Indravadan Modi-led Cadila Pharmaceuticals said it has recieved regulatory approval for conducting rabies vaccine toxicology studies in India and clinical study of influenze vaccine is planned for 2012.

CPL Biologics (CPLB), its joint venture in India with US based Novavax Inc, is preparing to initiate clinical studies of vaccines to prevent influenza and rabies, in 2012 and 2013, resepectively, a statement said.

"Our joint venture with Novavax Inc. is progressing well and remains on track to begin clinical testing of two new vaccines," Chairman Cadila Pharamaceutical Indravadan A Modi said, in a statement.

CPLB completed positive preclinical immunogenecity studies of a rabies G-protein nanoparticle vaccine and recently recieved approval from the Review Committee on Genetic Manipulation(RCGM) to begin toxicology studies of its vaccine prior to initiating human clinical trials.

The CPLB facility at Dohlka taluka of Ahmedabad will be used initially to produce clinical supplies of the two vaccines and will later be used to produce commercial products as well.

Novavax, is a clinical stage biopharmaceutical company creating novel vaccines for infectious diseases using virus like particle and recombinant nanoparticle technology.

ISTA Pharmaceuticals, Inc. announced it has initiated a Phase 2 clinical study of its BEPOSONE(TM) nasal spray combining bepotastine besilate with a steroid for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. The randomized, placebo-controlled, parallel-group environmental study will evaluate the safety and efficacy of the combination nasal spray, dosed twice daily, in patients presenting with allergic rhinitis caused by one of the most potent seasonal allergy triggers, Mountain Cedar pollen.

ISTA expects to enroll approximately 600 patients in Texas who will be treated with either the bepotastine besilate-steroid combination nasal spray, nasal spray containing only one of the active agents, or placebo nasal spray for two weeks. Patients will grade both individual nasal and ocular symptoms on a daily basis during the treatment period.

ISTA submitted the Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for BEPOSONE nasal spray in October 2011. The company expects to report results of this Phase 2 clinical study for BEPOSONE in the first half of 2012.

Scientists from the reputed British Medical Journal or BMJ have found that pharma companies under report data from clinical trials to regulatory authorities and journals, and at times also concealing their trial study. BMJ studied, to what extend companies reveal the details of the process of the trials and found that the "registry reports and publications submitted by companies insufficiently report clinical trials but may supplement each other".

Clinical trial studies are a pre requisite before launching and marketing a drug.

The journal undertook a detailed research that focussed on the three areas where clinical trial data are published; they looked at medical publications, clinical study reports and registry reports to evaluate to the reporting standards. The study found that 'publication bias' and 'outcome reporting bias' are a problem and responsible for distorting scientific evidences. The journal said "perception of the effects of healthcare interventions based on published literature is biased towards overestimating benefits and underestimating harms. This problem of distorted public record is widely prevalent".

Pharma companies have to register their clinical trials and also submit the study results with regulators; this information has to be accessible to the public. In 2005 drug companies signed what was known as the Ottawa statement, which made it mandatory for pharma companies to publish not only the initial study data, but also negative impact of the a particular drug.

The need for detailed reporting in clinical trial became evident when British pharma giant Glaxo SmithKline was held guilty by the New York State Supreme Court for withholding information and misrepresenting data of its anti depressant drug Paxil. In India too, there have been serious allegations against drug companies for undertaking clinical trial by misleading patients. The trial for Human Papilloma virus (HPV) vaccine undertaken by US Pharma Company Merk in association with the NGO PATH created a controversy when four tribal girls from Andhra Pradesh and Gujarat died while undergoing the trial.

The BMJ scientists say that insufficient public information leads to difficulty for healthcare professionals to arrive at a reliable medical conclusion and provide accurate medical interventions. The report concludes that, "there is a need for mandatory registration of all clinical trials and for a mandatory standard for registry reports containing sufficient details on study methods and results to allow full evaluation of the validity of a clinical trial and its outcomes".