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Rx Drugs

January 27, 2021 | Daily News

The U.S. government will collaborate with monoclonal antibody developers to target the potentially serious impacts a new strain of COVID-19 found in South Africa poses to the therapy’s efficacy, the White House COVID-19 Response Team announced Wednesday (Jan. 27).

January 27, 2021 | Daily News

A bipartisan group of top government health officials representing the National Academy of Medicine are recommending FDA and CMS policies that the Biden administration could use to control drug prices.

January 26, 2021 | Daily News

The federal government will purchase an additional 200 million doses of Pfizer’s and Moderna’s two-dose COVID-19 vaccines, the White House announced Tuesday (Jan. 26).

January 26, 2021 | Daily News

FDA is keeping a close eye on existing and possible emerging COVID-19 mutations and is considering developing a pathway for potential changes to emergency authorized products, including vaccines, for COVID-19 should they be needed, acting agency chief Janet Woodcock said Monday evening (Jan. 25).

January 26, 2021 | Daily News

The Biden administration reportedly plans to pull back a buprenorphine prescribing guideline that was announced by HHS in the last days of the Trump administration and would exempt physicians from certain certification requirements needed to prescribe buprenorphine for opioid use disorder.

January 25, 2021 | Daily News

Moderna announced Monday (Jan. 25) it will begin trials for booster shots that, when paired with the company’s FDA-authorized COVID-19 vaccine, could offer increased protection against variant strains of the virus that have emerged out of the United Kingdom and South Africa, coming as U.S. health officials and experts from the World Health Organization say they’re keeping a close eye on the mutations.

January 22, 2021 | Daily News

The White House Office of Management and Budget pulled six FDA guidances and rules from its review, a move prompted by President Joe Biden’s freeze on all regulations issued by the Trump administration that have not yet gone into effect.

January 22, 2021 | Daily News

One of President Joe Biden’s executive orders out Thursday steps into the still smoldering issue over coverage of non-diagnostic COVID-19 testing, demanding that HHS clarify insurers’ responsibilities.

January 22, 2021 | Daily News

White House Press Secretary Jen Psaki confirmed Friday (Jan. 22) the Defense Production Act has been invoked and processes to ramp up COVID-19 response supplies, including vaccine and test supplies, are “rapidly ongoing,” coming as New York officials say the state is on the verge of running out of its first-dose batches.

January 22, 2021 | Daily News

Eli Lilly will pursue an expanded emergency use authorization for its monoclonal antibody, bamlanivimab, the company said Friday (Jan. 22) as it revealed that data from an ongoing trial suggest the therapy reduced long-term care facility residents’ risk of contracting symptomatic COVID-19 by 80% compared with those who did not receive the therapy.

January 21, 2021 | Daily News

HHS is freezing for 60 days an 11th-hour final rule from the Trump administration that makes certain health clinics pass 340B discounts on insulin and epinephrine to patients -- but health clinics say the rule might raise prices for some patients.

January 21, 2021 | Daily News

President Joe Biden on Thursday (Jan. 21) signed an executive order directing HHS and other agencies involved in COVID-19 response to take immediate action using all available authorities, including using the Defense Production Act, to fill vaccine, testing and personal protective equipment supply gaps and to take steps to address the pricing of pandemic response supplies.

January 21, 2021 | Daily News

The House Energy & Commerce health subcommittee, and possibly the oversight subcommittee, are expected to hold coronavirus hearings the week of Feb. 1, according to lobbyists.

January 21, 2021 | Daily News

The Senate Finance Committee on Thursday (Jan. 14) released a bipartisan report that blames both drug companies and pharmaceutical benefit managers for rising insulin prices.

January 21, 2021 | Daily News

The Maryland legislature last week overrode GOP Gov. Larry Hogan’s veto of funding for the nation’s first state board created to make drugs affordable.

January 19, 2021 | Daily News

CMS is using a demonstration to weaken two pillars of patient protections in Part D: protected drug classes and the requirement that insurers cover at least two drugs in each class.

January 19, 2021 | Daily News

FDA chief Stephen Hahn blasted an 11th-hour agreement that HHS penned with the U.S. Department of Agriculture shifting FDA’s regulation of animal food biotechnology products to USDA, with the outgoing FDA head vowing his agency will continue to oversee genetically modified animals intended for human consumption.

January 19, 2021 | Daily News

New York Gov. Andrew Cuomo (D) wants to purchase COVID-19 vaccine doses directly from Pfizer rather than waiting for allocations from the federal government, but HHS, which has to give Pfizer permission to sell directly to state governments, isn’t on board with the idea.

January 15, 2021 |

President-elect Joe Biden on Friday (Jan. 15) outlined his plan to expand the availability of and access to COVID-19 vaccines by releasing most of the available doses in reserve, invoking the Defense Production Act to ensure there’s a robust supply, expanding vaccine eligibility to people ages 65 and over, and standing up more vaccination centers across the country and launching mobile vaccination clinics.

January 15, 2021 | Daily News

President-elect Joe Biden on Friday (Jan. 15) outlined his plan to expand the availability of and access to COVID-19 vaccines by releasing most of the available doses in reserve, invoking the Defense Production Act to ensure there’s a robust supply, expanding vaccine eligibility to people ages 65 and over, and standing up more vaccination centers across the country and launching mobile vaccination clinics.

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