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FiercePharma |
PhIII data puts AZ one step closer to severe-asthma showdown with GSK
FiercePharma Last week, the British drugmaker announced that its candidate for severe asthma with eosinophilic inflammation–benralizumab–had nailed its primary endpoint in two Phase III studies, beating out placebo at paring down the annual asthma exacerbation … |
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Nephron recalls more than 80000 cartons of its asthma products
FiercePharma Nephron, which two years ago got crosswise with the FDA over the asthma product, is recalling three lots, comprised of 32,490 cartons, of its Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator refills. It also is recalling 47,754 cartons of … |
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Sweden says AstraZeneca used questionable asthma drug API from Indian plant
FiercePharma Manufacturing AstraZeneca ($AZN) said last week it was closing a plant in India that made the API for asthma drugs, noting there is not much demand any longer for the terbutaline sulfate it makes. But what the U.K. company did not say was that before its closing … |
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Advera Health: Novartis, GSK asthma meds linked to more side effects than …
FiercePharma Healthcare informatics firm Advera Health Analytics scoured FDA postmarketing safety reports to compile data on side effects for companies producing asthma meds. Advera uses a reporting odds ratio (ROR) to compare the actual number of side effects … |
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FDA cites Cipla India plant after U.S. recall of asthma drug
FiercePharma Manufacturing In May, India's Cipla voluntarily pulled a lot of its levalbuterol from the U.S. market after the asthma inhalation drug failed a test for a degradant. Shortly after, FDA inspectors visited the plant in Indore where Cipla made the product and came away … |
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ProPublica: Safety questions over GSK's Advair linger after years on the …
FiercePharma Recent research suggests that a significant percentage of asthma patients begin using Advair inappropriately, the watchdog says, and that can trigger the "risk of asthma-related death" described on the med's label. And while the FDA in 2010 required … |
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GSK's Breo for asthma? FDA panel says yes–but only in adults
FiercePharma Good news for GlaxoSmithKline ($GSK): An FDA panel of experts says the efficacy and safety data for blockbuster wannabe Breo support the asthma indication it's gunning for in adults 18 and older. When it comes to children aged 12 to 17, though? UPDATE 2-FDA panel backs Glaxo asthma drug for adults, not adolescents U.S. Panel Backs Glaxo's Breo for Asthma in Adults, Not Kids FDA panel backs Glaxo asthma drug for adults, not adolescents |
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Fox News |
FDA slaps cardiovascular warnings on Roche/Novartis asthma blockbuster Xolair
FiercePharma It was way back in 2009 when the FDA first indicated it was worried about reports of heart attacks and strokes in patients taking Xolair, the asthma treatment co-marketed by Novartis ($NVS) and Roche ($RHHBY). Now the agency is taking action, slapping … FDA says asthma drug Xolair raises risk of heart, brain problems Heart, Mini-Stroke Risks From Asthma Drug: FDA FDA adds cardiovascular risks to Xolair label for asthma treatment |
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French Tribune |
Novartis says asthma blockbuster Xolair also effective against serious hives
FiercePharma But Novartis says in financial filings that its pricing is under pressure for the asthma treatment. In the U.K., the price watchdog NICE last fall indicated it might drop approval of the drug there but then relented in March after Novartis offered up … Novartis reports new Phase III data showing omalizumab significantly improves … Novartis skin drug helps patients with chronic hives Novartis' omalizumab effective for severe hives |
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Glenmark's Singulair generic recalled for fishy smell
FiercePharma Manufacturing It has happened again, and this time, it involves nearly 600,000 bottles of Glenmark Pharmaceuticals' generic version of the Merck ($MRK) blockbuster asthma med, Singulair. The company is voluntarily recalling 29 lots of its montelukast sodium tablets. |
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