Tag:
Gilenya
Latest Headlines
Latest Headlines
UPDATED: EMA approves Novartis' Gilenya
The drug dodged a bullet in the EU when the European Medicines Agency said it could remain on the market.
Ono's oral MS drug eliminates brain lesions in promising PhII study
An oral MS drug was credited with eliminating a large percentage of the brain lesions characteristic of the disease.
Novartis reports patient taking Gilenya developed rare brain disease
Expectations for the blockbuster status of Gilenya dimmed when Novartis disclosed that a patient taking the drug has developed a rare brain disease.
Watchdog says FDA should consider restricting Gilenya
The Institute for Safe Medicine Practices has zeroed in on Novartis' new multiple sclerosis pill.
Novartis persuades NICE to endorse Gilenya
The U.K.'s cost-effectiveness watchdog has changed its mind about Gilenya. The National Institute for Health and Clinical Excellence at first rejected the Novartis multiple sclerosis pill, in spite of an up-front discount offer. Now, thanks to some new data from the Swiss drugmaker, NICE has decided to recommend the drug instead.
Active Biotech gets boost from late-stage oral MS program
Active Biotech's ( $ACTI ) shares jumped after its partner Teva Pharmaceutical ( $TEVA ) touted results of a late-stage trial for an oral multiple sclerosis drug under development with Active. While...
Gilenya market share drops after FDA review
An FDA safety review is taking its toll on Gilenya sales. The Novartis ( $NVS ) multiple sclerosis pill, the first oral therapy for the debilitating disease, lost market share in January after reports that some patients died while using the drug.
Biogen Idec races to FDA and EMA with a blockbuster app for BG-12
Biogen Idec has filed an NDA on BG-12 , another step in its blockbuster quest to gain an approval on its best near-term hope for a game-changing new treatment.
Old drug + potential new use = headache for pharma
Potential new uses for approved drugs crop up regularly. Most drug companies build their business plans around adding indications to new products; after all, the more patients who are eligible to use
New death reports prompt EMA review of Gilenya
European regulators are taking a closer look at Novartis' ( $NVS ) multiple sclerosis pill Gilenya . After the November death of a 59-year-old patient who'd just begun Gilenya therapy, triggering an FDA
