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FDA & FTC Crackdown On Internet Medical & Health Fraud/Scams.
May 31, 2001... On June 14, 2001, the US Federal Trade Commission (FTC), US Food & Drug Administration (FDA) and other law enforcement agencies announced they have moved to stop Internet scams for "medical devices," supplements and other products that purport...
Agfa Announces New Agreement With Health Services Corp of America for Full Line of Agfa Analog and Digital Medical Imaging Products.(Agfa Medical Imaging)
May 31, 2001... GREENVILLE SC -- Agfa Medical Imaging announced that it recently extended and expanded its long-standing contract with Health Services Corp of America to provide its full analog and digital product line to HSCA's more than 2,000 member...
Aptagen Inc. Acquires ProteinGenesis Inc.
May 31, 2001... TUCSON AZ -- Aptagen Inc. in Herndon VA, has acquired ProteinGenesis Inc. (PGI), a protein engineering company founded in 1993 by Research Corp Technologies (RCT) and the University of Delaware. Aptagen is a gene and protein bioengineering...
Bausch & Lomb Completes Structure.
May 31, 2001... ROCHESTER NY -- Bausch & Lomb Inc (NYSE: BOL) -- Mark M. Sieczkarek was named Corporate Sr VP and President - Americas region; Alan H. Farnsworth was named Corporate Sr VP and President - Europe.
BD Congratulates GlaxoSmithKline On Receiving FDA Approval to Market Prefilled Vaccine System; Pediatric Vaccines To Be Packaged with BD SafetyGlide Needles.(Becton, Dickinson and Co.)
May 31, 2001... FRANKLIN LAKES NJ -- BD (Becton, Dickinson & Co) (NYSE:BDX) congratulates GlaxoSmithKline (NYSE:GSK) on receiving approval from the U.S. FDA to market the first vaccine delivery system to incorporate the use of the BD SafetyGlide.
Beacon Photonics Creates New Venture Capital Development Co, Beacon Life Sciences; Joseph Lovett, Healthcare/VC Veteran, Named President.
May 31, 2001... BOSTON MA-- Beacon Photonics announced the creation of its second vertically focused venture capital development company, Beacon Life Sciences. Joseph F. Lovett, an experienced health care executive and venture capitalist, has been hired as...
BioCapital Biotech and Healthcare Fund to Invest $2 Mln in Art.(Advanced Research Technologies Inc.)
May 31, 2001... SAINT-LAURENT QUE CANADA- Advanced Research Technologies Inc. (TSE: AILS), a leading developer of laser and thermal imaging technologies for the detection of anomalies in the medical sector and the electronics industry, announced that...
Biocept Appoints Chief Business Officer & Exec VP.(Charlotte P. Clark)
May 31, 2001... CARLSBAD CA -- Biocept Inc., a private company, appointed Charlotte P. Clark as Chief Business Officer and Exec VP.
Bionutrics, Inc. Advises of NASDAQ Notification of Additional Deficiency.
May 31, 2001... PHOENIX AZ-- B ionutrics Inc, (NASDAQ: BNRXD) announced that it received notification on June 21, 2001 of a Nasdaq Staff Determination that the Co fails to comply with the net tangible assets/market capitalization/net income requirement for...
Biopool Intl/Xtrana Appoints CEO/Board Member.(Timothy J. Dahltorp)
May 31, 2001... VENTURA CA -- Biopool Intl Inc./Xtrana (OTCBB :BIPL) announced that it has named Timothy J. Dahltorp as CEO. Dahltorp was also appointed to fill the current vacancy on the firm's board of directors.
Corixa and Kirin Collaborate to Discover and Develop Therapeutic Monoclonal Antibodies.
May 31, 2001... SEATTLE WA-- Corixa Corp (Nasdaq:CRXA), a developer of immunotherapeutics, and Kirin Brewery Co., Ltd., announced an agreement to discover and develop fully human monoclonal antibodies directed against targets from Corixa's extensive library.
Court Denies Preliminary Injunction in Patent Infringement Suit Against Cooper Companies' Unit.
May 31, 2001... LAKE FOREST CA -- The Cooper Companies, Inc. (NYSE:CO0) said today that the US District Court for the Central District of California denied a petition by Wesley Jessen Corp for a preliminary injunction involving the Co's CooperVision unit.
DB Capital Management and Partners Select Garra Sciences Inc. as New Name for Optigenix Nutraceutical Joint Venture.
May 31, 2001... PHOENIX AZ-- Dr. Ronald Pero was elected to serve as Chairman of Garra Sciences DB Capital Management, a wholly-owned subsidiary of Digital Bridge Inc. (OTCBB: DGBI). They also announced "Garra Sciences Inc." as the new name for its Joint...
Dendreon Corp Appoints Assoc General Counsel.
May 31, 2001... SEATTLE WA- Dendreon Corp (Nasdaq:DNDN) announced that Deborah Elvins has joined the company as associate general counsel. Elvins joins Dendreon from a 20-year career in private practice with a leading Pacific Northwest law firm.
Dragon Acquires Rights to Novel Slow Release EPO Formulation.
May 31, 2001... Dragon Pharmaceuticals Inc. (OTC BB: DRUG) announced that it has entered into an agreement related to a novel, slow-release formulation for Erythropoietin (EPO) with Transworld Pharmaceuticals Corp.
Eli Lilly & Co: Two Studies in New England Journal of Medicine Show ReoPro Significantly Improves Outcomes in Patients Receiving Stents.
May 31, 2001... INDIANAPOLIS iN-- Target demonstrates superiority to tirofiban in patients receiving stents; Admiral shows significant long-term benefit to heart attack patients in two new studies, published in NEJM.
Employers Health Care Coalition Opposes S. 283.
May 31, 2001... LOS ANGELES CA -- The Employers Health Care Coalition of Los Angeles has announced its opposition to S. 283, the Patients' Bill of Rights, also known as the Kennedy-McCain-Edwards bill. The coalition is writing to Senators to educate them about...
Eye Dynamics Engages The Geneva Group for Investment Banking Services.
May 31, 2001... TORRANCECA -- Eye Dynamics Inc. (OTCBB:EYDY) announced it has engaged Valhalla Capital LLC dba Geneva Group to provide investment banking services. Geneva will provide several services for the firm.
Genomica Corp Appoints Savage to its Board.
May 31, 2001... BOULDER CO -- Genomica Corp (Nasdaq: GNOM), a leading bioinformatics company developing software tools to facilitate gene discovery and drug development, announced the appointment of Michael Mick J. Savage to its Board.
GlaxoSmithKline Signs Contract with Numoda Corp for Wireless Clinical Study.
May 31, 2001... PHILADELPHIA PA-- GlaxoSmithKline (GSK) has signed a contract with Numoda Corp to deploy Numoda Trial handheld software on Symbol Devices to automate patient screening and data collection for an upcoming GSK clinical study.
Hambrecht & Quist Capital Management Announces Management Change.
May 31, 2001... BOSTON MA--Hambrecht & Quist Capital Management Inc, investment adviser to both H&Q Life Science Investors (NYSE:HQL) and H&Q Healthcare Investors (NYSE:HQH), announced the appointment of Dr. Daniel R. Omstead as President & CEO.
Hybrigen and Automated Cell Announce Drug Target Discovery and Validation Program; Two Companies to Focus on Autoimmune Diseases.
May 31, 2001... DALLAS & PITTSBURGH -- Hybrigen, Inc. and Automated Cell, Inc. announced plans to discover and validate 12 drug targets in autoimmune diseases over the next 12 months. Both Automated Cell and Hybrigen possess novel and proprietary technologies....
Immune Network Sells B.C. Research Interest to CroMedica.
May 31, 2001... VANCOUVER BC CANADA -- Immune Network Ltd. (OTC:IMMKF)(CDNX:IMM.) signed a letter of intent to sell its two-thirds interest in BC Research to CroMedica Global Inc. The proceeds of the sale, valued at about $8 mln, will be applied to all...
Info-X Selected by Catholic Health Initiatives; Preferred Vendor Solution for 'Medical Necessity' Available.
May 31, 2001... NORTHVALE NJ -- Info-X Inc, a company that offers medical coding and compliance intelligence for the healthcare industry, has been selected by Catholic Health Initiatives as a vendor of medical necessity solutions for its 68 hospitals and 48...
Intl Wex Technologies Says Safety Study Complete.
May 31, 2001... VANCOUVER BC CANADA-- Intl Wex Technologies Inc (CDNX:WXI.) announced that the clinical aspect of the multi-dose safety study for two indications (opiate withdrawal treatment and pain management) has now been completed in Canada.
IVAX Announces Laboratorio Chile Shareholders Approve Bylaw Amendments; Over 85% of Shares Tendered to Date.
May 31, 2001... MIAMI FL -- IVAX (AMEX:IVX) said that Laboratorio Chile S.A.'s shareholders have approved the bylaw amendments necessary to consummate IVAX pending tender offers in the US and in Chile for all of the outstanding shares and American Depositary...
Large Scale Biology and Plant Bioscience Ltd. Announce an Exclusive Licensing Agreement in Plant Functional Genomics.
May 31, 2001... VACAVILLE CA -- Large Scale Biology Corp (NASDAQ:LSBC) and Plant Bioscience Ltd. (PBL), Norwich, UK, announced a broad, exclusive licensing and option agreement in plant functional genomics that will enable a major expansion of LSBC's...
Ligand Earns Milestone as AHP Moves to Phase III for TSE-424 for Osteoporosis and TSE-424 + Premarin for HRT.
May 31, 2001... SAN DIEGO CA--With the second of three late-stage SERM products now in Phase III, advancing prospects of future royalties, Ligand Pharmaceuticals Inc (Nasdaq: LGND) announced that it has earned an undisclosed milestone payment.
Maxicare Health Plans Announces Delisting.
May 31, 2001... LOS ANGELES CA -- Maxicare Health Plans Inc. (Nasdaq:MAXIQ) announced that the firm's common stock will be delisted from the NASDAQ National Market at the opening of business on June 25, 2001. The firm's stock will begin trading on the Pink...
Medi-Hut's Facility and Production Update.
May 31, 2001... LAKEWOOD NJ -- Medi-Hut Co., Inc. (OTC BB:MHUT) announced that is has moved its Korean Production of its icc Elite Safety Syringe into MediHut Intl (Mfg.) Ltd Facility in Korea.
Miravant Cardiovascular Appoints New President.(Robert W. Scott appointed president of Miravant Medical Technologies' subsidiary)
May 31, 2001... SANTA BARBARA, CA- Miravant Medical Technologies (Nasdaq:MRVT) announced that Robert W. Scott, M.D. has joined the company as President of subsidiary Miravant Cardiovascular, Inc. (MCI). Dr. Scott previously held senior positions in...
Myron Levy Named CEO of Herley Industries, Inc.
May 31, 2001... LANCASTER PA --Herley Industries, Inc. (Nasdaq:HRLY) announced that the Board of Directors has named Myron Levy, Herley's CEO, effective August 9,2001, the 36th anniversary of Herley's founding. Mr. Levy will succeed Lee N. Blatt, who will...
NaPro Licenses Paclitaxel in Japan to JCR Pharmaceuticals.(NaPro Biotherapeutics Inc.)
May 31, 2001... BOULDER CO & ASHIYA, JAPAN -- NaPro BioTherapeutics, Inc. (Nasdaq:NPRO) and JCR Pharmaceuticals Co., Ltd. (Osaka) announced that they have entered into a mutually exclusive development, supply and distribution agreement for NaPro paclitaxel in...
New Firm for a New Era - Aventor Provides Integrated Consulting Services for Pharmaceutical, Medical Device, and Biologics Companies.
May 31, 2001... WASHINGTON DC -- A next-generation consulting firm launched today gives medical technology companies integrated, single-source solutions to the array of regulatory, reimbursement, and political challenges that influence introduction of new...
New Survey Funded by Amgen Finds Many Patients With Diabetes May Unknowingly Suffer From Anemia.
May 31, 2001... PHILADELPHIA PA -- Low awareness of link between diabetes and anemia may leave patients at risk for serious heart complications data from a recent survey of patients with diabetes suggest that the vast majority of them are unaware they are at...
New Target-Validation Technologies Will Help Pharmaceutical & Biotech Companies Achieve Profitability Goals.
May 31, 2001... NEWTON UPPER FALLS MA -- Target validation, experts agree, is pivotal to the survival of pharmaceutical and biotech companies seeking to pump up pipelines and improve efficiency through genomics. To meet this need, a growing range of...
Nexell Therapeutics Announces Results of Annual Meeting of Stockholders.
May 31, 2001... IRVINE CA--Nexell Therapeutics Inc. (Nasdaq:NEXL) announced that stockholders at the company's Annual Meeting re-elected a slate of eight Directors, approved an amendment to the company's stock option plan.
PDC Innovative Industries Announces Prototypes.(PDC Innovative Industries Inc. announces Hypo-Pro 2000 medical device prototypes)
May 31, 2001... CORAL SPRINGS FL -- PDC Innovative Industries Inc. (OTCBB:PDCI) says that five prototypes of the Hypo-Pro 2000 medical device which are planned for sales to medical centers, hospitals and clinics have been completed and are being tested under...
PhotoMedex Reports On Status of Coverage and Reimbursement for the XTRAC Laser Treatment for Mild to Moderate Psoriasis.
May 31, 2001... RADNOR PA -- PhotoMedex, Inc. (Nasdaq:PHMD) announced that significant progress has been achieved during the second quarter of 2001 in obtaining health insurance coverage and reimbursement for the treatment of mild to moderate psoriasis using...
Pipeline Interactive is Selected by Ohmeda Medical.(as interactive consultant)
May 31, 2001... LEBANON PA-- Pipeline Interactive announced that it has been selected as interactive consultant to Ohmeda Medical, of Laurel MD, according to Pipeline Interactive President Denny Miller.
Prescription Drug Use Patterns Complicated by Wide Regional Variation; "Total Drug Spending Up Again in 2000, Fastest Prescription Cost Increase for Children's Medications".
May 31, 2001... ST. LOUIS MO -- California and New York may be the nation's most populous states, but they and other big states like Florida, New Jersey, Minnesota, and Massachusetts, placed at or near the bottom when Express Scripts (Nasdaq:ESRX) measured per...
Progen Receives Ethics Committee Approval for Phase II Trial of Anti-Cancer Drug in US.(Progen Industries Ltd. receives approval for PI-88)
May 31, 2001... BRISBANE, AUSTIL~LIA-- Australian biotech company Progen Industries Limited (Nasdaq:PGLAF) (ASX:PGL) has received hospital ethics committee approval for its first Phase II trial of anti-cancer drug PI-88 in human melanoma patients.
SangStat Completes $15 Mln Private Placement.
May 31, 2001... FREMONT CA- SangStat (Nasdaq: SANG) announced that it has completed a private placement of approx. 1.36 mln shares of common stock for aggregate proceeds of approx. $15 mln with a group of institutional investors.
Sensormatic Announces New Exec VP.(Sensormatic Electronics Corp. appoints Thomas R. Metz executive vice president)
May 31, 2001... BOCA RATON FL -- Sensormatic Electronics Corp (NYSE: SRM) announced the appointment of Thomas R. Metz, 59, to the position of Exec VP of its Americas business unit, reporting to Per-OlofLoof, Sensormatic's President and CEO.
Tenet Names Corbeil Sr VP of Operations.(Tenet Healthcare Corp. appoints Stephen E. Corbeil senior vice president operations for Central States-Massachusetts Region)
May 31, 2001... SANTA BARBARA CA -- Tenet Healthcare Corp (NYSE:THC) announced that Stephen E. Corbeil has been promoted to Sr VP, operations for Tenet's Central States-Massachusetts Region. Corbeil is responsible for overseeing Tenet's 14 acute care units.
Tenet Names Schreck Sr VP of Operations.(Tenet Healthcare Corp. appoints Ted Schreck senior vice president of operations for Southern California Region III)
May 31, 2001... SANTA BARBARA CA -- Tenet Healthcare Corp (NYSE:THC) announced that Ted Schreck has been promoted to Sr VP, Operations, for Tenet's Southern California Region III. Schreck has more than 27 years of experience in health care.
Three-Tier Drug Copays Reach 35% of IPA HMOs.
May 31, 2001... HIRC Releases Spring 2001 Data On Pharmaceutical Three-Tier Copays and Percentage Copays Across HMOs, PBMs, Employers, and Coalitions SANTA CRUZ CA -- Three-tier copays are realizing rapid, widespread adoption, and are currently covering about...
Valley Forge Scientific Names Product Manager for Neurosurgical Products.(Susan Anderson named product manager)
May 31, 2001... OAKS PA-- Valley Forge Scientific Corp. (NASDAQ: VLFG; BSE: VLF), which develops and manufactures medical device products for hospital and healthcare markets worldwide, announced that Susan Anderson, has joined the company as Product Manager.
Vascular Architects Completes Sufficient Enrollment To Begin Phase II Clinical Trial.(of Vascular Architects Spire Covered Stent and Controlled Expansion Delivery System)
May 31, 2001... SAN JOSE CA--Vascular Architects Inc, announced that it has completed sufficient enrollment in its Phase I clinical trial evaluating use of the Vascular Architects Spire Covered Stent and Controlled Expansion Delivery System.
Viventia Biotech's Lead Product H11 Awarded Patent No. 6,207,153 From US PTO.("fully human" monoclonal antibody awarded patent)
May 31, 2001... TORONTO ONT CANADA -- Viventia Biotech Inc. (TSE:VBI.) announced that its lead product, H11a "fully human" monoclonal antibody, has been awarded a patent from the US Patent & Trademark Office.
Xanelim in Pivotal Phase III Study Shows Initial Positive Results; Study Findings Presented from First of Two Pivotal Phase III Clinical Trials.(report from Genentech Inc. and XOMA Ltd.)
May 31, 2001... SOUTH SAN FRANCISCO CA & BERKELEY CA --Genentech Inc. (NYSE: DNA) and XOMA Ltd. (Nasdaq: XOMA) announced that initial results from the first of two pivotal Phase III investigational trials of Xanelim (Efalizumab) were presented today at a key...
X-Ray Guided Interventional Procedures Rarely Result.(in radiation injury)
May 31, 2001... A relatively small number of patients are suffering radiation injuries when they undergo x-ray guided interventional procedures, such as coronary angioplasty, a new study documents. The study illustrates the need for physicians conducting these...
Yamanouchi Pharma Technologies, Inc. Integrates R&D and Mfg Operations.
May 31, 2001... PALO ALTO CA -- Yamanouchi Pharma Technologies, Inc. ("YPT"), a subsidiary of Yamanouchi Pharmaceutical Co., Ltd., has announced that its research, development and manufacturing operations will be consolidated into a single business unit...
Orphan Drug Act: Implementation & Impact.
May 31, 2001... A new DHHS Office of the Inspector General (OIG) report (OEI-09-00-00380) assesses the implementation on the Orphan Drug Act of 1983. That law is designed to stimulate the development of drugs for rare diseases.
The OIG found that the...
List Of Analytes Currently On The FDA Waived List.
May 31, 2001...
Tests Waived By FDA From Jan. 31, 2000-May 2, 2001
Alcohol, Saliva
Amines
Amphetamines
Bladder Tumor Associated Antigen
Cannabinoids (Thc)
Catalase, Urine
Cholesterol
Cocaine Metabolites
Creatinine
Erythrocyte Sedimentation...
BIO 2001 Exhibitor Profiles.(BIO 2001 International Biotechnology Convention and Exhibition)
May 31, 2001... Brief news profiles are listed below of some of the economic development and other exhibitors at the annual BIO 2001 International Biotechnology Convention & Exhibition on June 24-27, 2001, at the San Diego Convention Center.
Company: ...
Bionow Promotes Bioscience in NW England.
May 31, 2001...
Northwest Development Agency
Warrington England
BACKGROUND
The emerging biotech community in Northwest England is set to become the UK's next successful cluster of worldwide biotech expertise and resources. The Northwest...
BUSINESS DEVEL/MEETINGS.(upcoming biotechnology industry events)
May 31, 2001...
MANAGED CARE SYMPOSIUM: CONSUMERDRIVEN
& DEFINED CONTRIBUTION
HEALTHCARE: EMERGING MODELS, PLAN
DESIGN & EMPLOYEE CHOICE
JULY 12-13, 2001
CHICAGO IL
SHERATON HOTEL & TOWERS
It's the first independent managed care symposium to...
FDA PMA Approvals [High-Tech Products] : February 2001 - May 2001.(product marketing approvals)
May 31, 2001... MAY 2001 PMA ORIGINAL APPROVALS
Medical Carbon Research Institute, LLC
Austin TX 78754
P000037
5/30/01
On-Xr Prosthetic Heart Valve, #ONXA
Approved On-Xr Prosthetic Heart Valve, #ONXA in aortic position including sizes 19, 21,...
FDA 510(k) Substantially Equivalent Product Approvals.
May 31, 2001...
MAY 2001
322 FDA APPROVED
3M Co
Xse
KO 11167 (Traditional)
Karen O'Malley
651-736-7326
3m Ctr Bldg 260-2b-12
Date Apprvd: 17-May-01
St Paul MN 55144
A & A Medical Inc
Balloon Cannula Short
#R65-985; Balloon...