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FDA approves new smallpox vaccination

The U.S. Food and Drug Administration (FDA) has approved Vaccinia Immune Globulin Intravenous (VIGIV) - the first intravenous human plasma-derived product available to treat certain rare complications of smallpox vaccination.

20 Feb 2005

FDA will create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues

In a recent meeting with employees, HHS Secretary Mike Leavitt shared an emboldened vision for the Food and Drug Administration (FDA) that included a new culture of openness, improved oversight and enhanced independence.

16 Feb 2005

Merck issues statement on Vioxx lawsuits

The federal Judicial Panel on Multidistrict Litigation today granted motions by several parties, including Merck, to transfer all Vioxx product liability lawsuits pending in federal courts nationwide into one consolidated Multidistrict Litigation (MDL) for coordinated pre-trial proceedings.

16 Feb 2005

New report detailing how animal experiments misled scientists on Vioxx

Tommorow, February 17, John J. Pippin, M.D., FA.C.C., will testify before Food and Drug Administration (FDA) officials and present a new report detailing how experiments on mice, dogs, and other animals misled scientists and ultimately contributed to a tragic outcome for human patients exposed to Vioxx and other drugs.

15 Feb 2005

Renovis announces investigational medicine for multiple sclerosis study

Renovis announced today the initiation of a Phase Ia clinical trial for REN-850, an investigational oral small molecule that is being targeted for the treatment of multiple sclerosis (MS).

14 Feb 2005

Merck may have known the overuse of mercury in their vaccines posed a dangerous health threat to children

A Los Angeles Times article today reports that Merck, a leading manufacturer of prescription drugs, knew the overuse of mercury in their vaccines posed a dangerous health threat to children.

8 Feb 2005

New advice about the use of Strattera (atomoxetine)

New advice to doctors and patients about the use of Strattera, (atomoxetine), was issued today by the Medicines and Healthcare products Regulatory Agency, (MHRA).

3 Feb 2005

Solbec announces pre-clinical study to confirm findings into the effect of Coramsine combined with CpG in the treatment of murine mesothelioma

Solbec Pharmaceuticals Ltd has announced the commencement of a pre-clinical study to confirm and extend the findings of an earlier investigation into the effect of Coramsine™ combined with CpG in the treatment of murine mesothelioma.

3 Feb 2005

Withdrawal of the commonly prescribed painkiller, co-proxamol

A phased withdrawal of the commonly prescribed painkiller, co-proxamol, has been announced by the Medicines and Healthcare products Regulatory Agency.

1 Feb 2005

Solutions to royalty stacking issues a top priority in pharmaceutical and biotechnology sectors

As new technologies are innovated in the pharmaceutical and biotechnology sectors, the number of fresh patents and related regulations is also on the rise.

31 Jan 2005

Clinical trials to test the safety of a first-of-its-kind human hookworm vaccine

Clinical trials to test the safety of a first-of-its-kind human hookworm vaccine will begin in the Washington, DC area in a couple of months after the U.S. Food and Drug Administration conferred investigational new drug status on the vaccine.

27 Jan 2005

Enbrel to treat rheumatoid arthritis approved in Japan

Wyeth K.K. and Takeda Pharmaceutical Company Limited (Takeda) have announced that Enbrel (etanercept) has been approved by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to existing therapies.

27 Jan 2005

$Phenoxodiol gets fast track status for its intended use in patients with hormone-refractory prostate cancer$

Phenoxodiol gets fast track status for its intended use in patients with hormone-refractory prostate cancer

Marshall Edwards today announced that the U.S. Food and Drug Administration (FDA) has granted the investigational anti-cancer drug, phenoxodiol, fast track status for its intended use in patients with hormone- refractory prostate cancer (HRPC).

26 Jan 2005

Tentative approval of co-packaged lamivudine/zidovudine fixed dose combination tablets and nevirapine tablets

The Food and Drug Administration (FDA) has announced the tentative approval of a co-packaged antiretroviral drug regimen manufactured by Aspen Pharmacare of South Africa for the treatment of HIV-1 infection in adults.

26 Jan 2005

Schering and Novartis agree on joint commercialization of novel cancer drug

Schering AG, Germany announced today that, following regulatory approvals, it will co-promote the novel oral angiogenesis inhibitor PTK787/ZK 222584 (PTK/ZK) for all oncology indications together with Novartis Pharma AG in Europe, North America and Japan. This agreement will enable both Schering and Novartis to maximize the compound's full potential.

25 Jan 2005

Monoclonal antibody therapeutics to fill vacuum left by ineffective conventional therapies

Currently, the limited efficacy of conventional therapies, especially in the case of several oncology and autoimmune and inflammatory disorders (AIID), is creating the need for safe and effective treatment alternatives.

25 Jan 2005

Launch date announced for Abraxane to treat metastatic breast cancer

American Pharmaceutical Partners announced today that February 8, 2005 is the launch date of Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). Abraxane will be marketed by the national sales force of Abraxis Oncology, APP's proprietary sales and marketing division.

25 Jan 2005

Vioxx withdrawal raises many questions concerning drug policy

Daniel H. Solomon, M.D., M.P.H., from Brigham and Women’s Hospital, Boston, and Jerry Avorn, M.D., of Harvard University School of Medicine, write in the January 24 issue of Archives of Internal Medicine that the withdrawal of rofecoxib (Vioxx) from the market in September 2004 by its manufacturer, Merck & Co., “raises many questions concerning drug policy, scientific evidence, and treatment alternatives.

24 Jan 2005

Phenoxodiol increases the effectiveness of Docetaxel by at least 100 times

The investigational anti- cancer drug, phenoxodiol, considerably enhances the ability of the drug, docetaxel (Taxotere(R), Sanofi-Aventis), to kill human ovarian cancer cells in the laboratory. The findings are reported in the current issue of Oncology Research.

24 Jan 2005

Orally ingested drug to help Type 2 diabetes sufferers

A new drug invented by Monash University researchers Paul Zimmet and Frank Ng could help Type 2 diabetes sufferers lower blood glucose levels and enhance the potency of insulin, with few side effects.

24 Jan 2005

Pharmaceutical News

FDA approves new smallpox vaccination

FDA will create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues

Merck issues statement on Vioxx lawsuits

New report detailing how animal experiments misled scientists on Vioxx

Renovis announces investigational medicine for multiple sclerosis study

Merck may have known the overuse of mercury in their vaccines posed a dangerous health threat to children

New advice about the use of Strattera (atomoxetine)

Solbec announces pre-clinical study to confirm findings into the effect of Coramsine combined with CpG in the treatment of murine mesothelioma

Withdrawal of the commonly prescribed painkiller, co-proxamol

Solutions to royalty stacking issues a top priority in pharmaceutical and biotechnology sectors

Clinical trials to test the safety of a first-of-its-kind human hookworm vaccine

Enbrel to treat rheumatoid arthritis approved in Japan

Phenoxodiol gets fast track status for its intended use in patients with hormone-refractory prostate cancer

Tentative approval of co-packaged lamivudine/zidovudine fixed dose combination tablets and nevirapine tablets

Schering and Novartis agree on joint commercialization of novel cancer drug

Monoclonal antibody therapeutics to fill vacuum left by ineffective conventional therapies

Launch date announced for Abraxane to treat metastatic breast cancer

Vioxx withdrawal raises many questions concerning drug policy

Phenoxodiol increases the effectiveness of Docetaxel by at least 100 times

Orally ingested drug to help Type 2 diabetes sufferers

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