Novartis announces US FDA approval of Xolair® for chronic idiopathic urticaria

Novartis announced that the US Food and Drug Administration (FDA) has approved Xolair® (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), an unpredictable and debilitating skin disease that is known as chronic spontaneous urticaria (CSU) outside of the US. In the US, Xolair is indicated for CIU in adults and adolescents (12 years of age and above) who remain symptomatic despite H1-antihistamine treatment.

.

Mood-stabilizing drug could reduce risk of head and neck cancer

Valproic acid (VPA) is a medication used to treat epilepsy and manic-depressive illness, such as bipolar disorder.

However, the medication is able to block histone acetyl transferases (HATs) - enzymes that control gene expression by altering DNA structure. This is a process that occurs in the early stages of many cancers, including lung, bladder, prostate, and head and neck cancers.

Therefore, Valproic acid (VPA) has the potential to be used as an anticancer agent.

Sujatha and Vamsi Krishna of ACRI, presented on the new technical topic of “Pharmacovigilance System Master File(PSMF)’’.This was a very good presentation explaining even the minutest detail.

Reshmi and Prasanthi of ACRI, gave an excellent presentation on the technical topic of “Additional Monitoring”. This was the most applauded Presentation so far.

Pavithra and Jakeer of ACRI, presented on the technical topic of “Regulations of Medical Devices’’. It was very well organized and informative.

Asha and Saimohan of ACRI, gave a very good presentation on technical topic of “OTC DRUGS”.

ACRI offers Post Graduation Diploma in Clinical SAS

SAS is a comprehensive statistical software system which  incorporates utilities for storing, modifying, analyzing, and  graphing data.

SAS runs on both Windows and UNIX platforms.It was created in the early 1960s by the Statistical Department at North Carolina State University. Today SAS is developed and marketed by SAS Institute.

 
                                    

SAS is a set of explanations for enterprise-wide business operators and provides a powerful fourth-generation programming language for performing tasks such as these:

1. Data entry, retrieval,and management.
2. Report writing and graphics.Statistical and mathematical analysis.
3. Business planning, forecasting, and decision support.
4. Operations research and project management.
5. Quality improvement.
6. Applications development.

SAS TRAINING:

• Base SAS
• Advanced SAS

CAREERS:

• Project Managers.           
• Biostatisticians.
• Clinical Data Auditors.
• Clinical Application Programmers.
• Data Base Administrators.
• Project Managers.
• System Analysts.
• Clinical Application Developers.
• Data managers.
• Programmer Analysts.

A one day workshop on Careers in Clinical Research was conducted on 8^th March 2014 at ACRI.

The speaker for the day, Dr. Smita Singh gave a magnificent presentation on Drug Discovery & Development and Careers in Clinical Research. Students actively participated in the workshop and also clarified their queries w.r.t the course duration, fee, hostel…etc. They were highly motivated and were optimistic about taking up the course post the completion of their Bachelors. 

Today's group discussion topic was "SCOPE OF PHASE I TRIALS IN INDIA''.

Too much protein in middle age ' as bad as smoking '

Middle-aged people who eat a lot of protein, particularly animal-derived, have increased cancer risk and shorter lives, although moderate protein intake may benefit older people.

New Interferon-Free Drugs for Hep C Show High Cure Rates

Interferon has been the primary treatment for chronic hepatitis C for 2 decades, but new drugs promise better results with fewer adverse effects.

In the PEARL-III trial, treatment-naïve noncirrhotic adults with chronic genotype 1b (GT1b) hepatitis C were treated with an investigational all-oral interferon-free treatment from AbbVie plus ribavirin. After 12 weeks of treatment, sustained virologic response rates reached 99.5%. Even in difficult-to-treat cirrhotic patients, response rates reached 92% to 96%.