Sunday, June 25, 2017

Delay in 'Made in India' chikungunya vaccine, researchers seek government intervention

India offers a rare ray of hope for an indigenously-made vaccine against chikungunya, but delay in finding volunteers is impeding its development. 

With chikungunya spreading very fast in the country, researchers are seeking urgent government intervention for speedy completion of the vital clinical trials. 

Chikungunya is a dreaded infection transmitted through the bite of the mosquito. There is no known cure and till date, there is no vaccine anywhere in the world again .. 

The novel vaccine candidate against chikungunya crossed a big hurdle last year when Bharat Biotech, a Hyderabad-based vaccine pioneer, got permission to start human trials and the first human subjects received the vaccine a few months ago. 

The company says the phase-I trials will "evaluate the vaccine's safety, tolerability and immunogenicity. The placebo controlled study involving 60 healthy volunteers would test escalating doses of the vaccine in prime-boost regimen". 

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Sunday, June 18, 2017

Evolving Pharmaceutical Ecosystem Transforms Clinical Trials and Research Outsourcing

Access to advanced research tools will expand growth opportunities for CRO participants, finds Frost & Sullivan's Transformational Health team

The clinical trials and research outsourcing (CRO) market is growing, leveraging the global pharmaceutical industry's urgent need to succeed in late clinical trials and build the pipeline of new molecules. While cost benefits, focus on core competencies, rise in innovative therapeutic options, and increased drug efficacy and safety norms will continue to encourage global pharma companies to outsource, CROs must increase their range of services to better serve, and become the preferred partner to, bio-pharmaceutical companies.

"Expanding CRO services into early stages of drugs, emergence of virtual biotech, out-licensing, and risk sharing between pharma and CROs are disrupting traditional business models," noted Transformational Health Research Analyst Sanjeev Kumar. "They are also opening up greater opportunities for CROs in terms of access to a huge market, newer areas such as commercial and post-launch, bioanalytical testing and development services, and partnerships with small-to-midsize biotech and virtual pharma customers."


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Friday, June 16, 2017

India Orthopedic Procedures Market information about clinical trials in progress 2021

"India Orthopedic Procedures Outlook to 2021", provides key procedures data on the India Orthopedic Procedures. The report provides procedure volumes within market categories - Hip Replacement Procedures, Knee Replacement Procedures, Shoulder Replacement Procedures, Small Joints Procedures, Arthroscopy Procedures, Cranio Maxillofacial Fixation (CMF) Procedures, Spinal Surgery Procedures, Trauma Fixation Procedures, Orthopedic Prosthetics (Amputation Procedures) and Orthobiologics Procedures (Bone Graft Procedures).

The data in the report is derived from dynamic market forecast models. uses epidemiology based models to estimate and forecast the procedure volumes. The objective is to provide information that represents the most up-to-date data of the industry possible.

The epidemiology-based forecasting model makes use of epidemiology data gathered from research publications and primary interviews with physicians to establish the target patient population and treatment flow patterns for individual diseases and therapies. Using prevalence and incidence data and diagnosed and treated population, the epidemiology-based forecasting model arrives at the final numbers.

Extensive interviews are conducted with key opinion leaders (KOLs), physicians and industry experts to validate the procedure volumes.

 

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Thursday, June 15, 2017

New method to make lung cancer drug trials more successful

Australian researchers have developed a new method for finding participants in clinical trials of lung cancer drugs, it was announced on Wednesday.

Researchers from Melbourne's Walter and Eliza Hall Institute (WEHI) were optimistic that the new recruitment process will boost the success rate of drugs being trialled as treatments for lung squamous cell carcinoma, the second most common type of lung cancer.

By mimicking the complexity of human tumours with a research tool, the scientists were able to identify a "biomarker" which could serve as an indication as to which patients would better respond to certain drugs, Xinhua news agency reported.

Marie-Liesse Asselin-Labat, the lead author of the study, said patients with the biomarker were more likely to respond positively to fibroglast growth factor receptor (FGFR) drugs.

"We found that high levels of the anti-cancer drug's target, FGFR1, in a patient's tumour ribonucleic acid (RNA) were a better predictor of their potential response to the drug than the current tests that are used," Asselin-Labat said on Wednesday.

Ben Solomon, a medical oncologist from the Peter MacCallum Cancer Centre, said the finding meant future clinical trials could be designed to succeed.

"Fewer than 10 per cent of new cancer drugs make it past phase 1 clinical trials. In many cases this isn't because of the drug itself, but because of a limitation in clinical trial design," Solomon said.

"Understanding which patients are most likely to respond to certain drugs in clinical trials is crucial both for patients to receive the best treatment, and for new drugs to make it to the clinic."

"Hopefully these data will help to improve trial outcomes by recruiting patients who otherwise might not have been matched to the right trial for them," Solomon said.



Saturday, June 3, 2017

New hope for multiple sclerosis patients

In what might come as a relief for many patients who suffer from disability due to multiple sclerosis (a neurological disorder in younger persons), clinical trials for a medicine to treat this disease has been approved.



The move is despite stringent regulations recently introduced by the Drug Controller General of India which had halted clinical trials in the country for a while.PGIMER is one of seven such institutes in India which has been selected for the trials to be conducted in 32 countries.

The drug `ofatumumab' for which the trial will start soon is expected to offer lesser side effects and will be more effective than the existing drug `teriflunomide' in patients who suffer from relapsing multiple sclerosis. In India, some 9-10 in every 1 lakh persons suffer from the disease. It is believed that there are over 1 lakh patients in the country .


Usually patients show recurring and recovering pattern of neurological symptoms (also called relapsing and remitting). The common symptoms include visual problems, overwhelming fatigue, difficulty in maintaining balance and coordination, various levels of impaired mobility , muscle weakness and stiffness.