Biomedical Market Newsletter articles from August 2002

Biomedical Market Newsletter archives from August 2002

FDA unveils new initiative to enhance pharmaceutical GMPs. (Breaking News...).(Good Manufacturing Practice)(Brief Article)
August 31, 2002... On Aug. 21, 2002, the Food & Drug Administration (FDA) announced that it is undertaking a significant new initiative to enhance the regulation of pharmaceutical manufacturing and product quality. FDA officials say they want to "bring a 21st...

Researchers create potential new source of human antibodies from cows. (Breaking News).(Brief Article)
August 31, 2002... AUG. 13, 2002 -- Scientists have reported the successful application of proprietary cloning techniques to produce four calves that express a human chromosome fragment coding for the broad range of human antibodies. The research was the...

The Kidney & Urology Foundation of America announced the appointment of actor Robert Wagner as Honorary Chairman for the not-for-profit organization. (Breaking News).(Brief Article)
August 31, 2002... JULY 2002 -- The Kidney & Urology Foundation of America announced the appointment of actor Robert Wagner as Honorary Chairman for the not-for-profit organization.The appointment was made at a reception in New York City celebrating the...

New research from Rutgers, the State University of New Jersey, links acetaminophen, the medicine in pain relievers such as Tylenol, to improved heart muscle recovery following ischemic attacks. (Breaking News).(Brief Article)
August 31, 2002... JULY 2002 -- New research from Rutgers, the State University of New Jersey, links acetaminophen, the medicine in pain relievers such as Tylenol, to improved heart muscle recovery following ischemic attacks (periods of reduced blood flow typical...

Medicare program: review of National Coverage Determinations & Local Coverage Determinations: condensed version. (Breaking News).(Brief Article)
August 31, 2002... DEADLINE FOR COMMENTS: Oct. 21, 2002 [Federal Register; Vol. 67, No. 163; Aug. 22, 2002; pp. 54534-54563; Proposed Rules] 42 CFR Parts 400, 405, and 426 [CMS-3063-P] RIN 0938-AK60 AGENCY: Centers for Medicare & Medicaid Services...

Premier statement on OIG inquiry. (Breaking News).(Office of Inspector General)(Brief Article)
August 31, 2002... SAN DIEGO CA -- AUG. 15, 2002 -- Premier, Inc. leaders said today the company will cooperate with any inquiry of the Office of Inspector General (OIG) of the US DHHS. Premier received a subpoena from the OIG late Wednesday seeking information...

Alloy Polymers (privately-held).(Brief Article)
August 31, 2002... RICHMOND VA -- Paul Bryant is its new VP of Sales & Marketing, from Nova Chemicals.

Biomedical Market Newsletter Inc (privately-held).(Brief Article)
August 31, 2002... COSTA MESA CA -- Wally Turner was appointed to the new position of Manager E-mail News Service Sales, at its new Santa Ana CA sales office.

Biosite Diagnostics Inc (NASDAQ:BSTE).(Brief Article)
August 31, 2002... SAN DIEGO CA -- Gary King is the new VP of WW Marketing.

Endocardial Solutions (NASDAQ:ECSI).(Brief Article)
August 31, 2002... ST PAUL MN -- J. Robert Paulson, new CFO, was previously Sr VP/GM in the auditory products division of Advanced Bionics.

GenoSpectra Inc (privately-held).(Brief Article)
August 31, 2002... FREMONT CA -- Frank Witney, Ph.D. was appointed to the new position of CEO. He was President, Drug Discovery Tools at PerkinElmer Life Sciences.

GenVec Inc (NASDAQ:GNVC).(Brief Article)
August 31, 2002... GAITHERSBURG MD -- David W Robinson, new VP Mktg & Sales, from GlaxoSmithKline, announced Dr Paul H Fischer, President/CEO.

Ischemia Technologies Inc (privately-held).(Brief Article)
August 31, 2002... DENVER CO -- John H. Carter is its new Chief Technology Officer; he was was VP Diagnostic Products Marketing & Scientific Affairs for Carter-Wallace Inc, announced Peter Crosby, President/CEO.

Memry Inc (privately-held).(Brief Article)
August 31, 2002... MENLO PARK CA -- Dean Tulumaris is the new VP/ General Manager.

Novo Nordisk (NYSE:NVO).(Brief Article)
August 31, 2002... PRINCETON NJ -- Dr. Peter Aurup is its new VP of Drug Development, said President Martin Soeters. Bernard C. Wright was also named Director of Strategic Sourcing, reporting to Phil Fornecker, VP of Finance.

Paratek Pharmaceuticals Inc (privately-held).(Brief Article)
August 31, 2002... BOSTON MA -- Donna Supko, Ph.D. is its new Director of Regulatory Affairs.

Prana Biotechnology Ltd (OTC: PRNAF; ASX: PBT).(Brief Article)
August 31, 2002... MELBOURNE AUSTRALIA -- Dianne Angus is the new VP of Intellectual Property & Licensing.

Staar Surgical Co (NASDAQ:STAA).(Brief Article)
August 31, 2002... MONROVIA CA -- Nicholas Curtis is its new Sr VP Sales & Marketing. He was a founding member of Chiron Vision, a subsidiary of Chiron, and former Sr Territory Mgr at Allergan Medical Optics (Irvine CA).

Theragenics Corp (NYSE:TGX).(Brief Article)
August 31, 2002... BUFORD GA -- James A MacLennan, new CFO/Treasurer, was Exec VP/CFO of Lanier Worldwide. He succeeded Bruce W Smith, who was appointed Exec VP.

Thoartec Inc (NASDAQ:THOR).(Brief Article)
August 31, 2002... PLEASANTON CA -- Jeffrey Nelson, was appointed President of its newly-created cardiovascular division.

Tyco Healthcare Group (NYSE:TYC).(Brief Article)
August 31, 2002... NEW YORK NY -- Eric Pillmore was appointed to the newly created position of Sr VP of Corporate Governance; he was Sr VP/CFO of Multilink Technology. Tyco Intl appointed Edward Breen as Chairman/CEO; he is the former President/COO of Motorola.

US Centers for Medicare & Medicaid Services.(Brief Article)
August 31, 2002... WASHINGTON DC -- Wallace Fung, is its new Chief Technology Officer.

FDA's drug review process: ensuring drugs are safe & effective. (Drug Discovery: part 2).
August 31, 2002... The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. An important use of a drug may also be discovered by accident. For...

PhRMA claims significant errors in drug study backed by Blue Cross/Blue Shield Plans: new research shows drug costs are only a fraction of increases in Health Insurance Premiums. (Market Research Studies).(Pharmaceutical Research & Manufacturers of America)(Brief Article)
August 31, 2002... WASHINGTON DC -- JUNE 11, 2002 -- The Pharmaceutical Research & Manufacturers of America has released details of what it claims are significant errors in a new study by the National Institute of Health Care Management (NIHCM). PhRMA says the...

FTC report contradicts generic industry bill: provides no support for S.812. (Market Research Studies).(Federal Trade Commission)(Brief Article)
August 31, 2002... WASHINGTON DC -- JULY 30, 2002 -- The Pharmaceutical Research & Manufacturers of America (PhRMA) said today it welcomed the Federal Trade Commission report vindicating current laws that help patients, by both encouraging new drug development...

Pharmaceutical companies are developing 256 medicines to counter infectious diseases, including bioterrorist threats. (Market Research Studies).(Brief Article)
August 31, 2002... WASHINGTON DC -- APRIL 03 2002 -- Infectious diseases--both those that could result from a bioterrorist attack and those that occur naturally--are the target of 256 medicines and vaccines in development, reports a new survey by the...

Clinical trial websites: a promising tool for improving processes & reducing costs. (Market Research Studies).
August 31, 2002... Released: May 2002 Condensed Version PURPOSE To assess the role of clinical trial websites in fostering informed consent and of institutional review boards (IRBs) in overseeing the information on these websites. FINDINGS ...

Statement by Jackie Cottrell, Pharmaceutical Research & Manufacturers of America, on a drug safety study in the Journal of the American Medical Association (JAMA). (Market Research Studies).(Brief Article)
August 31, 2002... Americans should have confidence in the safety of pharmaceuticals and the system for developing, approving and monitoring drugs. While all medicines, including aspirin, involve some risk, the FDA approves medicines when the benefits are shown...

New 2001 data claims big drug companies spent almost 2 1/2 times as much on marketing, advertising & administration as they spent on R&D: drug company profits exceeded R&D spending by 60%; executive compensation & deferred stock options were large. (Market Research Studies).(Brief Article)
August 31, 2002... WASHINGTON DC -- JULY 17, 2002 -- US drug companies that market the 50 most often prescribed drugs to seniors spent almost 2 1/2 times as much on marketing, advertising, and administration as they spent on R&D in 2001, claims a new study...

Success of private sector patient information with prescription medicines assessed. (Market Research Studies).(Brief Article)
August 31, 2002... WASHINGTON DC -- JUNE 18, 2002 -- The FDA today announced findings from a 2001 study designed to assess the extent and usefulness of private sector prescription information that patients receive when filling their prescriptions. Study results...

New CDC study claims sharp increases in prescription rates across all ages & in nearly all specialties: at current rate, drug spending would double in next 5 years. (Market Research Studies).
August 31, 2002... WASHINGTON DC -- JULY 09, 2002 -- At a time when Congress is struggling to create a viable prescription drug benefit and consumers are increasingly worried about drug costs, a new study claims that physicians are prescribing medications to...

Biggest drug companies are expanding their lobbying army: controversial new public citizen report reveals size, strength & connections of drug lobby. (Market Research Studies).(Brief Article)
August 31, 2002... WASHINGTON DC -- JUNE 13, 2002 -- In 2001, the drug industry's army of lobbyists outnumbered all 535 members of Congress, as pharmaceutical companies employed 623 different lobbyists, claims a new Public Citizen report based on newly available...

Drug companies are testing over 800 new medicines to better treat the elderly: Medicare prescription drug benefit becomes more important than ever before. (Market Research Studies).
August 31, 2002... WASHINGTON DC --JUNE 28, 2002--As momentum for enacting a Medicare prescription drug benefit grows in Congress, a new survey released today by the Pharmaceutical Research & Manufacturers of America (PhRMA) shows what the promise of drug...

Prescription antiviral drug market to top $14 bln by 2006: average annual growth rate of 8.4% will be generated by incidence & new products. (Market Research Studies).(Brief Article)
August 31, 2002... Business Communications Company, Inc. Norwalk CT Viruses are the smallest known genetic parasites, ranging in size from 20-300 nm. They are composed of generic material, DNA and RNA, and a capsule surrounding the generic material....

US generic prescription drug industry to hit $19 bln: average annual growth rate of 11.4% will be generated by respiratory & other markets. (Market Research Studies).(Brief Article)
August 31, 2002... Business Communications Company, Inc. Norwalk CT During the latter half of the 1990s, the generic drug industry was a relatively lackluster sector besieged by difficulties in gaining approval to market drugs facing patent expiration....

Establishment of prescription drug user fee rates for Fiscal Year 2003. (FDA Guidance).
August 31, 2002... [Federal Register: Aug. 2, 2002; Vol. 67, No. 149; pp. 50448-50451] SUMMARY: The FDA is announcing the rates for prescription drug user fees for fiscal year (FY) 2003. The Federal Food, Drug, and Cosmetic Act (the act), as amended most...

Pharmaceutical cGMPs for the 21st century: a risk-based approach. (Market Research Studies).(current Good Manufacturing Practice)
August 31, 2002... Aug. 21, 2002 US Food & Drug Administration Washington DC A science and risk-based approach to product quality regulation incorporating an integrated quality systems approach INTRODUCTION FDA oversees the quality of drug...

Direct final rule on presiding officers at regulatory hearings released by FDA: companion proposed rule on same subject also published (see page. 47 of BMN). (FDA Guidance).
August 31, 2002... [Federal Register: Aug. 15, 2002; Vol. 67, No. 158; pp. 53305-53306; 21 CFR Parts 5 & 16; Docket No. 02N-0251] SUMMARY: The FDA is amending its administrative regulations governing who may act as a presiding officer at a regulatory...

FDA proposed rule released on presiding officers at regulatory hearings. (FDA Guidance).
August 31, 2002... [Federal Register: Aug. 15, 2002; Vol. 67, No. 158; Proposed Rule; pp. 53324-53326; 21 CFR Parts 5 & 16; Docket No. 02N-0251] SUMMARY: The FDA is proposing to amend its administrative regulations governing who may act as a presiding...

Medical device recall authority: FDA information collection activities; proposed collection; comment request. (FDA Guidance).
August 31, 2002... ACTION: Notice. [Federal Register; Aug. 19, 2002; Vol. 67, No. 160; pp 53803-53805; Docket No. 02N-0355] DHHS Food & Drug Administration Washington DC SUMMARY: The FDA is announcing an opportunity for public comment on the...

Frequently asked questions on the recognition of consensus standards: guidance for industry & for FDA staff. (FDA Guidance).
August 31, 2002... July 22, 2002 This document supersedes "Guidance on Frequently Asked Questions on Recognition of Consensus Standards," issued June 20, 2001 U.S. Department of Health & Human Services Food & Drug Administration Center for Devices &...

FDA export certificates: guidance for industry. (FDA Guidance).
August 31, 2002... Aug. 8, 2002 (Condensed Version) I. Introduction This guidance document is intended to provide a general description of FDA Export Certificates to industry and foreign governments. Firms exporting products from the US are often...