My Clinical Trials Diary

 The US health regulator has cleared Glenmark Pharma's investigational new drug application to initiate phase one study of GBR 1342, a humanised monoclonal antibody for treatment of multiple myeloma, the company said today. This is Glenmark's second investigational new drug from its immuno-oncology portfolio to enter clinical trials. "GBR 1342 is designed to activate the patient's immune system by redirecting immune cells towards tumour tissue, which may lead to targeted destruction of tumours. It is based on Glenmark's proprietary BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) technology platform," Glenmak said in a BSE filing. The first-in-human phase 1 study of GBR 1342 will enrol subjects with multiple myeloma who have exhausted available therapies. "… our flagship biotechnology platform and antibody science are beginning to become a reality for patients now that we have a second oncology candidate entering clinical trials,...

The vaccine created by the team of scientists, which has completed the pre-clinical trial (animal experimenting), will induce an immune response comprising of antibodies. However, the menace continues to prevail, causing diseases like malaria and dengue. The vaccine created by the team of scientists, which has completed the pre-clinical trial (animal experimenting), will induce an immune response comprising of antibodies.   The vaccine created by the team of scientists, which has completed the pre-clinical trial (animal experimenting), will induce an immune response comprising of antibodies. Chennai: Fogging and using mosquito coils and nets are only a few among various methods many use to protect themselves from mosquitoes. However, the menace continues to prevail, causing diseases like malaria and dengue. Therefore, as a means to check malaria transmission, a team of scientists from New Orleans, USA, has invented a vaccine targeting the sexual development of malaria parasites in the ...

Swiss multinational drug giant  Novartis , which was among a few firms that suffered setbacks in the Indian market pertaining to patents protection and clinical trials, wants India to ensure consistency in the regulatory environment to retain and attract global investors. Referring to episodes like overnight changes in key regulations governing clinical trials a few years back that destabilised investments of MNC pharma firms, Novartis global drug development head  Vas Narasimhan  said such inconsistencies send out wrong signals to investors.  Narasimhan, who was in India to participate in Bio Asia 2017 conclave at Hyderabad, said sudden regulatory shifts will affect MNC drug companies, who make long-term investments in innovation.  "We (multinationals) cannot simply keep adjusting. That sends a signal that maybe, we shouldn't invest as much," he told ET.  Admitting that things have improved in consistency with rest of the world and the regulatory environment has got bett...

Orbis Research Present's Chronic Pain-API Insights, 2017 And has been prepared based on an in-depth market analysis with inputs from industry experts. The active pharmaceutical ingredients worldwide market is in continuous development from the recent years. There is expected to be a major impact on the global API industry, with the large number of blockbuster drugs going off patent in the coming years. It is going to affect the revenue of the API market as generic drugs occupy the market. Get a PDF Sample of Chronic Pain Market Report India and China produce a large percentage of a majority of the APIs and intermediates produced in the world currently. The USFDA and EMA have strict guidelines for API manufacturing 'Process Validation: General Principles and Practices'. While countries such as Japan and Singapore are signatories to the ICH Q7 regulation, India and China follow their national GMP guidelines. The efficiency and expertise of Asian contract manufacturers have po...

Global Clinical Trial Management System Market Will Reach $1,848.5 Million in 2019: Asia to Witness Highest Growth ResearchMoz added Latest Research Report titled " Global Market Study on Clinical Trial Management System: Asia to Witness Highest Growth by 2019 " to it's Large Report database. Clinical Trial is a medical research study performed on humans to check the safety and efficacy of drugs, devices and therapeutic products before they are finally launched in the market. Proper management of clinical trials has become a priority for hospitals, pharmaceutical companies and clinical research organizations (CRO).Clinical trial management system (CTMS) is a software solution for proper management, storage and analysis of drugs associated clinical data. CTMS is primarily employed to manage the large amount of data involved in a clinical trial including planning, preparation and reporting. CTMS also provides data to a business intelligence system. It provides a user-friend...

We The People, debates if clinical trials in India have too many or few safeguards.  Are poor still vulnerable?  And do the latest regulatory norms water down the safety norms?  With government waiving Phase III trials for drugs that are already tested in countries that have robust regulatory mechanism, does the pursuit of new drugs and vaccines have very few safeguards? Watch this video: http://www.ndtv.com/video/news/we-the-people/we-the-people-clinical-trials-in-india-saving-or-risking-lives-445136

A study published in the Journal of the National  Cancer  Institute, found that obesity increases the risk of multiple  myeloma , a cancer of the blood. The study, by a team at Washington University School of Medicine in St. Louis, found that being overweight or  obese  has been known to increase the risk of multiple myeloma, a cancer of the plasma cells in the blood and bone marrow that develops more often after age 60. Multiple myeloma is preceded by a blood disorder called monoclonal gammopathy of undetermined significance (MGUS) in which abnormal plasma cells produce many copies of an antibody protein. This precancerous condition does not cause symptoms and often goes undiagnosed. Continue reading ᐧ