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Daily News

October 08, 2020

FDA on Wednesday (Oct. 7) quietly updated its COVID-19 testing frequently asked questions webpage to say it will no longer review emergency use authorization requests for laboratory-developed tests for COVID-19.

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Health care analytics company IQVIA reports that biosimilars are on track to reduce drug costs in the United States by $100 billion over the next five years, five times more than biosimilars saved during the past five years, because more biosimilars are becoming available and health insurers are instituting policies that favor the products.

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A U.S. appeals court ruling in a case between GlaxoSmithKline and Teva Pharmaceuticals could discourage the use of so-called “skinny labels” to speed generic competition, according to the dissenting judge in the case.

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October 07, 2020

President Donald Trump on Wednesday (Oct. 7) conceded that a vaccine likely won’t be available until after the November presidential election, but he blamed it on so-called political games.

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President Donald Trump announced in a video posted on Twitter Wednesday (Oct. 7) that he has authorized FDA to grant emergency use authorization to experimental COVID-19 antibody cocktails developed by Regeneron and Eli Lilly, adding that they’ll be distributed to patients at no cost.

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FDA is open to using data from other countries to approve a COVID-19 vaccine, biologics center director Peter Marks told physicians during a Wednesday (Oct. 7) webinar.

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Eli Lilly plans to price its coronavirus antibody candidates based on how much money they save by avoiding hospitalizations, emergency room visits “or other problems associated with COVID-19," and the company will tier pricing among countries so rich countries pay more than poor countries, Eli Lilly Chairman and CEO Dave Ricks said Wednesday (Oct. 7).

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CMS Administrator Seema Verma on Wednesday (Oct. 7) said her agency will prioritize those most at risk for COVID-19 to get vaccines once they are available, and that includes those in nursing homes.

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The Congressional Budget Office tells senators it still expects there will eventually be two types of short-term plans -- traditional short-term plans that provide little coverage and others that provide enough benefits for CBO to consider enrollees “covered” -- but says it will continue to monitor the market.

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Nearly half of the consumers responding to a recent survey by the National Association of Insurance Commissioners (NAIC) indicated they don’t know whether their plans fully cover COVID-19 testing and treatment, and about one-third said they received a bill for a COVID-19 related service that they expected their insurance would cover.

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HHS is soliciting nominations for a group that will examine policies and strategies to help individuals who were eligible for Medicaid while incarcerated have a seamless transition back into health coverage when they reenter communities, more than a year after the Trump administration missed a SUPPORT Act deadline to set up the group.

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October 06, 2020

In a Tuesday (Oct. 6) letter, a group of more than 60 medical academics and scientists, including former Obama-era health officials, urge FDA Commissioner Stephen Hahn and biologics center director Peter Marks to strengthen the agency’s guidance on safety criteria for COVID-19 vaccines brought to market under an emergency use authorization.

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HHS will begin the 14-week compliance window Wednesday (Oct. 7) under its interim final rule that requires hospitals to report COVID-19 data directly to the department or face being kicked out of Medicare and Medicaid.

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Connecticut Attorney General William Tong told drug makers Eli Lilly, Novartis, Sanofi, AstraZeneca and Merck to stop policies that could limit 340B discounts available through contract pharmacies, though some following the issue say it’s unclear what a state attorney general could do to halt the practices as 340B is a federal program.

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Supreme Court justices heard arguments Tuesday (Oct. 6) in a case that could determine whether states may regulate pharmacy benefit managers to lower drug prices, and many justices sounded skeptical states have that authority.

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Despite prior opposition from the White House, FDA on Tuesday (Oct. 6) published guidance that lays out the criteria for any COVID-19 vaccine maker seeking emergency use authorization.

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President Donald Trump tweeted Tuesday (Oct. 6) he has broken off talks on another COVID-19 relief package until after the Nov. 3 election and has asked Senate Republicans to focus entirely on confirming Amy Coney Barrett to the Supreme Court, even as Federal Reserve Chair Jerome Powell warned that too little relief will stunt economic growth.

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President Donald Trump signed an executive order Monday (Oct. 5) to create a working group charged with examining how COVID-19 has affected mental health, the same day he was released from Walter Reed National Military Medical Center after his COVID-19 diagnosis.

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Radiation oncologist and other physician groups are asking CMS to push back the radiation oncology demonstration and ease the cuts that are built into the model, especially given the ongoing COVID-19 pandemic.

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The Medicare Payment Advisory Commission on Thursday (Oct. 1) expressed support for a staff recommendation to shift indirect Medicare education payment towards outpatient-centric settings, although no official vote was taken.

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