Novartis muscle wasting drug gets 'breakthrough' status
ZURICH Novartis said on Tuesday U.S. regulators have granted breakthrough therapy status for its investigational compound bimagrumab for the potential treatment of patients with sporadic inclusion body myositis (sIBM).
The U.S. Food and Drug Administration (FDA) created the "breakthrough therapy" designation earlier this year for medicines deemed likely to demonstrate "substantial improvement" over existing drugs.
sIBM is a rare yet potentially life-threatening muscle-wasting condition. Patients suffering from the disease can gradually lose the ability to walk. There are currently no approved treatments, according to Novartis.
Bimagrumab was developed by Novartis in collaboration with Morphosys. The drug works by stimulating muscle growth by blocking from inhibitory molecules.
(This corrects day of the week to Tuesday from Thursday)
(Reporting by Caroline Copley)
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Novartis muscle wasting drug gets 'breakthrough' status
ZURICH Novartis said on Tuesday U.S. regulators have granted breakthrough therapy status for its investigational compound bimagrumab for the potential treatment of patients with sporadic inclusion body myositis (sIBM). The U.S. Food and Drug Administ2013-08-20 NOVARTIS -
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n">Sarepta Therapeutics Inc said the U.S. Food and Drug Administration has requested for additional data for its muscle-wasting treatment as the agency decides whether to approve the drug or not. Shares of the company rose 24 percent to $19.90 in -
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AstraZeneca wins FDA breakthrough status for key cancer drug
LONDON The U.S. Food and Drug Administration has granted breakthrough therapy designation to AstraZeneca's biggest new drug hope durvalumab as a treatment in bladder cancer, the drugmaker said on Wednesday. The experimental medicine is a so-called P -
Pfizer cancer drug wins special status; shares jump
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Ersatzhaut für Verbrennungsopfer Orphan-Drug-und biologischen Status von der FDA erteilt
Eine Gewebeersatztherapie eine Ersatzhaut zu schaffen katastrophalen Brandopfern eigenen Hautzellen 'wurde ein kombiniertes Orphan-Drug-und biologischen Produkt Status von der US Food and Drug Administration unter Verwendung der zur Behandlung von Pa -
FDA staff question Novartis cystic fibrosis drug
WASHINGTON U.S. drug reviewers questioned whether Novartis AG's experimental inhaled antibiotic powder truly helped cystic fibrosis patients breathe better, according to documents posted by the Food and Drug Administration on its website Friday. The -
FDA panel backs Novartis cystic fibrosis drug
WASHINGTON Drug advisers on Wednesday backed a new form of Novartis AG's inhaled antibiotic that treats a lung infection linked to cystic fibrosis. A panel of outside advisers to the Food and Drug Administration voted 13 to 1 that Novartis had demons -
US FDA probes brain infection in patient on Novartis's MS drug
n">The U.S. Food and Drug Administration said it was investigating a case of a rare and serious brain infection that developed in a patient in Europe, who was being treated with Novartis's multiple sclerosis drug, Gilenya. The FDA said this was th -
FDA staff review recommends against Novartis heart failure drug
WASHINGTON A drug to treat acute heart failure made by Novartis AG should not be approved because there is insufficient evidence to show it improves symptoms, according to an initial review by the U.S. Food and Drug Administration. The review, posted -
Novartis closes heart drug study early after strong results
ZURICH Novartis has ended a late-stage clinical trial of a chronic heart failure drug early, following strong interim results, giving the Swiss drugmaker a boost after recent setbacks to another heart failure medicine. The Basel-based firm said on Mo -
U.S. regulator rejects Novartis heart failure drug
ZURICH U.S. health regulators turned down an application to approve Novartis' experimental heart failure drug due to insufficient evidence that it improves symptoms, the Swiss drugmaker said on Friday. Novartis said in a statement the Food and Drug A -
EU agency recommends against Novartis heart failure drug
ZURICH EU health regulators have recommended against approving Novartis's experimental heart failure drug for the second time this year due to insufficient evidence it improves symptoms, the Swiss drugmaker said in a statement on Friday. The ruling b -
FDA sets approval path for Prosensa muscle disorder drug
n">Prosensa Holding NV said the U.S. Food and Drug Administration had outlined an accelerated regulatory approval path for its most advanced drug, aimed at treating a muscle disorder. The Netherlands-based company said on Tuesday it planned to con
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