Biomedical Market Newsletter articles from January 2003

Biomedical Market Newsletter archives from January 2003

FDA launches new initiative to improve development & availability of innovative products. (Breaking News).
January 1, 2003... On Jan. 31, 2003, the US Food & Drug Administration (FDA) announced a broad initiative to help make innovative medical technologies available sooner, and to reduce the costs of developing safe and effective medical products. At the same time,...

Russian government is tightening control over imported pharmaceuticals. (Breaking News).(Brief Article)
January 1, 2003... MOSCOW, RUSSIA -- JAN. 2003--Due to increasing amounts of counterfeit pharmaceuticals entering Russia (12% in 2002 vs. 7% in 2001), the Russian Government is tightening control over imported pharmaceuticals. A new regulation requires that...

Statement of Dr. Mark McClellan, FDA commissioner, on approval of the Omnibus Appropriation Bill. (Breaking News).(Brief Article)
January 1, 2003... WASHINGTON DC -- Feb. 24, 2003--On Feb. 19, 2003, the President signed the FY 2003 Omnibus Appropriation Bill which provides the FDA a program level budget of $1.64 bln, or a 21% increase over the original FY 2002 appropriation. We are...

Report details national health care spending in the US increases in 2001. (Breaking News).
January 1, 2003... WASHINGTON DC -- JAN. 08, 2003--Health care spending in the US rose to $1.4 trillion in 2001 (the latest available year for final data), an 8.7% increase over the previous year, announced a new report by the US Centers for Medicare & Medicaid...

FDA's continuing investigation of particulate matter in blood shows normal blood components & no evidence for increase in adverse events. (Breaking News).
January 1, 2003... WASHIINGTON DC -- FEB. 27, 2003--The US FDA released the following statement, which provides an update to the ongoing investigations of reports of unusual particulate matter in some blood components, primarily red blood cells (RBCs). ...

Additional funding to fight the spread of AIDS in Africa requested by president Bush. (Breaking News).
January 1, 2003... WASHINGTON DC -- JAN. 28, 2003--During President George W. Bush's State of the Union address, Jan. 28, 2003, he asked Congress to commit $15 bln to afflicted African nations and the Caribbean, to help fight the spread of the AIDS virus. In...

FDA investigates improper disposal of bioengineered pigs. (Breaking News).
January 1, 2003... WASHINGTON DC -- FEB. 5, 2003--The FDA has determined that pigs involved in certain bioengineering studies at the University of Illinois -Urbana/ Champaign were possibly not properly disposed of, and may have entered the food supply. FDA...

New York State lawsuit targets alleged illegal pricing scheme for cancer drugs: NY Attorney General Spitzer Cites Alleged Bribery, Kickbacks & False Statements by Leading Drug Companies. (Breaking News).
January 1, 2003... NY Attorney General Spitzer Cites Alleged Bribery, Kickbacks & False Statements by Leading Drug Companies ALBANY NY -- FEB 13, 2003--New York Attorney General Eliot Spitzer today accused three of the nation's leading pharmaceutical...

FDA publishes final rule to require labeling about antibiotic resistance. (Breaking News).
January 1, 2003... WASHINGTON DC -- FEB. 5, 2003--The FDA today announced a final rule outlining new labeling regulations designed to help reduce the development of drug-resistant bacterial strains. The final rule is aimed at reducing the inappropriate...

Mergers & Acquisitions.
January 1, 2003... American Medical Systems (NASDAQ:AMMD) MINNEAPOLIS MN -- JAN. 2, 2003--AMS has completed the acquisition of CryoGen Inc (San Diego CA), which develops/markets cryoablation technology for gynecological and other applications. AMS develops...

Institute for Systems Biology (Nonprofit). (Drug Discovery Update).(Brief Article)
January 1, 2003... SEATTLE WA -- JAN. 1, 2003--ISB, along with its two laboratory partners, have completely sequenced chromosome 14 as part of the Human Genome Project. The group, led by Dr. Leroy Hood and Dr. Lee Rowen, was responsible for mapping and sequencing...

Advanced Medical Optics Inc (NYSE:AVO). (Business Deals).(Brief Article)
January 1, 2003... SANTA ANA CA -- JAN. 2003--Advanced Medical announced a strategic partnership with Optikon to market its vitreal retinal system. The deal will allow Optikon to sell its product through Advanced Medical's global distribution network and expand...

Carefx Corp (Privately-held). (Business Deals).(Brief Article)
January 1, 2003... MESA AZ -- DEC. 31, 2002--Carefx Corp has entered into a strategic development relationship with the Univ of Washington Academic Medical Center (Seattle) to implement the firm's Fusion Context Manager[TM]. UW is using the program to give...

Dade Behring (OTC:DBEH) & HealthTrust Purchasing Group LP (Privately-held). (Business Deals).(Brief Article)
January 1, 2003... DEERFIELD IL & BRENTWOOD TN -- JAN. 2003--The firms agreed to extend their contract to Dec. 2005 for Dimension[R] chemistry instruments, reagents and supplies. Dade also agreed to continue distributing Diagnostic Products Corp.'s...

Enzon Pharmaceuticals (NASDAQ:ENZN) SkyePharma PLC (NASDAQ:SKYE; LSE:SKP). (Business Deals).(Brief Article)
January 1, 2003... BRIDGEWATER NJ -- JAN. 2, 2003--The two companies will jointly develop up to three products for future commercialization, based on SkyePharma's proprietary platforms and Enzon's proprietary PEG modification technology.

Ivax Corp (AMEX:IVX) (LSE:IVX.L). (Business Deals).(Brief Article)
January 1, 2003... MIAMI FL -- JAN. 2003--Ivax entered into a license agreement with Novartis Pharma AG to utilize its Airmax[TM] multi dose dry powder inhalers for Novartis' medicines Foradil[R] (formoterol) and Miflonide[R] (budesonide) in the EU and other...

Calypte Biomedical Corp (OTCBB:CALY). (Business Deals).(Brief Article)
January 1, 2003... ALAMEDA CA -- JAN. 6, 2003--Calypte received a second commercial order for its HIV-1 antibody tests from Zhong Yang Pute Co, a distributor based in China. The order, totaling approx. 160,000 tests, is expected to ship in early 2003. Calypte...

Global Medical Products Holdings Inc (OTCBB:GMDP). (Business Deals).(Brief Article)
January 1, 2003... LAGUNA HILLS CA -- JAN. 2003--Ecom Shanghai Intl Trading Co, a Global Medical subsidiary, has signed a distribution agreement with B. Braun Medical (HK) Ltd., a unit of B. Braun of Germany. The agreement gives Ecom the distribution rights to B....

Innovative Technology Acquisition Corp (OTCBB:ITAQ). (Business Deals).(Brief Article)
January 1, 2003... NEW YORK -- JAN. 6, 2003--ITA will begin marketing/distributing Nutraplete, developed by its wholly-owned subsidiary, BioSource Therapeutics Inc, during the first quarter of 2003. Nutraplete is a multicomponent, proprietary, nutritional...

OSI Systems Inc (NASDAQ:OSIS). (Business Deals).(Brief Article)
January 1, 2003... HAWTHORNE CA -- JAN. 2003--Its subsidiary, Osteometer MediTech, received a $2.1 mln order from a medical distributor for its new FDA approved DexaCare[R] G4 Bone Densitometers. The company said the new system will allow health care...

Proxima Therapeutics Inc (Privately-held). (Business Deals).(Brief Article)
January 1, 2003... ALPHARETTA GA -- JAN. 2003--Proxima's first patient outside the US has been treated with its GliaSite[R] radiation therapy system. The male patient, in his 60s, was treated at Klinikum Saarbrucken, Germany, for a second recurrence of...

HHS adopts final security standards, transaction modifications, for electronic health information under HIPAA. (Breaking News).(Health Insurance Portability & Accountability Act )
January 1, 2003... WASHINGTON DC -- FEB. 13, 2003--HHS Secretary Tommy G. Thompson today announced the adoption of final security standards for protecting individually identifiable health information when it is maintained or transmitted electronically. At the...

HHS releases final HIPAA security rule. (Market Research Studies).(Health Insurance Portability & Accountability Act )
January 1, 2003... Davis Wright Tremaine LLP Seattle, Washington Davis Wright Tremaine LLP today released its analysis of the important new Health Insurance Portability & Accountability Act (HIPAA) security rules. Four years and 11 months ago, the...

FDA commissioner speech at generic pharmaceutical association meeting. (Guest Editorial).
January 1, 2003... Prepared Remarks of Mark B. McClellan, M.D., Ph.D. FDA Commissioner Jan. 29, 2003 I appreciate this opportunity to meet with a relatively new group that has quickly become influential in health policy, reflecting the generic drug...

Presentation of the president's FY2004 HHS budget. (Guest Editorial).
January 1, 2003... Excerpts of remarks of HHS Secretary Tommy G. Thompson Feb. 3, 2003 I hank you all for coming to this briefing on President Bush's budget for the Department of Health & Human Services--a budget that continues to advance the...

FDA issues letter discussing its enforcement policy for unapproved drugs. (Breaking News).
January 1, 2003... WASHINGTON DC -- FEB. 26, 2003--The US FDA provided additional details today on its enforcement policy on unapproved drugs, in letters issued 66 manufacturers and distributors of an unapproved expectorant drug product. In the follow-up...

Scientists initiate new national effort to fight Parkinson's disease. (Market Research Studies).
January 1, 2003... ROCHESTER NY -- Feb. 28, 2003--Scientists nationwide have come together through the initiative of the University of Rochester Medical Center in a coordinated national effort to pursue a new treatment for Parkinson's disease, officials announced...

FDA completes 1st steps of broad initiative to improve regulation of pharmaceutical manufacturers. (Market Research Studies).
January 1, 2003... WASHINGTON DC -- FEB 20, 2003--The US Food & Drug Administration (FDA) today announced that it has accomplished the initial objectives set in its ongoing initiative to modernize the agency's regulation of pharmaceutical manufacturing and...

FDA deputy commissioner speech at American society of microbiology meeting. (Guest Editorial).
January 1, 2003... Excerpts of Prepared Remarks of Lester M. Crawford, Jr., D.V.M., Ph.D. FDA Deputy Commissioner Feb. 7, 2003 I am doubly pleased and honored to have been invited to this meeting. It gives me an opportunity, as a representative of the...

Pharmaceutical cGMPs for the 21st century: a risk-based approach. (Market Research Studies).
January 1, 2003... Questions & Answers US Food & Drug Administration Feb. 27, 2003 1. How does this initiative affect the Systems-Based Inspections Pilot Program? Is the systems-based approach expressed in the compliance program reinforced by the...

Pharmaceutical cGMPs for the 21st century: a risk-based approach: progress report: proposed process for dispute resolution. (Market Research Studies).
January 1, 2003... US Food & Drug Administration Feb. 27, 2003 I. Introduction * In Aug. 2002, FDA announced a new initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach." The initiative focuses, in part, on FDA's current Good...

83 new medicines are in development for HIV/AIDS. (Market Research Studies).
January 1, 2003... WASHINGTON DC -- The pharmaceutical industry is continuing its all-out effort to develop more effective ways to prevent and treat HIV/AIDS, with 83 new medicines in development, a new survey by the Pharmaceutical Research and Manufacturers of...

FDA advisory committee discusses steps for potentially continuing certain gene therapy trials that were recently placed on hold. (Market Research Studies).
January 1, 2003... WASHINGTON DC -- FEB. 28, 2003--The FDA's Biological Response Modifiers Advisory Committee (BRMAC) met today to discuss possible measures that could potentially allow a number of gene therapy trials that involve the use of retroviruses to...

1st new blood test to evaluate heart attacks. (Market Research Studies).
January 1, 2003... WASHINGTON DC -- FEB. 14, 2003--The FDA today cleared for marketing a new lab blood test that will significantly increase the ability of doctors to rule out a heart attack when a person shows up at an emergency room with severe chest pains. ...

HHS announces research plan to fight autoimmune diseases. (Market Research Studies).
January 1, 2003... WASHINGTON DC -- JAN. 10, 2003--HHS Secretary Tommy G. Thompson today announced the release of a comprehensive research plan from HHS' National Institutes of Health (NIH) to fight autoimmune diseases, a collection of disorders including...

FDA budget proposal for FY 2004 released. (Breaking News).
January 1, 2003... WASHINGTON DC -- FEB. 3, 2003--The President's budget request for the US Food & Drug Administration (FDA) for fiscal year (FY) 2004 (Oct. 1, 2003--Sept. 30, 2004) totals $1.7 bln, including $1.4 bln in budget authority and $300 mln in user...

Significant HHS accomplishments during 2002. (Market Research Studies).
January 1, 2003... US Dept of Health & Human Services Washington DC BIOTERRORISM PREPAREDNESS America ended the year 2002 much better prepared to confront terrorism. Under HHS Secretary Tommy G. Thompson's leadership, the department led the nation's...

Acusphere Inc (Privately-held).(Brief Article)
January 1, 2003... WATERTOWN MA -- John F. Thero, new Sr VP, Finance & Administration & CFO, was Sr VP, Finance & CFO at Abiomed Inc.

AdvaMed (nonprofit association).(Brief Article)
January 1, 2003... WASHINGTON DC -- Marjory Searing is its new Executive VP of Global Strategy & Analysis.

Agfa Gevaert (OTC:AFGTF).(Brief Article)
January 1, 2003... MORTSEL BELGIUM -- Steven Nakashige is its new CEO of Worldwide HealthCare Informatics Business.

Align Technologies (NASDAQ:ALGN).(Brief Article)
January 1, 2003... SANTA CLARA CA -- Eldon Bullington is its new VP of Finance & CFO.

Alpha Therapeutic Corp.(Brief Article)
January 1, 2003... LOS ANGELES CA -- Thomas Speace is its new VP of Worldwide Marketing & Intl Operations.

Ambion Inc (Privately-held).(Brief Article)
January 1, 2003... AUSTIN TX -- Dr. Jeffrey Williams is the new Executive VP & General Manager of its Ambion RNA Diagnostics Division.

America Service Group Inc (NASDAQ:ASGR).(Brief Article)
January 1, 2003... BRENTWOOD TN -- Lawrence H. Pomeroy was promoted to Sr VP and Chief Development Officer, replacing Gerard F. Boyle, who resigned to become CEO of a private Nashville-based healthcare company. He was previously with HCA.

Andrx (NASDAQ:ADRX).(Brief Article)
January 1, 2003... DAVIE FL -- James Schwier is its new VP of Manufacturing Operations. Previously, Schwier was Director of Manufacturing at that firm's largest solid-dosage plant in Vega Baja, Puerto Rico.

Angstrom Pharmaceuticals Inc.
January 1, 2003... SAN DIEGO CA -- Virgil Thompson, new President & CEO, previously worked for several early stage biopharmaceutical companies, including Chimeric Therapies Inc, Bio-Technology General Corp and Cytel Corp.

Ascend Therapeutics Inc (Privately-held).(Brief Article)
January 1, 2003... HERNDON VA -- Dana C. Hilt, MD, is its new Chief Medical Officer and Sr VP of Drug Development. He was VP of Clinical Research, Drug Metabolism & Toxicology and Chief Medical Officer of Guilford Pharmaceuticals.

Association of Academic Health Centers.(Brief Article)
January 1, 2003... NEW YORK NY -- Dr. Barbara Ross-Lee, VP for Health Sciences & Medical Affairs, Dean, New York College of Osteopathic Medicine, and Dean, School of Allied Health and Life Sciences at New York Institute of Technology, has been named Chair-Elect...

Axonyx Inc (NASDAQ:AXYX).(Brief Article)
January 1, 2003... NEW YORK -- Gosse B. Bruinsma, MD, COO, is its new VP Product Development, replacing Robert Burford, who resigned.

Bausch & Lomb (NYSE:BOL).(Brief Article)
January 1, 2003... ROCHESTER NY -- David R. Nachbar, new Sr VP of HR, will also serve on its Corporate Strategy Board. Gary M. Phillips, MD, is its new Corporate VP for Global Pharmaceutical and Vitreoretinal products.

Bayer AG (NYSE:BAY).(Brief Article)
January 1, 2003... LEVERKUSEN GERMANY -- Rolf Classon is its new Chairman of the Board of the future Bayer HealthCare AG. Classon also will serve as Chairman of Bayer HealthCare's executive committee. He has been with Bayer since 1991 and most recently was head...

Beckman Coulter Inc (NYSE:BEC).(Brief Article)
January 1, 2003... FULLERTON CA -- Elias Caro is President of its new Biomedical Research Division.

Biogen Inc (NASDAQ:BGEN).(Brief Article)
January 1, 2003... CAMBRIDGE MA -- Bob Hamm is Sr VP of North American Commercial Operations, a new position.

Biolucent (Privately-held).(Brief Article)
January 1, 2003... ALISO VIEGO CA -- Jill Anderson, the new President, was promoted from VP.

BioMS Medical Corp (TSX:MS).(Brief Article)
January 1, 2003... EDMONTON ALB CANADA -- Don Kimak, new CFO, was Controller at NQL Drilling Tools Inc.

Bio-Rad Laboratories Inc (Amex:BIO; BIO.B).(Brief Article)
January 1, 2003... HERCULES CA -- Norman Schwartz, VP & Group Manager of Life Science, is the new President & CEO, replacing David Schwartz, founder, who is the new board Chairman. Retiring Executive VP & COO James Bennett will become a board member. Christine...

Boston Biomedica (NASDAQ:BBII).(Brief Article)
January 1, 2003... WEST BRIDGEWATER MA -- William Wilson, new Chairman, replaces Richard Schumacher, who remains as Director. Kevin Quinlan is the new President & COO. Cardiome Pharma Corp

(OTCBB:COMRF) (TSX:COM).(Brief Article)
January 1, 2003... VANCOUVER BRITISH COLUMBIA -- Doug Janzen, its new CFO, was Managing Director of Health Sciences, and Partner at Sprott Securities, a Toronto-based institutional investment bank. Christina Yip is its new VP of Finance & Administration.

Centene Corp (NASDAQ:CNTE).(Brief Article)
January 1, 2003... ST. LOUIS MO -- Daniel R. Paquin, its new Sr VP of Health Plan Business Group, was Regional President, Midwest/Medicaid.

Centerpulse (NYSE:CEP).(Brief Article)
January 1, 2003... ZURICH SWITZERLAND -- Mike McCormick is its new President of its Spine-Tech division; Thomas Zehnder is its new Global Coordinator.

ChromaVision Medical Systems Inc (NASDAQ-NMS:CVSN).(Brief Article)
January 1, 2003... SAN JUAN CAPISTRANO CA -- Stephen T. D. Dixon is its new Executive VP & CFO, replacing Kevin C. O'Boyle, who resigned to pursue other business interests. Dixon was with the Scully Companies, announced CEO/President Carl W. Apfelbach. Charles...

Closure Medical (NASDAQ:CLSr).(Brief Article)
January 1, 2003... RALEIGH NC -- Daniel Pelak is its new President & CEO, succeeding Robert Toni, who is retiring.

Cogent Healthcare Inc (Privately-held).(Brief Article)
January 1, 2003... IRVINE CA -- Navneet Kathuria, MD, M.P.H, is its new National Medical Director for the inpatient management programs. He was Associate Chief in the division of general medicine at St. Luke's-Roosevelt Hospital Center and was on the faculty at...

Corautus Genetics Inc (AMEX:CAQ).(Brief Article)
January 1, 2003... SAN DIEGO CA -- Following a merger between GenStar Therapeutics Corp and Vascular Genetics Inc, Richard E. Otto is its new CEO; Robert E. Sobol MD is its President; Robert T. Atwood is the new CFO; Yawen Chiang PhD is Sr VP of Research; and...

Corixa Corp (NASDAQ:CRXA).(Brief Article)
January 1, 2003... SEATTLE WA -- Wayne R. Gombotz, PhD, is its new VP of Process Sciences & Pharmaceutical Development. He was Sr Director, Analytical Chemistry & Formulation at Amgen (formerly Immunex).

C. R. Bard Inc (NYSE:BCR).(Brief Article)
January 1, 2003... MURRAY HILL NJ -- Timothy Ring will become Chairman & CEO on Aug. 8, 2003, replacing retiring William Longfield. John Weiland will be President & COO; he is currently is Group President of its Surgical, Urological and Endoscopic Technology...

CryoCath Technologies (OTC:CYAF; TSE: CYT).(Brief Article)
January 1, 2003... MONTREAL CANADA -- Gerald Mahoudeau, its new Director of European Business, was VP of Medtronic's cardiac surgery division in Europe.Henri Vienneau is its new Chairman. Steven Arless is its new President & CEO.

CTI Molecular Imaging (NASDAQ:CTMI).(Brief Article)
January 1, 2003... KNOXVILLE TN -- Greg Brophy is its new Sr VP and General Counsel.

Cubist Pharmaceuticals Inc (NASDAQ:CBST).(Brief Article)
January 1, 2003... LEXINGTON MA -- David H. Schubert is its new VP of Regulatory Affairs & Quality; he was VP of Regulatory Affairs and Quality Assurance at Zycos Inc. Barry I. Eisenstein, MD, new Executive VP of R&D, was President, Chief Scientific and Medical...

Curon Medical (NASDAQ:CURN).(Brief Article)
January 1, 2003... SUNNYVALE CA -- Larry Heaton II, new President & CEO, was President & CEO of Response Genetics.

Cyberkinetics Inc (Privately-held).(Brief Article)
January 1, 2003... PROVIDENCE RI -- Timothy Surgenor is its new President/CEO; he was Exec VP of Haemonetics, announced Mark Carthy, Chairman.

Cyberonics Inc (NASDAQ:CYBX).(Brief Article)
January 1, 2003... HOUSTON TX -- Michael Cheney was promoted from VP of Marketing to Sr VP of Marketing & Sales.

Dendreon Corp (NASDAQ:DNDN).(Brief Article)
January 1, 2003... SEATTLE WA -- Elizabeth C. Smith was promoted to VP of Regulatory Affairs, along with Lizabeth J. Cardwell to VP of Quality. Mitchell H. Gold, MD, promoted to CEO, replacing Christopher S. Henney, PhD, D.Sc., who served as CEO since 1995 and...

DiaSys Corp (AMEX:DYX).(Brief Article)
January 1, 2003... WATERBURY CT -- Marshall Witzel is its new CEO, replacing Todd DeMatteo, who resigned.

Document Control Systems Inc.(Brief Article)
January 1, 2003... SALT LAKE CITY UT -- Carl Accettura, new VP of FDA Solutions, will direct its validation services team.

Domantis Ltd (Privately-held).(Brief Article)
January 1, 2003... CAMBRIDGE UK & CAMBRIDGE MA -- Dr. Steve Holmes, new Sr Director, Therapeutic Targets, was Director of Antibody Discovery at Oxford GlycoSciences.

Drug Development Resources Inc.(Brief Article)
January 1, 2003... BOSTON MA -- Daniel T. Madden, new VP of Software Solutions, was Associate Director of Business Systems at Biogen Inc.

Electromed Inc (TSX:MED).(Brief Article)
January 1, 2003... LAVAL QUEBEC CANADA -- Dennis Wood was appointed Chairman after Wood Holdings acquired a 25% fully diluted interest in Electromed. Wood replaces Vital Dumais, who held the position since Electromed was founded.

Elusys Therapeutics Inc (Privately-held).(Brief Article)
January 1, 2003... PINE BROOK NJ -- Elizabeth Posillico, PhD, new VP of Business Development, was Executive Director of Business Development and Marketing for Physiome Sciences.

Encore Medical (NASDAQ:ENMC).(Brief Article)
January 1, 2003... AUSTIN TX -- Marc Olarsch and William Fain, are new area VPs in its surgical division.

EpMedSystems Inc (NASDAQ:EPMD).(Brief Article)
January 1, 2003... WEST BERLIN NJ -- Mark Adams is its new VP Sales & Marketing, from Irvine Biomedical.

EraGen Biosciences.(Brief Article)
January 1, 2003... MADISON WI -- Samraat S. Raha, new Chief Business Officer, was VP of Discovery Services at Incyte Genomics.

Essential Therapeutics (NASDAQ:ETRX).(Brief Article)
January 1, 2003... WALTHAM MA -- Martha Carter is its new Sr VP Regulatory Affairs.

Etiologics.(Brief Article)
January 1, 2003... OXFORD ENGLAND -- Ian Kent, new Chairman, is currently Chairman of several venture funded start-ups, including Ribotargets and Ardana Bioscience Ltd, and chairs LGC Holdings Ltd, Intercytex, and Adprotech Ltd. He is Non-Executive Director of...