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Rx Drugs

April 28, 2021 | Daily News

The attacks on the main metric used to evaluate drug prices -- quality-adjusted life years (QALYs) -- are increasing in intensity and frequency as lobbyists for patients and drug makers prepare for a fight over government price negotiation.

April 28, 2021 | Daily News

Although drug pricing legislation is taking center stage, there are some policies, including appraisals and reporting requirements, that likely would need to be handled administratively because budget reconciliation rules would prohibit them, sources say.

April 28, 2021 | Daily News

The Biden administration’s American Families Plan, set to be unveiled Wednesday night, invests $200 billion to make permanent the rescue plan’s hiked Affordable Care Act tax credits, which the White House is framing as a tax cut for millions of families that would be offset through tax reforms.

April 27, 2021 | Daily News

FDA’s oncology advisory committee on Tuesday (April 27) voted 7--2 in favor of allowing Genentech to continue marketing its oncology drug Tecentriq (atezolizumab) for use in combination with nab-paclitaxel to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) even though the drug has not shown clinical benefit in postmarket confirmatory trials.

April 27, 2021 | Daily News

Key House Democrats plan to include drug pricing reforms in infrastructure legislation regardless of whether the president calls for letting Medicare negotiate drug prices in his American Families Plan, but Senate Democrats are keeping quiet about their next steps if President Joe Biden excludes drug pricing.

April 27, 2021 | Daily News

Pfizer is developing an oral COVID-19 treatment that company CEO Albert Bourla expects will be available by the end of 2021.

April 27, 2021 | Daily News

The Institute for Clinical and Economic Review on Monday (April 26) released a slate of 10 policy reforms FDA and payers could undertake to strengthen FDA’s accelerated approval pathway.

April 27, 2021 | Daily News

FDA oncology center officials Richard Pazdur and Julia Beaver defended FDA’s accelerated approval pathway in a recent journal article, saying just because a small number of accelerated approval drugs haven’t shown clinical benefit in postmarket studies doesn’t mean the pathway is a failure.

April 27, 2021 | Daily News

U.S. Trade Representative Katherine Tai spoke with the top executives of Pfizer and AstraZeneca on Monday about a proposed waiver of obligations to the Agreement on Trade-Related Aspects of Intellectual Property, where the ambassador expressed “deep sympathy” for the people of India, where COVID-19 deaths have reached alarming rates in recent days.

April 26, 2021 | Daily News

Vermont Rep. Pete Welch (D-VT) said Monday (April 26) that House Democrats have numerous good ideas on how to spend the $456 billion or so that could be gleaned through government negotiation and other policies in their drug-pricing bill, but they need to focus on ensuring the legislation can pass before fighting over other health care investment priorities.

April 26, 2021 | Daily News

The Biden administration is moving the right direction on the pandemic-related proposal to waive some intellectual property obligations at the World Trade Organization, Rep. Jan Schakowsky (D-IL) said on Friday, pointing to support from the U.S. Agency for International Development, among others.

April 26, 2021 | Daily News

The Biden administration announced Monday (April 26) that it’s diverting its order of raw materials for AstraZeneca’s coronavirus vaccine to India to help the country rapidly scale vaccine manufacturing as it experiences a surge of COVID-19 cases.

April 26, 2021 | Daily News

Canada’s drug regulation authority is relying on information provided by Emergent BioSolutions’ troubled manufacturing facility in Baltimore, which recently halted its production of COVID-19 vaccines after an FDA inspection found deficient manufacturing practices dating back to February, to vouch for millions of doses of AstraZeneca’s COVID-19 vaccine donated by the United States last month prior to the inspection findings.

April 23, 2021 | Daily News

A Johns Hopkins hematologist told members of the Centers for Disease Control and Prevention’s immunizations advisory committee that he’s still unsure what could be causing people who received the Johnson & Johnson and AstraZeneca COVID-19 vaccines to experience a rare blood clot condition known as thrombosis with thrombocytopenia.

April 23, 2021 | Daily News

The Centers for Disease Control and Prevention’s immunizations advisory committee on Friday (April 23) agreed to restart use of Johnson & Johnson’s COVID-19 vaccine in the United States with new warning statements about potential blood clots included in FDA’s health care provider and patient fact sheets.

April 23, 2021 | Daily News

The Supreme Court ruling against the Federal Trade Commission on Thursday (April 22) is expected to make it difficult for FTC to police anticompetitive practices in the drug industry.

April 23, 2021 | Daily News

The lobbies representing non-profit, community-based health plans are asking the Biden administration to give carriers access to federal vaccination data so they can help reach out to enrollees.

April 23, 2021 | Daily News

Despite six months of discussion, a proposal to waive a swath of intellectual property obligations at the World Trade Organization to facilitate COVID-19 vaccine and therapeutics access is no closer to approval, with developed members, including the U.S., continuing to question whether it would be effective and if IP rights are indeed barriers.

April 22, 2021 | Daily News

The House Energy & Commerce Committee plans to hold a hearing May 4 on Democrats’ drug pricing bill following its reintroduction Thursday morning (April 22), lobbyists said.

April 22, 2021 | Daily News

Generic drug makers are lobbying to get their products excluded from penalties for excessive price increases in drug pricing legislation, lobbyists say.

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