Drug News
China denies cover-up of drug linked to 6 deaths
|
|
China has denied covering up reports of adverse reactions linked to a banned antibiotic treatment, newspapers reported on Wednesday.
Beijing last week banned the use of Clindamycin Phosphate Glucose Injection, produced by a company in the eastern province of Anhui for treatment of bacterial infections and linked to at least six deaths and severe reactions in more than 80 patients.
The first notice of an adverse reaction to the drug was posted on the State Food and Drug Administration (SFDA) Web site on July 27, the Beijing News said, but an emergency report banning the drug was not released until August 3.
Barr CEO says amending Plan B drug bid
|
|
Barr Pharmaceuticals Inc. will amend its plans to limit nonprescription sales of its morning-after contraceptive by age, but cannot be held responsible if pharmacists disregard the restrictions, Chief Executive Bruce Downey said on Wednesday.
Downey said the drugmaker would incorporate ideas from the U.S. Food and Drug Administration, which has said the Plan B drug could be made available without a doctor’s note for women at least 18 years old if kept behind pharmacy counters.
The FDA said Barr, in order to win agency clearance, must come up with a rigorous plan for making sure younger girls cannot buy the product without a prescription.
Experimental drug trial victim has cancer
|
|
One of the men who suffered severe reactions to an experimental drug during a drug trial in London, UK, says he now has cancer.
The trial of TGN 1412, designed to treat chronic inflammatory conditions and leukaemia, was conducted on behalf of German firm TeGenero by contract research firm Parexel.
New Zealand born David Oakley who suffered organ failure and pronounced swelling, was one of six men who became seriously ill following trials of the drug and now has the early signs of cancer.
You know anybody who needs an “anti-stupid” pill?
|
|
A German scientist has been testing an “anti-stupidity” pill with encouraging results on mice and fruit flies, Bild newspaper reported Saturday.
It said Hans-Hilger Ropers, director at Max-Planck-Institute for Molecular Genetics in Berlin, has tested a pill thwarting hyperactivity in certain brain nerve cells, helping stabilize short-term memory and improve attentiveness.
States petition US FDA on generic insulin, hormone
|
|
Four governors, looking to ease drug costs under state programs, petitioned the U.S. Food and Drug Administration on Thursday to provide guidelines for generic versions of insulin and human growth hormone.
The FDA has been developing regulatory advice for companies who want to make cheaper copycat versions of the injectable drugs since 2001, but recently delayed issuing final guidelines.
In their petition, the governors joined other critics in accusing the agency of dragging its feet.
Radiation may offer better way to make vaccines
|
|
Vaccines made with bacteria killed by gamma rays may be more effective than those made using standard heat or chemical inactivation, U.S. government researchers said on Wednesday.
Such vaccines do not have to be kept cold, the team at the University of California, San Diego, School of Medicine reported in the journal Immunity.
Dr. Sandip Datta and colleagues made a vaccine from Listeria monocytogenes bacteria, a common cause of food poisoning.
Annan pushes AIDS drug makers to lower prices
|
|
U.N. Secretary-General Kofi Annan encouraged executives from nine drug companies on Monday to lower prices of AIDS medicines and step up efforts to develop AIDS drugs and diagnostics for children.
Annan for the first time included generic drug makers in his latest in a series of meetings with top drug makers at U.N. headquarters over the past five years.
The meetings aim to encourage the pharmaceutical firms to broaden access to AIDS drugs, care and support services in low- and middle-income countries.
Australia scientists work on anti-Alzheimer’s pill
|
|
Australian mental health researchers have developed a once-a-day pill they believe might stop or slow the onset of Alzheimer’s disease, with human trials expected within two months.
A 15-month trial on mice showed the drug called PBT2 reduced the amyloid protein, which many scientists believe causes Alzheimer’s, by 60 percent within 24 hours, said researchers at The Mental Health Research Institute of Victoria.
Institute director George Fink said on Monday the drug attacked one of the root causes of Alzheimer’s, a degenerative brain disease and the most common form of dementia, particularly in people over the age of 65.
Parents press China for answer to bad, fake drugs
|
|
Cradled in her mother’s arms, tiny Liang Jiayi stares blankly. Foam begins to flow from her mouth and her body suddenly goes into a spasm.
“She’s cramping,” her father Liang Yongli cries out as he and his wife massage the contorted limbs of the five-year-old.
Jiayi used to be lively and mischievous but everything changed when she was given a vaccine shot against Japanese encephalitis B in August 2003 in a government hospital near her home in Jiangmen, in China’s southern Guangdong province.
Patent issued for method to manufacture Immtech’s drug candidate compounds
|
|
Immtech Pharmaceuticals has announced that The United States Patent and Trademark Office issued a patent related to the manufacturing of Immtech’s drug candidate compounds.
Immtech has an exclusive, worldwide license under this patent, based on Immtech’s license agreement with the Company’s consortium of scientists. The patent, entitled “Process for the synthesis of bis-aryl diamidoxime compounds,” claims a method for making drug candidate compounds, such as Immtech’s pafuramidine maleate (DB289). The patent names scientists from both the University of North Carolina at Chapel Hill and Georgia State University as inventors.
First-in-class biologics poised to drive malignant melanoma drug market
|
|
Decision Resources, Inc., a research and advisory firm focusing on pharmaceutical and healthcare issues, finds that first-in-class targeted biologics will enter the malignant melanoma market during the next five years.
Their premium price and robust uptake (as a result of the current lack of efficacious therapies) will drive market expansion.
According to the new Pharmacor report entitled Malignant Melanoma, Medarex/Bristol-Myers Squibb’s ipilimumab and Pfizer’s ticilimumab will be the first monoclonal antibodies to launch for the treatment of malignant melanoma.
Antidepressants linked to suicide risk in elderly
|
|
The risk of suicide among older patients appears to be increased during the first month of therapy with selective serotonin reuptake inhibitor (SSRI) antidepressants, but this increased risk is fairly low, researchers in Canada report.
Dr. David N. Juurlink, of the Institute for Clinical Evaluative Sciences, Toronto, and colleagues examined coroner’s data, along with data on prescriptions, physician billing claims and hospitalization, for more than 1.2 million subjects who were at least 66 years of age between 1992 and 2000.
A total of 1138 individuals who suicide were identified and these individuals were closely matched to 4,552 subjects who served as comparison group, according to the team’s report in the American Journal of Psychiatry.
Parkinson’s patients stomach new drug better than conventional meds
|
|
Several studies conducted at Baylor College of Medicine (BCM) in Houston show that a new kind of orally disintegrating tablets provides improved symptom relief for patients with Parkinson’s disease. Results are reported in the journal Therapy.
A new form of the medication selegiline, used for years to manage motor complications in Parkinson’s patients, avoids first-pass metabolism and sidesteps compromises to its efficacy and tolerability. The drug is currently awaiting U.S. Food and Drug Administration approval for use as an adjunctive therapy to the drug levodopa in the management of the neurodegenerative disease.
“Although a variety of therapeutic options exist, there is a tremendous amount of unmet need in the treatment of Parkinson’s disease,” said co-author Dr. Joseph Jankovic, professor of neurology at BCM and director of the college’s Parkinson’s Disease Center and Movement Disorders Clinic.”
FDA approves Gardasil as a treatment for cervical cancer
|
|
Merck & Co. has announced that the U.S. Food and Drug Administration (FDA) approved Gardasil as a treatment for cervical cancer, vulvar and vaginal pre-cancers caused by HPV types 16 and 18 and to prevent low-grade and pre-cancerous lesions and genital warts caused by HPV types 6, 11, 16 and 18.
In the United States, approximately 10,000 women are diagnosed with cervical cancer every year, and an average of 10 women die each day from the disease.
The FDA has approved Gardasil for the prevention of cervical cancer; cervical pre-cancers, adenocarcinoma in situ and vaginal pre-cancers caused by HPV types 16 and 18. Gardasil is also approved for the prevention of genital warts and low-grade cervical lesions caused by HPV types 6, 11, 16 and 18. Gardasil is approved for 9- to 26-year-old girls and women.
Merck’s cervical cancer vaccine wins US approval
|
|
The first vaccine to prevent cervical cancer won U.S. approval on Thursday when health officials cleared a Merck & Co. Inc. vaccine to block a sexually transmitted infection that causes the deadly disease.
Public health experts called the Gardasil vaccine a major advance against a disease that kills about 300,000 women worldwide annually. Industry analysts said the product also should help revive the fortunes of struggling Merck with annual sales that could top $2 billion.
The vaccine blocks infection with certain types of the human papillomavirus (HPV), which causes genital warts and most cervical cancer.
