Even as the dust is yet to settle down over the HPV vaccine trial and death of three tribal girls in Andhra Pradesh, records showed that the total number of deaths among the clinical trial subjects, though not officially termed as part of the trials, are on the increase in India.

 Bangalore, Mar, 23, 2010: Syngene International, a subsidiary of Biocon has entered into a discovery and development collaboration with Endo Pharmaceuticals, USA to develop novel biological therapeutic molecules against cancer.

Under the agreement Endo will retain all rights to the molecules developed, while Syngene International will receive research fees, milestone payments and success fees from Endo.

In some areas of the world, one in four people with tuberculosis (TB) becomes ill with a form of the disease that can no longer be treated with standard drugs regimens, a World Health Organization (WHO) report says.

 India’s clinical research organizations (CROs) are set for exponential growth going by the number of assignments which are coming in here. The global economic slowdown which has seriously impacted western world has benefited the Indian clinical research industry. Scores of assignments are pouring in to conduct clinical trials, pharmacovigilance studies and data management works.

March 22, 2010 — The US Food and Drug Administration (FDA) announced today viral contamination of GlaxoSmithKline's Rotarix vaccine. The agency is recommending that doctors stop using the vaccine until further investigations are complete.

An independent academic research team testing the product recently identified porcine circovirus 1 in the vaccine and notified regulators.

 IR SPECTROSCOPY

 The Indian Pharmaceutical Association (IPA) has demanded to amend the Drugs & Cosmetics Act and Rules 1945 to make only the pharmacy graduates eligible to become expert staffs in the pharma manufacturing units. In the resolutions passed during the just concluded IPA Convention, the IPA also urged the government to expedite action to amend the Rules in such way that all regulatory positions in the country must be an exclusive area for experienced and qualified pharmacists.

 The National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad, is all set to launch India's first dedicated course in medical devices segment from the new academic year starting from July, 2010. The institute is currently in talks with some of the major educational institutes conducting similar courses in the country for expert opinion and will finalise the curriculum soon, senior officials of the institute said.

 Technology Vision Group (TVG) has announced a collaboration with India-based MMActiv, ABLE and the Vision Group on Biotechnology to produce BioPartnering India (BPI) at Bangalore India Bio, India's largest biotechnology event, which is scheduled on June 2-4, 2010. These combined events offer delegates the opportunities for partnering in India.

BundelKhand University, Jhansi

Jaypee Institute, Noida, UP; Waknaghat, HP; Guna, MP

March 16, 2010 (Atlanta, Georgia) — Genotyping warfarin  patients resulted in a 30% reduction in all-cause hospitalizations and hospitalizations for bleeds/thromboemboli, a new study suggests.

The primary duty of the regulatory bodies across the world is to prevent harm from unsafe drugs. In the United States, the law ensures that there shall be a written stability testing programme to assess the stability characteristics of drug products. Stability is the critical quality attribute of a drug product. Further it ensures the capacity of a drug substance, said Kim Huynh-Ba, Technical director of Pharmalytik, Newark in USA.

Janssen-Cilag announced that Priligy (dapoxetine) is now approved and available for use in New Zealand for the treatment of premature ejaculation (PE) in men 18-64 years of age.

PE is a common men's medical condition, but it is rarely talked about. However, it is widespread and could affect the quality of life of an estimated 250,000 New Zealand men and their partners .

Two H1N1 drugs - oseltamivir and zanamavir, the controversial sub-fertility drug letrozole, popular non-steroidal anti-inflammatory drug nimesulide, decongestant drug phenylpropanolamine (PPA), antibiotic drug gatifloxacine, chronic constipation drug tegaserod, type-2 diabetes drug pioglitazone and rosiglitazone have been selected for the first phase of national pharmacovigilance programme which will begin in select 40 medical colleges across the country from April this year.

GVK Biosciences, a contract research organization, has commissioned its new clinical pharmacology unit (CPU) in Ahmedabad. The facility adds 110 beds to the company's existing capacity of 144 beds and will conduct a range of tests on healthy volunteers.

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