The Senate passed by a vote of 96-1 the spending bill for the outbreak of the new coronavirus (COVID-19), which will be on President Donald Trump’s desk by week’s end. The bill provides $7.8 billion in new funds to tackle the outbreak and another $490 million in existing funds for telehealth, all with the aim of speeding the response to the pathogen.
The first wave of biosimilars began lapping at U.S. shores five years ago when the FDA approved Sandoz Inc.’s Zarxio on March 6, 2015, giving it a label identical to that of its reference biologic, Amgen Inc.’s Neupogen (filgrastim). But the tsunami of biosimilars, and the multibillion dollars of savings they were expected to bring, has yet to wash ashore.
The March 4 congressional hearing on the budget for the NIH was peppered with questions about the COVID-19 outbreak, although the general sentiment is that the agency will receive yet another boost in appropriations in fiscal 2021.
Lowering levels of tau protein improved multiple symptoms of autism spectrum disorders (ASD) in two different mouse models of the disease, both of which are driven by hyperactivity of the mTOR PI3 kinase pathway.
With battles over the future of American health care being waged in the courts and at the ballot box, JAMA, the Journal of the American Medical Association, has devoted its latest issue to better understanding what Deputy Editor Gregory Curfman called the "challenging problem" of "relentless increases" in prescription drug prices.
Against the backdrop of the global spread of COVID-19, India announced restrictions Tuesday on the export of 26 active pharmaceutical ingredients (APIs) and formulations of those ingredients.
COVID-19 is bringing more pressure to bear on Congress to pass S. 2723, the Mitigating Emergency Drug Shortages (MEDS) Act, which has been sitting in the Senate Health, Education, Labor and Pensions (HELP) Committee since Sen. Susan Collins (R-Maine) introduced it in October 2019 – a few months before the novel coronavirus emerged.
The U.S. FDA is well known for encouraging industry to meet with the agency “early and often” for complex premarket filings, but the Combination Products Coalition (CPC) says a recent draft guidance seems to offer the exception. The group said the December 2019 FDA guidance for feedback on combination product applications “seems to generally discourage” the use of the combination product agreement meeting (CPAM). It added that the complexity of some combination products suggests that such a meeting may well be crucial to an efficient application process.
Beyond every binary is a more complex reality. And so it is with driver and passenger mutations. The separation of tumor mutations into drivers and passengers underpins much progress in the development of targeted therapies.
Rated the No. 1 most prepared country in the world to tackle an epidemic, the U.S. could see its preparedness put to the test as it responds to the growing COVID-19 outbreak. While the administration is pointing to that rating from a recent global survey to calm fears about the risk in the U.S., the coronavirus emergency is spotlighting cracks in the nation’s preparedness.
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