Beginning on 1 January 2018, Health Canada will only accept submissions for certain regulatory procedures in electronic common technical document (eCTD) format. As of that date, Health Canada says that sponsors must use eCTD format for all new drug submissions (NDS) and abbreviated new drug submissions (ANDS), as well as supplements to both submission types. The agency also notes that sponsors can request an exemption from the requirement for individual products, but says it expects companies to provide their "rationale for the exemption as well as an intended plan for converting to eCTD format." [ Read more]
Shruti Bhat, PhD (Tech.), MBA, Certified Lean Six Sigma Black Belt is Continuous Improvement mastermind for Pharmaceuticals & Medical Devices Industry. She is often called "Profitability expert' More about Shruti at http://www.shrutibhat.com/
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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.
Presented below are updates in Pharmaceutical and clinical research-
Experimental Drug Appears To Shrink Tumors In Lung Cancer Patients With A Certain Genetic Variation.
Lung cancer is one of the "hardest cancers to treat," but scientists in South Korea "have made progress in taming" one form. In fact, using a "focused approach," the researchers were able to significantly shrink "tumors...in a majority of patients with ...
Investigational Drug May Help Improve Survival In Patients With Advanced Breast Cancer.
Eribulin, a chemotherapy drug being developed by Eisai Co. Ltd., may help improve survival in patients with advanced breast cancer, according to a study scheduled to be ...
Avastin May Extend Progression-Free Survival In Ovarian Cancer Patients.
The cancer drug Avastin [bevacizumab] extends progression-free survival by 39% in ovarian cancer patients." This "study, reported Sunday at a Chicago meeting of the American Society of Clinical Oncology, is also the first to use the drug as first-line therapy for ovarian cancer." The "trial involved 1,873 women with newly diagnosed Stage 3 or Stage 4 ovarian cancer who had undergone surgery to remove as much cancer ...
Data Suggest Two Drugs May Be Better Than Gleevec For Patients With Newly Diagnosed CML.
Research presented at the American Society of Clinical Oncology meeting and published online in the New England Journal of Medicine suggests that Bristol-Myers Squibb Co.'s Sprycel (dasatinib) and Novartis's Tasigna (nilotinib) may be better than Novartis AG's Gleevec ...
Drug Shows Promise In Treating Drug-Resistant Medulloblastomas. An experimental drug, currently called GDC-0449, "has shown promise in treating" drug-resistant medulloblastomas, "a small study unveiled at ...
Ipilimumab Nearly Doubles Number Of Late-Stage Melanoma Patients Surviving One Year.
An experimental immune therapy may provide a new way to fight advanced melanoma." Specifically, "in a study of two novel treatments -- a therapeutic vaccine called gp100 and an immune stimulator called ipilimumab -- ipilimumab nearly doubled the number of patients surviving one year, found ... .
Erbitux Provides No Benefit Among Patients With Early-Stage Colon Cancer.
For the second time in a year, researchers have found that a drug that has proved useful in treating advanced colon cancer provides no benefit in the early stages of the disease. It is well known that "cancer drugs are typically tested first in the most advanced cases for ...
Adding Everolimus To Herceptin May Benefit Some Patients With Metastatic Breast Cancer.
Adding the targeted agent everolimus (Afinitor) to therapy for women with metastatic breast cancer resistant to trastuzumab (Herceptin) results in clinical benefit for ...
More at ... http://www.pharm-education.com/2010/06/experimental-drug-appears-to-shrink.html
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