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Rx Drugs

June 11, 2021 | Daily News

The Biden administration has asked HHS to study whether new reimbursement policies could be used to shore up domestic supplies of critical medicines, including the possibility of new federal payment policies that hike profit margins for certain generic sterile injectables and cancer drugs, procurement guarantees and flexible acquisition policies.

June 11, 2021 | Daily News

In a bid to increase availability of Johnson & Johnson’s COVID-19 vaccine, FDA on Friday (June 11) announced it will allow two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore to be released for use in the United States or exported to other countries, despite several quality control and facility management issues at the facility.

June 11, 2021 | Daily News

Democrats are considering adding Medicare drug price negotiation to the president’s American Families Plan and using budget reconciliation to pass it separately from the infrastructure bill, if a bipartisan deal is struck on infrastructure, drug and consumer lobbyists said.

June 10, 2021 | Daily News

Moderna on Thursday (June 10) asked FDA to expand emergency use authorization for its COVID-19 vaccine to kids ages 12 to 17 after the two-dose mRNA vaccine was found to be 100% effective in teens. The vaccine is already authorized for use in adults ages 18 and up.

June 10, 2021 | Daily News

The United States will purchase and donate half a billion doses of Pfizer’s COVID-19 vaccine to 92 low- and lower middle-income countries and the African Union through the end of 2021 and into the beginning of 2022, the Biden administration announced Thursday (June 10).

June 09, 2021 | Daily News

The White House has asked HHS to lead a consortium comprising nearly a dozen federal agencies, the private sector and nonprofit entities charged with crafting a strategy to secure the pharmaceutical supply chain by boosting U.S. production, developing new manufacturing technologies, and increasing the resilience of U.S. and allied pharmaceutical production.

June 09, 2021 | Daily News

The Biden administration committed to pay Merck $1.2 billion for 1.7 million courses of an investigational COVID-19 treatment, molnupiravir (MK-4482), on the condition that FDA at least grants the antiviral an emergency use authorization.

June 09, 2021 | Daily News

World Trade Organization members agreed this week to move ahead with text-based talks on proposals aimed at improving the international pandemic response -- both a waiver of some intellectual property obligations and an alternative from the European Union -- with the United States calling for the final product to focus directly on access to vaccines.

June 09, 2021 | Daily News

Regulatory experts say the development of booster vaccines for COVID-19 raises key regulatory and approval questions for FDA, namely whether the booster shots will be considered wholly new products and have to go through the standard biologics testing and approval process, and whether booster shots from one manufacturer can be mixed and matched with original vaccine regimens from another manufacturer.

June 08, 2021 | Daily News

In a new supply chain report released Tuesday (June 8), the White House, HHS and FDA call for Congress to give FDA the power to collect information about drugs and drug ingredients moving through the U.S. supply chain, coming as the COVID-19 pandemic sheds light on several gaps in FDA’s ability to collect data on the availability of drug ingredients and respond to drug shortages.

June 08, 2021 | Daily News

The prospect of waiving certain provisions of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property garnered widespread support ahead of a Tuesday (June 8) TRIPS Council meeting and following a weekend endorsement from Asia-Pacific Economic Cooperation trade ministers.

June 08, 2021 | Daily News

President Joe Biden’s budget proposes spending $17 million next year on the operations and oversight of the 340B drug discount program, $7 million more than this year, and the budget asks Congress to give HHS the authority to audit hospital records of how savings from the program are spent.

June 08, 2021 | Daily News

The Biden administration is committing $60 million to develop technology that improves manufacturing of complex generic drugs, the White House announced Tuesday (June 8).

June 07, 2021 | Daily News

The drug price watchdog ICER said FDA failed to protect patients by approving Aduhelm (aducanumab) because there isn’t enough evidence that the Alzheimer’s drug works yet there is evidence of serious side effects, and ICER said the drug is grossly overpriced.

June 07, 2021 | Daily News

During weekend meetings, Asia-Pacific Economic Cooperation trade ministers agreed to support a temporary waiver of certain intellectual property protections on COVID-19 vaccines and treatments and committed to speeding up the flow of vaccines, according to a joint statement issued Saturday.

June 07, 2021 | Daily News

The European Union on Friday (June 4) proposed an alternative to the widely debated waiver of certain World Trade Organization intellectual property obligations -- of which the bloc remains critical -- outlining instead an initiative to limit export restrictions on COVID-19-related products, encourage expanded production of vaccines and facilitate intellectual property flexibilities, including issuing compulsory licenses.

June 07, 2021 | Daily News

FDA and industry are in talks about how the agency can support scientific research around and issue guidance on biosimilar interchangeability, according to a summary of a recent biosimilars user fee meeting.

June 07, 2021 | Daily News

FDA on Monday (June 7) approved Biogen’s Alzheimer’s drug Aduhelm (aducanumab) after months of contentious debate during which the agency’s own advisers spoke out against approving the drug, while patients and patient advocates pushed for approval.

June 04, 2021 | Daily News

FDA has granted emergency authorization for a subcutaneous injection version of Regeneron’s COVID-19 antibody therapy -- a move the agency hopes will dramatically increase access since up to now patients could only get the treatment through IV infusions.

June 04, 2021 | Daily News

CMS’ innovation center likely will take a different approach to the drug pricing favored-nation demo attempted by the Trump administration and now delayed by the courts, Center for Medicare and Medicaid Innovation Director Elizabeth Fowler said Thursday (June 3).

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