On Monday, Signifor – Novartis’ newest drug aimed at treating a rare hormonal disorder called acromegaly – was approved by the European Union. Signifor is now available in 27 European member states, including Iceland and Norway. An application for Signifor’s approval had been also currently filed in the US. The European Commission’s approval for Novartis’ new acromegaly drug was mainly based on … [Read more...]
Cardio Drug Novel Novartis Faced Rejection By FDA
A complete response letter has been issued by FDA in context with the biologics license application for RLX030, Novartis reported. The move is the latest blow to a treatment Novartis yearned would be a keystone of a cardiovascular franchise. Also known as serelaxin, the drug is similar to the naturally occurring human hormone relaxin-2, which has been found to help women adjust to the … [Read more...]
Novartis’ Signifor LAR therapy highly effective in acromegaly patients
Swiss drug maker Novartis on Monday presented the final-stage trial of Signifor long-acting release (LAR) therapy and expressed confidence that it can do wonders in treating patients with the endocrine disorder acromegaly than existing therapies. The clinical trial was presented at the 16th European Congress of Endocrinology3. The study, conducted by Novartis, showed that patients who took … [Read more...]
FDA gives green signal to Novartis’s ‘Zykadia’ to treat lung cancer
The U.S. Food and Drug Administration has give its green signal to Novartis's new therapy drug 'Zykadia'(ceritinib) to treat a certain type of late stag non-small cell lung cancer (NSCLC). The early approval comes as a surprise as FDA was expected to finish reviewing the drug application by August 24, 2014 and then pronounce its verdict. Zykadia is the fourth drug with breakthrough … [Read more...]
Novartis To Seek Approval For Heart Failure Drug LCZ696 As Trial Ends Positively
Bolstering its prospects of getting cardiovascular franchise, Swiss company Novartis is going to seek approval for an experimental heart failure treatment sooner than it had expected. An independent panel has recommended Novartis to close a late-stage trial for a twice-a-day pill LCZ696 after the clinical trial results showed patients taking the drug lived longer without being … [Read more...]
Novartis plans to approach FDA as its Plaque psoriasis drug clears trial
Swiss drugmaker Novartis on Saturday said that its experimental drug secukinumab proved to be more effective than Enbrel at clearing psoriasis in a phase III clinical trial. According to the firm, the drug showed good results in a two late-stage clinical trials when used by patients suffering from moderate-to-severe plaque psoriasis. The study findings were presented at the American Academy … [Read more...]
Novartis in trouble for breaking trial protocol in Japan
The employees of Swiss drugmaker Novartis are under fire for violating a trial protocol by inappropriately transferring clinical test results for one of its cancer drugs. According to the drugmaker, the employee at its Japanese unit violated clinical trial rules by wrongfully indulging in the transfer of data on a cancer drug from research centers to University of Tokyo Hospital. Meanwhile, … [Read more...]
