Latest California Healthline Stories
FDA Guards Against Abuse Of ‘Orphan Drug’ Program
Following a KHN and NPR investigation, the Food and Drug Administration has moved to speed up approvals of “orphan drugs” while closing a loophole that allowed drugmakers to skip pediatric testing.
Over-The-Counter Devices Hold Their Own Against Costly Hearing Aids
In a head-to-head comparison, several of the cheaper devices performed nearly as well as the expensive hearing aids. The study lends credence to lawmakers’ efforts to get the FDA to set standards for the “personal sound amplification products.”
FDA Ruling On Aussie Biotech Could Boost Congressman’s Investment
Innate Immunotherapeutics, whose largest shareholder is Buffalo-area Rep. Chris Collins, received FDA approval to begin U.S. trials of its drug for treating advanced multiple sclerosis.
Nearly 1 In 3 Recent FDA Drug Approvals Followed By Major Safety Actions
More than 70 drugs approved from 2001 through 2010 ran into safety concerns later that resulted in withdrawals from the market, “black box” warnings or other actions.
A Spoonful Of Kids’ Medicine Makes The Profits Go Up
Even as drug pricing issues continue to draw scrutiny, federal safety regulations and incentives offer drug companies a new avenue to get a sweet return on their development costs.
Dispositivos que salvan vidas en los Estados Unidos se fabrican en México
Casi todos los estadounidenses con marcapasos -y personas en todo el mundo- caminan portando partes fabricadas en Tijuana, México, en donde se ha creado una industria que podría estar en riesgo si la administración Trump cambia el juego del comercio global.
Also Made In Mexico: Lifesaving Devices
The medical supply industry makes a particularly revelatory case study of the difficulties of untangling global trade.
Trump’s Promise To Rein In Drug Prices Could Open Floodgate To Importation Laws
Sen. Bernie Sanders’ bill to allow Americans to buy cheaper medicines from Canada would bypass a requirement that blocked past legislative efforts over two decades.
$89,000 Orphan Drug Gets A New Owner — And Likely A New Price
Marathon, maker of an expensive treatment for Duchenne muscular dystrophy, sells the drug for $140 million in cash and stock to PTC Therapeutics.
By The Numbers: Trump’s Choice For FDA Chief Is Versatile And Entrenched In Pharma
The numbers show that President Trump’s choice for FDA commissioner, Scott Gottlieb, has long-standing ties to pharmaceutical companies as a board member or consultant and that he had to recuse himself multiple times while working at the FDA.