NEW YORK (Reuters Health)—In what is believed to be the largest study investigating genetic and clinical determinants of osteoporotic fracture risk, only a genetic predisposition to low bone mineral density (BMD) had a potential causal role to play. “Notably, genetic predisposition to lower levels of vitamin D and estimated calcium intake from dairy sources were…
Search results for: Novartis
FDA Names Drugmakers Potentially Acting to Delay Cheap Generics
(Reuters)—The U.S. Food and Drug Administration on Thursday listed drugmakers, including Celgene Corp, Johnson & Johnson, Gilead Sciences and Novartis AG, who the regulator says are potentially blocking access to samples of their drugs to delay generic competition. Generic drugmakers may not be able to develop alternatives without access to samples of branded products they…
Secukinumab Promising for Sustained Improvements in Palmoplantar & Nail Psoriasis
In clinical trials, secukinumab proved safe and effective as a long-term treatment for both palmoplantar and nail psoriasis…
New Drug Approvals Hit 21-Year High in 2017
LONDON (Reuters)—U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light—more than double the previous year—while the figure also rose in the European Union. The European Union (EU) recommended 92 new drugs, including generics, up from 81; and China laid out plans to speed up approvals in what…
U.S. Approves Digital Pill that Tracks When Patients Take It
(Reuters)—U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.1 The medicine is a version of Otsuka Pharmaceutical Co Ltd’s established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking…
Rheumatology Drug Updates: Efficacy Studied Following Accelerated Drug Approvals; Plus Secukinumab Meets Benchmark for Psoriasis
Medications for serious or life-threatening conditions may receive accelerated approval from the U.S. Food and Drug Administration (FDA) by showing an effect on surrogate measures that are reasonably likely to predict a treatment’s clinical benefit. Post-approval confirmatory drug trials are then required to determine whether or not these effects translate into clinical improvements. In recent…
Report on EU’s Experience with Biosimilar Drugs Released: Will U.S. Experience Be Similar?
As questions about biosimilar medications swirl among U.S. rheumatologists, a recently released report sheds some light on the European experience with biosimilars—and may offer some important insights for the U.S. market. The report, Biosimilars in the EU: Information Guide for Healthcare Professionals, was released in late April by the European Medicines Agency (EMA) and the…
Secukinumab Meets 5-Year Benchmark for Psoriasis
In an extension study, nearly half the patients with plaque psoriasis taking secukinumab maintained skin clearance for the five years of the study…
Many Drug Companies Fail to Conduct Timely Safety Checks on Medicines after FDA Approval
(Reuters Health)—In the rush to approve new medicines, the U.S. Food and Drug Administration often requires drug companies to study possible side effects and alternative doses for medicines once they hit the broader market. A September 20 online analysis in the New England Journal of Medicine concludes that, in many cases, that’s not being done….
Costly Drugs to Weigh on U.S. Employers’ Expenses in 2018
(Reuters)—U.S. employers are bracing for higher health care expenses in 2018 as spending on new drugs to treat diseases, such as cancer, multiple sclerosis and hepatitis C, is expected to rise more than 7%, according to consultancy firm Mercer.1 Between 40 and 50 new specialty drugs are set to hit the market each year in…
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