Friday, July 14, 2017

Zero-fat, clean, lab-made chicken on the way

Here is the good news for the non-vegetarians. Very hygienic, healthy and tasty laboratory-made chicken is coming soon into the Indian market. Research by biotechnology scientists proved that chicken can be made in the lab with same qualities, colour and taste as natural chicken. Moreover, the laboratory made chicken will be zero-fat. 

The first phase of the laboratory chicken (cultured or artificial chicken) research project was successfully completed at GITAM University. There are some satellite cells in human and animals. The cells are born automatically and healthy. These cells have unique feature that they can be developed or changed into any other cells in body. 


Sunday, July 9, 2017

'Include local advice for drug trials in India'

'Include local advice for drug trials in India'

Clinical trials done in India should be guided by local concerns and have a strong local participation, felt Roy Rampling, eminent neuro-oncologist and researcher. Delivering the Tata oration in clinical oncology on Friday, Rampling -a professor at the University of Glasgow -said he was surprised to find that clinical trials in India were often controlled entirely by foreign agencies and local investigators had no say in deciding their courses. "All trials are done in India should include local advise. It should be designed for the gain of the local community," said the Malta-born Rampling.

Describing India as the ideal venue for clinical trials, Rampling said the country was ready to take off in medical research...

Saturday, July 8, 2017

Is ‘Right-to-try’ bill right?

The bill would exempt doctors and drug companies from liability of prescribing and supplying experimental drugs

image courtesy: Scienceblogs

'Right-to-try' is being debated fiercely in US as the American Congress is considering a bill on the topic. It is a practice allowing patients diagnosed with terminal illnesses to use drugs that are yet to be approved and are out of clinical trials, but have passed the first clinical test of safety. However, usage of even such drugs also requires Food & Drugs Administration (FDA) approval. The bill in the US Congress however, seeks to eliminate this FDA approval and monitoring of the process.

The Trump administration has supported the bill and this is termed by many as a part of the administration's passion for deregulation. In all 33 states have already passed 'Right-to-try' laws. Efforts of Goldwater institute, a libertarian non-profit organisation that drafted the model law, have led to passing of the laws in the states. In general, overall anti-regulatory environment in the society appears to have provided strength to the 'Right-to-try' moment.

Those supporting the bill claim that as it is the terminally ill patients have no hope for cure from the regular drugs that are given to them. So, why not allow them to try new drugs though it is little risky proposition as all stages of clinical trials are not completed yet. In the process of receiving approval after completing all phases of trials, the drug will be available after long time. But if allowed it to use before that it may be successful in some cases and save life to terminally ill patient.

Thursday, July 6, 2017

India Contract Research Organization Market, is projected to grow at a CAGR of 20.4% and is expected to reach US$ 6,310.5 million by 2022

Market Research Future published a Statistic research report on India Contract Research Organization Market, from 2017 to 2022″ – Market Analysis, Scope, Stake, Progress, Trends and Forecast to 2023.

India Contract Research Organization Market, is projected to grow at a CAGR of 20.4% and is expected to reach US$ 6,310.5 million by 2022. In India contract research organization market, drug development/clinical trials accounted for the largest market share in 2016.

A Contract Research Organization (CRO) is a service association that offers help to the pharmaceutical business and offers an extensive variety of outsourced pharmaceutical research administrations to help in R&D system and in this way a basic tool for undertaking clinical trials in the present situation when high stakes are included in the drug discovery process. This industry likewise offers a safe choice of venture as the business is to a great extent recession-proof, with a critical upscale development.

India Contract Research Organization is one of the growing markets. The India Contract Research Organization market is majorly segmented into Drug Development/Clinical Trials, Drug Discovery and Post Marketing Services. Further on the bases of drug discovery services type the market is segmented into Clinical Services, Biology Services and Chemistry Services. 

The major factors is the low cost of CRO in developing countries like in India, increasing new players entering in the CRO market with resulting in high competition and better healthcare infrastructure and institutions in these countries and growing private funds and government initiatives in the region. India Contract Research Organization market statistical report published by Market Research future contains a brief overview of India Contract Research Organization market. 

The market has been segmented into Drug Development/Clinical Trials, Drug Discovery and Post Marketing Services. Further on the bases of drug discovery services type the market is segmented into Clinical Services, Biology Services and Chemistry Services. Drug Development/Clinical Trials accounted for the largest market share in 2016 and is expected to grow continuously during the forecasted period of 2017-2022. The report analyzed the India Contract Research Organization market and present systematic data of market share on the basis of segments and countries, and its growth rate for 2014 to 2017, along with forecast till 2022.

Wednesday, July 5, 2017

BIOCAD’s rituximab biosimilar to receive MA soon in India

In August 2017, BIOCAD will receive permanent market authorization in India, which represents a strategic milestone for BIOCAD's international expansion.

Central Drugs Standard Control Organization(CDSCO) has recommended Acellbia, the first rituximab biosimilar made in Russia, for approval in India.

In August 2017, BIOCAD will receive permanent market authorization in India, which represents a strategic milestone for BIOCAD's international expansion.

Today, the Indian market for rituximab exceeds $40 m, with an annual growth of 8%. According to experts, this volume may reach $58 million in the next five years.

Meanwhile, India experiences low rituximab availability. Therefore, the Russian biosimilar marketed here will not only boost competition among the existing players, but will make this product available for larger numbers of patients with certain types of lymphomas and autoimmune disorders.

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". 

Continue reading here: Source

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."

Continue reading

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.



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.

Wednesday, May 17, 2017

Anti-myeloma drug gets clinical trial nod from USFDA

 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," Glenmark Pharma President and Chief Scientific Officer Kurt Stoeckli said. "While there is still significant development ahead, these steps signify that Glenmark's investment in discovery and development of biologics is rapidly progressing."

The study is being conducted in two parts.

GBR 1342 is also being considered for the treatment of other malignancies, the company said.

Wednesday, March 1, 2017

Chennai: Malaria vaccine awaits 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 mosquito vector.

Vector-borne diseases account for 17 per cent of the estimated global burden of all infectious diseases, according to reports of the World Health Organisation (WHO), and are a major public health problem, particularly in tropical and sub-tropical regions. Some of these diseases are fatal if not treated, while others leave patients disfigured and disabled.

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. "When a mosquito bites a human being, it will pick up parasites mixed along with the antibodies.

The antibodies will prevent the parasites from further developing," said head of the team, Prof. Nirbhay Kumar, Professor of Tropical Medicine and Director of the Vector Borne Infectious Diseases centre, Tulane University, New Orleans, US, at the sidelines of the 13th conference on vector and vector borne diseases, jointly organized by the National Academy of Vector Borne Diseases, with the Central University of Tamil Nadu.

Monday, February 27, 2017

Novartis seeks regulatory consistency in India

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 better now from both intellectual property and clinical trials' perspective, he said, such environment enables MNCs "invest with certainty over longer periods of time." 

However, he said "the key is it stays this way and keeps improving. Then, I think you will have more (clinical) trials coming in". 

Novartis currently conducts more than 50 clinical trials in India across all its therapeutic segments. 

Apart from ensuring consistency in regulatory policy environment, India should also allay the apprehensions of global investors at the earliest "so that it gives confidence to the principles all over the world because these clinical trials have been planned for long-term investments and they will have implications on global (drug) filings," Novartis India president Jawed Zia said.

Friday, February 24, 2017

Clinical Trials Review of Chronic Pain-API Insights, 2017

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 positioned them in a very strategic space in the global pharmaceutical supply chain, with a vast majority of the APIs and intermediates being sourced from markets such as India and China.

Chronic Pain -API Insights, 2017 Report describes the current therapeutics that are propelling the pharmaceutical markets worldwide. The report gives the clear idea on the United States Drug Master File (USDMF) and Europe DMF filed by worldwide countries related to the Chronic Pain. It also provides the India and China API Manufactures who are driving the current API Market. The report also highlights the patent and patent exclusivity information. The research analysis also presents the global sales data till 2016.


Monday, February 20, 2017

Global Clinical Trial Management System Market: Asia to Witness Highest Growth

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-friendly infrastructure that enables clinicians to manage trials of varying complexity.

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Monday, January 9, 2017

We The People: Clinical Trials In India - Saving Or Risking Lives?

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?