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Friday, July 1, 2022

Sanofi flu vaccines licensed and approved for 2022-2023 influenza season

 Fluzone® High-Dose Quadrivalent (Influenza Vaccine) and Flublok® Quadrivalent (Influenza Vaccine) are the only two flu vaccines proven to help prevent more cases of flu in older adults, compared to their standard-dose flu vaccine comparators as assessed in randomized controlled trials, the gold standard in evaluating clinical evidence for vaccine licensure1,2

*  Fluzone® High-Dose (Influenza Vaccine) is the first and only influenza vaccine with superior flu protection and 10 years of evidence in preventing flu-related hospitalizations in adults aged 65+2,3,a,b
*  As the leaders in flu, Sanofi is committed to protecting patients most at-risk for the flu and its related complications, including hospitalizations due to pneumonia & cardiovascular events4

White House Promotes 'AbortionFinder' Tool Helping Minors Skirt Parental Notification

The memo came from Health and Human Services, and the White House passed it along on official letterhead. “Know Your Rights: Reproductive Health Care,” read the title of the document that represents the latest effort by the Biden administration to make good on the president’s post-Roe promise to “do all in my power to protect a woman’s right” to an abortion.

The memo in question points the public to AbortionFinder.org, an online tool that provides pregnant women information on where they can terminate their pregnancy. The website also directs minors “15 or younger,” RealClearPolitics was first to report, to resources for bypassing parental notification laws.

“Some states require people under 18 to involve a parent or guardian when getting an abortion,” a pop-up window announces to minors seeking an abortion. “If you need to avoid involving a parent or guardian, contact the If/When/How Judicial Bypass (JB) Helpline for information about getting a judicial bypass.”

That hotline and the accompanying online Abortion Finder are products of Power to Decide, a pro-abortion nonprofit funded, in part, by federal grants from the Department of Health and Human Services. And for now, the White House is leaning on allied outside organizations like these to preserve access to abortion.

The regulatory landscape has already shifted with almost half of the states preparing to significantly limit or outlaw abortion altogether. Some Democrats, including Massachusetts Sen. Elizabeth Warren and New York Rep. Alexandria Ocasio-Cortez, have called on the president to build abortion clinics in federal parks and on military bases. Others want Biden to expand the number of justices on the Supreme Court, adding pro-abortion judges for the express purpose of reversing the opinion. He has rejected both those ideas. Otherwise, the president is all ears.

Biden called on Congress to codify Roe, either during this Congress or the next, if Democrats expand their majorities. And the president supports changing the Senate filibuster to ease passage.

Meanwhile, according to HHS Secretary Xavier Becerra, options are limited. “There is no magic bullet,” Becerra told reporters at a Tuesday press conference, “but if there is something we can do, we will find it and we will do it.” As of now, that includes giving minors the resources needed to find an abortion provider and, if necessary, to secure an abortion without notifying their parents.

Power to Decide has focused on reducing teen pregnancy since its founding in 1996, and the abortion advocacy organization lists Google, the Ford Foundation, and the Bayer Corporation among its many major funders. It has also received significant financial support from the federal government since 2001. Previously called the National Campaign to Prevent Teen and Unplanned Pregnancy, Power to Decide has received nearly $16 million in grants from the HHS, a figure that includes $897,585 awarded in the first year of the Biden administration.

According to public lobbying disclosures, the federally funded group also lobbied Congress in support of a number of key White House priorities. “We also worked to advance policies that would reduce barriers to abortion care,” the organization wrote in its 990 tax-exempt documents, “including the elimination of the Hyde Amendment from the president’s budget and the House-Passed FY2022 appropriations bill and the passage of the Women’s Health Protection Act.”

Power to Decide declined to comment when contacted by RealClearPolitics. The White House, meanwhile, referred RCP to HHS when asked about its efforts to shore up abortion access and, in some cases, to provide resources to minors looking to skirt parental notification laws. That agency, however, did not return repeated RCP requests for comment.

Congressional Republicans are already furious. “Here’s Joe Biden turning to a Google and Big Pharma-funded outfit to help teenagers - 15 and younger - get abortions. Priorities,” tweeted Missouri Sen. Josh Hawley. Michigan Rep. Lisa McClain blasted the Biden administration, telling Fox News that the move was "unbelievable."

Abortion advocates such as the ACLU have long argued that parental notification laws jeopardize the health of teenagers and that “the risks of delayed and denied health care far outweigh the costs of permitting teens to consent on their own to abortion services.”

Abortion opponents respond that parental notification laws are necessary safeguards to protect minors who, in some cases, may be victims of sexual assault.

“The White House instructing young girls on how to go around their parents to get abortions is radical and dangerous. Parental involvement policies are wildly popular – they protect children from exploitation by the profit-driven abortion industry and abusers and traffickers who use abortion to cover up their crimes,” said Mallory Carroll, a spokeswoman for Susan B. Anthony Pro-Life America.

Abortion opponents such as Carroll warn that the White House is overplaying its hand. “Pro-abortion Democrats have failed to learn the political and moral lesson from the Virginia elections last year that you don’t come between parents and their children,” she told RCP in a statement. “They should expect similar results.”

https://www.realclearpolitics.com/articles/2022/07/01/white_house_promotes_abortionfinder_tool_helping_minors_skirt_parental_notification__147832.html

Reining In the Agencies

 The Supreme Court saved a crucial decision for the last day of its term, ruling 6–3 in West Virginia v. Environmental Protection Agency that the Clean Air Act does not allow the EPA to move from regulating individual power plants to regulating regional emissions through its interpretation of the Clean Power Plan. The opinion, written by Chief Justice John Roberts, cited the major questions doctrine, according to which Congress must “speak clearly if it wishes to assign to an agency decisions of vast economic and political significance.”

“This decision properly keeps the EPA in its lane and rejects the agency’s efforts to usurp national energy policy from Congress,” Jones Day partner Yaakov Roth, who argued the case in front of the Supreme Court on behalf of the plaintiffs, told me. “It is a very important step toward political accountability and economic certainty” Indeed, the case has far-reaching implications for other agencies that could currently be exceeding their statutory remits. The Securities and Exchange Commission, for example, recently proposed requirements for companies to disclose their exposure to climate risk and to provide details about the climate effects of their operations. Meantime, the National Labor Relations Board is considering making franchise businesses such as McDonald’s accountable for the actions of local franchises. Such rules could find themselves on the wrong side of the Court’s approach, which found the EPA’s rulemaking to be an example of “agencies asserting highly consequential power beyond what Congress could reasonably be understood to have granted.”

The Clean Air Act allows the EPA to set maximum levels of new and existing emissions sources. However, the Clean Power Plan, proposed in 2015 under President Barack Obama, went further. If emissions exceeded the EPA’s requirements, a state, or group of states, would be required to shut down power plants or to install renewable energy sources. The plan was similar to the American Clean Energy and Security Act, introduced by Democratic congressmen Henry Waxman and Edward Markey in 2009, and the American Power Act, introduced by senators John Kerry and Joe Lieberman in 2010. Neither bill became law, despite sizeable Democratic majorities in both chambers.

Writing for the majority, Chief Justice Roberts argued that “EPA claimed to discover an unheralded power representing a transformative expansion of its regulatory authority in the vague language of a long-extant, but rarely used, statute designed as a gap filler. That discovery allowed it to adopt a regulatory program that Congress had conspicuously declined to enact itself.” The dissent, written by Justice Elena Kagan, parted ways on the grounds that “Congress . . . gives an expert agency the power to address issues—even significant ones—as and when they arise.” Given that climate change is such an issue, the dissent holds, the EPA has the authority to regulate carbon emissions and therefore reduce the environmental danger. But Justice Neil Gorsuch elaborated on the major-question doctrine in a concurring opinion, writing, “The framers believed that the power to make new laws regulating private conduct was a grave one that could, if not properly checked, pose a serious threat to individual liberty.”

Severe, government-imposed cuts in carbon emissions raise the cost of electricity and American-made goods. Under the Clean Power Plan, some states or groups of states would have had to meet EPA targets by ensuring plants cut emissions or by financing reductions in other ways, such as suppressing consumer demand or investing in more costly renewable energy. In any case, carbon emissions are declining naturally without the plan. Emissions of energy-related carbon dioxide declined by 14 percent from 2007 to 2019, according to the Energy Information Administration. Between 2014, when the Clean Power Plan was proposed, and 2019, two years after the Trump administration rescinded it, these emissions fell by 5 percent.

Cleaner air and efficient power generation are worthwhile goals. But so is the security that comes from the rule of law. The Supreme Court has just weighed in on that balance, and could weigh in further in the years ahead.

DC Health Dept lays off 131 workers, ends COVID contact tracing program

 The DC Health Department ended its COVID-19 contract tracing program on Thursday, laying off 131 workers employed by the program.

“The COVID-19 Contact Trace Force has been instrumental in helping slow the spread of COVID-19 in the District of Columbia,” DC Health told The Hill. “However with COVID infection levels coming down and easier access to at-home testing kits, the COVID-19 Contact Trace Force is no longer as effective or vital a tool as it was during the peak of the pandemic.”

The District of Columbia government currently considers COVID-19 infection levels in the area “low,” the most recent weekly case rate coming in at 195.9 for the week of June 19 to 25 and the most recent hospital admission rate at 0.4 percent.

DC Health emphasized that its department gave advance notice of the end of the trace force and aided its employees in finding new roles.

“DC Health provided contact tracers with opportunities to learn more about new positions and even a career fair,” a spokesperson told The Hill, adding that many will continue to work in DC government and disease investigation.

The DC government will continue operating its mobile contact tracing system despite the closure of its overall contact tracing program, allowing DC residents to opt in for notifications about potential exposure to COVID-19.

“The DC CAN digital exposure notification system for mobile devices will remain in place and fully supported, and DC Health will continue to monitor the spread of diseases in the community, including COVID-19, and provide consultative services to high-risk facilities,” wrote the department.

https://thehill.com/homenews/state-watch/3543643-dc-health-department-lays-off-131-workers-ends-covid-contract-tracing-program/

Novavax expects COVID vaccine targeting Omicron in fourth quarter

 Novavax Inc said on Friday it expects to provide a COVID-19 vaccine targeting Omicron in the fourth quarter as it accelerates development of shots to protect against the BA.4 and BA.5 subvariants.

The U.S. FDA on Thursday recommended COVID-19 vaccine manufacturers change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 subvariants.

Novavax expects additional preclinical data on shots tailored against the fast-spreading Omicron subvariants in late summer or fall.

The company's vaccine, based on an earlier strain of the virus, has not yet been authorized in the United States and is currently under U.S. Food and Drug Administration review.

https://finance.yahoo.com/news/novavax-expects-covid-vaccine-targeting-183223757.html

Opana® ER Antitrust Trial Concludes With Jury Verdict in Endo's Favor

 Endo International plc (NASDAQ: ENDP) announced today that a federal jury in Chicago, Illinois, has returned a verdict in favor of the Company's subsidiaries Endo Pharmaceuticals Inc. and Endo Health Solutions Inc. (collectively Endo), in an antitrust trial.

As Endo previously disclosed, it has been involved since 2014 in various legal proceedings filed by multiple plaintiffs, including classes of direct and indirect purchasers, which have been consolidated in the United States District Court for the Northern District of Illinois under the caption In re Opana® ER Antitrust Litigation.  Plaintiffs in the cases alleged, among other things, that the terms of a 2010 patent settlement agreement between Endo and Impax Laboratories, Inc. (now Amneal Pharmaceuticals, Inc.) (Impax) violated the antitrust laws.  A trial of all plaintiffs' claims began in June and concluded today with a verdict in favor of Endo on all counts.

"Endo is very pleased with the jury's verdict and is grateful for its careful deliberation," said Matthew J. Maletta, Endo's Executive Vice President, Chief Legal Officer and Company Secretary. "Today's verdict confirms that the 2010 settlement agreement between Endo and Impax was procompetitive and enabled Impax to come to market with its generic version of Opana® ER years earlier than otherwise would have been permitted."

https://finance.yahoo.com/news/opana-er-antitrust-trial-concludes-173200437.html

Belite started at Buy by Benchmark

 Target $57

https://finviz.com/quote.ashx?t=BLTE&ty=c&ta=1&p=d