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Posts tagged with "FDA"

CMS Rules

CMS Announces It Will Cover Alzheimer's Drugs, With a Caveat

Last Thursday, the Centers for Medicare and Medicaid Services (CMS) announced that it would reverse course on anti-amyloid treatments for Alzheimer's patients and cover Leqembi should it receive full approval from the U.S. Food and Drug Administration (FDA). June is Alzheimer's Awareness month. Leqembi, produced by Biogen and Eisai,...
National News

Alzheimer's Treatment Leqembi May Be Authorized by CMS Despite Hefty Price Tag

Support for Medicare coverage of the anti-Alzheimer's drug Leqembi is growing on Capitol Hill, but estimates of the drug's cost may prove to be prohibitive for the Medicare program. Coverage of the drug through the Medicare program would raise costs for the program by $2 billion to $5 billion per year, according to a new study by...
National News

Eli Lilly Poised to Release Findings in Alzheimer's Treatment Study

As pressure mounts from stakeholders and lawmakers, Eli Lilly, producer of the experimental Alzheimer's antibody drug donanemab, is saying that it expects the Centers for Medicare and Medicaid Services (CMS) to reverse its prohibition of anti-amyloids. A bipartisan group of nearly half of U.S. state attorneys general sent a letter to...
National News

COVID-19 Update April 20, 2023

A single shot of the bivalent booster will become the standard vaccination regimen for people seeking their first COVID-19 vaccination. Only a single dose will be needed for most people, instead of the currently-recommended two doses. According to the Wall Street Journal, a second booster will be authorized for groups that are high...
National News

Texas Judge Blocks Mifepristone Authorization, Biden Administration Appeals

Late last Friday, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a ruling that invalidated the U.S. Food and Drug Administration's authorization of mifepristone, one of two drugs used in combination to induce abortion. The Washington Attorney General Bob Ferguson then attempted to intervene...
National News

Reproductive Health Update March 29, 2023

District Judge Matthew Kacsmaryk is taking his time returning a verdict on a case that could set a major precedent for the courts to intervene in regulatory authority. Wyoming passed a bill banning all forms of abortion, but the law was swiftly cut down by a District Court judge. Judge Kacsmaryk of the Western District of Texas wanted...
COVID-19 Update March 16, 2023 Arizona News

COVID-19 Update March 16, 2023

Last Saturday marked the third anniversary of COVID-19 being declared a worldwide pandemic. As the Arizona Republic points out in a retrospective, since that declaration, COVID-19 has killed more than 1.1 million Americans and 33,000 Arizonans. There were 4,262 new cases of COVID-19 in Arizona this week with 56 new deaths related...
Arizona Legislative Update March 16, 2023 Arizona News

Arizona Legislative Update March 16, 2023

Arizona lawmakers made progress on several bills related to healthcare and COVID-19 this week. Last Tuesday, the Arizona Senate Health and Human Services Committee approved HB 2474, which would prohibit schools from requiring immunizations issued by the U.S. Food and Drug Administration (FDA) under emergency use authorization for...
Arizona News

Reproductive Health Update March 9, 2023

This week in reproductive health care news, anti-abortion activists ask the Arizona Supreme Court to reinstitute the Territorial-era total ban on abortion. Attorneys for the Alliance Defending Freedom contend that the state appellate court was incorrect when it said the law did not apply to abortion providers. The Capitol Times...
COVID-19 Update March 2, 2023 Arizona News

COVID-19 Update March 2, 2023

The Occupational Safety and Health Administration (OSHA) will allow Arizona to continue operating its own state plan for worker safety and health. The Centers for Medicare and Medicaid Services (CMS) offer insight into life without the COVID-19 public health emergency (PHE). The U.S. Food and Drug Administration (FDA) issued an...
Arizona News

AZ AG Joins Suit to Relax Regulations on Mifepristone

A group of 12 Democratic State Attorneys including Arizona's Attorney General Kris Mayes filed a lawsuit last Thursday asking the U.S. Food and Drug Administration (FDA) to remove prescription and dispensation restrictions on mifepristone. The attorneys general argue that removing the FDA restrictions would increase access to...
COVID-19 Update February 2, 2023 Arizona News

COVID-19 Update February 2, 2023

On Monday, the Biden administration announced that it would end the COVID-19 public health emergency (PHE) declaration. The announcement came as the U.S. House of Representatives passed two bills that would curb federal authority in pandemic response. In Arizona, legislators are pushing bills that would ban schools from requiring...
Arizona News

Abortion News Update: Arizona Abortion Ban on Genetic Fetal Anomaly Stands

This week, a federal judge ruled that an Arizona abortion restriction will stand, and anti-abortion advocates file a lawsuit that would challenge the U.S. Food and Drug Administration's (FDA) authority to authorize mifepristone. Late last week, the U.S. Department of Health and Human Services (HHS) released a report that details the...
National News

FDA Approves New Alzheimer's Drug, Medicare Decision Pending

The U.S. Food and Drug Administration (FDA) has approved the drug Leqembi (lecanemab) for the treatment of Alzheimer's disease, but patients will have a difficult time accessing the treatment due to Medicare rules and a hefty price tag. Leqembi, developed by the Japanese pharmaceutical manufacturer Eisai and its stateside partner...
COVID-19 Update December 29, 2022 Arizona News

COVID-19 Update December 29, 2022

COVID-19 cases across the state are down this week, but are expected to rise following the winter holidays. The Supreme Court ruled that a Trump-era border restriction enacted due to the COVID-19 pandemic will remain in effect while the court settles the issue. The U.S. Supreme Court allowed the controversial Title 42 to remain in...
COVID-19 Update: November 17, 2023 Arizona News

COVID-19 Update: November 17, 2023

The U.S. Department of Health and Human Services (HHS) has signaled that it will delay the end of the public health emergency (PHE) related to the COVID-19 pandemic until April, quelling fears from stakeholders that not enough time was given to review Medicaid eligibility for everyone enrolled since the pandemic began. In Arizona,...
COVID-19 Update October 6, 2022 Open

COVID-19 Update October 6, 2022

National Institute of Allergy and Infectious Disease Director Dr. Anthony Fauci announced on Tuesday that there is a possibility of a new COVID-19 variant emerging this winter. Over the past two winters, the U.S. has experienced drastic surges in cases, most recently due to the outbreak of the Omicron variant BA.1. Fauci said in his...
FDA Approves Pricey Drug for ALS Despite Concerns Over Effectiveness National News

FDA Approves Pricey Drug for ALS Despite Concerns Over Effectiveness

The FDA panel originally rejected approval of the drug due to insufficient data in March. In a rare move, the panel reversed its decision in a 7 to 2 vote after Amylyx provided more data, estimating Relyvrio could extend life expectancy by nearly 10 months compared with placebo. The FDA approved Relyvrio for the treatment of ALS on...
COVID-19 Update September 22, 2022 Arizona News

COVID-19 Update September 22, 2022

In a 60 Minutes interview on Sunday, President Joe Biden announced that the COVID-19 pandemic is over, but many disagree. The Moderna Omicron-specific booster has resumed production and distribution. The president puzzled epidemiologists, the public and members of his own administration with his remarks in an interview Sunday in which...
Arizona News

Monkeypox and Vaccine Distribution in Arizona

With more than 7,000 confirmed cases of monkeypox across the country, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra announced a public health emergency (PHE) for the monkeypox epidemic. The PHE declaration may help to streamline vaccination efforts, but stockpiles of vaccine are low and a drug that could...
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