remedies. Aim-listed Chi-Med sells traditional medicines in China and also has a research and development laboratory in Shanghai where its scientists analyse herbal remedies, some dating back 2,000 years, to establish their active ingredients.

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Endo Pharmaceuticals Provides Regulatory Update on AVEED(TM) Injection

Kimberly Obrien — Thu, 24 Dec 2009 06:36:57 +0000

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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Astellas and XenoPort Announce Submission of a New Drug Application in Japan

Kimberly Obrien — Thu, 17 Dec 2009 04:50:21 +0000

Astellas Pharma Inc. and XenoPort, Inc. have announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS). The acceptance of filing of the NDA triggers a $5 million milestone payment from Astellas to XenoPort.

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Targeted Breast Ultrasound Could Reduce Need For Invasive Biopsies For Women Under 40

Kimberly Obrien — Fri, 11 Dec 2009 12:46:21 +0000

University of Washington researchers explored the effectiveness of targeted breast ultrasound showed it was able successfully to tell the difference between benign and cancerous tumors in young women with lumps or other specific, localized signs or symptoms of breast cancer; so much so that the researchers recommended this method as a “tool of choice” for evaluating palpable lumps in women under 40, thus reducing the need for invasive biopsies.

Bristol-Myers’ Abilify To Treat Irritabilty In Pediatric Patients With Autistic Disorder gets FDA Approval

Kimberly Obrien — Fri, 04 Dec 2009 14:50:51 +0000

Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co., Ltd. said that FDA has approved the supplemental New Drug Application or sNDA for Abilify for the treatment of irritability associated with autistic disorder in pediatric patients of ages 6 to 17 years. The approval of Abilify for the treatment of irritation in patients with autistic disorder in pediatric patients is based on data from two eight-week, randomized, double-blind, placebo-controlled, multi-center, Phase III studies.