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Rx Drugs

March 25, 2021 | Daily News

Longtime Democratic operative Chris Jennings has joined the governance board of the Institute for Clinical and Economic Review, an independent organization that assesses drug values and that could become a key part of Democrats’ plan to control drug prices.

March 25, 2021 | Daily News

FDA announced Thursday (March 25) that it has raised facility fees for its over-the-counter monograph user fee program to make up for the lack of revenue from non-traditional hand sanitizer manufacturers that temporarily entered the market provide sanitizer during the COVID-19 pandemic and were then carved out of the user fee program by the Trump administration.

March 25, 2021 | Daily News

Germany’s drug pricing model, which makes drug companies justify prices to an independent panel, got a lot of attention Tuesday (March 23) at a Senate subcommittee hearing that highlighted the higher prices Americans pay for drugs compared to prices in the rest of the world.

March 25, 2021 | Daily News

HHS will stop distributing Eli Lilly’s COVID-19 monoclonal antibody bamlanivimab as a single therapy across the United States due to increased spread of COVID-19 variants that are resistant to bamlanivimab when it’s administered by itself, the department announced Wednesday (March 24).

March 25, 2021 | Daily News

The Washington state senate recently passed a bill to partner with other states and nonprofit organizations to make generic drugs for state employees and programs, but Washington does not plan to build state drug making facilities like California is considering.

March 24, 2021 | Daily News

Sen. Amy Klobuchar (D-MN) on Monday (March 22) reintroduced legislation to let Medicare negotiate drug prices, and the bill has 32 Democratic senator cosponsors, including Sen. Joe Manchin (D-WV), who has frustrated Democrats on other policies.

March 24, 2021 | Daily News

Former FDA head Scott Gottlieb urged drug makers to take the lead and start investing in innovative technologies to facilitate prescription-to-over-the-counter switches, rather than waiting for FDA to issue regulations that lay down the rules of the road.

March 23, 2021 | Daily News

House Speaker Nancy Pelosi (D-CA) said everything is on the table for the next legislative package that is expected focus on infrastructure improvements and include health care provisions like a permanent increase to the Affordable Care Act tax credits -- and she said the package likely will be paid for by tackling prescription drug prices.

March 23, 2021 | Daily News

AstraZeneca came under fire Tuesday (March 23) after the National Institutes of Health called the company out for publicly sharing outdated information about its COVID-19 vaccine.

March 23, 2021 | Daily News

Science and policy experts say HHS should stop distributing Eli Lilly’s FDA-authorized COVID-19 monoclonal antibody bamlanivimab throughout the United States as FDA has found the therapy is less effective against new strains of COVID-19 compared than are other emergency authorized antibody cocktails.

March 22, 2021 | Daily News

AstraZeneca on Monday (March 22) announced that it will seek emergency use authorization for its two-dose COVID-19 vaccine, which raised questions about whether a potential authorization could create a vaccine surplus in the United States and allow the Biden administration to share additional doses with other countries.

March 22, 2021 | Daily News

Acting FDA chief Janet Woodcock wants the medical research sector to move toward more pragmatic clinical studies where investigations of repurposed drugs would be run primarily off of health records, and to focus on conducting more community-based research that would enable more diverse clinical trials.

March 19, 2021 | Daily News

A top FDA official told Congress on Thursday (March 18) that FDA could feasibly authorize updates or changes to COVID-19 vaccines without requiring clinical studies in humans in the hopes of speeding the premarket regulation process to mitigate the spread of new strains of the virus.

March 19, 2021 | Daily News

Once COVID-19 vaccine booster shots become available, people with compromised immune systems and other preexisting health conditions likely will need to be first in line to get the shots since their antibody levels will wane faster than those of otherwise healthy people, National Institute of Allergy and Infectious Diseases Director Anthony Fauci told lawmakers during a Senate health committee hearing Thursday (March 18).

March 18, 2021 | Daily News

A federal Indiana court’s decision to temporarily halt the 340B administrative dispute resolution process because of the Trump HHS’ unusual rulemaking procedures will have little near-term effect because the Biden administration has yet to fill the ADR panels, an industry lawyer said.

March 18, 2021 | Daily News

The preliminary injunction in favor of Eli Lilly’s lawsuit against a 340B rule could help pharmaceutical benefit managers in a separate legal challenge to HHS’ Medicare Part D rebate-ban rule.

March 18, 2021 | Daily News

The Biden administration hopes to donate 4 million of the 7 million releasable doses of the AstraZeneca COVID-19 vaccine, which is not yet authorized for use in the United States, to Mexico and Canada, White House Press Secretary Jen Psaki said Thursday (March 18).

March 18, 2021 | Daily News

The rapid invention of coronavirus vaccines with government funding has sparked conversations about taxpayers assuming a greater responsibility for drug development, and therefore price setting, that traditionally has been left to private investors.

March 18, 2021 | Daily News

The pandemic relief law that President Joe Biden signed Thursday (March 11) takes a new approach to using the Defense Production Act to buy and make medical supplies, including drugs and vaccines.

March 18, 2021 | Daily News

Congress should abolish biosimilars and instead set biologics prices, following their 12 years of exclusivity, that would give their inventors a 10% profit, according to researchers at the nonprofit, nonpartisan Drug Pricing Lab.

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