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Rx Drugs

May 07, 2021 | Daily News

Pfizer and BioNTech on Friday (May 7) began the process of seeking full FDA approval of their COVID-19 vaccine for people ages 16 and older.

May 06, 2021 | Daily News

CMS on Thursday (May 6) more than doubled the reimbursement for home infusion of COVID-19 monoclonal antibodies to treat those with coronavirus, from a national average payment rate of $310 to $750 and raised the pay rate for most health care settings from $310 to $450.

May 06, 2021 | Daily News

Opponents of the COVID-19-related waiver of World Trade Organization intellectual property protections, surprised by the U.S. announcement Wednesday that it would back the effort, are being pushed to follow Washington's lead, which has decisively changed the conversation in Geneva.

May 06, 2021 | Daily News

Boehringer Ingelheim executives hope to be the first to get a biosimilar designated as interchangeable by the end of this year.

May 06, 2021 | Daily News

The USC Schaeffer Center and the Aspen Institute published a paper with recommendations for how the government should achieve the president’s plan for an organization that appraises the value of drugs.

May 05, 2021 | Daily News

The pharmaceutical industry is incensed by the Biden administration’s announcement that it will support a proposed waiver of World Trade Organization intellectual property protections for COVID-19 vaccines, arguing it will “undermine” the global pandemic response and calling it an “empty promise.”

May 05, 2021 | Daily News

The U.S. will support a proposed waiver of World Trade Organization intellectual property obligations for COVID-19 vaccines and “actively participate” in text-based negotiations in Geneva, U.S. Trade Representative Katherine Tai announced on Wednesday, arguing the global emergency “calls for extraordinary measures.”

May 05, 2021 | Daily News

More than 100 House Democrats have thrown their weight behind a proposed World Trade Organization waiver of certain intellectual property obligations for COVID-19 vaccines and medicines, with half the caucus entreating the Biden administration to support the waiver as a moral, economic and public health priority.

May 04, 2021 | Daily News

The House Energy & Commerce health subcommittee will hold a hearing next Wednesday (May 12) with HHS Secretary Xavier Becerra to discuss HHS’ 2022 discretionary budget request, and lawmakers will use the opportunity to quiz Becerra on the administration’s vague plans to cut prescription drug costs and expand health coverage.

May 04, 2021 | Daily News

As soon as FDA authorizes Pfizer’s COVID-19 vaccine for kids ages 12 to 15, the Biden administration will launch a comprehensive plan to make sure as many adolescents as possible can get vaccinated by July 4, administration officials announced Tuesday (May 4), coming amid reports that FDA will announce the emergency authorization by early next week.

May 03, 2021 | Daily News

Policy experts applauded the release of a bipartisan Senate bill that focuses on ramping up the antibiotic supply chain, but the experts say lawmakers also should focus on crafting and passing legislation that creates incentives for antibiotic developers.

May 03, 2021 | Daily News

The Biden administration on Friday (April 30) withdrew an eleventh-hour Trump-era policy that would have required FDA to publish review timelines for certain drug product applications.

May 03, 2021 | Daily News

Co-sponsors at the World Trade Organization of a proposed waiver of certain intellectual property commitments said on Friday they would review, and potentially revise, the language with an eye to finding common ground, even as the U.S. remains skeptical of the waiver’s likelihood of delivering more vaccine production.

April 30, 2021 | Daily News

FDA’s panel of oncology advisers on Thursday (April 29) voted 6-2 against letting Merck Sharpe & Dohme’s Keytruda (pembrolizumab) keep its accelerated approval status as a third-line treatment for gastric cancer.

April 30, 2021 | Daily News

FDA’s oncology advisory committee on Thursday (April 29) narrowly voted against letting Bristol-Myers Squibb’s Opdivo (nivolumab) maintain its accelerated approval as a second-line treatment for patients with a type of liver cancer known as hepatocellular carcinoma.

April 28, 2021 | Daily News

President Joe Biden said he wants to move on drug price negotiation this year and use savings to shore up the Affordable Care Act beyond a permanent extension of enhanced tax credits included in the American Rescue Plan and expand Medicare coverage benefits.

April 28, 2021 | Daily News

FDA’s oncology advisory committee on Wednesday (April 28) voted in favor of allowing Merck Sharpe & Dohme’s Keytruda (pembrolizumab) and Genentech’s Tecentriq (atezolizumab) maintain their accelerated approvals for treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

April 28, 2021 | Daily News

A broad-based coalition focused on value-based insurance design is re-upping its push to let high-deductible health plans (HDHP) linked to health savings accounts (HSAs) cover more items and services needed to manage chronic diseases, like diabetes, prior to the deductible.

April 28, 2021 | Daily News

President Biden has not decided whether to support a proposed waiver of some World Trade Organization intellectual property rights rules as a part of a global pandemic response, nor has U.S. Trade Representative Katherine Tai made a recommendation to him, White House Press Secretary Jen Psaki said on Tuesday.

April 28, 2021 | Daily News

House Energy & Commerce Committee Democrats are trying to restore the Federal Trade Commission’s power to make companies return illegal profits and pay back victims of scams after the Supreme Court last week ruled that FTC does not have that authority.

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