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Rx Drugs

May 20, 2021 | Daily News

FDA on Thursday (May 20) released a revised, more detailed version of its 2019 draft guidance that explains how drug and biologics sponsors can use covariates in their clinical trials to more precisely estimate potential treatment effects on trial participants rather than using predictive biomarkers to identify groups of people that would more likely benefit from an investigational treatment.

May 20, 2021 | Daily News

The U.S. Supreme Court denied Sandoz’s petition to review a patent dispute over the company's biosimilar Erelzi, so the earliest Erelzi can be sold in the United States is 2029, even though FDA approved it in 2016.

May 20, 2021 | Daily News

Since announcing U.S. support for a proposed waiver of World Trade Organization intellectual property rules, U.S. Trade Representative Katherine Tai has been making overtures to her holdout counterparts -- including, on Wednesday, those from Japan and Switzerland -- while proponents this week gained another high-profile backer in China.

May 20, 2021 | Daily News

Researchers at the Duke Human Vaccine Institute are seeking funds from the National Institutes of Health to move Duke’s potential pan-coronavirus vaccine platform into phase 1 safety trials in humans.

May 20, 2021 | Daily News

A new working group at the Federal Trade Commission is seeking public input on the commission’s reviews of drug industry mergers, which are becoming more common and have raised concerns about anticompetitive conduct.

May 19, 2021 | Daily News

Emergent BioSolutions officials blamed the manufacturing issues at the company’s COVID-19 vaccine plant in Baltimore on the unprecedented scale-up of production, missing investments and unclear intellectual property agreements, but several Democratic lawmakers noted internal documents show Emergent had multiple warnings about its facility’s shortcomings.

May 19, 2021 | Daily News

The House on Wednesday (May 19) overwhelmingly passed, by a vote of 402 to 23, a bipartisan bill aimed at closing a loophole in the Orphan Drug Act that drug policy experts say has let drug makers inappropriately create monopolies on certain products.

May 19, 2021 | Daily News

FDA plans to set up an inspections council tasked with developing a multi-year strategic plan to optimize the agency’s inspection program and update data infrastructure, Judy McMeekin, FDA associate commissioner for regulatory affairs, announced Wednesday (May 19).

May 19, 2021 | Daily News

Democratic chairs of two House committees asked the Federal Trade Commission Tuesday (May 18) to investigate whether AbbVie broke antitrust laws by fending off biosimilar competition with its patent strategy.

May 18, 2021 | Daily News

The remaining opponents of a proposed waiver of World Trade Organization intellectual property rules for COVID-19-related products should support moving to text-based negotiations “as soon as possible,” the co-sponsors said this week, pledging to kickstart those talks by releasing a revised version “soon.”

May 18, 2021 | Daily News

The Department of Justice and HHS Office of Inspector General this week warned providers that they cannot charge individuals seeking a COVID-19 vaccination and that doing so might violate the False Claims Act and lead to criminal as well as civil penalties.

May 18, 2021 | Daily News

FDA on Monday (May 17) updated its inspection question-and-answer guidance with information on how it will handle drug applications, including when it will approve applications or issue complete response letters, when a physical facility inspection cannot be done due to COVID-19-related travel restrictions.

May 17, 2021 | Daily News

FDA on Monday (May 17) issued a final guidance detailing how product sponsors can use master protocols to test drugs and biologics intended to treat or prevent COVID-19.

May 17, 2021 | Daily News

The Supreme Court on Monday (May 17) agreed to take up a case over Mississippi’s law that bans abortion after 15 weeks, a move seen as the first direct challenge to Roe v. Wade in decades, setting up a high-profile decision to come out in the runup to the mid-term elections.

May 17, 2021 |

The U.S. government plans to share an additional 20 million doses of Pfizer’s, Moderna’s and Johnson & Johnson’s COVID-19 vaccines with other countries, President Joe Biden announced Monday (May 17).

May 17, 2021 | Daily News

The U.S. government plans to share an additional 20 million doses of Pfizer’s, Moderna’s and Johnson & Johnson’s COVID-19 vaccines with other countries, President Joe Biden announced Monday (May 17).

May 17, 2021 | Daily News

Key health policy experts from both sides of the political spectrum say a recent survey by the Purchasers Business Group on Health (PBGH) and the Kaiser Family Foundation (KFF) finding employers are increasingly open to government intervention to rein in health care costs could boost the prospects of Congress acting this year to lower prescription drug costs.

May 17, 2021 | Daily News

South African and Indian officials late last week provided U.S. Trade Representative Katherine Tai updates on revisions to a proposed waiver of World Trade Organization intellectual property obligations for COVID-19 vaccines, which the two countries began pushing last year.

May 14, 2021 | Daily News

The White House is reviewing a batch of four draft and final guidances from FDA that lay out how drug makers can comply with certain requirements under the Drug Supply Chain Security Act, including how they can identify and notify FDA of illegitimate drug products, and how to include product identifiers with product packages.

May 14, 2021 | Daily News

HHS plans to rescind a midnight regulation by the Trump administration that makes health centers pass 340b discounts for insulin and epinephrine to patients, according to a proposal being reviewed by the White House budget office.

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