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Government should plough drug savings into Pharmaceutical Benefits Scheme (PBS)

Doctors and medicine-makers today called for an expected $280 million Pharmaceutical Benefits Scheme (PBS) windfall to be ploughed into bringing down the price of new cancer and HIV drugs.

9 Jan 2005

Trial of naproxen and celecoxib suspended

Use of study drugs in a large, federally funded Alzheimer prevention trial has been suspended following a decision by the study's leadership on Dec. 17, 2004.

9 Jan 2005

Abraxane, first in a new class of albumin-bound nanotechnology for the treatment of metastatic breast cancer

Abraxane (paclitaxel protein-bound particles for injectable suspension), a next generation taxane, and the first in a new class of albumin-bound nanotechnology, was approved for the treatment of metastatic breast cancer.

9 Jan 2005

FDA approves Abraxane for metastatic breast cancer

American Pharmaceutical Partners, Inc. and American Bioscience, Inc. (ABI) announced that the U.S. Food and Drug Administration (FDA) has approved Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in metastatic breast cancer.

9 Jan 2005

Fallout from Vioxx and Celebrex market recall challenges industry

The pharmaceutical and biotechnology industries face further marketing and sales challenges in 2005 as the fallout from the Vioxx and Celebrex market recall and warning make it increasingly challenging for companies across the industry to reach physicians and consumers with effective campaigns without the distractions of the unfavorable press these recent events have generated.

7 Jan 2005

FDA clearance to test influenza vaccine, Fluviral

ID Biomedical Corporation announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to begin immediate clinical testing of its influenza vaccine, Fluviral, in the United States under an Investigational New Drug application (IND).

7 Jan 2005

States to explore putting restrictions on AIDS drug Trizivir

AIDS Healthcare Foundation (AHF) has sent a letter dated October 20, 2004, to the heads of all state Medicaid programs asking them put in use treatment authorization request (TAR) procedures on GlaxoSmithKline's (GSK) fixed-dose combination AIDS drug, Trizivir, as a standalone regimen for treatment naïve patients.

6 Jan 2005

European approval of Cymbalta/Xeristar for treatment of major depressive episodes

Eli Lilly and Company and Boehringer Ingelheim announced today that Cymbalta/Xeristar (duloxetine hydrochloride)(+) has been granted marketing authorization by the European Commission for the treatment of major depressive episodes.

5 Jan 2005

Bush Administration pressures Canada to eliminate drug importation

The following news release is being issued by CIPA - Canadian mail-order drug importation may become illegal soon due to new regulations proposed by the Liberal Government. After quietly supporting the practice for four years, the Liberals made a conspicuous about face after President Bush's November visit to Canada.

4 Jan 2005

First new leukemia treatment approved specifically for children in more than a decade

Ash Stevens was approved to manufacture the bulk drug substance Clofarabine, the active ingredient in Genzyme Corp.'s Clolar (clofarabine) for the treatment of children with refractory or relapsed Acute Lymphoblastic Leukemia (ALL). This is the first new leukemia treatment approved specifically for children in more than a decade.

4 Jan 2005

The rise in over the counter drugs, why?

Switching of prescription drugs to over the counter availability is increasingly common, but what are the motives behind this trend, ask US researchers in this week's BMJ?

3 Jan 2005

Eli Lilly aware in the 1980s that fluoxetine had troubling side effects

The BMJ has turned over confidential drug company documents that went missing from a 10 year old murder case to the US Food and Drug Administration (FDA) for review.

3 Jan 2005

New painkiller was discovered in natural form in venomous snails in 1979

The natural form of Prialt – a new drug for severe pain approved this week by the U.S. Food and Drug Administration – was discovered at the University of Utah in 1979 by an incoming freshman studying toxins produced by cone snails.

30 Dec 2004

Information submitted via new drug applications could easily be made accessible to the public

A researcher at Oregon Health & Science University and the Portland Veterans Affairs Medical Center is calling upon the U.S. Food and Drug Administration (FDA) to share more information provided by pharmaceutical companies regarding their clinical drug trials.

28 Dec 2004

Lessons learned from troubles with COX-2 inhibitors

One of the nation’s leading cardiovascular medical researchers has issued a call for less aggressive direct-to-consumer advertising and better safety assurances of medications in a special article posted online by JAMA because of its relevance to the recent withdrawals and warning labels on the pain-relieving drugs known as COX-2 inhibitors.

28 Dec 2004

Update on world antimalarial drug supply

On 8 November, the World Health Organization (WHO) announced a shortfall of artemether + lumefantrine, an artemisinin-based combination therapy (ACT) used to treat malaria, for the period between November 2004 and March 2005

26 Dec 2004

Supply problem with the opiate painkiller, diamorphine

The UK Department of Health has advised the NHS that there is a supply problem with the opiate painkiller, diamorphine, and that stocks may rapidly reach a critical level in the next few weeks.

26 Dec 2004

FDA issues not approvable letter to Cellegy Pharmaceuticals

Cellegy Pharmaceuticals has announced receipt of a communication from the U.S. Food and Drug Administration in the form of a Not Approvable Letter for its product Cellegesic(TM) (nitroglycerin ointment).

26 Dec 2004

Public health advisory for the use of non-steroidal anti-inflammatory drug products

The Food and Drug Administration (FDA) has issued a Public Health Advisory summarizing the agency's recent recommendations concerning the use of non-steroidal anti-inflammatory drug products (NSAIDs), including those known as COX-2 selective agents.

23 Dec 2004

FDA approves Enablex for the treatment of overactive bladder

Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Enablex® (darifenacin) extended-release tablets (7.5mg and 15mg) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency.

22 Dec 2004