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Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . November 8th, 2005

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Drug Law Weekly | Other Publications

Acon Laboratories, Inc. - CLIA waiver received for drugs of abuse tests

Acuity Medical - Macular degeneration device improves vision in 26% of treated eyes in trial

Aerie Pharmaceuticals, Inc. - Glaucoma therapy developer closes $21M series A financing

Amnis Corp. - Three issued patents cover firm's expansions

Avax Technologies, Inc. - M-Vax launched in Switzerland for the treatment of patients with stage III-IV melanoma

Bausch & Lomb - Medicare reimbursement terms for Retisert published

Connetics Corp. - Dermatology-focused company files patent infringement lawsuit against Agis

Cryo-Cell International, Inc. - Exclusive license signed to market new stem cell service

Detroit Medical Center - Cold treatment may protect against infant disability and death from oxygen loss

Healthcare Coverage - Health benefits company introduces Medicare Part D prescription drug plans

Healthcare Coverage - WellCare Health Plans introduces prescription drug plans for Medicare beneficiaries

Healthcare Coverage - WellPoint offers prescription drug plans to Medicare eligible seniors

ITV Direct, Inc. - Dietary supplement marketing company files suit against U.S. Federal Trade Commission

Maxxon, Inc. - Safety syringe sample batch to be produced; patent filed for plunger technology

Medicare - Anthem Blue Cross and Blue Shield offers new Blue MedicareRx plans

AKH-Wien - Computer-assisted 3-D navigation improves extracorporeal shock wave efficacy

AVI BioPharma, Inc. - Data presented on development of nanoparticle delivery of antirestenotic drugs

Abbott - U.S., E.U. regulatory submission made seeking approval of Humira in ankylosing spondylitis

Abmaxis, Inc. - Milestone achieved in monoclonal antibody collaboration with Merck

Accelr8 Technology Corp. - Agreement signed with Promega for microarraying slides

Acuity Pharmaceuticals - Phase II trial initiated for Cand5 in wet age-related macular degeneration

Advanced Medical Solutions Group plc - AMS announces further progress with expansion into the Japanese wound care market

Akers Biosciences, Inc. - Rapid diagnostics developer reports 22% increase in sales

Almirall, S.p.A. - Agreement signed for the commercialization of Pantopan (pantoprazole)

AlphaRx, Inc. - Three new sites added to Indaflex phase II trial for osteoarthritis of the knee

American Society of Health-System Pharmacists - Patients with chronic pain don't have to suffer in silence

AmpliMed - Patient enrollment begins for phase I trial of Amplimexon plus docetaxel

Antigenics, Inc. - Median survival improved by more than half in phase III metastatic melanoma trial of Oncophage

Arpida, Ltd. - Positive in vitro results reported in study of bactericidal antibiotic

Asthma & Allergy Foundation of America - Asthma group launches national Flu Shot Finder

Avantogen Limited - Research team identifies genes in common cancers that may predict response to treatment

Azienda Ospedale-Universita, Padua - Colorectal cancer adjuvant treatment in elderly patients discussed

Basilea Pharmaceutica, Ltd. - Antibiotic ceftobiprole aims at broader indication, including diabetic foot infections

Bayer Healthcare - TB Alliance and Bayer launch historic global drug trials for tuberculosis

Bioenvision - Oncology company reports decrease of 26.3% in revenues

Catholic University of Leuven - Angiogenic factors are modulated in murine obesity models during fat tissue development

Cell Therapeutics, Inc. - Drug prolongs survival in women with advanced lung cancer, trial results show

Center for Research in Population Health, Cuernavaca - Dietary vitamin D and calcium involved in development of endometrial cancer

Centre Hospitalier de l'Universite de Robert Debre, Reims - Chemotherapy with 5-fluorouracil and cisplatin compared with surgery alone

CepTor Corp., Inc. - Development-stage biopharmaceutical submits application for orphan drug status for Myodur

Chinese University of Hong Kong - Novel TCM-platinum anticancer agents show high potency and low toxicity

Chonnam National University - Statins decrease restenosis in patients with high C-reactive protein levels

Clavis Pharma - First patient included in phase II study with the cancer drug ELACYT

Codexis, Inc. - Privately held biotech expands alliances in generic-pharmaceutical manufacturing

Cognate Therapeutics, Inc. - Brandon J. Price named CEO of stem-cell-focused biopharmaceutical company

Critical Therapeutics, Inc. - ZYFLO maker announces details of asthma treatment's commercial launch

Curis, Inc. - Drug-development company announces the receipt of second extension of funding from Genentech

Curtin University of Technology, Perth - Lipophilic counter-ions improve benzydamine membrane diffusion

Dana-Farber Cancer Institute, Boston - Errors in chemotherapy orders are rare, but there is still room for improvement

Dana-Farber Cancer Institute, Boston - Herceptin trial shows lower risk of breast cancer recurrence when used following chemotherapy

Drug Abuse - San Francisco Fire Department supplied with OralStat saliva drugs of abuse test

EDAP TMS, SA - Company opens its first HIFU prostate cancer treatment center in Australia

Evanston Hospital - New device brings hope to severe heart disease patients

Exactech, Inc. - U.S. Food and Drug Administration clears Connexion GXL enhanced polyethylene hip acetabular liner

ExonHit Therapeutics - Service, supply deal signed for microarray, RNA splicing technologies

Facilities - Healthcare products company, The Children's Shelter open residential treatment center

Finance - $13.2M in grants awarded for mental health services for older adults

G.B. Pant Hospital, New Delhi - Balloon mitral valvuloplasty feasible under transthoracic echocardiographic guidance

GeneGo, Inc. - U.S. FDA to use systems biology technology for research, review of genomics data

GenoMed - Internet-based clinical trials for influenza and avian influenza begun

GlaxoSmithKline - GSK's hepatitis vaccine has been approved for use in children12 months and older

Glenmark Pharmaceuticals, Ltd. - Formulations facility at Goa approved by three international regulatory agencies

Hiroshima University, Higashi-Hiroshima - Beta-lactamase gene identified from an enterohemorrhagic E. coli O157:H7 outbreak strain

Idera Pharmaceuticals, Inc. - HYB2055 phase II renal cell carcinoma protocol amended

OSI Systems, Inc. - U.S. FDA grants 510(k) approval for sale, distribution of anesthesia systems in U.S. market

Osiris Therapeutics, Inc. - Clearance granted for phase II trial of treatment for acute graft vs. host disease

POZEN, Inc. - Trexima NDA accepted for review by U.S. Food and Drug Administration

Purdue University, West Lafayette - Early awareness might prevent avian flu pandemic

Retractable Technologies, Inc. - Safety needle device company receives U.S. Food and Drug Administration approval

U.S. Food & Drug Administration - IL-4 receptor is promising target for advanced ovarian cancer therapy

U.S. Food & Drug Administration - Pigment yellow 74 is metabolized by rat and human microsomal proteins

University of California, San Diego - OTC nicotine replacement products increase smoking cessation efforts

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