FDA approves expanded indication for Spiriva HandiHaler.
"Spiriva HandiHaler [inhaled tiotropium bromide]" has been approved by the US Food and Drug Administration "as a treatment for reducing symptoms and difficulty breathing because of chronic obstructive pulmonary disease (COPD)."
The new indication was based on results of two clinical trials with nearly 8,000 patients combined -- one called UPLIFT and a separate six-month study with patients in a Veterans Affairs setting. Although the UPLIFT study did not achieve its primary endpoint of showing a slowed rate of lung function decline relative to placebo, clinical data demonstrated that the addition of tiotropium to preexisting respiratory medications sustained improved lung function during four years and reduced COPD exacerbations.
EU drug regulators recommend approval of Prolia.
Sources from Amgen Inc. said that the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of the biotechnology company's osteoporosis drug Prolia, also called denosumab." The drug is still under FDA review "as a potential treatment for postmenopausal osteoporosis and as a treatment for bone loss in breast and prostate cancer patients undergoing therapy."
Researchers investigating whether oral enzymes, immunotherapy effective in celiac disease. Many efforts underway to develop new, non-dietary treatments for celiac disease," including "a gluten-free diet" and protecting "patients from occasional gluten exposure" using "oral enzymes that target gluten." Researchers have found that when gluten is "broken down into smaller fragments" by combining "enzymes from bacteria and barley," it "no longer causes inflammation in the intestines." Meanwhile, researchers are also investigating whether training "the immune system to tolerate gluten" and allowing "patients to eat a regular diet" is effective. This "category of treatment, known as immunotherapy," quells "immune response in the gut," which "is driven by...cells known as T cells."
Sanofi stops tests on drugs for insomnia, atrial fibrillation.
Sanofi-Aventis SA reportedly stopped tests on two medicines for insomnia and atrial fibrillation because of setbacks in development." The drug-maker "withdrew applications in Europe and the US for the insomnia pill eplivanserin because of the need for 'significant further clinical development and market access constraints,' the Paris-based company said." Meanwhile, according to Sanofi, "the idrabiotaparinux medicine for use in preventing clots in patients with atrial fibrillation is being discontinued because of 'recent therapeutic advances in the field.'
Celgene says Revlimid slowed multiple myeloma progression.
Celgene Corp. Correspondent stated that data from a late-stage study show Revlimid [lenalidomide] significantly slowed the progression of multiple myeloma in patients following a type of stem cell treatment." The study included patients "who...received autologous stem cell transplants, a procedure where stem cells are removed from a person's bone marrow prior to chemotherapy, then reintroduced after chemotherapy." The drug is currently "approved as treatment for multiple myeloma patients who have received at least one prior therapy."
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"Spiriva HandiHaler [inhaled tiotropium bromide]" has been approved by the US Food and Drug Administration "as a treatment for reducing symptoms and difficulty breathing because of chronic obstructive pulmonary disease (COPD)."
The new indication was based on results of two clinical trials with nearly 8,000 patients combined -- one called UPLIFT and a separate six-month study with patients in a Veterans Affairs setting. Although the UPLIFT study did not achieve its primary endpoint of showing a slowed rate of lung function decline relative to placebo, clinical data demonstrated that the addition of tiotropium to preexisting respiratory medications sustained improved lung function during four years and reduced COPD exacerbations.
EU drug regulators recommend approval of Prolia.
Sources from Amgen Inc. said that the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of the biotechnology company's osteoporosis drug Prolia, also called denosumab." The drug is still under FDA review "as a potential treatment for postmenopausal osteoporosis and as a treatment for bone loss in breast and prostate cancer patients undergoing therapy."
Researchers investigating whether oral enzymes, immunotherapy effective in celiac disease. Many efforts underway to develop new, non-dietary treatments for celiac disease," including "a gluten-free diet" and protecting "patients from occasional gluten exposure" using "oral enzymes that target gluten." Researchers have found that when gluten is "broken down into smaller fragments" by combining "enzymes from bacteria and barley," it "no longer causes inflammation in the intestines." Meanwhile, researchers are also investigating whether training "the immune system to tolerate gluten" and allowing "patients to eat a regular diet" is effective. This "category of treatment, known as immunotherapy," quells "immune response in the gut," which "is driven by...cells known as T cells."
Sanofi stops tests on drugs for insomnia, atrial fibrillation.
Sanofi-Aventis SA reportedly stopped tests on two medicines for insomnia and atrial fibrillation because of setbacks in development." The drug-maker "withdrew applications in Europe and the US for the insomnia pill eplivanserin because of the need for 'significant further clinical development and market access constraints,' the Paris-based company said." Meanwhile, according to Sanofi, "the idrabiotaparinux medicine for use in preventing clots in patients with atrial fibrillation is being discontinued because of 'recent therapeutic advances in the field.'
Celgene says Revlimid slowed multiple myeloma progression.
Celgene Corp. Correspondent stated that data from a late-stage study show Revlimid [lenalidomide] significantly slowed the progression of multiple myeloma in patients following a type of stem cell treatment." The study included patients "who...received autologous stem cell transplants, a procedure where stem cells are removed from a person's bone marrow prior to chemotherapy, then reintroduced after chemotherapy." The drug is currently "approved as treatment for multiple myeloma patients who have received at least one prior therapy."
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