The European Commission has granted Novartis the marketing right of Rasitrio, its innovative triple combination medication for high blood pressure. The Swiss pharma company said Monday that Rasitrio, the first triple combination of aliskiren, amlodipine and hydrochlorothiazide (HCT) in a single pill, ...

The National Institute for Health and Clinical Excellence (NICE) has rejected three drugs as the second-line treatment of advanced metastatic colorectal cancer. The England and Wales cost agency has issued a final draft guidance not recommending Merck Serono’s Erbitux (cetuximab), Roche's Avastin (bevacizumab) and Amgen's ...

Summit Corporation said its experimental drug SMT C1100 was granted orphan drug status by FDA for the treatment of Duchenne Muscular Dystrophy (DMD), a fatal genetic neuromuscular disorder.  The European Medicines Agency had granted SMT C1100 orphan drug status in December 2008 The ...

The U.K.'s National Institute for Health and Clinical Excellence (NICE) has recommended Bristol-Myers Squibb and Pfizer's blood-thinner Eliquis for preventing blood clots after surgery. The UK cost agency said in a final guidance that Eliquis, also known as apixaban,  can be used ...

The US Food and Drug Administration has on Friday revoked the approval of Roche's Avastin (bevacizumab) for breast cancer treatment, saying the cancer drug had "not been shown to be safe and effective for that use."  FDA's ruling bringing to ...

The European Commission has granted Pfizer the marketing right of  Vyndaqel (tafamidis) for the treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP) in adult patients with stage 1 symptomatic polyneuropathy. The decision followed the positive opinion of CHMP earlier this summer. TTR-FAP ...

The US Food and Drug Administration had approved Incyte's Jakafi (ruxolitinib) to treat patients with the bone marrow disease myelofibrosis (MF).  Jakafi is the first and only drug granted license specifically for the treatment of the rare blood cancer. MF is a ...

Biogen Idec has received conditional approval from the European Commission for its multiple sclerosis therapy Fampyra, which improves walking in MS patients. The company notes that Fampyra (prolonged-release fampridine) is the first treatment that addresses "this unmet ...

Salix Pharmaceuticals said that the U.S. FDA has rejected its supplemental New Drug Application for Xifaxan 550 mg for the treatment of irritable bowel syndrome (IBS), an anticipated response from the U.S. regulator. FDA turned down the drugmaker's application seeking to market Xifaxan 550 mg tablets ...

FDA request more data for MS pill cladribine Two weeks after Merck KGaA's pulled out its Europe application for the multiple sclerosis drug cladribine after the EU regulator required more data, the German drugmaker suffered further setback on the investigational drug as the U.S. FDA also ...