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Phase I Clinical Trials Update: April 2008 Company * Product Description (Country; Symbol) AUTOIMMUNE Hadasit -- Based on monoclonal antibody (technology (anti-CD3) and a glycolipid transfer company given separately and [...]

Phase II Clinical Trials Update: April 2008 Company * (Country; Product Description Symbol) AUTOIMMUNE Genentech Inc. Rituxan Rituximab (NYSE:DNA) and (FDA-approved) Biogen Idec Inc. (BIIB) ZymoGenetics Inc. Atacicept Antagonist protein [...]

Phase I Clinical Trials Update: March 2008 Company * (Country; Product Description Symbol) AUTOIMMUNE Targeted Genetics tgAAC94 A therapy that uses an Corp. (TGEN) adeno-associated viral vector to deliver the [...]

Pivotal/Phase III Clinical Trials Update: February 2008 Company * (Country; Product Description Symbol) AUTOIMMUNE Centocor Inc. (unit of Ustekinumab A human monoclonal Johnson & Johnson) antibody that targets the cytokines [...]

In what it termed a 'significant milestone,' Northfield Laboratories (Evanston, Illinois) said last month it is pinning hopes on a first-ever protocol approval from the FDA for its oxygen-carrying product [...]

FDA Submissions, Approvals And Other Actions: April 2008 Company * (Country; Product Description Symbol) AUTOIMMUNE UCB SA (Belgium; Cimzia Certolizumab pegol; a PEGylated BR:UCB) anti tumor-necrosis-factor-alpha antibody CANCER Medarex Inc. [...]

Non-U.S. Clinical Trials And Regulatory Actions: April 2008 Company * Product Description (Country; Symbol) AUTOIMMUNE MediGene AG Oracea A delayed-release formulation of (Germany; (FDA-approved) doxycycline FSE:MDG) CANCER Abraxis Abraxane Paclitaxel [...]

FDA Submissions, Approvals And Other Actions: February 2008 Company * (Country; Product Description Symbol) AUTOIMMUNE Abbott (NYSE:ABT) Humira Adalimumab (FDA-approved) UCB SA (Belgium; Cimzia PEGylated anti-TNF biologic BR:UCB) therapy CANCER [...]

Now that the initial surprise has worn off regarding the FDA's decision to grant accelerated approval for Genentech Inc.'s Avastin (bevacizumab) in breast cancer, the industry can begin to digest [...]

Finding a drug that can re-educate the body's confusion in lupus has proven a puzzler for biotech firms for years, and opinion is divided on which companies might be getting [...]

Figuring out the pulmonary arterial hypertension race is like betting on horses, but a trio of leading PAH doctors who dined with C.E. Unterberg, Towbin in San Francisco earlier this [...]

Already getting the colloquial hairy eyeball from some observers because of slowed (though still strong) sales, Avastin stumbled further last week on news that the FDA wants more information about [...]

It was only Phase I data, but favorable results earlier this month with Sirna Therapeutics Inc.'s compound for age-related macular degeneration piqued the interest of Wall Street--mainly because the smaller [...]

Arthritis affects around 10 million people in France alone, and World Health Organization (WHO; Geneva, Switzerland) estimates place arthritis at the top of the global list of afflictions causing physical [...]

The focus on biomaterials continues its evolutionary change from physical to biological materials, yielding a new generation of biomaterials that use molecular recognition and cell-signaling to direct biological processes. Presentations [...]

Washington Editor WASHINGTON u The FDA's blessing last week of the world's first clinical trial of a human embryonic stem cell (hESC) therapy has not only launched what may be [...]

Staff Writer A new era for stem cell research could lie ahead in the U.S., thanks to President Barack Obama's lifting of the ban on stem cell research and the [...]

BioWorld International Correspondent PARIS - Neovacs SA, which is developing therapeutic vaccines for the treatment of AIDS, cancer and autoimmune and allergic diseases, initiated a Phase I/II trial of TNF-alpha [...]

BioWorld International Correspondent PARIS - Transgene SA and F. Hoffmann-LaRoche initiated a Phase II trial of TG4001/R3484 in the indication of high-grade cervical intraepithelial neoplasia (CIN 2/3). TG4001 is a [...]

Staff Writer As three of its own Immunodrug vaccine candidates advance through clinical trials, Cytos Biotechnology AG signed a CHF150 million (US$139 million) technology deal with Pfizer Inc.'s vaccine unit. [...]

BioWorld International Correspondent LONDON - Antisoma plc reported further clinical progress with its first-in-class vascular disrupting agent ASA404, announcing two-year survival of 33 percent in hormone refractory prostate cancer patients [...]

Washington Editor Shares of Antisoma plc rose 9 percent Friday on the news that its partner Novartis AG has started a pivotal Phase III trial of ASA404, a tumor-vascular disrupting [...]

In brief ... * Cardiome Pharma (Vancouver) said interim results from its Phase IIb trial with oral vernakalant to prevent recurrence of atrial fibrillation (AF), originally due in 4Q07, will [...]

BioWorld International Correspondent LONDON - Antisoma plc announced positive survival data from a second Phase II trial of ASA404 as an adjunctive treatment in lung cancer, showing median time to [...]

Agreements roundup Lumera extends collaboration with S.C. medical university A Diagnostics & Imaging Week Staff Report Lumera (Bothell, Washington), a developer of nanotechnologies, reported extending a collaboration with the Medical [...]

SHEA, IDSA call for vaccine emphasis in plan The federal government's pandemic influenza plan lacks urgency in the area of vaccine development, which must be the linchpin to any public [...]

International report AGA initiates new trial of migraine/PFO link A CDU Staff Report AGA Medical (Golden Valley, Minnesota) reported enrollment of the first patients in its newest clinical trial -- [...]

BioWorld International Correspondent PARIS - MAT BioPharma is about to embark on a Phase III trial of Ferritarg P, a 90 Yttrium radio-labeled rabbit polyclonal antibody for Hodgkin's disease. The [...]

Truvada trials hold promise for new HIV prevention strategy Once-a-day might keep HIV away Researchers and public health officials say they hope ongoing research will eventually show efficacy with a [...]

Threat of pandemic leads to 'Ethics of Vaccines' project Panel will craft ethical guidelines The Center for Bioethics at the University of Pennsylvania School of Medicine has begun an 18-month [...]

News Briefs Researchers Argue the Benefits of Homeopathic Remedies The benefits of homeopathy have come under attack by Swiss researchers in a recent issue of The Lancet. The claim that [...]

From the lab Medical risks and psychology fueling resistance to tPA By ANETTE BREINDL CDU Science Editor It improves outcomes for patients, but for Genentech's (South San Francisco, California) Activase [...]