FDA agrees to review Merck's Suvorexant for sleeplessness

The US FDA have accepted the New Drug Application (NDA) for suvorexant, Merck's investigational insomnia medicine. Suvorexant will be evaluated by the Controlled Substance Staff of the FDA during NDA review. If approved by the FDA, suvorexant will become available after a schedule assessment and determination has been completed by the U.S. Drug Enforcement Administration, which routinely occurs after FDA approval.

The NDA for suvorexant was based on data from a broad clinical development program, including: two pivotal, three-month efficacy trials that evaluated the ability of suvorexant to help patients fall asleep and stay asleep; a 12-month study, followed by a two-month discontinuation phase, that was designed to assess the safety of suvorexant, while also evaluating its longer term efficacy and the impact of stopping treatment; and two next-day driving studies that provided an assessment of residual effects following evening use of suvorexant.

Merck researchers developed suvorexant to target and block orexins, chemical messengers that help to keep you awake. By temporarily blocking the actions of orexins, suvorexant helps to facilitate sleep. If approved, suvorexant would be the first in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep

Are Pharma Companies increasing the number of Voluntarily initiated Phase IV trials

The study, “Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management,” conducted by Cutting Edge Information found that 82% of surveyed companies’ post-marketing trials are voluntarily initiated. That percentage is an increase from 61% of Phase IV trials that were voluntarily initiated by drug manufacturers in 2006.

I took a quick look at the number of phase IV trials at the ClinicalTrials.gov registry and surprised to see that the number of Phase IV trials disclosed by Pharmaceutical companies was on a decline. Is the disclosure limited to trials that are conducted as part of Life Cycle Managment of the drugs or are the companies conducting trials purely for commercial reasons and do not have an obligation to report those.

Here is what ClinicalTrials.gov reflects on the phase IV trials run by pharmaceutical companies.



Hyderabad holds the potential to become the medical tourism hub of India

With IMTCA (Indian Medical Tourism Conference and Alliance) 2012 kick starting its 1st edition in Hyderabad, the two day conference (2nd, 3rd) had unlocked the huge potentials that can be explored in the medical tourism sector in India. With advanced hospitals and well developed healthcare infrastructure, Hyderabad is set to become the medical tourism hub of India, revealed speakers at the conference.


With a potential of $35 billion global markets, the medical tourism sector holds a great growth potential if explored in the right direction. At present South Korea is leading in the medical tourism sector with a rapid growth of $6.9 millions in 2009 to 27.8 millions in 2011. In view of this India too can be explored to earn great revenues through promoting medical tourism in the country. With a well developed hospital infrastructure and well trained nurses and doctors Hyderabad stands in the forefront to grab the opportunity of become the India’s leading medical tourism hub.

Initiated as an objective to bring all stake holders (medical practitioners, doctors, hospitals, tourism and hospitality industry) at one place, the IMTCA event also gave an apt platform for networking with delegates and exchange ideas on research, academic and economic values
  About 200 medical practitioners, tourism professionals and specialists from across the country took part in the 1st edition of the IMTAC 2012. The two day event largely focused on global medical tourism and potential of Hyderabad as a medical tourism hub in India

DBT invites applications for “Innovative Young Biotechnologist Award”

The department of biotechnology (DBT) has invited applications for the “Innovative Young Biotechnologist Award” (IYBA) for the year 2012. The Award was instituted by the DBT in the year 2005, as an attractive, career-oriented scheme to identify and nurture outstanding young scientists with innovative ideas and desire to pursue research in frontier areas of biotechnology.


For the year 2012 awards, the department invites applications from the young investigators upto the age of 35 years. The award will consist of financial support for a project and cash award/fellowship for the awardees.

Awardees having a regular employment will receive a cash award of Rs.1 lakh every year during the course of the project in addition to grants-in-aid of Rs.50 lakhs for a project. The awardees, those are not in the regular employment will receive a fellowship of Rs.40,000 per month with grants-in-aid and shall be attached to a senior scientist (mentor) in a university, research institute, medical/agriculture/ veterinary college or any other institute of repute. The applications should reach the DBT by November 23, 2012.

The applicant should have an excellent academic career and also should have publications in high impact journals and/or should have invented technologies supported by Indian/ International patents. The proposed research project should clearly reflect the innovative thinking and execution capabilities of the applicant.

The minimum eligibility criteria for applicants include: the candidate should have secured First Class grades in examinations of all academic courses for award of a degree from the graduate level onwards; and cumulative publication impact factor of 10 of only either first author or corresponding author OR Cumulative publication impact factor of five of only either first author or corresponding author with two published Indian Patents or one International patent.

Minimum qualification for the applicant is Ph.D. in any branch of life sciences including medicine, veterinary sciences, pharmacy, agricultural sciences, and engineering sciences. Master degree in medicine, engineering/technology is also eligible to apply.
  Source: Pharmabiz

Novartis future growth prospects

Pharmaceuticals Division growth over the next 5 years expected to be driven by portfolio of recently launched products

 

• Division had 7 blockbusters in portfolio in 2011 and expects to achieve 14 or more blockbusters by 2017

Industry-leading Pharmaceuticals pipeline with 73 new compounds presented:

 

• 9 key regulatory milestones achieved so far in 2012
• Over the next 12 months, data read out of 13 late-stage pipeline projects, 9 filings and up to 7 regulatory decisions expected
• Oncology pipeline, AIN457 and heart failure (LCZ696 and RLX030) expected to provide significant newsflow; filing of RLX030 planned to commence in early 2013 in US and EU
• LAMA/LABAs, including QVA149 have potential to become new standard of care for COPD

 Oncology business aims to grow through Glivec patent expiry

 

• Robust late stage pipeline including 13 new chemical entities and 19 new indications
• Oncology late-stage pipeline products expected to contribute more than USD 1 billion in sales by 2017
• Afinitor now expected to contribute USD 2 billion sales in advanced breast cancer alone by 2017
• Start of broad scale clinical development program announced for leading PI3K inhibitor BKM120 across multiple indications (PRISM