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Rx Drugs

May 13, 2021 | Daily News

National Institutes of Allergy and Infectious Diseases Director Anthony Fauci on Thursday (May 13) touted a potential new vaccine developed by the Duke Human Vaccine Institute that he says provides evidence it’s possible to develop a universal vaccine that protects against current coronaviruses and future pre-emergent coronaviruses.

May 13, 2021 | Daily News

Bolivia has waded into the fray over intellectual property rights at the World Trade Organization, announcing this week that it intends to import COVID-19 vaccines via a built-in compulsory license framework -- a WTO-compliant pathway that has frequently triggered U.S. ire in the past.

May 13, 2021 | Daily News

The Centers for Disease Control and Prevention on Thursday (May 13) announced that anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physical distancing.

May 13, 2021 | Daily News

Democratic Sen. Michael Bennet (CO) plans to reintroduce his bipartisan antimicrobial drug reimbursement bill this year with revisions that include the Centers for Disease Control and Prevention’s recommendations for tackling antibiotic resistance, the lawmaker told former FDA chief Mark McClellan Wednesday (May 13).

May 13, 2021 | Daily News

Coronavirus booster shots will be free to everyone if they’re needed before the end of the pandemic, White House Chief Science Officer David Kessler said Tuesday (May 11) at a Senate hearing, but it’s not clear how much people will have to pay for coronavirus vaccinations, or what the price will be, once the pandemic is over.

May 13, 2021 | Daily News

Anna Kaltenboeck, program director and senior health economist at Memorial Sloan Kettering Cancer Center’s Center for Health Policy and Outcomes, is joining the Senate Finance Committee to work on drug pricing, with a focus on Medicare reimbursement of outpatient drugs.

May 13, 2021 | Daily News

Proponents of march-in rights view the Biden administration’s support for waiving international patent protections on coronavirus vaccines as an indication the administration might reverse the Trump administration’s proposal to undermine domestic patent march-in powers under the Bayh-Dole Act.

May 12, 2021 | Daily News

Lawmakers from both parties pressed HHS Secretary Xavier Becerra over surprise billing implementation, Medicare policy and non-ACA-compliant plans, including the Trump-era short-term plans and Association Health Plans during a wide-ranging hearing on the department’s fiscal 2022 discretionary budget.

May 12, 2021 | Daily News

The Centers for Disease Control and Prevention on Wednesday (May 12) revealed that it will amend its clinical guidance to allow for COVID-19 vaccines and other childhood vaccinations to be co-administered on the same day or within 14 days of each other, coming just two days after Pfizer and BioNTech’s two-shot product became the first COVID-19 vaccine to be authorized by FDA for use in kids under the age of 16.

May 12, 2021 | Daily News

U.S. Trade Representative Katherina Tai on Wednesday defended the Biden administration’s decision to support talks on waiving some World Trade Organization intellectual property protections for COVID-19 vaccines, telling skeptical senators she acted within her authority to take that position without congressional input.

May 12, 2021 | Daily News

House Majority Leader Steny Hoyer (D-MD) next week will bring back to the House floor a bipartisan bill that aims to close a loophole in the Orphan Drug Act, after Republicans blocked the bill’s passage Tuesday evening (May 11) due to a fallout between the measure’s lead Democratic sponsor and former GOP co-sponsor Rep. Buddy Carter (GA).

May 12, 2021 | Daily News

FDA and National Institutes of Health officials grappled with GOP Sen. Bill Cassidy (LA) over whether people who have previously been infected with COVID-19 need to receive the second dose of the two-dose COVID-19 vaccine regimen.

May 12, 2021 | Daily News

Ten House Democrats are urging Speaker Nancy Pelosi (D-CA) to pursue bipartisan, bicameral drug pricing legislation that focuses on affordability, instead of prices.

May 11, 2021 | Daily News

The Biden administration should have consulted Congress before announcing its support for a waiver of some World Trade Organization intellectual property protections for COVID-19 vaccines, Sen. Chuck Grassley (R-IA) said on Tuesday.

May 11, 2021 | Daily News

FDA reveals in an inspection roadmap that, in the best-case scenario, the agency likely will only be able to complete 27% of the 15,514 domestic inspections it would need to conduct this year to catch up from the surveillance lag caused by the COVID-19 pandemic.

May 11, 2021 | Daily News

HHS Secretary Xavier Becerra on Friday (May 7) told a Hawaii district court that FDA will review and consider potential modifications to its in-person prescribing and dispensing restrictions on abortion drug mifepristone, coming less than a month after the agency announced it had temporarily lifted the restrictions for the duration of the public health emergency.

May 10, 2021 | Daily News

FDA on Monday (May 10) authorized Pfizer and BioNTech’s COVID-19 vaccine for use in kids ages 12 to 15 after data found it to be 100% effective for that age group a week after the second shot, which means the vaccine is now authorized for everyone ages 12 and older.

May 10, 2021 | Daily News

A bipartisan group of 20 House lawmakers wants Congress to stop blocking FDA from using appropriations funding to finalize a rule that would require pharmaceutical prescribing information be shared electronically, rather than in paper format.

May 07, 2021 | Daily News

In a joint statement Friday (May 7), the International Coalition of Medicines Regulatory Authorities and World Health Organization call on drug makers to make clinical trial information about new medicines and vaccines accessible to the public by publishing clinical trial reports without redactions.

May 07, 2021 | Daily News

Biogen’s investigational Alzheimer’s drug aducanumab is worth between $2,500 and $8,300, according to an interim report by the Institute for Clinical and Economic Review, far below of that which some Wall Street analysts predict the price would be if approved.

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