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The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, the Chinese government maintains that the situation is “preventable and controllable.”
Immuno-oncology has produced some exciting successes, but the field has become intensely crowded. Enormous resources are being poured into duplicative work and shaky hypotheses—overshadowing other pursuits in cancer research while producing limited results. It is time to re-evaluate how the sector should be pursuing innovation in cancer and how it can be smarter in its use of resources—financial investment, talent, bandwidth, patients and data.
An expert panel at CES 2020 discussed Deloitte's vision for health care in 2040, with the empowered consumer managing their own health, enabled by a new ecosystem of secure, open access to data and "nudges" to change behaviors. Consulting firm Deloitte foresees outside disruptors dismantling the traditional health-care system, but panelists from Johnson & Johnson and Anthem flexed their muscles.
The US-Mexico-Canada (USMCA) treaty calls for the three countries to “recognize audits” performed under the Medical Device Single Audit Program. MDSAP is already used by device makers in the US and Canada so they can undergo one audit by an accredited third party to satisfy quality regulations. That leaves Mexico as the odd country out when it comes to using the popular program – and that means it has some catching up to do after the USMCA is ratified by all three nations. Former longtime FDA official Kim Trautman weighs in on how Mexico can incorporate MDSAP into its regulatory framework.
The introduction of gene therapies has been the highest-profile new modality to reach the market, but new RNA-based therapeutics hold significant potential and could be more accessible for patients. Scrip reviews the leading drug developers in this space.
An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.
Biktarvy’s powerful sales growth and the potential of a first-in-class capsid inhibitor in both prevention and heavily treatment-experienced patients are key to Gilead’s plan for staying on top in HIV.
After a year full of disappointing and unexpected events, the South Korean pharma sector is hoping for a turnaround in 2020, with expected biosimilar launches in global markets, progress in drug pipelines, large IPOs and implementation of a new law on cutting-edge biologics.
California’s 2020-2021 fiscal budget includes plans to work with manufacturers to establish the state’s own generics label. But industry is sceptical that the initiative will deliver the savings that the US state hopes for.
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