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Biovail files abbreviated new drug application for Fenofibrate tablets

Biovail Corporation today announced that the United States Food and Drug Administration (FDA) has accepted the Company's abbreviated new drug application (ANDA) for a generic formulation of 145mg and 48mg strengths of fenofibrate tablets (sold under the brand name Tricor by Abbott Laboratories).

3 Sep 2008

Concern raised again about heart drugs Zetia and Vytorin

The editors of the New England Journal of Medicine have raised concern regarding the cholesterol-lowering drugs Zetia and Vytorin.

3 Sep 2008

Spinifex secures major investment to develop pain drug

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced it has secured venture capital investment of A$12 million from GBS Venture Partners Limited, Brandon Capital Partners and Uniseed to fund the development of its pain management drug, EMA401.

2 Sep 2008

Economic pressures lead some uninsured to stop medications, cut doses

The Jackson Clarion-Ledger on Wednesday examined how some U.S. residents who cannot afford health insurance are reducing the amount of medications they take or cutting doses, as well as seeing the doctor less frequently, to save money.

1 Sep 2008

WSJ examines drugmakers' use of 'unbranded product advertising' to promote disease awareness, treatment options

The Wall Street Journal on Friday examined "unbranded product advertising" for brand-name drugs, which allow drugmakers to drive television viewers to Web sites promoting drugs without the requirement of listing the products' side effects in the TV advertisement.

1 Sep 2008

Antiangiogenic and anti-inflammatory drugs: are they safe?

Since Rofecoxib (Vioxx) was withdrawn from the worldwide market based on the safety findings of the Adenomatous Polyp Prevention on Vioxx (APPROVe) study, the uncertainty around the cardiovascular safety of NSAIDs and COX-2 inhibitors remains and leaves practitioners with difficult management decisions for the hundreds of millions of patients worldwide who continue to require pain-relieving therapy to maintain an acceptable quality of life.

1 Sep 2008

Medicare overpaid for prescription drugs with new generic versions because of delay in incorporating new prices into payment calculations

Medicare overpaid for irinotecan, a cancer drug sold by Pfizer under the name Campostar, by $6.5 million in March because of a delay in updating its pricing formula, according to a report released on Tuesday by the HHS Office of Inspector General, Bloomberg/Los Angeles Times reports.

29 Aug 2008

Infectious Disease Research Institute receives $6.3 million NIAID grant to study TB vaccine

Seattle's Infectious Disease Research Institute on Tuesday announced it has received a $6.3 million grant from NIH's National Institute of Allergy and Infectious Diseases to study a new tuberculosis vaccine, the Puget Sound Business Journal reports (Puget Sound Business Journal, 8/27).

29 Aug 2008

Barr receives U.S. approval for generic Razadyne tablets

Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., received final approval from the U.S. Food & Drug Administration (FDA) to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne (galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets. Barr intends to launch its generic Razadyne tablets product immediately.

28 Aug 2008

New beta-blocker for heart disease and angina

Researchers at The University of Nottingham have been awarded £2.8 million by the Wellcome Trust to develop a new drug that could ease the suffering of hundreds of thousands of heart disease patients who are unable to take beta-blockers.

28 Aug 2008

FDA grants IND for Davanat to treat breast cancer patient

Pro-Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of Davanat in combination with 5-FU to treat a breast cancer patient at the Brown Cancer Center in Louisville, Kentucky. Davanat also is being administered in Phase II clinical trials for first-line treatment of colorectal and biliary cancer patients.

28 Aug 2008

Thiazolidinediones - diabetes drugs carry significant cardiovascular risks

A class of oral drugs used to treat type 2 diabetes may significantly increase the risk of serious cardiovascular events, according to an editorial published online in Heart Wednesday by two Wake Forest University School of Medicine faculty members.

28 Aug 2008

Gleevec receives FDA priority review for gastrointestinal stromal tumors after surgery

Novartis has announced that Gleevec (imatinib mesylate) tablets, (known as Glivec (imatinib) outside the US, Canada and Israel), has been granted priority review status by the US Food and Drug Administration (FDA) as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumors (GIST).

27 Aug 2008

FDA grants CLIA waiver to American Bio Medica for drug test

American Bio Medica Corporation has announced today that the US Food and Drug Administration (FDA) has granted CLIA waived status to the Company's Rapid TOX point of collection drug test product line.

From Medica Corporation 27 Aug 2008

Drug Lucentis to save eyesight of thousands in the UK

The eyesight of thousands of people in the UK will be saved with a new drug available under the National Health Service.

27 Aug 2008

Stanford University to limit pharmaceutical industry financing of CME

Stanford University officials on Tuesday plan to announce a new policy under which pharmaceutical and medical device companies no longer will have the ability to select continuing medical education courses that they seek to finance for physicians at the university's School of Medicine, the New York Times reports.

26 Aug 2008

Stanford Medical School severely restricts industry funding of continuing education for physicians

The Stanford University School of Medicine will no longer accept support from pharmaceutical or device companies for specific programs in continuing medical education, as industry-directed funding may compromise the integrity of these education programs for practicing physicians, officials said.

26 Aug 2008

Lack of oversight by CMS to ensure private Medicare drug plans have anti-fraud programs in place 'risks significant use of funds,' according to GAO

CMS has not conducted audits to ensure that Medicare prescription drug plans have implemented programs to prevent fraud as required by law, a lack of oversight that "risks significant misuse of funds in this $39 billion program," according to a Government Accountability Office report scheduled for release on Monday, the AP/Orlando Sentinel reports. For the report, GAO examined five unnamed plans to determine whether they met requirements to participate in the Medicare prescription benefit.

26 Aug 2008

FDA issues new rules on product warning label updates for pharmaceuticals, medical devices

FDA last week issued new rules that aim to ensure medication warning labels provide clear and concise information to consumers, the AP/Denver Post reports.

26 Aug 2008

Galapagos acquires structure-based drug discovery from Sareum

Galapagos NV and Sareum Holdings plc has announced today that Galapagos has acquired Sareum's assets in drug discovery services, for a total cash consideration of EUR 695,000 (£553,000). These assets will position Galapagos' service division BioFocus DPI strongly in the growing field of structure-based drug discovery.

26 Aug 2008