Susan Hasty, Publisher
Table of Contents . . . January 12th, 2004
Non-Subscriber - Summaries OnlyRelated 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
NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.