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Biotech Business Week

Susan Hasty, Publisher

Table of Contents . . . January 12th, 2004

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Biotech Business Week | Other Publications

Hepatitis C Therapy - Data reported from phase IB trial of Isatoribine

Alzheimer Disease - Alzheimer disease treatment slows progression of cognitive decline in study

Genitourinary Disorders - Patents acquired for development of genitourinary disorder treatments

Genomics - Genaissance enters into HAP Technology license agreement

Genomics - Human Genome Sciences announces license agreement

Genomics R&D - New genomics screening platform technology developed

Genomics Research - New business venture formed to commercialize microparticle technology

HIV Therapy - 48-Week data submitted to FDA for full approval of HIV fusion inhibitor

Hepatitis C Virus - Investigational drug, merimepodib, well tolerated in hepatitis C clinical trial

Hepatitis Virus - Biotechnology company increases production capacity of liver treatment

Hepatotoxicity - Collaboration signed with AstraZeneca focused on predictive toxicity

Immunoactivity - Peyote cactus extract can activate NO, increase cytokines, kill tumor cells

Alzheimer Disease - Scope of Phenserine trial; sub-study to include brain scans

Immunodeficiency Disease - FDA license granted for intravenous immunoglobulin

Infection Control - Program designed to help hospitals, physicians slow spread of flu, SARS

Influenza - Health plan provider expands coverage to include intranasal flu vaccines

Influenza - Plan expands coverage to nasal flu vaccine

Influenza A - Hand sanitizer provides greater than 99% kill against influenza A in studies

Information Technology - Study examines impact of clinical guideline messaging at point of care

Joint Replacement - FDA clears Palacos G antibiotic-loaded bone cement

Legal Issues - Lumenis litigation settled

Lung Cancer - Cancer drug development status reported

Lung Cancer - Neovastat's clinical development plan updated

Anticancer Drugs - Phase I clinical trial for encapsulated anticancer drug delayed until third quarter 2004

Magnetic Resonance Imaging - Nanomagnetic particles used as contrast agent improves detail

Malignant Pleural Effusion - FDA grants approval of Sterile Talc Powder

Market Analysis - 2003 was biotech's second best year with market cap up 32%

Market Analysis - Report reveals how companies optimize biomarker research

Market Analysis - Survey says reduced leisure time activities may contribute to obesity

Market Trends - Report forecasts more device-based interventions for prostate disease

Marketing Trends - Launching blockbuster drugs: Marketing budgets push drugs to success

Memory Improvement - Concord grape juice improved memory, neuromotor skills in animal study

Mergers and Acquisitions - Acquisition to advance treatment of viral diseases and neurological disorders

Mergers and Acquisitions - Agreement signed to acquire biopharmaceutical distribution subsidiary of Roche

Antisense Technology - Molecula receives license to key RNAi patent

Mergers and Acquisitions - Clinomics Biosciences in agreement to be acquired

Mergers and Acquisitions - Diagnostics company acquires assets of imaging developer

Mergers and Acquisitions - Intermagnetics agrees to acquire patient monitoring company for $22/share

Mergers and Acquisitions - Oral fluid diagnostics company sells laboratory subsidiary

Mergers and Acquisitions - Point-of-care diagnostics company acquired by pharmaceutical firm

Mergers and Acquisitions - Recently acquired San Diego operations closed by oncology firm

Metastatic Cancer - Oncolytic vector technology licensed for development of cancer therapy

Microarray Technology - New microarray hybridization chamber launched

Microarray Technology - New technology to help development of medical and diagnostic antibodies

Nanotechnology - NanoBio forms company to commercialize drug-delivery and imaging technology

Arthritis - FDA grants approval for Indomethacin capsules

Nerve Dysfunction - Device company's neurotechnology improves foot sensation in diabetics

Non-Hodgkin Lymphoma - Trial yields positive results for Rituxan plus CVP chemotherapy

Obesity Management - FDA approves labeling for use of Xenical in adolescent patients

Obesity Therapy - Nutrient selected for study of gastric bypass surgery patients

Oncology - NaPro completes sale of worldwide paclitaxel business

Patents - European regulatory authorities revoke patent related to Cellegesic

Patents - Micro-electro-mechanical systems patent granted on multi-target chip technology

Patents - New adenoviral vector technology wins patent; Introgen gets license

Patents - Oncolytic viral technology licensed to Introgen Therapeutics

Personnel - Biotech company brings business development veteran on board

Asthma - Second phase II study initiated to evaluate Corus 1030

Personnel - Butz named VP of global regulatory affairs at drug discovery firm

Personnel - CNS-focused biopharmaceutical company announces new vice president

Personnel - Cardiovascular/metabolic disease-focused company opens representative office in Japan

Personnel - Davenport named CEO at medical device company

Personnel - Davenport named VP, business development at drug delivery firm

Personnel - Drug development company appoints new chief financial officer

Personnel - Executive director of medical affairs appointed at pharmaceutical firm

Personnel - Garrett named president, chief operating officer at biomedical company

Personnel - Medical device manufacturer names new VP of regulatory and clinical affairs

Personnel - Microarray technology company broadens scientific advisory board

Atrial Flutter - U.S. pivotal trial begins for cardiac cryoblation system

Personnel - Peptidomics company names new chief scientific officer

Pharmaceutical Manufacturing - Genentech inks Rituxan manufacturing agreement

Pharmaceutical Marketing - Frequent sales force realignments drag down long-term effectiveness

Pregnancy Test - Inverness to supply Pfizer with a digital version of its e.p.t pregnancy test

Premenstrual Dysphoric Disorder - New drug application submitted to FDA for lower-dose Yasmin

Product Safety - Pharmaceutical distributors face new requirements to reduce counterfeiting

Prostate Cancer - Alternative treatment options available for prostate cancer patients

Prostate Cancer - Black men should be screened for prostate cancer at younger age

Prostate Cancer - Immulite, Immulite 2000 PSA, third-generation PSA assays get CE mark approval

Prostate Cancer - Isonics wins key brachytherapy order

Barrett Esophagus - CPMP positive opinion issued in Europe for Photobarr

Prostate Cancer - Japanese biopharmaceutical company co-promotes prostate cancer treatment

R&D Equipment - New instruments delivered to genomics company

RNA Research - siSTABLE siRNA launched with increased stability, extended silencing

Radiation Therapy - Companies to collaborate on intensity-modulated radiation therapy

Regulatory Issues - FDA completes inspection of manufacturing facility for oral diagnostics company

Renal Cancer - Positive results confirmed for tumor targeted superantigens cancer product

Sepsis - Agreement signed for preclinical testing of gene-silencing antibacterial agent

Solid Tumors - European patent granted for phospholipid vascular targeting agent program

Sterile Aerosol Saline - Drug delivery company enters U.S. eye care market

Thrombocythemia - Agrylin licensed in Japan for treatment of thrombocythemia

Bile Duct Tumors - Investigational new drug application filed for XL119

Tissue Processing - Company licenses novel technology for microorganism inactivation

Trends - Report forecasts 17% annual growth in peripheral vascular stent market

Trends - Study: Noninvasive technologies poised for dramatic growth

Vascular Imaging - New drug application submitted for approval of MR angiography indication

Weight Loss - Preclinical studies completed on obesity compound

Weight Management - Home metabolic analysis kit now available

Wound Therapy - Chinese regulatory authorities accept application for approval of wound therapy

Bioinformatics - Novel method for prioritizing genes for drug development published

Autologous Cellular Therapy - Applikon collaboration leads to manufacturing system breakthrough

Blood Transfusions - Study shows significant reduction in blood transfusion needed in trauma patients

COPD - Daxas to be submitted for European approval in February 2004

Cancer Diagnostics - Genomics/proteomics-based therapeutics company to develop cancer diagnostic tests in Japan

Cancer Therapy - Cleveland Clinic installs Novalis radiation therapy device

Cancer Therapy - Clinical trials begin of antiangiogenesis antibody, CNTO 95

Cancer Treatment - Antibody-drug conjugate collaboration designates additional antigen targets

Cervical Cancer - 20th ThinPrep imaging system shipped to Pennsylvania hospital

Chlamydia - Application filed with FDA for approval of chlamydia test

Cholesterol - Mouse strain lacking cholesterol develops with little effect

Cloning - Boston researchers create human clone embryo, magazine reports

Collaborations - Molecular cytogenetics alliance formed to validate cancer drug targets

Collaboration - Third European marketing agreement signed for glaucoma treatment devices

Collaborations - $9M service contract signed for bioanalytical services

Collaborations - Agreement made for development of key cancer treatment component

Collaborations - Alliance formed to study pharmacologic roles of nitric oxide

Collaborations - Alliance signed to study kinase drug targets

Collaborations - Alliance to develop human c-MPL agonist antibody to treat thrombocytopenia

Collaborations - Biotech companies join to develop treatments for urological cancers

Collaborations - Cardiovascular safety study, other contracts total $8.1M

Collaborations - Companies form joint venture for R&D of infectious diseases diagnostics

Collaborations - Contract signed for 20th Gamma Knife Center in Tennessee

Cystic Fibrosis - Orphan drug designation granted for DX-890

Collaborations - Deal signed for INRatio capillary test strips

Collaborations - Development agreement executed with Martek Biosciences

Collaborations - Genetics company announces osteoporosis collaboration

Collaborations - Genmab joins with Dutch nonprofit to improve hemophilia treatment

Collaborations - Genomic capabilities of microarray company bolstered through alliance

Collaborations - HMGene enters obesity drug agreement

Collaborations - Lexicon enters neuroscience alliance for drug development

Collaborations - Medarex announces research and license agreement with Maryland company

Collaborations - Merck, KgaA, to exit orthopedics joint venture to focus on core businesses

Collaborations - New alliance to focus on cardiovascular disorders

Mergers and Acquisitions - Genaissance to acquire genomic-services company

Collaborations - Nonexclusive HCV license granted to Boehringer Ingelheim

Collaborations - Oncology deal signed for development of orally active MEK inhibitor

Collaborations - Pharmaceutical company signs agreement for probiotics development

Collaborations - Project milestone achieved in alliance with Tanabe

Collaborations - Research deal to use genomic high throughput RNAi in human cells

Collaborations - Services deal signed with GE Medical Systems for ProteinChip systems China

Collaborations - Stem cell licensing deal signed

Collaborations - Supply agreement signed with Chinese hospitals for ultrasound systems

Collaborations - U.S. Department of Defense awards $3.2M contract for antimicrobial nanoemulsions

Compliance - Report shows 85% of prescriptions never get refilled

Trends - Report: Gene therapy moving toward approval and introduction within the decade

Compliances - Patients skip doses of prescribed drugs on purpose

Contraception - FDA panel votes to allow sale of emergency contraceptive

Coronary Artery Disease - Pivotal trials of AI-700 phase III clinical program initiated

Corporate Update - Disease management firm changes name to XLHealth

Cosmetic Procedures - FDA approves Restylane for soft tissue augmentation

Cystic Fibrosis - Milestone earned for development of malabsorption treatment

Dermatology - FDA approves Polaris WR wrinkle treatment system

Diabetes - FDA grants second major patent for insulin delivery patch

Diabetes Therapy - Second approvable letter issued for Symlin

Disease Management - CorSolutions provides programs to airline employees to reduce healthcare costs

Acne - Pulsed dye laser receives clearance for acne treatment

Drug Delivery - Company announces newly patented lorazepam nasal delivery system

Drug Delivery - PediaMed acquires multisite drug delivery platform offering multiple delivery modes

Drug Delivery - Pharmaceutical company discusses aerosol delivery at AARC meeting

Drug Delivery - Phase I study completed comparing needle-free system to traditional syringe

Drug Development - Market research's role expands, aids pharmaceutical launches

Drug Development - New company launched to help biotech, pharma firms handle data management

Drug Discovery - INGENOtyping agreement inked with Max-Planck Institute

Drug Discovery - University and pharmaceutical company form drug discovery collaboration

Finance - Biotech company announces cancellation of shares

Finance - Contract research organization reports 23% increase in revenue

Advanced Renal Cancer - $15M milestone payment awarded for developments in anticancer compound

Finance - Drug delivery company adopts Rule 10B5-1 policy

Finance - Enabling science and technology firm to spin-off discovery business to stockholders

Finance - GTC takes equity position in MM-093 developer

Finance - Gene identification company reports 73.7% gross profit margin

Finance - Japanese corporations invest $11 million in proteomics company

Finance - Mechanism-based drug discovery firm raises $29M in private placement

Finance - Medical device company announces conversion of warrants

Finance - Medical products company reports fiscal 2003 and fourth quarter results

Finance - Oncology company announces approval of shares listing on Nuovo Mercato

Finance - Oncology company completes $4M private placement

Allergy - Survey shows allergy treatment more costly due to insurance restrictions

Finance - Oncology-focused biotech firm files $50M shelf registration statement

Finance - Pain relief-focused company completes $10 million financing

Finance - Pharmaceutical company to begin trading on NASDAQ national market

Finance - Pharmaceutical company to purchase up to $5 billion of common stock

Finance - Pharmaceutical firm reports lower revenues, provides clinical update

Finance - Shareholder rights agreement amended by biotech company

Food Technology - Opsonophagocytic assay may be a useful test for safe enterococcal strains

Fungal Infections - Abbreviated new drug application filed with FDA for Fluconazole

Gene Function Discovery - Foreign rights expanded for product discovery from biodiversity

Gene Silencing Applications - Novel algorithm licensed for gene silencing applications

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