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Biotech Business Week

Susan Hasty, Publisher

Table of Contents . . . March 1st, 2004

Non-Subscriber - Summaries Only

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

Hemodialysis Catheter - Silver coating on dialysis catheters can reduce infection

Kidney Disease - Role of beta-2 microglobulin in end-stage renal disease reviewed

Chronic Obstructive Pulmonary Disease - FDA approves Spiriva HandiHaler

Collaborations - Rutgers enters partnership to explore science of taste buds

Coronary Artery Disease - Study of adult stem cell reimplantation initiated

Dysmenorrhea - Positive results reported from phase II study of lidocaine vaginal gel

Hepatitis B Virus - Phase I study to begin for therapeutic vaccine for hepatitis

Acne - FDA approves Syneron Aurora for dermatological use

Acne - FDA urged to crack down on Internet sales of isotretinoin

Age-Related Macular Degeneration - Disease threatens to blind 12 million Americans

Allergy Medicine - Moving non-sedating antihistamines to third-tier status yields greatest savings

Alzheimer Disease - Scientists identify compound that may offer new Alzheimer treatment

Amyotrophic Lateral Sclerosis - Final efficacy results awaited as ALS trial of Ikomio moves forward

Angina - Data presented demonstrate enduring benefits of TMR

Ankylosing Spondylitis - Phase III trial initiated to explore use of Humira

Antimicrobial Solutions - Anti-infective technology licensed to GMP

Autoimmune Disease - Structure of key autoimmune disease target discovered

Avian Influenza - Avian flu virus continues to spread in Asian countries

Bipolar Disorder - Pediatric bipolar disorder has unique symptoms

Blood Screening - Procleix Ultrio Assay clinical trials commence

Blood Testing - FDA provides marketing clearance for magnesium assay

Breast Cancer - FDA accepts NDA with priority review for RSR13

Breast Cancer - Full-field breast ultrasound complements mammography

Breast Pain - New estrogen inhibitor in phase II development

Business & Finance - Biotech begins the year with a bang

Business & Finance - Company to close Palo Alto facilities, cut workforce, focus on drug discovery

Business & Finance - Diagnostics company goes public

Business & Finance - Drug discovery company announces 2003 financial results, research collaboration

Business & Finance - Inspection of drug-eluting stent facility completed; finances reported

Business & Finance - NASDAQ completes favorable review of company's new board

Business & Finance - Small molecule drug company files registration statement for IPO

Business Update - Drug discovery company announces name change, new appointments

Business Update - House of Brussels forms medical research subsidiary

Business Update - Pharmaceutical company announces dismissal of all lawsuits

Cancer - New research may lead to orally administered small-molecule cancer drug

Cancer Therapy - Fourth phase II trial initiated for new stem cell transplantation drug candidate

Cancer Therapy - Update provided on Polymer Platinate AP5346 program

Cervical Cancer - Publication points to increasing use of HPV testing in cervical cancer screening

Clinical Trial Trends - Mistrust limits minority representation in U.S. biomedical research

Clinical Trials - Industry experts form patient recruiting firm for clinical trials

Collaborations - Axeda DRM software licensed for proactive remote service

Collaborations - BIS technology to be integrated across monitoring product line

Collaborations - Biotech companies sign licensing deal for protein therapeutics development

Collaborations - Co-brand partnership agreement signed with 3M

Collaborations - Companies ink agreement to develop MicroPyramid-based vaccine delivery

Collaborations - Company expands its proteomic capabilities through agreement with Novartis

Collaborations - Deal signed with Amylin Pharmaceuticals to develop Omniclonal antibodies

Collaborations - Device firm to develop immunochromatographic rapid test devices

Collaborations - Distribution agreement signed for Testim testosterone gel in Canada

Collaborations - Drug discovery and development collaboration amended

Collaborations - Genetronics announces strategic alliance

Collaborations - Labopharm to develop once-daily formulation of trazodone

Collaborations - Marketing agreement signed for promotion of aspergillus test

Collaborations - Milestone payment made in anticipation of NDA filing of Clofarabine

Collaborations - Partnership to develop new treatment for tropical disease

Collaborations - Questra to provide remote monitoring for medical instruments

Collaborations - Supply agreement signed with Hepatotech for preservation solutions

Colon Cancer - Xeloda shows promising tolerability results in colon cancer study patients

Colorectal Cancer - FDA approves Erbitux for metastatic disease

Congestive Heart Failure - PEECH trial reaches enrollment target

Corporate Update - CAP nanotechnology product developments reported

Corporate Update - Nucleic acid detection technology developer forms subsidiary

Counterfeit Drugs - Major pharma unveils enhanced effort to combat counterfeit drugs

Diabetes - Patent granted for advanced insulin pump infusion sets

Diabetes - Positive preclinical data reported on GLP-1 and Gastrin combination therapy

Diabetes Therapy - New drug researched for war on diabetes

Diagnostics - Human BioSystems signs exclusive sales agreement for MyoVision line

Drug Abuse - Report shows 56% of opiate dependencies begin through legal prescriptions

Drug Delivery - Inhaled Alveair insulin achieves better bioavailability than IV injection

Drug Development - Fluidigm granted nonexclusive sublicense to nanovolume crystallization patents

Drug Discovery - Telepathology product installed for drug discovery and research

Eczema - Studies show tacrolimus is more effective than pimecrolimus

Electrophysiology - SonoPrep skin permeation device receives FDA marketing clearance

Enzymology - Specific fumagillin analogues suppress angiogenesis

Epilepsy - Pharmaceutical company announces acquisition of epilepsy product candidate

Erectile Dysfunction - Results announced for TA-1790 phase II head-to-head study with Viagra

Facial Lipoatrophy - FDA accepts filing for Sculptra

Finance - Allograft implant processor announces 2003 financial results

Finance - Anal fissure drug maker announces investment by SJ Strategic Investments

Finance - Biopharmaceutical company files $1B universal shelf registration statement

Finance - Biopharmaceutical company raises $37M to advance clinical development programs

Finance - Biopharmaceutical company receives $5M equity investment

Finance - Biopharmaceutical company reports net loss of $0.40 per share

Finance - Biotech company increases share capital as a result of employee warrants

Finance - Biotech company reports loss of $0.22 per share

Finance - Cachexia drug developer secures $12M in financing

Finance - Cardiac device company reports first profitable quarter

Finance - Device firm raises $13.5M in private placement of common stock

Finance - Diabetes drug maker closes private placement funding

Finance - Drug discovery company reports 2003 financial results

Finance - Enzyme company completes $9.2 million financing

Finance - Gates Foundation commits $82.9 million to develop new tuberculosis vaccines

Finance - Genomics company completes $25.5M public offering of common stock

Finance - Gould named chief financial officer at drug delivery company

Finance - Imaging company announces approval of stock issuance

Finance - Imaging company executives adopt 10b5-1 trading plans

Finance - Imaging company reports revenue rises 28%

Finance - Immunotherapeutics company prices $52.5M public offering

Finance - Insurer awards grants to help reduce healthcare disparities in Hartford

Finance - Nanotechnology coatings completes first round of financing

Finance - Nutraceutical company reports net income of $109,000

Finance - Oncology company raises $1.5M in private placement of common stock

Finance - Pharmaceutical company announces 2003 financial results

Finance - Pharmaceutical company reports improved 2003 financial results

Finance - Pharmaceutical services company reports record fourth quarter results

Finance - Therapeutics company announces completion of private placement

Financed - Genomics company reports loss of $1.51 per share

Food Poisoning - Bacteria lingering in body may pose future food poisoning risks

Fungal Infection - Whole genome optical map completed of world's most frequent fungal infection

Gene Expression - Biotechnology company awarded $150,000

Genomics - Biotechnology and medical genomics partnership awards research grants

Genomics - Collaboration to apply Systems Biology to toxicology study

Genomics - Whole human genome microarray launched

Healthcare Coverage - Company introduces new long-term care insurance options

Healthcare Trends - Americans find prescription drug advertising helpful, survey shows

Heart Disease Diagnostics - FDA clearance granted for new cardiac imaging software

Heart Failure - CE Mark issued for Celacade chronic heart failure treatment

Heart Failure - U.S. clearance granted for AxSYM BNP test

Hematology - Adeno-associated virus encoded for factor IX ameliorates hemophilia B in vivo

Hemoglobinuria - Results of Eculizumab trial reported

Hepatic Cancer - Cotara phase I hepatic cancer study published in cancer journal

Hepatitis Virus - Clinical trials of Procleix Ultrio Assay begin on Procleix Tigris system

Hip Arthroplasty - MIS hip procedure granted U.S. patent

Hormone Replacement Therapy - FDA approves first transdermal gel for estrogen therapy

Hypertension & High Cholesterol - FDA approves Caduet as dual therapy

Imaging - Hologic inks agreement for Direct-to-Digital General Radiography systems

Infectious Diseases - Nonprofit drug company attacks developing-world diseases

Influenza - Availability of work site vaccinations increases rate of adult flu shots

Information Technology - Group awarded $2M NIH grant for in Silico heart modeling, research

Information Technology - LabChip maker unveils next generation in microfluidic drug discovery systems

Information Technology - Two new real-time PCR systems detect, quantify nucleic acid sequences

Insulin Therapy - Oral insulin study data indicate desired activity, no hypoglycemic events

Insulin Therapy - Results of phase I study of intranasal insulin reported

Irritable Bowel Syndrome - Probactrix irritable bowel syndrome clinical trial begins in Toronto

Joint Replacement - Multiyear partnership to expand patient benefits of MIS joint replacement

Laser Therapy - FDA clears Waterlase for bone, periodontal, soft tissue indications

Lung Cancer - FDA approves Alimta-cisplatin combination

Lung Cancer - FDA panel recommends approval of new CAD system

Lung Cancer - Sarasar clinical study in non-small cell lung cancer discontinued

Market Analysis - $800M U.S. diet pills market looks for better news in 2004

Market Analysis - 125,000 deaths caused by patient non-compliance each year

Market Analysis - Big pharma's compliance pains: 66% of patients misuse prescriptions

Market Analysis - Bristol-Myers Squibb, GlaxoSmithKline, Abbott dominate HIV drug market

Market Analysis - Explosive growth to push cancer vaccine market past $1B

Medicare - Insurer reduces premium rates, increases payments to providers

Medicare - Merck to provide drugs to low-income beneficiaries who exceed discount card cap

Menopause - Cenestin 0.45-mg tablets approved by FDA

Mental Health - Study uncovers barriers to diagnosis, treatment of postpartum depression

Mergers and Acquisitions - Acquisition of dialysis services provider valued at $345 million

Mergers and Acquisitions - FTC clears merger of Caremark and AdvancePCS

Mergers and Acquisitions - Is the pharmaceutical industry preparing for more M&A?

Mergers and Acquisitions - MIM acquires regional specialty provider

Mergers and Acquisitions - Shareholders approve Genome Therapeutics merger

Microarray - New dual chamber MAUI Mixer launched for microarray hybridization

Multiple Sclerosis - Preliminary data presented on ATL1102 phase I study

Muscular Dystrophy - FDA Orphan Drug Status filed for muscular dystrophy treatment

Mutagenesis - Binding sites keep hepatitis C virus sensitive to non-nucleoside inhibitors

Nearsightedness - Panel recommends FDA approval of Artisan/Verisyse lens

Non-Hodgkin Lymphoma - Orphan drug designation granted by FDA for BCX-1777

Oncology - Additional data on mechanism of action of KRX-0401 published

Ophthalmic Disease - FDA extends Vitrase New Drug Application by 90 days

Orthopedics - FDA clears U.S. distribution of cement hip spacer containing antibiotics

Osteoarthritis - FDA approves Orthovisc; Anika to receive $20M milestone payment

Pain - Intranasal Fentanyl for breakthrough pain shows rapid delivery in study

Pancreatic Cancer - New cancer test expands tumor marker menu on immunoassay systems

Parkinson Disease - Parkinson groups award more than $4M through Community Fast Track program

Patents - Fifth U.S. patent granted for small molecule program

Patents - Patent filed on second drug abuse resistance technology for oxycodone

Patents - Patent granted for EradicAide technology to diagnose, prevent, treat AIDS

Patents - Report: Intense legal aggression from generics causes concern for pharma

Patents - U.S. patent granted covering methods to inhibit Hedgehog pathway

Personnel - Biopharmaceutical company appoints Kevin Reilly to board of directors

Personnel - Biotech industry association leader to retire at year end

Personnel - Biotechnology company appoints new member to board of directors

Personnel - Device firm names biosciences executive Jack Ball as first CEO

Personnel - Drug discovery company announces new vice president

Personnel - Healthcare products company appoints new member to board of directors

Personnel - McBride named senior VP of business development at biotech firm

Personnel - Medical device manufacturer names Gene Starr new president and CEO

Personnel - Nanotechnology leader named to scientific advisory board at biochip company

Personnel - Radio frequency identification expert named to advisory board

Personnel - Rice named CEO at pharmaceutical firm

Policy - Political economy of FDA drug review policy analyzed

Premature Ejaculation - Phase IIa trial of erectile dysfunction drug completed

Presbyopia - License rights reacquired to Scleral Implant and Surgical Spacing Procedure

Prescription Drug Coverage - New products gaining traction in managed care, report says

Preterm Birth - Pre-pregnancy antibiotics do not prevent preterm birth, study shows

Prostate Cancer - Pharmaceutical company discovers prostate cancer biomarker

Prostate Cancer - ThermoDox study expanded; FDA allows two amendments

Prostate Cancer - Update announced on clinical trials of Triapine as a single agent

Pulmonary Arterial Hypertension - European regulators grants Sildenafil orphan drug designation

Rheumatoid Arthritis - U.S. patent issued for CTLA4-Ig rheumatoid arthritis treatment

SARS - SARS vaccine phase I clinical testing commences

Saphenous Vein Grafts - Initial enrollment completed for Rule-SVG Rubicon Filter study in Europe

Secondary Hyperparathyroidism - Phase I study of ABX-PTH initiated

Stem-Cell Transplantation - Novel membrane reactor enhances cord blood cell expansion

Stomach Cancer - Results reported in phase II trial of G17DT in combination with cisplatin, 5-FU

Stroke - Cool brain opens stroke treatment window

Tissue Valve Calcification - FDA approves ThermaFix process

Uterine Fibroids - ACOG promotes use of uterine artery embolization

West Nile Virus - Bio-insecticide applications show promise in controlling West Nile virus

Wound Repair - Angiogenesis can be tracked in the skin of vegfr2 luc transgenic mice

Wounds - Remaining patent issued for the CryoSeal platform products

Wounds - TB4 stimulates critical wound healing protein, study shows

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