Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data.
Antiretroviral Therapy Treatment May Reduce Perinatal AIDS Transmission.
According to studies published June 17 in the New England Journal of Medicine, "AIDS transmission to babies was blocked in 99 percent of cases when breastfeeding mothers infected with the HIV virus took triple-drug combinations." In fact, one study in Botswana of 730 pregnant women with HIV found that "virus transmission fell to 1.1 percent when mothers were assigned to one of three combination regimens initiated before birth and continued through six months of pregnancy." But, "without the drugs, the infection rate would be at least 25 percent."
The second study, which took place in Malawi, "found that giving babies an antiretroviral drug once a day during their first six months of life reduced the transmission rate to 1.7 percent." Researchers came to that conclusion after giving 2,369 "HIV-positive mothers...either antiretrovirals after delivery and while breast-feeding, or" instructing them "to give their babies a single vial of the drug nevirapine daily." Meanwhile, "infants in a third control group received a single dose of nevirapine and seven days of two other antiretroviral drugs."
According to accompanying editorial "debate over which regimen is best 'should not be used to justify inaction.'" Rather, "the choice of regimen is secondary to identifying, caring for, and treating HIV-positive women and their infants."
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aTKRE8oVsUVg
http://consumer.healthday.com/Article.asp?AID=640176
http://content.nejm.org/cgi/content/full/362/24/2271
http://www.medpagetoday.com/HIVAIDS/HIVAIDS/20717
Experimental Colon Cancer Treatment Fails To Meet Goal In Midstage Study.
A potential colon cancer treatment failed to meet its goal in a midstage study." The research "was conducted by Curis' partner Roche and that company's Genentech unit." A drug, a so-called hedgehog-pathway inhibitor, combined with the Avastin [bevacizumab] tumor drug and chemotherapy didn't keep the disease at bay or extend lives of patients compared with those given standard treatment." This "study of 199 patients was the biggest yet for the hedgehog treatment," known as GDC-0449.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aJxiB1BIwgUM
http://www.forbes.com/feeds/ap/2010/06/16/business-health-care-us-curis-mover_7694092.html
http://www.reuters.com/article/idUSSGE65F0G020100616
After 12 Months, Aspirin OK Without Plavix For Patients With Stents.Giving aspirin alone to patients who have had stents implanted seems just as good as giving aspirin along with the blood thinner Plavix [clopidogrel]," according to a study presented at the American College of Cardiology annual meeting. Researchers discovered that, after an initial year receiving the dual anti-clotting therapy, patients who went off Plavix and just took aspirin had the same rate of heart attacks and death as those patients continuing on the two drugs together. Dr. Gurpreet Sandhu, an interventional cardiologist with the Mayo Clinic, cited ACC guidelines, saying, "In general, this fits with current guidelines, so it's not going to be practice-changing, per se."
Investigational Implantable Sensor May Reduce Risk Of Hospitalizations For Heart Failure.
A study being called the start of a revolution in the management of heart failure." Among heart failure patients with moderate to severe disease, six months of monitoring with an investigational implantable sensor that measures pulmonary artery pressure was associated with a 30% relative risk reduction in hospitalizations for heart failure," according to the research, presented at the Heart Failure Congress. Investigators found that, "after six months there were 83 hospitalizations for heart failure among the 270 patients randomized to treatment guided by hemodynamic measurements from the CardioMems Heart Sensor, compared with 120 heart failure hospitalizations in the 280-patient control arm." One of the researchers "said the data suggests that using the pulmonary monitoring device to guide treatment in just eight heart failure patients for six months would result in one less hospitalization for heart failure."
FDA Seeks More Information On Inhaled Insulin Drug.
MannKind Corp.allegedly "failed to win approval from US regulators to market its inhaled insulin drug, Afrezza, for people with diabetes." The FDA "asked for more information about the medication and the inhaler patients will use, MannKind said today in a statement," and although the agency "didn't cite any safety concerns, they requested updated safety data." The FDA questioned whether the inhaler used in clinical trials was similar to another one the company created and wants to market with Afrezza.
Related links-
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm215515.htm http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm216214.htm http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm216218.htm http://www.medscape.com/viewarticle/723988
Do you have questions for the author?
Antiretroviral Therapy Treatment May Reduce Perinatal AIDS Transmission.
According to studies published June 17 in the New England Journal of Medicine, "AIDS transmission to babies was blocked in 99 percent of cases when breastfeeding mothers infected with the HIV virus took triple-drug combinations." In fact, one study in Botswana of 730 pregnant women with HIV found that "virus transmission fell to 1.1 percent when mothers were assigned to one of three combination regimens initiated before birth and continued through six months of pregnancy." But, "without the drugs, the infection rate would be at least 25 percent."
The second study, which took place in Malawi, "found that giving babies an antiretroviral drug once a day during their first six months of life reduced the transmission rate to 1.7 percent." Researchers came to that conclusion after giving 2,369 "HIV-positive mothers...either antiretrovirals after delivery and while breast-feeding, or" instructing them "to give their babies a single vial of the drug nevirapine daily." Meanwhile, "infants in a third control group received a single dose of nevirapine and seven days of two other antiretroviral drugs."
According to accompanying editorial "debate over which regimen is best 'should not be used to justify inaction.'" Rather, "the choice of regimen is secondary to identifying, caring for, and treating HIV-positive women and their infants."
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aTKRE8oVsUVg
http://consumer.healthday.com/Article.asp?AID=640176
http://content.nejm.org/cgi/content/full/362/24/2271
http://www.medpagetoday.com/HIVAIDS/HIVAIDS/20717
Experimental Colon Cancer Treatment Fails To Meet Goal In Midstage Study.
A potential colon cancer treatment failed to meet its goal in a midstage study." The research "was conducted by Curis' partner Roche and that company's Genentech unit." A drug, a so-called hedgehog-pathway inhibitor, combined with the Avastin [bevacizumab] tumor drug and chemotherapy didn't keep the disease at bay or extend lives of patients compared with those given standard treatment." This "study of 199 patients was the biggest yet for the hedgehog treatment," known as GDC-0449.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aJxiB1BIwgUM
http://www.forbes.com/feeds/ap/2010/06/16/business-health-care-us-curis-mover_7694092.html
http://www.reuters.com/article/idUSSGE65F0G020100616
After 12 Months, Aspirin OK Without Plavix For Patients With Stents.Giving aspirin alone to patients who have had stents implanted seems just as good as giving aspirin along with the blood thinner Plavix [clopidogrel]," according to a study presented at the American College of Cardiology annual meeting. Researchers discovered that, after an initial year receiving the dual anti-clotting therapy, patients who went off Plavix and just took aspirin had the same rate of heart attacks and death as those patients continuing on the two drugs together. Dr. Gurpreet Sandhu, an interventional cardiologist with the Mayo Clinic, cited ACC guidelines, saying, "In general, this fits with current guidelines, so it's not going to be practice-changing, per se."
Investigational Implantable Sensor May Reduce Risk Of Hospitalizations For Heart Failure.
A study being called the start of a revolution in the management of heart failure." Among heart failure patients with moderate to severe disease, six months of monitoring with an investigational implantable sensor that measures pulmonary artery pressure was associated with a 30% relative risk reduction in hospitalizations for heart failure," according to the research, presented at the Heart Failure Congress. Investigators found that, "after six months there were 83 hospitalizations for heart failure among the 270 patients randomized to treatment guided by hemodynamic measurements from the CardioMems Heart Sensor, compared with 120 heart failure hospitalizations in the 280-patient control arm." One of the researchers "said the data suggests that using the pulmonary monitoring device to guide treatment in just eight heart failure patients for six months would result in one less hospitalization for heart failure."
FDA Seeks More Information On Inhaled Insulin Drug.
MannKind Corp.allegedly "failed to win approval from US regulators to market its inhaled insulin drug, Afrezza, for people with diabetes." The FDA "asked for more information about the medication and the inhaler patients will use, MannKind said today in a statement," and although the agency "didn't cite any safety concerns, they requested updated safety data." The FDA questioned whether the inhaler used in clinical trials was similar to another one the company created and wants to market with Afrezza.
Related links-
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm215515.htm http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm216214.htm http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm216218.htm http://www.medscape.com/viewarticle/723988
Do you have questions for the author?
