Weingarten sole witness in school pandemic response hearing

 A fight between Republicans and teachers unions three years in the making will come to a head Wednesday as GOP members of the Select Subcommittee on the Coronavirus Pandemic laser in on American Federation of Teachers (AFT) President Randi Weingarten.

Weingarten will be the sole witness to appear at the 2 p.m. hearing, which Chairman Brad Wenstrup (R-Ohio) has said will “delve into the role Ms. Weingarten and the AFT played in editing the CDC’s school reopening guidance and keeping schools closed longer than necessary.”

Wenstrup was referring to the “Operational Strategy for K-12 Through Phased Mitigation” guidance the Centers for Disease Control and Prevention (CDC) released during the height of the pandemic that made suggestions on how and when schools should reopen for in-person learning. 

Weingarten, Wenstrup said, “may have jeopardized the well-being of our nation’s children during the COVID-19 pandemic. If so, she should be held accountable.”

The hearing will not be the first time tension between Republicans and teachers unions has bubbled to the surface, with the GOP’s embrace of school choice and the traditional Democratic support for the unions causing strife for years.

Republican members will no doubt take the opportunity to voice a number of grievances with teachers unions at the hearing, which itself has been a long time coming.

Almost two years ago, Americans for Public Trust released emails they received from a Freedom of Information Act (FOIA) request that showed communications between AFT and the CDC regarding the guidance, infuriating the GOP.

“We are grateful for the agency’s effort to bring some measure of organization and framework to guidance. We are likewise grateful for the inclusion of some of the mitigation efforts we have been calling for since last year,” read an email from AFT to the CDC. “It is our hope that we can be engaged early in the process moving forward, as we believe our experiences on the ground can inform and enrich thinking around what is practicable and prudent in future guidance documents.”

The correspondence showed Weingarten joined a call with CDC officials, and the CDC said in emails they accepted some of the suggestions from AFT on the guidance. 

Since the release of the documents, Republicans have blamed AFT and other teachers unions for keeping students out of in-person classes, saying their suggestions to the guidance are the reason schools did not open quicker.

AFT, along with others, did get an advanced look at the guidance with the ability to make suggestions. Wenstrup sent out letters to 14 nongovernmental organizations the CDC worked with on its guidance asking about communications between the groups. 

AFT, however, argues Republicans have blown the influence its union had out of proportion and that the few changes the CDC accepted from it did not have any effect on school closures. 

AFT counsel Michael Bromwich, a high-profile attorney who has represented former FBI deputy director Andrew McCabe and now-Justice Brett Kavanaugh accuser Christine Blasey Ford, sent a letter to Wenstrup last week detailing the “false and misleading claims” Republicans have made. 

The only proposal changes the CDC approved from AFT, according to Bromwich, was the guidance should encourage schools to provide accommodations for teachers at high risk for COVID-19 and language that said guidance might have to be updated if a new variant caused transmissions to spike. 

“During the call, the AFT promised to send the CDC proposed language to consider related to accommodations for high-risk educators and staff, which a senior AFT staff member sent to the CDC on February 1, 2021,” Bromwich said. 

Bromwich argued it would have been “irresponsible” for the CDC not to consult with AFT on any of the guidance, since the teachers union has 1.7 million members. 

Republicans on the subcommittee dismissed the letter last week.

“A letter is like a free throw, no one is playing defense. Next week, Ms. Weingarten will be under oath. The Select Subcommittee appreciates AFT foreshadowing her testimony, and we look forward to discussing it on Wednesday,” a subcommittee spokesperson said. 

Weingarten has already submitted her written opening testimony, reiterating much of what Bromwich said in the letter to the committee. 

The union leader also spends much of the testimony talking about how she was pushing for school reopenings since 2020, pointing to news articles written about her efforts and AFT’s school reopening plan released in May 2020. 

“We did all this work… yet Chairman Wenstrup, you and this Subcommittee are focusing on a few sentences in the CDC’s 38-page Operational Strategy. Not the relentless efforts and numerous steps the AFT took to reopen schools safely,” Weingarten said in the submitted testimony. 

This hearing is a sequel: Part one last month examined the general consequences of school closures during the pandemic. The topic ended up becoming a debate over who was to blame for the prolonged closures, with Republicans pointing the finger at teachers unions while Democrats said it was the fault of the Trump administration in handling the pandemic. 

In her testimony, Weingarten is set to reiterate the Democrats’ point during the last hearing, blaming the policies of the Trump administration for schools having to be closed because they weren’t supported in safe practices to reopen. 

“It is offensive to suggest, as your letter does, that our agenda was otherwise—to keep schools closed. We are schoolteachers, school nurses and school-related personnel. We teach children, and we believe kids need to be in school. In school buildings,” she plans to say. 

“And it is even more offensive to suggest that our views at any time were shaped by considerations other than our profound desire and duty to protect children and their educators from the ravages of COVID-19."

https://thehill.com/homenews/education/3970518-gop-sets-up-showdown-with-head-of-teachers-union/

2nd American dies in Sudan amid unrelenting battles despite ceasefire

 The Biden administration on Wednesday confirmed a second American citizen was killed in Sudan amid an outbreak of heavy combat between competing military generals in the capital Khartoum.

A three-day, U.S.-brokered ceasefire has decreased fighting, National Security Council Spokesperson John Kirby told reporters while confirming the death of the American. Kirby said President Biden has “asked for every conceivable option to help as many Americans as possible.”

Following the outbreak of fighting, the State Department last week estimated there are about 16,000 Americans, largely dual U.S. and Sudanese citizens, in country — a number that is highly approximate given that Americans are not obligated to register their travel or their location with U.S. missions abroad.

At least 500 American citizens had contacted the embassy as of last week, a congressional source told The Hill, with about 55 asking for direct U.S. assistance to leave Khartoum.

The Biden administration greenlighted a high-stakes evacuation of about 100 embassy staff from Sudan’s capital over the weekend, and Kirby said on Wednesday that the U.S. is “actively facilitating the departure of a relatively small number of Americans who have indicated to us that they want to leave.” 

Sudanese, American and other foreign nationals fleeing Khartoum, the center of the fighting between warring military factions of the Sudanese Armed Forces and the paramilitary group the Rapid Support Forces, are reported to be traveling by convoys from the capital to the Port of Sudan. 

Kirby said that U.S. “intelligence, surveillance and reconnaissance assets” are stationed along the land evacuation route and are moving naval assets in the region to help U.S. and other civilians exit the country. 

While fighting has continued following the implementation of the ceasefire, which took effect Monday at midnight local time, combat has decreased, Kirby said, adding the U.S. is in direct contact with both heads of the warring parties.

“We urge both military factions to fully uphold the ceasefire and to further extend it. We’ve said this many, many times, but the violence is simply unconscionable and it must stop,” Kirby said. 

The intense military conflict broke out nearly two weeks prior, between Gen. Abdel Fattah al-Burhan, the head of Sudan’s Armed Forces, and Mohamed Hamdan Dagalo, known as Hemedti, who has control of the paramilitary group Rapid Support Forces.

The heavy combat, including airstrikes, shelling and gun battles in the street, has paralyzed the capital city, killing hundreds, wounding thousands and plunging it into a humanitarian crisis by threatening access to water, electricity, internet, food, medicine and health care.

The fighting between Burhan and Hemedti has highlighted the failure of years of U.S. and regional diplomacy to help realize Sudanese ambitions to transition to a democratic, civilian government. 

Burhan seized power of the country in 2021 in a military coup and that suppressed a transitional, civilian-military government in place since a grassroots revolution ousted longtime dictator Omar al-Bashir from power in early 2019. 

https://thehill.com/policy/international/3972603-second-american-dies-sudan-ceasefire/

USDA mulls changes to reduce salmonella infections from chicken

 The U.S. Department of Agriculture (USDA) is considering declaring salmonella an adulterant in breaded and stuffed raw chicken products, as part of a larger effort to reduce salmonella infections from poultry.

The proposed changes, announced on Tuesday, would allow breaded and stuffed raw chicken products to be considered adulterated if their chicken component contains at least one colony forming unit of salmonella per gram.

Breaded and stuffed raw chicken products, which USDA notes are pre-browned and may look cooked, have been associated with 14 salmonella outbreaks and 200 cases in the last 25 years. An outbreak in 2021 included cases in 11 states, according to the department.

“USDA is taking science-based, decisive action to drive down Salmonella illnesses linked to poultry products,” Agriculture Secretary Tom Vilsack said in a statement. 

“Today’s proposal represents the first step in a broader effort to control Salmonella contamination in all poultry products, as well as a continued commitment to protecting American consumers from foodborne illness,” he added.

The department proposed a new regulatory framework to combat salmonella infections in October, which included declaring salmonella as an adulterant in certain products and testing incoming flocks for salmonella before they enter an establishment.

https://thehill.com/homenews/administration/3972654-usda-mulling-changes-intended-to-reduce-salmonella-infections-from-chicken/

US Senate Kicks Off Fresh Round of Drug Pricing Control Legislation

 Tuesday, U.S. Sens. Bernie Sanders (I-VT) and Bill Cassidy (R-LA) announced plans to hold an official markup session to discuss proposed legislation for lowering drug prices. The hearing is scheduled for May 2.

Sanders is the chairman of the Senate’s Health, Education, Labor and Pensions (HELP) Committee, while Cassidy is a ranking member. The HELP Committee will examine four bills, including the RARE Act, the Ensuring Timely Access to Generics Act of 2023, the Expanding Access to Low-Cost Generics Act of 2023 and the Pharmacy Benefit Manager Reform Act.

The HELP Committee announcement came one day after more than 20 Democrats introduced new legislation seeking to lower prescription drug prices for patients by empowering Medicare.

The bill, dubbed the Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act, is being sponsored by Sen. Amy Klobuchar (D-MN) and Peter Welch (D-VT), with support from other Democrat colleagues such as Tammy Baldwin (D-WI), Richard Blumenthal (D-CT) and Cory Booker (D-NJ).

“By strengthening Medicare’s ability to negotiate drug prices, our legislation will lower prescription costs on even more drugs and save taxpayers money,” Klobuchar said in a statement.

The SMART Prices Act builds upon the Inflation Reduction Act (IRA), which was signed into law in August 2022. Under the IRA, the federal government can negotiate with pharmaceutical companies for a maximum fair price for specific high-spend medicines after a certain amount of time has passed.

Prices of small-molecule drugs can be negotiated nine years after FDA approval, while biologics are afforded four more years, with protection from negotiations lasting for 13 years. The Act’s provisions for negotiations will take effect starting in 2026.

The IRA will also require drugmakers to pay rebates to Medicare if price hikes outpace inflation.

Klobuchar’s SMART Prices Act seeks to shorten the window of protection for both biologics and small-molecule drugs, allowing Medicare to kick off drug price negotiations five years after being approved by the FDA. If signed into law, the SMART Prices Act would also enable Medicare to negotiate prices for more drugs overall.

Biopharma Bristles at Drug Pricing Legislation

In August, soon after the U.S. Senate passed the IRA, Stephen Ubl, CEO of Pharmaceutical Research and Manufacturers of America, called the decision a “tragic loss for patients,” saying that the government’s control over drug prices would discourage companies and research groups to innovate, leading to fewer new cures and treatments.

Just prior to the IRA’s passing, Merck CEO Robert Davis said the IRA would be “highly chilling on future innovation.”

Aside from the IRA, the U.S. government has taken other steps recently to put a cap on drug prices. In March, Sanders wrote to Sanofi and Novo Nordisk, urging them to follow Eli Lilly’s lead and lower insulin prices. Both ultimately did follow suit, with Novo vowing to cut some insulin prices by 75% beginning in 2024 and Sanofi slashing the price of Lantus by 78% beginning on Jan. 1, 2024.

https://www.biospace.com/article/u-s-senate-kicks-off-fresh-round-of-drug-pricing-control-legislation/

TG: Data from the ULTIMATE I and II Phase 3 Trials of BRIUMVI in MS

 TG Therapeutics, Inc. (NASDAQ: TGTX), today announced presentations highlighting data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology (AAN) annual meeting.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, 'We are pleased to present additional analyses from the ULTIMATE I & II Phase 3 trials and further in-vitro characterization of BRIUMVI at the AAN conference this week. We look forward to continuing to share additional exploratory analyses throughout the year.'

https://www.marketscreener.com/quote/stock/TG-THERAPEUTICS-INC-13314736/news/TG-Therapeutics-Announces-Presentation-of-Data-from-the-ULTIMATE-I-and-II-Phase-3-Trials-of-BRIUMVI-43646381/

Inhibrx Initiates Trial of INBRX-101 in AATD and Announces Lift of Partial Clinical Hold

 Inhibrx, Inc. (Nasdaq: INBX), a clinical-stage biopharmaceutical company dedicated to the development of therapeutics for oncology and rare diseases, announced today that it has initiated a registration-enabling trial for INBRX-101, an optimized recombinant human AAT-Fc fusion protein, for treatment of patients with emphysema due to alpha-1 antitrypsin deficiency (AATD). Additionally, the Company announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on studies evaluating its death-receptor 5 (DR5) agonist, INBRX-109.

https://www.marketscreener.com/quote/stock/INHIBRX-INC-111065685/news/Inhibrx-Initiates-a-Registration-Enabling-Trial-of-INBRX-101-in-AATD-and-Announces-Lift-of-Partial-C-43645837/

Seagen to Highlight Data From Oncology Portfolio and Pipeline

 Long-term follow-up data for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) in advanced bladder cancer to be featured as oral presentation –

- Updated Phase 1 data on first-in-class integrin beta-6 targeted antibody-drug conjugate (ADC) (SGN-B6A) to be presented –

Seagen Inc. (Nasdaq: SGEN) today announced the presentation of 17 abstracts at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6, 2023, in Chicago. Data will be presented across Seagen's portfolio of approved medicines and pipeline agents in a range of cancer types and in earlier lines of therapy.

“Seagen has worked towards revolutionizing cancer care for 25 years by linking scientific innovation to meaningful impacts in patients’ lives,” said Roger Dansey, M.D., President, Research and Development and Chief Medical Officer at Seagen. “Our data presented at ASCO demonstrate continued progress in our efforts to discover and develop transformative medicines.”

Highlights include new data from a robust clinical development program in bladder cancer with trials across multiple lines of treatment and into earlier stages of disease for muscle-invasive and non-muscle invasive forms of bladder cancer. Long-term follow-up data from a clinical trial of PADCEV^® (enfortumab vedotin-ejfv) (EV-103 dose-escalation and Cohort A) will be featured in an oral presentation on Monday, June 5. The EV-103 dose-escalation/Cohort A study is evaluating PADCEV, developed in partnership with Astellas, in combination with Merck’s anti-PD-1 therapy KEYTRUDA^® (pembrolizumab) as first-line treatment in patients with locally advanced or metastatic urothelial carcinoma who are ineligible to receive cisplatin-based chemotherapy. Merck is known as MSD outside the United States and Canada.

Updated Phase 1 data will be presented for SGN-B6A, a wholly-owned, first-in-class vedotin ADC directed to integrin beta-6, a novel target that is highly expressed in multiple solid tumors.

Additionally, initial data will be presented from studies evaluating Seagen’s approved medicines in potential new cancer types. Data from a Phase 2 basket study of TUKYSA^® (tucatinib) and trastuzumab in previously treated HER2-positive metastatic biliary tract cancer will be featured in an oral presentation on Friday, June 2.

https://www.marketscreener.com/quote/stock/SEAGEN-INC-10808/news/Seagen-to-Highlight-Data-From-Oncology-Portfolio-and-Pipeline-at-the-2023-American-Society-of-Clinic-43647939/