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President Barack Obama late Wednesday signed into law a bill to compensate patients who participate in clinical trials involving rare diseases. Read More
Long-term efficacy data on two multiple sclerosis drugs — Novartis’ Gilenya and Sanofi’s Lemtrada — back their ability to keep relapsing MS at bay, while Roche’s investigational ocrelizumab performed well in both relapsing and primary progressive forms of the disease. Read More
The FDA last month awarded $19 million in research grants to boost the development of products to treat 17 different rare diseases, many of which have little or no available treatment options. Read More
The European Medicines Agency has released draft guidance explaining how drugmakers can use pharmacodynamic and pharmacokinetic analyses to hasten the development and review of new antibiotics. Read More
The FDA is seeking up to nine drugmakers to participate in a four-month pilot project to examine whether final submission of risk evaluation and mitigation strategies can be made more accessible to the public. Read More
Despite its lucrative promise, the U.S. Food and Drug Administration’s priority review voucher program has done little to spur development of novel treatments for tropical and rare pediatric diseases, a new study in JAMA concludes. Read More
Despite its lucrative promise, the FDA’s priority review voucher program has done little to spur development of novel treatments for tropical and rare pediatric diseases, a new study in JAMA concludes. Read More
Roche’s ocrelizumab proved effective in treating primary progressive multiple sclerosis in a Phase 3 study, making it the first investigational drug to show positive results for both PPMS and relapsing remitting MS. Read More