FDA Law Weekly

American Coll. for Advancement in Med. - Group defends use of EDTA therapy related to chelation therapy

Avax Technologies - IND filed for drug to treat patients with non-small-cell lung cancer

Barr Pharmaceuticals - FDA defers decision on Plan B over-the-counter application

Barr Pharmaceuticals - U.S. FDA grants approval for Allegra tablets

Baxter Healthcare Corp. - U.S. FDA grants approval for Ceftriaxone injection

Biogen Idec - Supplemental BLA submitted to U.S. FDA for Rituxan

Biosite - CLIA waiver granted for Triage BNP Test

Biotronik - Implantation of Lumos DR-T implantable cardioverter defibrillator announced

Bristol-Myers Squibb - Supplemental Biologics License Application filed for head, neck cancer treatment

C. Drew Univ. of Medicine & Science, Los Angeles - Nandrolone decanoate benefits HIV-infected men with weight loss

Cadence Pharmaceuticals - Phase III trial of CPI-226 initiated for catheter-related infections

Calypte Biomedical - Maryland facility approved for the manufacture of HIV-1 Urine EIA test

Caraco Pharmaceutical Laboratories - U.S. FDA grants tentative approval for Zolpidem Tartrate

CardioTech International - FDA clears heparin-coated auto transfusion and cardiotomy products

Cephalon - Agreement reached to promote Attenace for ADHD

A&G Pharmaceutical - Theranostics company completes series A financing

Accelerat BioPharmaceutical - Activation of antithrombin III increases its anti-HIV activity up to 1000-fold

Advaxis - Listeria cancer vaccine shows strong safety profile in toxicology studies

Allon Therapeutics - Compounds have potential to protect brain cells

Allon Therapeutics - Phase I trial begins for therapy for post-surgery mild cognitive impairment

Allos Therapeutics - Results from Efaproxyn study published in journal

Altachem Pharma - Oncology firm reconstitutes scientific advisory board

Altea Therapeutics - Steven P. Damon appointed to lead business development team at pharma firm

Antoni Van Leeuwenhoek Hospital, Amsterdam - Isolated limb perfusion palliated advanced limb disease

Archus Orthopedics - Clinical trial enrollment initiated for arthroplasty system

Argenta Discovery - Drug discovery collaboration signed with Cellzome

Bentley Pharmaceuticals - New president named at drug delivery-focused pharmaceutical firm

Biopure Corp. - Oxygen therapeutics company appoints Guido J. Neels to board of directors

Burnham Institute - Cancer drug target Chk1 may also be source of drug resistance

CHU Vaudois - Photodynamic therapy shows selectivity for mesothelioma

Candelaria Univ. Hospital, Santa Cruz de Tenerife -  Shigella sonnei outbreak in Canary Islands produced by a single strain

Centro Medico Nacional Siglo XXI, Mexico City - Hepatitis C infection remains stable despite therapy-induced neutropenia

Cerenis Therapeutics - HDL-focused company to develop new therapies based on PPAR delta agonists

Chaim Sheba Medical Center, Tel Hashomer - Researchers evaluate criteria for decisions on breast conservation therapy

Children's Hospital of Philadelphia - Children using community health centers more likely to be overweight