Here are some highlights from current pharma and clinical research news, views and data-
Experimental Prostate Cancer Drug Combined With Prednisone/Prednisolone Appears To Reduce Mortality Risk.
Bloomberg News reported, "Sanofi-Aventis SA said new data from the late-stage Tropic trial showed that the experimental prostate cancer medicine cabazitaxel combined with prednisone/prednisolone reduced the risk of death by 28 percent, in an emailed statement today."
In fact, the combo treatment improved survival by an average of 15.1 months, compared to the 12.7 months in patients administered mitoxantrone with prednisone/prednisolone. At present, the drug is undergoing a priority review by the FDA, which should be completed by the third quarter. Notably, the results are expected to be presented during the American Society of Clinical Oncology meeting.
Drug-maker Proposing Shortened Research Path For Cholesterol Drug.
Bloomberg News reported that Karo Bio AB, "a Swedish pharmaceutical company with no products on the market," is currently "hatching a drug-testing shortcut to catapult its experimental cholesterol pill," called eprotirome, "into a potential $1.3 billion-a-year seller." Being that "eprotirome works in a novel fashion, regulators such as the US Food and Drug Administration require patient testing that can take at least five years and cost more than $500 million -- time and money Karo doesn't have." Steven Nissen, head of cardiology at the Cleveland Clinic, "and Karo are proposing a shortened research path, one based on requirements the FDA imposed a year ago on diabetes drugs."
FDA Warned At Least 43 Drug Plants In Recent Months Over Manufacturing Practices.
USA Today reported that, "At least 43 drug factories supplying medication to thousands of US consumers have received government warnings in recent months for failing to correct shoddy manufacturing practices that may have exposed patients to health risks, a USA TODAY review of records shows." The violations "include plants using equipment and ingredients contaminated with bacteria or insects, failing to do proper testing to ensure drug strength and purity, and ignoring consumer complaints that products were making them sick." From 2002 to 2006, "more than half of inspections at domestic drug plants and 62% at foreign plants supplying the US had violations that didn't prompt warning letters, but were classified as requiring correction, FDA data published by the Government Accountability Office show. The FDA allegedly declined to provide more recent numbers."
Lamotrigine May Be Most Effective Antiepileptic Drug For Older Adults.
Medscape reported, "Lamotrigine is the most effective antiepileptic drug (AED) in older adults with epilepsy, with levetiracetam a close second, according to the results of a retrospective review of 10 AEDs reported in the April issue of the Archives of Neurology." The study compared "the effectiveness of AEDs in older adults with epilepsy seen at Columbia University, using a study sample of 417 outpatients at least 55 years old," and found that "lamotrigine had the highest 12-month retention rate (79%), which was significantly higher than the 12-month retention rate for carbamazepine (48%), gabapentin (59%)" and levetiracetam (73%).
Investigational Drug May Suppress Appetite, Lower Blood Pressure.
WebMD reported that "an experimental weight loss/blood pressure pill may pack a one-two punch against hunger and high blood pressure...according to new research presented at the American Society of Hypertension's 25th annual meeting in New York." The pill, called "Qnexa, combines the appetite suppressant phentermine with the anti-seizure drug topiramate in a unique formulation." Later this year, "data on this drug are slated to be reviewed...by an FDA advisory panel." Further, the highest dose of the drug combination induced a 'substantial' weight loss of 10% after one year and resulted in significant drops in systolic blood pressure.
Shingles Vaccine Appears To Be Well-Tolerated, But Not Widely Used.
MedPage Today reported, "The vaccine against shingles, already shown to be effective, is both safe and well-tolerated, researchers" at the Veterans Affairs New York Harbor Healthcare System "found after following more than 38,000 participants in the randomized trial that led to the 2006 approval of the vaccine." Meanwhile, after surveying some "600 internists and family medicine physicians," the authors of a second paper appearing in the Annals of Internal Medicine discovered that "few people are getting the vaccine, and for a variety of reasons -- including its cost." But, the "cost of treating postherpetic neuralgia is far more," a physician who was not involved with the study said.
Vitamin A May Improve Response To Standard HCV Treatment.
MedPage Today reported, "Early and sustained virologic responses to standard treatment for hepatitis C virus (HCV) infection were markedly improved when patients also received high doses of vitamin A," according to a Japanese study that included 42 participants. "After 48 weeks of treatment with standard doses of pegylated interferon-alpha2b, ribavirin (Rebetol), and 30,000 IU/day of vitamin A, 61.7% of patients had achieved sustained virologic responses, compared with 42.9% of patients taking only the standard therapies without the vitamin." Notably, the "recommended daily intake of vitamin A in the US ranges from 2,310 to 3,000 IU/day for adults," but the researchers pointed out that the "very high" doses administered during their trial had "no adverse effects."
Experimental Prostate Cancer Drug Combined With Prednisone/Prednisolone Appears To Reduce Mortality Risk.
Bloomberg News reported, "Sanofi-Aventis SA said new data from the late-stage Tropic trial showed that the experimental prostate cancer medicine cabazitaxel combined with prednisone/prednisolone reduced the risk of death by 28 percent, in an emailed statement today."
In fact, the combo treatment improved survival by an average of 15.1 months, compared to the 12.7 months in patients administered mitoxantrone with prednisone/prednisolone. At present, the drug is undergoing a priority review by the FDA, which should be completed by the third quarter. Notably, the results are expected to be presented during the American Society of Clinical Oncology meeting.
Drug-maker Proposing Shortened Research Path For Cholesterol Drug.
Bloomberg News reported that Karo Bio AB, "a Swedish pharmaceutical company with no products on the market," is currently "hatching a drug-testing shortcut to catapult its experimental cholesterol pill," called eprotirome, "into a potential $1.3 billion-a-year seller." Being that "eprotirome works in a novel fashion, regulators such as the US Food and Drug Administration require patient testing that can take at least five years and cost more than $500 million -- time and money Karo doesn't have." Steven Nissen, head of cardiology at the Cleveland Clinic, "and Karo are proposing a shortened research path, one based on requirements the FDA imposed a year ago on diabetes drugs."
FDA Warned At Least 43 Drug Plants In Recent Months Over Manufacturing Practices.
USA Today reported that, "At least 43 drug factories supplying medication to thousands of US consumers have received government warnings in recent months for failing to correct shoddy manufacturing practices that may have exposed patients to health risks, a USA TODAY review of records shows." The violations "include plants using equipment and ingredients contaminated with bacteria or insects, failing to do proper testing to ensure drug strength and purity, and ignoring consumer complaints that products were making them sick." From 2002 to 2006, "more than half of inspections at domestic drug plants and 62% at foreign plants supplying the US had violations that didn't prompt warning letters, but were classified as requiring correction, FDA data published by the Government Accountability Office show. The FDA allegedly declined to provide more recent numbers."
Lamotrigine May Be Most Effective Antiepileptic Drug For Older Adults.
Medscape reported, "Lamotrigine is the most effective antiepileptic drug (AED) in older adults with epilepsy, with levetiracetam a close second, according to the results of a retrospective review of 10 AEDs reported in the April issue of the Archives of Neurology." The study compared "the effectiveness of AEDs in older adults with epilepsy seen at Columbia University, using a study sample of 417 outpatients at least 55 years old," and found that "lamotrigine had the highest 12-month retention rate (79%), which was significantly higher than the 12-month retention rate for carbamazepine (48%), gabapentin (59%)" and levetiracetam (73%).
Investigational Drug May Suppress Appetite, Lower Blood Pressure.
WebMD reported that "an experimental weight loss/blood pressure pill may pack a one-two punch against hunger and high blood pressure...according to new research presented at the American Society of Hypertension's 25th annual meeting in New York." The pill, called "Qnexa, combines the appetite suppressant phentermine with the anti-seizure drug topiramate in a unique formulation." Later this year, "data on this drug are slated to be reviewed...by an FDA advisory panel." Further, the highest dose of the drug combination induced a 'substantial' weight loss of 10% after one year and resulted in significant drops in systolic blood pressure.
Shingles Vaccine Appears To Be Well-Tolerated, But Not Widely Used.
MedPage Today reported, "The vaccine against shingles, already shown to be effective, is both safe and well-tolerated, researchers" at the Veterans Affairs New York Harbor Healthcare System "found after following more than 38,000 participants in the randomized trial that led to the 2006 approval of the vaccine." Meanwhile, after surveying some "600 internists and family medicine physicians," the authors of a second paper appearing in the Annals of Internal Medicine discovered that "few people are getting the vaccine, and for a variety of reasons -- including its cost." But, the "cost of treating postherpetic neuralgia is far more," a physician who was not involved with the study said.
Vitamin A May Improve Response To Standard HCV Treatment.
MedPage Today reported, "Early and sustained virologic responses to standard treatment for hepatitis C virus (HCV) infection were markedly improved when patients also received high doses of vitamin A," according to a Japanese study that included 42 participants. "After 48 weeks of treatment with standard doses of pegylated interferon-alpha2b, ribavirin (Rebetol), and 30,000 IU/day of vitamin A, 61.7% of patients had achieved sustained virologic responses, compared with 42.9% of patients taking only the standard therapies without the vitamin." Notably, the "recommended daily intake of vitamin A in the US ranges from 2,310 to 3,000 IU/day for adults," but the researchers pointed out that the "very high" doses administered during their trial had "no adverse effects."
