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Treatment of chronic hepatitis C with interferon can be ineffective due to relapse

Treatment of chronic hepatitis C with interferon can be ineffective due to relapse. We aimed to reduce the 40% relapse rate of 6 months interferon–ribavirin combination therapy by prolonging treatment to 18 months.

4 Jul 2004

Generic fixed-dose combinations (FDCs) of antiretrovirals are a key factor in access to treatment of HIV/AIDS infection in the developing world

Combination therapy with three generic antiretroviral drugs in a single tablet has been validated for the first time in an open clinical study in a developing country. Follow-up of 60 patients treated in Yaoundé, Cameroon, has demonstrated the excellent efficacy and safety of a generic fixed-dose combination.

2 Jul 2004

U.S. drug prices rise by 3.4 percent during the first quarter of 2004, elderly especially hard hit

A new study released by AARP finds manufacturers' wholesale prices for the 197 brand name prescription drugs most frequently used by older Americans continued an upward climb.

1 Jul 2004

New drug application for cilansetron, an investigational product for the treatment of irritable bowel syndrome

Solvay Pharmaceuticals, Inc. has submitted a New Drug Application (NDA) for cilansetron, an investigational product being studied for the treatment of irritable bowel syndrome with diarrhea predominance (IBS-D), to the FDA on June 30, 2004.

1 Jul 2004

New drug application for regulatory approval of exenatide for the treatment of type 2 diabetes

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for regulatory approval of exenatide.

1 Jul 2004

Request for further evidence about the risks and benefits of the painkiller co-proxamol

The MHRA today issued a request for any further evidence about the risks and benefits of the painkiller co-proxamol, as part of an ongoing review being carried out by Committee on the Safety of Medicines (CSM).

30 Jun 2004

Alcon updates filing status of RETAANE® new drug application

Alcon, Inc. has announced that it has filed the second portion of its “rolling” New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for RETAANE® 15mg (anecortave acetate for depot suspension)

30 Jun 2004

Oxford Therapeutic Antibody Centre receives Manufacturer’s Authorisation

Oxford University's Therapeutic Antibody Centre (TAC) has received a Manufacturer's Authorisation (Investigational Medicinal Products) from the Medicines and Healthcare Products Regulatory Agency (MHRA).

29 Jun 2004

Treatment with Strattera makes children with ADHD fall asleep faster

Twice daily treatment with Strattera® (atomoxetine HCl), approved for the treatment of attention-deficit/hyperactivity disorder (ADHD), showed children with ADHD fell asleep faster compared to three-times daily treatment with methylphenidate

29 Jun 2004

Duloxetine reduces stress urinary incontinence and improves quality of life for women

Data presented today at the 3rd International Consultation on Incontinence, provide evidence for the efficacy of duloxetine, an investigational agent for the treatment of women with stress urinary incontinence (SUI).

29 Jun 2004

Exelixis files new drug application for a proprietary novel anticancer compound

Exelixis, Inc. has submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) for XL999, a proprietary novel anticancer compound.

29 Jun 2004

FDA finds gepirone ER “not approvable” as a treatment for Major Depressive Disorder

The U.S. Food and Drug Administration has determined that Organon’s gepirone ER New Drug Application is “not approvable.”

25 Jun 2004

47.2% of the estimated $16.0 billion spent on prescribed drugs in Canada was financed by the public sector in 2003

A new report released today by the Canadian Institute for Health Information (CIHI) shows that 47.2% of the estimated $16.0 billion spent on prescribed drugs in Canada was financed by the public sector in 2003.

24 Jun 2004

A new single pill is available for treating both high blood pressure and high cholesterol

Caduet, which was recently approved by the FDA, is the first medication that treats high blood pressure and high cholesterol in one pill.

24 Jun 2004

Possible association between the cholesterol lowering drug Crestor, and a serious condition called rhabdomyolysis

Health Canada is advising Canadians about a possible association between the cholesterol lowering drug Crestor®, and a serious condition called rhabdomyolysis.

23 Jun 2004

European marketing approval for new influenza vaccine

Solvay Pharmaceuticals announced today that it has obtained European marketing approval for its new virosomal influenza vaccine: INVIVAC®.

23 Jun 2004

Drug companies spend about 37% of their overall R&D budgets on clinical affairs

Over the last decade, clinical services industry growth has exploded. Today, study sponsors dedicate significant portions of their budgets to CROs, SMOs and patient recruiters to access the expertise needed to speed trials to safe and successful fruition.

23 Jun 2004

FDA to be sued by Mylan Laboratories

Mylan Laboratories Inc. today announced that it is filing suit against the Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia

23 Jun 2004

European Commission has approved the use of Herceptin® (trastuzumab) in combination with Taxotere®

The approval is based on study results which showed that for women with HER2-positive breast cancer, the combination of Herceptin and Taxotere significantly improved median life expectancy by more than one-third (31 months with Herceptin plus Taxotere vs. 22 months for Taxotere alone).

23 Jun 2004

Paclitaxel analog kills more cancer cells than natural product

Paclitaxel, a natural compound from yew trees, is the world's best-selling anticancer drug. Several analogs are in clinical trial, with others in preclinical development. One problem that paclitaxel and all its analogs share, however, is that they are all highly complex compounds, and cannot be prepared synthetically in a commercially viable way.

21 Jun 2004

Pharmaceutical News

Treatment of chronic hepatitis C with interferon can be ineffective due to relapse

Generic fixed-dose combinations (FDCs) of antiretrovirals are a key factor in access to treatment of HIV/AIDS infection in the developing world

U.S. drug prices rise by 3.4 percent during the first quarter of 2004, elderly especially hard hit

New drug application for cilansetron, an investigational product for the treatment of irritable bowel syndrome

New drug application for regulatory approval of exenatide for the treatment of type 2 diabetes

Request for further evidence about the risks and benefits of the painkiller co-proxamol

Alcon updates filing status of RETAANE® new drug application

Oxford Therapeutic Antibody Centre receives Manufacturer’s Authorisation

Treatment with Strattera makes children with ADHD fall asleep faster

Duloxetine reduces stress urinary incontinence and improves quality of life for women

Exelixis files new drug application for a proprietary novel anticancer compound

FDA finds gepirone ER “not approvable” as a treatment for Major Depressive Disorder

47.2% of the estimated $16.0 billion spent on prescribed drugs in Canada was financed by the public sector in 2003

A new single pill is available for treating both high blood pressure and high cholesterol

Possible association between the cholesterol lowering drug Crestor, and a serious condition called rhabdomyolysis

European marketing approval for new influenza vaccine

Drug companies spend about 37% of their overall R&D budgets on clinical affairs

FDA to be sued by Mylan Laboratories

European Commission has approved the use of Herceptin® (trastuzumab) in combination with Taxotere®

Paclitaxel analog kills more cancer cells than natural product

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