Here are some highlights from current pharma and clinical research news, views and data.
FDA Approves Novel Asthma Treatment. USFDA recently approved the "first non-drug asthma treatment- Alair." According to the developer the procedure known as "bronchial thermoplasty" would "only be appropriate for about two million adults with severe asthma who don't get relief from existing drugs."
The device, delivers radiofrequency energy directly to the airways, heating and reducing the thickness of lung tissue and improving users' ability to breathe, the agency said in a news release. But, "to achieve the device's full benefit, users will require multiple sessions targeting different parts of the lungs." Notably, "as a condition of approval," the California-based manufacturer "must conduct additional studies to evaluate the product's long-term safety and effectiveness, the FDA said."
The initial 297-patient study "found patients treated with Alair experienced an average 32% reduction in asthma attacks, 84% reduction in emergency" department "visits for respiratory symptoms, 73% reduction in respiratory-related symptoms, and 66% reduction in time absent from daily activities due to asthma,"
Adverse effects of system treatment include asthma attacks, wheezing, chest tightness, chest pain, atelectasis, hemoptysis, anxiety, headaches, and nausea. Moreover, certain individuals should not use the device, and "those with an active respiratory infection, coagulopathy, asthma exacerbation, or change in corticosteroid regimen within 14 days of intended device installation should wait until the condition clears before undergoing treatment.
FDA Approves Mylan, Teva Flomax Generics. Mylan Inc. and Teva Pharmaceutical Industries Ltd. "reported lately that, they are started selling their own versions of Flomax [tamsulosin HCl], a drug that treats enlarged prostate, after getting approval from the Food and Drug Administration." In March, Impax Laboratories also "began selling an authorized generic" due to "an agreement with Boehringer Ingelheim, the company that developed the drug."
Cancer Risk After Kidney Transplant Similar From All Antirejection Drugs. According to a study published in the April 29 issue of the Journal of the American Society of Nephrology, "the type of drug treatment used to prevent organ rejection in kidney transplant patients doesn't affect cancer risk." Researchers arrived at this conclusion after examining "the incidence of cancer in 481 kidney transplant patients" who "had received one of three treatment regimens: azathioprine and prednisolone; cyclosporine monotherapy; or cyclosporine monotherapy followed by a switch to azathioprine and prednisolone after three months," and who were then followed for 20 years after transplant.
Obese Children May Metabolize Common Medications At Different Rates Than Leaner Children. According to a study presented at the Experimental Biology annual meeting, "children who are obese appear to metabolize common medications at different rates than their leaner counterparts." After "evaluating the metabolism of active ingredients found in an over-the-counter cough syrup and in a soft drink in 16 healthy-weight children and nine obese children," researchers found that "the obese children had slower rates of breakdown of the cough syrup and higher rates for the soft drink compared to the leaner children."
Risk For Low-Dose Aspirin-Associated Peptic Ulcer May Be Higher In Elderly Women. The risk for low-dose aspirin (LDA)-associated peptic ulcer is higher in elderly women," according to a study in the World Journal of Gastroenterology that included 453 patients who underwent esophagogastroduodenoscopy. They "continued taking LDA during the entire observation period," and LDA-associated peptic ulcer was eventually "diagnosed in 119 patients (87 men and 32 women)." In short, "compared with male patients, female patients had a significantly shorter time to diagnosis of LDA-associated peptic ulcer by endoscopy."
FDA Approves Novel Asthma Treatment. USFDA recently approved the "first non-drug asthma treatment- Alair." According to the developer the procedure known as "bronchial thermoplasty" would "only be appropriate for about two million adults with severe asthma who don't get relief from existing drugs."
The device, delivers radiofrequency energy directly to the airways, heating and reducing the thickness of lung tissue and improving users' ability to breathe, the agency said in a news release. But, "to achieve the device's full benefit, users will require multiple sessions targeting different parts of the lungs." Notably, "as a condition of approval," the California-based manufacturer "must conduct additional studies to evaluate the product's long-term safety and effectiveness, the FDA said."
The initial 297-patient study "found patients treated with Alair experienced an average 32% reduction in asthma attacks, 84% reduction in emergency" department "visits for respiratory symptoms, 73% reduction in respiratory-related symptoms, and 66% reduction in time absent from daily activities due to asthma,"
Adverse effects of system treatment include asthma attacks, wheezing, chest tightness, chest pain, atelectasis, hemoptysis, anxiety, headaches, and nausea. Moreover, certain individuals should not use the device, and "those with an active respiratory infection, coagulopathy, asthma exacerbation, or change in corticosteroid regimen within 14 days of intended device installation should wait until the condition clears before undergoing treatment.
FDA Approves Mylan, Teva Flomax Generics. Mylan Inc. and Teva Pharmaceutical Industries Ltd. "reported lately that, they are started selling their own versions of Flomax [tamsulosin HCl], a drug that treats enlarged prostate, after getting approval from the Food and Drug Administration." In March, Impax Laboratories also "began selling an authorized generic" due to "an agreement with Boehringer Ingelheim, the company that developed the drug."
Cancer Risk After Kidney Transplant Similar From All Antirejection Drugs. According to a study published in the April 29 issue of the Journal of the American Society of Nephrology, "the type of drug treatment used to prevent organ rejection in kidney transplant patients doesn't affect cancer risk." Researchers arrived at this conclusion after examining "the incidence of cancer in 481 kidney transplant patients" who "had received one of three treatment regimens: azathioprine and prednisolone; cyclosporine monotherapy; or cyclosporine monotherapy followed by a switch to azathioprine and prednisolone after three months," and who were then followed for 20 years after transplant.
Obese Children May Metabolize Common Medications At Different Rates Than Leaner Children. According to a study presented at the Experimental Biology annual meeting, "children who are obese appear to metabolize common medications at different rates than their leaner counterparts." After "evaluating the metabolism of active ingredients found in an over-the-counter cough syrup and in a soft drink in 16 healthy-weight children and nine obese children," researchers found that "the obese children had slower rates of breakdown of the cough syrup and higher rates for the soft drink compared to the leaner children."
Risk For Low-Dose Aspirin-Associated Peptic Ulcer May Be Higher In Elderly Women. The risk for low-dose aspirin (LDA)-associated peptic ulcer is higher in elderly women," according to a study in the World Journal of Gastroenterology that included 453 patients who underwent esophagogastroduodenoscopy. They "continued taking LDA during the entire observation period," and LDA-associated peptic ulcer was eventually "diagnosed in 119 patients (87 men and 32 women)." In short, "compared with male patients, female patients had a significantly shorter time to diagnosis of LDA-associated peptic ulcer by endoscopy."
