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Clinical Research / Pharma News

India Adopts Long Waited Medical Device Guidelines

India Adopts Long Waited Medical Device Guidelines

One of the leading emerging Pharmaceutical markets, India has completed its long anticipated medical device guidelines. The guidelines are set to ease regulation of medical device manufacturing and development by freeing the sector from rules developed for the pharmaceutical industry.

So far, a lack of fully committed regulations addressing the greater part of medical devices left the industry operating under regulation designed…

Parexel’s Managed Access Program: How it will Bridge the Gap between Biopharma and Patients

Parexel’s Managed Access Program: How it will Bridge the Gap between Biopharma and Patients

Parexel’s expanded Managed Access Program allows bio-pharmaceutical organizations to offer compassionate access to patients as the sector faces a growing public demand for therapy choices.

Managed Access Programs offer accessibility to an investigational drug when individual enrollment in a clinical study is not possible. The programs are also commonly known as Expanded or Extended Access, Treatment IND, or compassionate use studies.

Vice President,…

After Six Years FDA Finalizes Guidance on Assessing Abuse Potential of Drugs

After Six Years FDA Finalizes Guidance on Assessing Abuse Potential of Drugs

After 6 years US FDA finalized Guidance on Assessing Abuse Potential of Drugs on 18th January 2017. The first draft was prepared almost six years back, this guidance seems to help sponsors of investigational new drugs in analyzing whether their new drug has abuse potential.

More particularly, US FDA states that the guidance provides suggestions for evaluating the abuse potential of central…

Repo-Man Protein Might Helpful in Treating Aggressive Cancers

Repo-Man Protein Might Helpful in Treating Aggressive Cancers

A protein that regulates cell division also has an essential role in switching genes on / off, researchers have identified, in a discovery which could change cancer treatment.

The protein phosphatase, Repo-Man is one of a clutch of essential proteins in cell division, an important process that goes into overdrive in cancer.

Now investigators at Brunel…

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New Antibody Design Might Helpful in Treating Brain Related Diseases

New Antibody Design Might Helpful in Treating Brain Related Diseases

Immunotherapy has confirmed to be efficient against many serious conditions. But to treat problems in the brain, the antibodies must initial get past the hurdle of the blood-brain barrier. In a new research, a study group at Uppsala University explains their development of a new antibody design that improves brain uptake of antibodies nearly 100 times.

Immunotherapy requires treatment with antibodies; it…

Anti-Influenza Compounds Might Protect From Zika

Anti-Influenza Compounds Might Protect From Zika

Investigators from the University of Helsinki have revealed that 3 anti-influenza compounds successfully inhibit Zika virus infection in human cells. The outcomes offer the base for development of the broad-spectrum cell-directed antivirals or their combos for treatment of Zika and other emerging viral conditions.

Globalization, environmental modifications, population development and urbanization make emerging virus conditions…

Scientists Grow Stomach in Laboratory

Scientists Grow Stomach in Laboratory

Researchers from Cincinnati Children’s Hospital Medical Center have developed a way in which cells from the stomach’s corpus/fundus region can be developed in the laboratory. These small organs could help research into common gastrointestinal problems and enhance drug research.

Stomach illnesses…

PD-1 Antibody: BMS and Ono Signed Agreement with Merck

PD-1 Antibody: BMS and Ono Signed Agreement with Merck

U.S. based one of the leading Pharmaceutical company Bristol-Myers Squibb ( BMS )and Japan based Ono Pharmaceutical Company, Ltd. recently declared that the organizations have agreed on an international patent license agreement with Merck & Co. Inc. to negotiate all patent-violation lawsuits relevant to Merck’s PD-1 antibody Keytruda (pembrolizumab). According to BMS, the deal will lead to the dismissal with prejudice of all patent lawsuits in between the organizations…

Pfizer and Novo Nordisck Invest $9 Million in AMRA

Pfizer and Novo Nordisck Invest $9 Million in AMRA

Pfizer and Novo (was founded in 1999 and is fully owned by the Novo Nordisk Foundation) are making contributions to a $9 million funding round for Swedish digital startup AMRA – which specializes in patient stratification technology.

The funds will go to the development of AMRA’s key offering, AMRA Profiler – a technological innovation which enables for highly accurate…

Immuno Oncology Market by 2022- A Global Forecast

Immuno Oncology Market by 2022- A Global Forecast

World’s one of the biggest and liable market research resource, Research and Markets recently published Immuno-Oncology Market, By Type and By Application- Global Forecast 2022.

Presently, Immuno oncology market has experienced a substantial number of improvements. The level of competition between the companies is accelerating. The biotechnology and pharmaceutical firms are attempting to obtain first mover benefits by introducing new and most effective therapies. This therapy is predicted to…

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