Medical 3D printing is making quick leaps and bounds and could soon be such a key integrated part of the medical world that we will wonder how we ever lived without it. Doctors are now able to print 3D “living” body parts – which will be a significant advancement for regenerative medicine. A positive breakthrough has already been made, with the successful implantation of bone, muscle and cartilage into [...]
Do cheaper, imported drugs really save money – or just compromise safety? 50 million Americans did not fill a prescription in 2012 because of its cost, a Commonwealth Fund report revealed.[1] Now, prescription costs are under the political spotlight again, with US presidential candidates Donald Trump, Hillary Clinton and Bernie Sanders all commenting on the issue. Speaking out against current Food and Drug Administration (FDA) laws that state it is [...]
Patients in England could have faster access to effective cancer treatments through the reincarnated Cancer Drugs Fund (CDF), the National Institute for Health and Care Excellence (NICE) has announced. The new fund will replace the existing – and greatly overspent – service, which provides access to cancer drugs that are not routinely available at the National Health Service (NHS) in England. Its costs rose to £340 million between 2015 [...]
Nearly one million people are diagnosed with cancer in the United States per year, according to The American Cancer Society, and although cancer therapeutics are among the most active areas in drug development, treatment still falls short of meeting patients’ needs. However, experts believe that immunotherapeutics – in particular T-cell immunotherapy – could help fill a vital gap, with Roots Analysis’ "T-Cell Immunotherapy Market, 2015-2030" report predicting the market [...]
The British pharmaceutical industry is facing new challenges following the UK’s decision to leave the European Union, a white paper has revealed. Published by Global Data, it warned of wide-reaching impacts. 51% of Britain’s medicinal and pharmaceutical products are exported to the European Union (EU). But in June, a referendum indicated the UK should leave the EU – the so-called “Brexit”. While Big Pharma companies emerged from the vote largely [...]
NICE’s Policies Under Fire The National Institute for Health and Care Excellence (NICE), an organization given the responsibility of setting the standards for high quality healthcare in the UK, has come under fire for being too conservative and resource-intensive. In a recent opinion piece in The Times of London, business editor Ian King cautioned that the pharmaceutical industry could abandon drug development in the UK if NICE doesn’t ease its [...]
Does the US Need Another Expedited Drug Development Pathway? The FDA’s meeting to discuss a proposed new pathway aimed at expediting the development of “medicines intended to treat serious or life-threatening conditions with unmet medical needs”, met with a mixed response on February 4th. The proposal was prompted by a report last fall from the US President’s Council of Advisors on Science and Technology(PCAST), which said a “special medical [...]
FDA Hearing on Faster Clinical Trial Process In January the FDA announced it will be holding a public hearing on February 4 and 5, 2013 to gather input on what may lead to a faster clinical trial process for drug and biological products development for "serious or life-threatening conditions that would address and unmet medical need". If approved, an expedited drug development process will be permitted for smaller subpopulations [...]