FDA's MedWatch Safety Alerts: April 2012 - TMCnet

Dangerous Mix for People With Diabetes or Kidney Disease FDA is warning of possible risks for people with diabetes or kidney disease who use blood pressure medicines containing aliskiren in combination with other drugs called angiotensin ...

Novartis to probe Indian drug approval allegations - Reuters

In the case of 11, including Novartis' everolimus and aliskiren, it found that "mandatory" Phase III trials - the final stage of testing before a drug is approved - had not been conducted as required. Specifically, in the case of everolimus ...

Have your drugs passed clinical trials for sure? - Daily News and Analysis

phase III clinical trials mandated by rules for 11 drugs were not conducted These drugs are Everolimus (Novartis), Colistimethate (Cipla), Exemestane (Pharmacia), Buclizine (UCB), Pemetrexid (Eli Lilly), Aliskiren (Novartis), Pentosan (West Coast ...

Eli Lilly Could Sink On Drug Collusion In India - Seekingalpha.com

A number of drugs were randomly assessed and in 11 cases, including Novartis' everolimus and aliskiren, it was found that "mandatory" Phase III clinical trials had not been conducted as required. In its defense, Novartis claims that it conducted trials as ...

Probe finds collusion between drug regulator, pharma firms - Reuters India

These included Novartis' (NOVN.VX) everolimus and aliskiren, and Eli Lilly's (LLY.N) pemetrexed. In the cases of everolimus and pemetrexed, the opinion of independent experts was not sought by the CDSCO, which relied on the judgment of non ...

UPDATE 2-Probe finds collusion between India's drug regulator, pharma firms - Reuters

These included Novartis' everolimus and aliskiren, and Eli Lilly's pemetrexed. In the cases of everolimus and pemetrexed, the opinion of independent experts was not sought by the CDSCO, which relied on the judgment of non-medical staff ...

GlaxoSmithKline, Novartis, Eli Lilly face Indian collusion charges - The Australian

Yesterday Novartis, whose drugs everolimus and aliskiren were also named in the report, said that it planned to investigate the claims. India's $US12 billion ($11.93bn) pharmaceutical market is the fourth-largest in the world in volume terms, according to ...

Panel exposes flaws in India’s drug approval procedure - Livemint.com

According to the committee’s findings, CDSCO approved 33 new drugs (including Cipla Ltd’s colistimethate and pirfenidone, Novartis Pharmaceuticals’s aliskiren and GlaxoSmithKline’s ambrisentan) between January 2008 and October 2010 without ...

Timing Is Right For Pfizer - Seekingalpha.com

The company claims that although two of its drugs, everolimus and aliskiren, had not undergone the "mandatory" Phase III clinical as required, the standard by which it approved drugs in India, namely by having non-medical staff determine the efficacy and ...

Probe finds collusion between India drug regulator, pharma firms - Yahoo Finance

These included Novartis' (NOVN.VX) everolimus and aliskiren, and Eli Lilly's (LLY.N) pemetrexed. In the cases of everolimus and pemetrexed, the opinion of independent experts was not sought by the CDSCO, which relied on the judgment of non ...