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Drug Surveillance System Needs To Be Fixed
The current drug surveillance system needs to be fixed, argues an editorial in this week's BMJ. The call follows a recent analysis of the diabetes drug rosiglitazone (Avandia) which raised serious questions about the drug's safety. Rosiglitazone was approved by the US Food and Drug Administration (FDA) in 1999 and by the European Medicines Agency (EMEA) in 2000.

2007-06-15 03:00

FDA Met With Pharmaceutical Industry 112 Times To Develop Prescription Drug User Fee Reauthorization Proposal
FDA officials over 15 months met 112 times with pharmaceutical industry representatives and only five times with consumer and patient advocacy groups to discuss the development of a proposal for legislation to reauthorize the Prescription Drug User Fee Act, according to data released on Monday by the House Appropriations Committee,

2007-06-14 19:00

ChemGenex Announces Publication Confirming Activity Of Ceflatonin In T315I-Positive CML
ChemGenex Pharmaceuticals Limited (ASX:CXS and NASDAQ:CXSP) has announced the publication of a report in the prestigious Nature publication Leukemia confirming the positive clinical activity of the company's lead compound, Ceflatonin® against Gleevec®-resistant, chronic myeloid leukemia (CML) associated with the T315I Bcr-Abl mutation.

2007-06-14 16:00

Federal Judge Tentatively Approves Settlement In Lawsuit Over Average Wholesale Prices For Prescription Drugs
U.S. District Judge Patti Saris this week awarded preliminary approval to a recently amended settlement that could reduce the price of thousands of prescription drugs and scheduled a fairness hearing on a final settlement for Nov. 14, the Wall Street Journal reports (Wisenberg Brin, Wall Street Journal, 6/9). In October 2006, publisher

2007-06-13 07:00

House Subcommittee Schedules Date To Consider Prescription Drug User Fee Act Bill
The House Energy and Commerce Health Subcommittee on June 14 plans to consider legislation to reauthorize the Prescription Drug User Fee Act and address FDA oversight of medication safety, CQ HealthBeat reports. In a memo, subcommittee Chair Frank Pallone (D-N.J.

2007-06-12 21:00

Federal Employee Program Contracts Awarded To Medco, CVS Caremark
Pharmacy benefits managers Medco Health Solutions and CVS Caremark on Wednesday announced that each had won part of a three-year government contract to provide prescription drug benefits to federal employees, retirees and dependents enrolled in the

2007-06-12 16:00

European Medicines Agency's Management Board Elects New Chair And Vice-chair
The European Medicines Agency's Management Board elected Pat O'Mahony, Chief Executive of the Irish Medicines Board, as new chair and Lisette Tiddens-Engwirda, Secretary-General of the Standing Committee of European Doctors (CPME), as vice-chair of the Board, with three-year mandates from 7 June 2007. Accepting his election, Pat O'Mahony said, "It is my ambition to do the very best during my mandate to make a difference for public and animal health in Europe.

2007-06-12 03:00

Elsevier's Inteleos Poised To Launch Integrating Technology For Drug Tracking And Analysis
Elsevier, a world-leading healthcare and scientific publisher, announced today, that it has renewed its agreement with AdvantTechnologies (aTi) paving the way for the launch of the Inteleos Universal IntegratorTM (UI) a revolutionary tool to integrate information on drug pipeline research from multiple sources.

2007-06-11 20:00

Thailand Will Continue With Plan To Issue Compulsory License For Abbott's Aluvia After Unsuccessful Talks, Health Ministry Says
The Thai Ministry of Public Health on Wednesday confirmed that it will continue with its plan to issue a compulsory license for Abbott Laboratories' antiretroviral Aluvia after the two sides could not reach a price agreement during recent negotiations, the

2007-06-10 15:00

Markup Date Delayed For Generic Biotechnology Drug Bill
The June 13 markup date for a Senate bill that would allow FDA to approve generic versions of biotechnology drugs has been pushed back a week, according to a spokesperson for Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.), CongressDaily reports (Edney, CongressDaily, 6/7). The bill (

2007-06-10 10:00

Drug Company Funding Of Drug Trials Greatly Influences Outcome
In head-to-head trials of two drugs, the one deemed better appears to depend largely on who is funding the study, according to an analysis of nearly 200 statin-drug comparisons carried out between 1999 and 2005.UCSF researchers examined 192 published results of trials comparing one cholesterol-lowering statin drug to another, or to a non-statin drug.Their findings found that two links stood out.

2007-06-10 06:00

Certified Pharmaceutical Industry Professional - ISPE-PCC Offers New Credential; First Exam Available In July
Enhanced credibility; peer respect and recognition; greater opportunities for professional advancement; and a competitive edge when job seeking, are some of the benefits that pharmaceutical manufacturing professionals can gain with certification as a Certified Pharmaceutical Industry ProfessionalSM (CPIPSM) made available through the ISPE Professional Certification Commission (ISPE-PCC).

2007-06-08 03:00

Baltimore Sun Examines Pharmaceutical Company Marketing Tactics For Medical School Students
The "common marketing tactic" of pharmaceutical companies holding promotional events and giving medical school students "food and trinkets" is drawing criticism for its potential to influence future medical decisions, the Baltimore Sun reports. Experts estimate that drug companies spend about $19 billion annually on marketing to physicians.

2007-06-07 15:00

FTC Calls On Supreme Court To Consider Exclusion Agreements
The Washington Post on Monday examined how "an intragovernmental dispute" between the Federal Trade Commission and the antitrust division of the

2007-06-07 13:00

FDA Lacks Personnel, Funding To Adequately Inspect Prescription Drug Imports, According To CongressDaily
FDA has insufficient personnel and funding to adequately inspect the safety and effectiveness of prescription drugs manufactured at foreign-owned firms and imported to the U.S., according to a CongressDaily investigation.

2007-06-07 10:00

Major New Study On Food Supplements In Europe Launched
At its 43rd Annual Meeting in Warsaw from 4 - 6 June 2007 the Association of the European Self-Medication Industry (AESGP) launched a major new study on the "Regulatory Framework for Food Supplements in Europe" covering the 27 European Union Member States and Iceland, Norway, Switzerland and Croatia. The study describes the legal requirements, regulatory practices and national particularities in the countries covered.

2007-06-07 03:00

Minnesota Physicians Continue To Receive Pharmaceutical Company Payments Despite Sanctions
The New York Times examined Minnesota state medical records showing that more than 100 physicians who had been cited for misconduct by the

2007-06-06 22:00

Manchester Researcher Wins Libyan Award
Abdul Gbaj, who is researching the pharmaceutical aspects of genetic and tumour sciences at the University's School of Pharmacy and Pharmaceutical Sciences, received his award from the Libyan Minister of Higher Education, Dr Akeel Hussain Akeel."When he told me I had won this award, I was very proud. There are 5,000 Libyan Masters and PhD students across the globe, 1,600 of them in the UK," Abdul said."I was very lucky to come to Manchester.

2007-06-05 22:00

Hawaii Prescription Drug Program Failing To Negotiate Discounts With Manufacturers
Hawaii's prescription drug discount program Hawaii Rx Plus, "continues to struggle, a victim of the state's inability to negotiate deeper discounts with drug makers," the Honolulu Advertiser reports.

2007-06-05 18:00

Mozambican Officials Call On Southern African Development Community To Create Regional Pharmaceutical Company For Antiretroviral Production
A five-member delegation from the Mozambican parliament at a meeting on Tuesday with Zimbabwe's secretary for health and child welfare called on Zimbabwe and the Southern African Development Community to create a regional pharmaceutical company to produce antiretroviral drugs, the Herald/AllAfrica.com reports.

2007-06-05 17:00

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