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Biocon confident of resolving issues with USFDA over biosimilar ‘pegfilgrastim’

While the company is set to launch proposed biosimilar, Pegfilgrastim in the United States market, the US Food and Drug Administration has issued Complete Response Letter (CRL) to it seeking more data on the cancer drug..............

Apollo Hospitals launches unique ‘Heart Disease Prevention & Reversal Program’

The comprehensive program which is preventive and personalised draws on global clinical research with proven results and is being spearheaded by an expert team of cardiologists.............

Higher risk of Alzheimer’s disease with India’s fast ageing population

On World Alzheimer’s Day, the Indian Society for Clinical Research (ISCR) highlights the need to intensify Alzheimer’s research to prepare for the impending population shift...........

“The worst is over for clinical research industry”

Having witnessed the loss of fortunes in near past, the Indian clinical research industry has regained its poise and is set towards much positive outlook, writes Naz Haji...........

DCGI tells unapproved FDC manufacturers to submit phase IV trial protocols

The Drugs Controller General of India (DCGI) has asked the pharmaceutical companies which are manufacturing the Fixed Dose Combinations (FDCs) without its approval to submit phase IV trial protocols with main focus on safety of drugs............

Leading CRO Ecron Acunova to get re-branded as Navitas Life Sciences

The unified Navitas Life Sciences will help in the consolidation of both infrastructure and operational capabilities of the existing entities and serve as an end-to-end strategic partner for clinical research requirements in India..........

Exclusive: Apex committee on clinical trials takes steps to streamline regulations

The issues related to streamlining of approvals to clinical trials were discussed and appropriate modifications were given green signal by the top health regulatory officials at their 34th apex committee meeting held recently at Delhi.........

‘Patients First’ ISCR’s theme for International Clinical Trials Day 2017

Need to encourage more innovation and research and development in India to make Make in India a reality for clinical research, says the Indian Society for Clinical Research (ISCR)..........

QuintilesIMS seals alliance with Salesforce to build next gen solutions

As part of the alliance, QuintilesIMS is building new solutions on the Salesforce Platform, taking advantage of built-in cloud, mobile, social and artificial intelligence (AI) capabilities........

Allow gene therapy for us: Thalassemia patient’s passionate appeal to govt

In a highly passionate appeal, Mr Gagandeep Singh Chandok, a patient suffering from Thalassemia has sought the intervention of Director General Health to allow clinical trials for Gene Therapy, the only for patients...........