Roche is expecting the U.S. Food and Drug Administration to approve the company’s SMA therapy risdiplam by May 24, 2020, and has suggested plans to undercut both Biogen and Novartis on price in order to make up for being third-to-market.
Novartis aims to give away 100 doses of the company’s $2.1 million-per-patient Zolgensma for spinal muscular atrophy (SMA) in 2020 in a free-drug program that one patient group worried was a “health lottery” that could neglect some babies.
Roche’s bid to rival Biogen and Novartis in treating spinal muscular atrophy (SMA) got a lift as the Swiss drugmaker’s drug risdiplam improved motor function of patients in a key study.
U.S. regulators halted a trial of Novartis’ Zolgensma treatment after an animal study raised safety concerns, in a setback for the drugmaker’s plan to expand the product’s use to older patients.
Biogen Inc. reported better-than-expected second quarter 2019 profit and raised the company’s full-year earnings forecast, driven by higher sales of the top-selling multiple sclerosis drug Tecfidera and lower taxes.
The U.S. Food and Drug Administration approved Zolgensma, a gene therapy that Novartis called a life-changing medicine, for children younger than 2 years of age who have been diagnosed with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 gene.
Expectations were high during 2018 for three new migraine drugs hitting the market from Amgen Inc., Eli Lilly and Co. and Teva Pharmaceutical Industries Ltd. Priced around $7,000 each, the drugmakers called them “breakthrough” treatments designed to prevent migraines when taken year-round, and estimated that millions of patients could benefit. But a small group of medical experts who quietly advise U.S. health insurers on new drugs was not impressed, according to a private meeting held at UnitedHealth Group’s OptumRx offices in Chicago that was attended by Reuters.
Novartis AG won U.S. Food and Drug Administration approval for the multiple sclerosis drug Mayzent as the Swiss company targets patients whose disease advances from intermittent attacks to a gradually worsening condition.
Roche is buying U.S.-based gene therapy specialist Spark Therapeutics for $4.3 billion after developments in this area convinced the Swiss drugmaker to “step up”, Chief Executive Severin Schwan said.
Biogen Inc.’s Spinraza treatment for spinal muscular atrophy and Swiss drugmaker Novartis AG’s experimental gene therapy are both expensive, but the gene therapy could be more cost effective once more is known about its U.S. price and long-term success rates, a preliminary report from an independent U.S. nonprofit organization said.