Large Drug-makers Placing New Emphasis On Targeted Cancer Treatments.
Increasingly, large pharmaceutical companies are restructuring their business models so that they can collaborate with small biotech firms to develop medications which target small groups, rather than large populations. This move is influenced in part by a new emphasis on personalized medicine and the need for targeted therapies. For instance, Pfizer has partnered with Abbott Molecular to develop a treatment called crizotinib, which would only benefit four percent of lung cancer patients. Meanwhile, AstraZeneca is seeking FDA approval so that its drug Iressa [gefitinib] can be used to treat EGFR-positive lung cancer patients...
Experts Warn Absence Of Clinical Trials For Biosimilar Drugs Could Hurt Safety, Effectiveness.
Medical experts warned that the absence of mandatory clinical trials for biosimilar drugs could compromise their safety and effectiveness." That provision was "designed to get biosimilars – and the cost savings that accompany them – to the marketplace more quickly" by allowing FDA to base its approval, "in part, on the safety and efficacy record of the original breakthrough drug." The provision, however, is "vague," according to critics, and "leaves FDA with a great deal of leeway to okay those drugs – including the flexibility to decide whether clinical trials are necessary at all." The "difference in manufacturing processes" between companies "can alter the drugs 'in ways that technology can't detect.'" ...
Number Of HIV-Positive Patients Receiving Antiretroviral Drugs Increased By More Than A Quarter In 2009.
The number of HIV-positive people receiving antiretroviral drugs for their infections jumped by more than a quarter in 2009, growing from four million to 5.2 million, the World Health Organization disclosed at the International AIDS Conference in Vienna." The organization's Dr. Hiroki Nakatani said, "This is the largest increase in people accessing treatment in a single year." But "unfortunately, that still leaves 10 million who need therapy." ...
Bosentan May Not Improve Exercise Capacity In Patients With Systemic Sclerosis.
"Treatment with the endothelin receptor antagonist bosentan (Tracleer) failed to improve exercise capacity in patients with systemic sclerosis, a randomized trial found." James R. Seibold, MD, of the University of Connecticut in Farmington, and colleagues said that after one year of treatment, "there was a nonsignificant mean change in the six-minute walk test in the bosentan-treated patients (−12 meters) compared with the change in the placebo group (9 meters)." In addition, the study found bosentan "had no effect on time to death or worsening pulmonary function test scores." ...
Clinical Trials To Continue For Potential Hemophilia Drug.
"Biogen Idec Inc. and Swedish Orphan Biovitrum stated they will continue clinical testing of a potential hemophilia drug based on promising results from an early trial." The companies "are testing a form of a protein called factor VIII," which "is involved in the formation of blood clots, and people with hemophilia A have little or none of it." Biogen and Biovitrum also "said that in an early study on 16 patients, their drug was safe and had 'a prolonged half-life' compared an older drug, Advate." ...
Vaccine May Help Shrink The Most Deadly Cancers.
"An injection to help kill off the most deadly cancers...has been created by scientists" in the UK. The "Middlesex University vaccine capitalizes on the finding that some of the most vicious tumors produce a hormone normally only found in pregnancy," that is, human chorionic gonadotropin. In fact, "a form of hCG is...made by around half of bladder and pancreatic cancers," and "some breast, bowel, ovarian, and cervical tumors also pump it out." The vaccine, however, "which is being developed in conjunction with US firm Celldex Therapeutics, revs up the immune system, directing it to destroy hCG." This "shrinks tumors -- and, crucially, stops them from spreading, or metastasizing." ..
Increasingly, large pharmaceutical companies are restructuring their business models so that they can collaborate with small biotech firms to develop medications which target small groups, rather than large populations. This move is influenced in part by a new emphasis on personalized medicine and the need for targeted therapies. For instance, Pfizer has partnered with Abbott Molecular to develop a treatment called crizotinib, which would only benefit four percent of lung cancer patients. Meanwhile, AstraZeneca is seeking FDA approval so that its drug Iressa [gefitinib] can be used to treat EGFR-positive lung cancer patients...
Experts Warn Absence Of Clinical Trials For Biosimilar Drugs Could Hurt Safety, Effectiveness.
Medical experts warned that the absence of mandatory clinical trials for biosimilar drugs could compromise their safety and effectiveness." That provision was "designed to get biosimilars – and the cost savings that accompany them – to the marketplace more quickly" by allowing FDA to base its approval, "in part, on the safety and efficacy record of the original breakthrough drug." The provision, however, is "vague," according to critics, and "leaves FDA with a great deal of leeway to okay those drugs – including the flexibility to decide whether clinical trials are necessary at all." The "difference in manufacturing processes" between companies "can alter the drugs 'in ways that technology can't detect.'" ...
Number Of HIV-Positive Patients Receiving Antiretroviral Drugs Increased By More Than A Quarter In 2009.
The number of HIV-positive people receiving antiretroviral drugs for their infections jumped by more than a quarter in 2009, growing from four million to 5.2 million, the World Health Organization disclosed at the International AIDS Conference in Vienna." The organization's Dr. Hiroki Nakatani said, "This is the largest increase in people accessing treatment in a single year." But "unfortunately, that still leaves 10 million who need therapy." ...
Bosentan May Not Improve Exercise Capacity In Patients With Systemic Sclerosis.
"Treatment with the endothelin receptor antagonist bosentan (Tracleer) failed to improve exercise capacity in patients with systemic sclerosis, a randomized trial found." James R. Seibold, MD, of the University of Connecticut in Farmington, and colleagues said that after one year of treatment, "there was a nonsignificant mean change in the six-minute walk test in the bosentan-treated patients (−12 meters) compared with the change in the placebo group (9 meters)." In addition, the study found bosentan "had no effect on time to death or worsening pulmonary function test scores." ...
Clinical Trials To Continue For Potential Hemophilia Drug.
"Biogen Idec Inc. and Swedish Orphan Biovitrum stated they will continue clinical testing of a potential hemophilia drug based on promising results from an early trial." The companies "are testing a form of a protein called factor VIII," which "is involved in the formation of blood clots, and people with hemophilia A have little or none of it." Biogen and Biovitrum also "said that in an early study on 16 patients, their drug was safe and had 'a prolonged half-life' compared an older drug, Advate." ...
Vaccine May Help Shrink The Most Deadly Cancers.
"An injection to help kill off the most deadly cancers...has been created by scientists" in the UK. The "Middlesex University vaccine capitalizes on the finding that some of the most vicious tumors produce a hormone normally only found in pregnancy," that is, human chorionic gonadotropin. In fact, "a form of hCG is...made by around half of bladder and pancreatic cancers," and "some breast, bowel, ovarian, and cervical tumors also pump it out." The vaccine, however, "which is being developed in conjunction with US firm Celldex Therapeutics, revs up the immune system, directing it to destroy hCG." This "shrinks tumors -- and, crucially, stops them from spreading, or metastasizing." ..
