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ProMetic Life Sciences Inc. reported that the U.S. Food and Drug Administration (FDA) has granted a Fast Track designation to ProMetic for its plasminogen drug candidate, currently in a phase 2/3 clinical trial in patients suffering from congenital Plasminogen deficiency.
Since the 1980s, continuous positive airway pressure (CPAP) - in which positive pressure is pushed through the nasal airways to help users breathe while sleeping - has been by far the most widely used treatment for obstructive sleep apnea (OSA). With more than 18 million people experiencing OSA, a number expected to rise, new results from a Penn case study of a new device implanted in the chest called hypoglossal nerve stimulation (HGNS) offers promise for patients with moderate to severe OSA who cannot tolerate CPAP. Researchers at the Perelman School of Medicine at the University of Pennsylvania will present data (abstract 0378) on their outcomes with hypoglossal nerve stimulation for the treatment of patients with sleep apnea at SLEEP 2016, the 30th annual meeting of the Associated Professional Sleep Societies LLC.
Much of the research on Alzheimer's disease has focused on the amyloid beta protein, which clumps together into sticky fibrils that form deposits in the brains of people with the disease. In recent years, attention has turned away from the fibrils themselves to an intermediate stage in the aggregation of amyloid beta. "Oligomers" consisting of a few molecules of the protein stuck together are more mobile than the large, insoluble fibrils and seem to be much more toxic. But the actual structure of these soluble oligomers remains unknown, and it's unclear how they trigger the neurotoxic effects that lead to Alzheimer's disease.
Nektar Therapeutics (NASDAQ: NKTR) today announced new preclinical data for NKTR-214, an immuno-stimulatory CD-122 biased cytokine currently being evaluated in cancer patients with solid tumors in a Phase 1/2 clinical trial being conducted at MD Anderson Cancer Center and Yale Cancer Center. The new preclinical data presented demonstrate that treatment with single-agent NKTR-214 mobilizes tumor-killing T cells into colon cancer tumors. In addition, mouse pharmacodynamics data demonstrated that a single dose of NKTR-214 can increase and sustain STAT5 phosphorylation (a marker of IL-2 pathway activation) through one week post-dose. These data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL from June 3-7, 2016.
Amgen announced new data from a prespecified interim analysis of the phase 3 TOWER study, in which Blincyto (blinatumomab) demonstrated an almost two-fold increase in median overall survival (OS) compared to standard of care (SOC). The randomized, open-label TOWER study evaluated the efficacy of Blincyto versus SOC chemotherapy in adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
The United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance on Cantargia AB’s (Cantargia) patent application regarding IL1RAP as a target molecule for antibody therapy of acute lymphatic leukemia (ALL).
ViiV Healthcare announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for dolutegravir 10mg and 25mg oral tablets, reducing the weight limit from at least 40kg to at least 30kg, in ages 6 to less than 12 years old, for the treatment of HIV-1 in children and adolescents.
ThromboGenics NV, a biotechnology company focused on developing novel medicines for back of the eye disease, announced that the Office of Biotechnology Products of the US Food and Drug Administration (FDA) has approved a new already-diluted formulation of its Jetrea (ocriplasmin).
The results of a study presented today at the European League Against Rheumatism Annual Congress (EULAR 2016) showed that when antibodies develop in response to the biological treatment Remicade® (infliximab), they also cross-react with the biosimilar of infliximab (CT-P13: Inflectra® or Remsima®). These findings suggest that antibody-positive patients being treated with Remicade should not be switched to treatment with the biosimilar, since these antibodies will interact with the new drug and potentially lead to a loss of response.
Biosimilars are similar to biotechnologically created proteins, but have been approved after the patent for the original branded product has lapsed. Unlike chemically-created generic drugs, the biosimilar molecule is not identical to the original product; it is highly similar. Over the past decade, several biosimilars have been introduced into medicine with the goal of reducing treatment costs and increasing accessibility to therapy for patients. The first infliximab biosimilar in Europe is marketed under two brand names: Inflectra (made by Hospira) and Remsima (made by Mundipharma).
Biopharmaceuticals (or 'biologics'), such as infliximab, have revolutionised the treatment of many rheumatic diseases. However, some patients generate an immune response to such drugs, with the resultant antibodies potentially limiting their clinical efficacy and safety.3 Infliximab is a TNF-α inhibitor which, in the European Union, is approved as an effective treatment of various inflammatory rheumatic diseases, including rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.
"While most studies show there are no significant differences in clinical response between a biosimilar and the original product, some physicians and patient advocacy groups have expressed concern about how interchangeable they really are, and whether it is safe to switch from the brand name version to the biosimilar," said lead author Dr Daniel Nagore of Progenika Biopharma, Derio, Spain.
"Our results have shown that all the antibodies that developed in patients being treated with Remicade cross-reacted with the biosimilar. The presence of these anti-infliximab antibodies is likely to enhance clearance of the drug from the body, potentially leading to a loss of response, as well as increasing the risk of side effects. Therefore, in patients where biological infliximab is ineffective due to the presence of circulating antibodies, switching to its biosimilar will lead to the same problems," Dr Nagore concluded.
The study included 250 rheumatoid arthritis and spondyloarthritis patients undergoing Remicade treatment who had never been previously treated with the biosimilar, and 77 control patients. Using assays to assess concentrations of anti-infliximab antibodies, half (50.4%) of the Remicade-treated patients tested positive for anti-infliximab antibodies, and 100% of those who tested positive for anti-infliximab antibodies also exhibited antibody reactivity against the biosimilar.
These results are aligned with previous infliximab antibody data among patients with inflammatory bowel diseases being treated with Remicade. Further studies are now planned with biosimilar-treated patients to better assess the potentially different immune responses associated with biologics.
The results of a study presented today at the European League Against Rheumatism Annual Congress (EULAR 2016) found a doubled risk of pre-malignant cervical changes, and potentially also an increased risk of cervical cancer, among women with Systemic Lupus Erythematosus (SLE) compared to the general female population. The highest risks were found in women with SLE who were treated with immunosuppressant drugs. These findings highlight the importance of regular cervical screening in all women with SLE, regardless of whether the increased risk is due to disease severity or treatment.
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