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Friday, April 4, 2025

Republicans May Override Senate's Nonpartisan Referee To Pass Trump's Agenda: What To Know

 by Joseph Lord and Jackson Richman via The Epoch Times,

Republicans have set the stage to potentially override the Senate parliamentarian as they move ahead with President Donald Trump’s policy proposals.

Republicans are seeking to pass Trump’s entire agenda—including tax cuts, energy policy, border policy, defense, and other areas—using the reconciliation process.

While this process allows the party to bypass the 60-vote filibuster threshold, which kills most partisan bills on arrival in the Senate, it’s heavily restricted. Rules governing its use prevent these types of bills from having a long-term impact on the deficit.

Ultimately, it’s up to the parliamentarian—the little-known referee in the Senate who interprets Senate rules—to decide what provisions make it into the final bill, and how long those provisions can last.

After Republicans released their resolution on April 2, Senate Majority Leader John Thune (R-S.D.) reported that Elizabeth MacDonough, the current parliamentarian, had given an initial green light to move ahead with the proposal under the Budget Act of 1974, which enables the reconciliation process.

Other questions linger that could still slow the legislation if the parliamentarian rules against Republicans. As Republicans move forward, leaders have given some indications that they won’t necessarily rely on the parliamentarian’s ruling about how to calculate the total financial impact of the bill.

Technically, the parliamentarian’s rulings aren’t binding on what the Senate does, and can be overridden by a simple majority of senators.

But historically, lawmakers have been hesitant to do so. The Senate operates largely on the basis of established customs, traditions, and guardrails—and the parliamentarian’s role has been established for decades.

Thus, should Republicans challenge any ruling from the parliamentarian—or the parliamentarian’s right to make a ruling—Democrats could interpret this as Republicans effectively “nuking” the filibuster, and could similarly disregard the rulings of the parliamentarian themselves in the future.

Here’s what to know about the burgeoning dispute—and the possibility that Republicans will “go nuclear” to override the parliamentarian.

Who Is the Parliamentarian?

A post established in 1935, the parliamentarian primarily serves to advise senators, staff, and others on the Senate’s arcane rules and procedures.

In recent decades, their most important role has involved refereeing reconciliation bills, which both parties often use when they have a trifecta in Washington.

Appointed by former Senate Majority Leader Harry Reid (D-Nev.) in 2012, MacDonough is the first woman to occupy the post—and she’s shown herself willing to defy both parties’ wishes at times.

MacDonough, who declined to be interviewed for this story, has described her view of her role as above partisanship.

“While serving its 100 members on a day-to-day basis, I still represent the Senate. … I represent the Senate with its traditions of unfettered debate, protection of minority rights, and equal power among the states,” she said in a 2018 commencement speech at Vermont Law School, which she attended.

In 2021, during the Biden administration, MacDonough ruled against the Democrats’ plan to include a $15 minimum wage and a pathway to citizenship in reconciliation bills.

Now, she’ll have a key role in making another decision that could put her in the majority party’s sights.

Senate Parliamentarian Elizabeth MacDonough (C) provides assistance during the certification of Electoral College ballots in the presidential election, in the House chamber at the Capitol in Washington on Jan. 6, 2021. J. Scott Applewhite/AP Photo

‘Tax Baseline Question’

Since the beginning, Senate Republicans have made clear that they hope to make any tax cuts included in their reconciliation package permanent, which would primarily include permanently extending the components of Trump’s 2017 tax cuts due to expire this year.

Under the rules of reconciliation, making any provision permanent requires compliance with the Byrd Rule—a restriction on reconciliation bills which requires that they not impact the deficit beyond a 10-year window.

Whether or not Republicans can meet this requirement depends in part on the baseline used to calculate the net impact on the deficit. There are two options: a “current policy” baseline and a “current law” baseline.

Republicans believe the current policy baseline will enable them to make their cuts permanent, and Budget Chairman Lindsey Graham (R-S.C.) used this standard in calculating the financial impact of the resolution.

While MacDonough has given approval to move the proposal forward in the reconciliation process, questions linger about whether Graham can make this call on his own. Republicans say he can.

Republicans Hesitant to Overrule

On the whole, Senate Republicans seemed hesitant to make any commitments to overruling the parliamentarian, though leaders have raised questions about whether they need MacDonough’s advice on this issue.

Following the April 1 Republican lunch, Thune and Majority Whip John Barasso (R-Wyo.) told reporters that the Budget Committee chairman could unilaterally make the legal determination on whether to use the current policy baseline.

“We think the law is very clear, and ultimately the budget committee chairman makes that determination,” Thune said. “But obviously, we are consulting regularly with the parliamentarian.”

Senate Majority Leader Sen. John Thune (R-S.D.) (C), accompanied by Sen. John Barrasso (R-Wyo.), left, speaks to reporters after a Senate policy luncheon at the Capitol in Washington on Feb. 25, 2025. Ben Curtis/AP Photo

When asked about the possibility of overruling MacDonough, Senate Republicans expressed confidence that the current policy baseline would be chosen.

“There’s clear and unequivocal precedent on current policy as the baseline,” Sen. Ted Cruz (R-Texas) told The Epoch Times, citing President Barack Obama’s use of the current policy baseline to extend Bush-era tax cuts in 2013. “I have every confidence that will be the conclusion here.”

Sen. Tommy Tuberville (R-Ala.) told The Epoch Times that Republicans have “no choice” but to respect the ruling, and was skeptical that her decision would be overridden.

Ultimately, the stage is set for a potential testing of the parliamentarian’s authority. It’s unclear whether Republicans intend to wait for her to make a ruling before moving forward, when that ruling could come, or what the final ruling would be.

Should it go against Republicans, it’s unclear whether they would go ahead anyway, as such a move could set a precedent for Democrats to use later.

https://www.zerohedge.com/political/republicans-may-override-senates-nonpartisan-referee-pass-trumps-agenda-what-know

GSK, Pfizer resolve RSV patent feud amid vaccine market uncertainty

 As the respiratory syncytial virus (RSV) vaccine field grapples with a significantly reduced market size thanks to regulatory uncertainties, GSK and Pfizer have decided to lay to rest their patent feud.

GSK and Pfizer have moved to scrap a patent lawsuit around their respective RSV vaccines, according to a filing in the U.S. District Court in Delaware.

The settlement comes after a U.K. high court in November sided with Pfizer, ruling that two GSK RSV vaccine patents were invalid.

GSK brought the lawsuit to Pfizer in 2023, shortly after the FDA’s back-to-back approvals for GSK’s RSV shot Arexvy and Pfizer’s rival product Abrysvo. The British pharma claimed that the Pfizer vaccine infringed on four of its patents related to the antigen technology used in its shot.

At that time, the emerging RSV vaccine market was billed as a major blockbuster opportunity. And GSK’s first-to-market Arexvy lived up to that expectation with $1.5 billion sales in its first year of commercialization.

Things took a drastic turn in mid-2024, when a Centers for Disease Control and Prevention (CDC) advisory committee narrowed its age recommendation for RSV vaccinations. Both GSK and Pfizer felt the pain immediately, with sales of GSK’s Arexvy declining 70% year over year in the last three months of 2024 and Pfizer’s Abrysvo revenues dropping 62% during the same period.

Moderna’s newer entry, mRESVIA, also suffered a muted launch since its May 2024 approval, with merely $15 million in fourth-quarter sales. The disastrous RSV rollout was a significant reason behind Moderna’s launch of a $1.5 billion cost-cutting initiative

While the companies didn’t expect the CDC to change its position on RSV vaccines this year, they were at least hopeful that with forthcoming longer-term data, a more favorable policy might emerge. Then vaccine skeptic Robert F. Kennedy Jr. became the new secretary of the Department of Health and Human Services (HHS).

Just a few weeks into his tenure, RFK Jr. has pushed his anti-vaccine agenda on many fronts. A regular meeting of the CDC vaccination committee was postponed days after RFK Jr. took office. Then, an FDA vaccine advisory committee meeting was canceled.

If those weren’t clear enough signals that the RFK Jr.-led health department had turned against vaccines, Peter Marks, M.D., Ph.D., the longtime director of the FDA’s Center for Biologics Evaluation and Research, was pushed out last week because of a disagreement with the HHS boss on vaccine policy.

Then, word came out that the FDA’s principal deputy commissioner, Sara Brenner, M.D., intervened in the review process of Novavax’s COVID-19 vaccine candidate and demanded to see more data. The unusual move by a political appointee at the agency led to the FDA missing its deadline to decide on approval for the Novavax shot.

“If you’re going to be a biotech company right now, don’t be a vaccine company,” Leerink Partners analyst Mani Foroohar, M.D., told Fierce Pharma in an interview this week.

For drugmakers to keep pressing patent litigation, there needs to be a big enough potential financial gain to make the effort worthwhile. In GSK’s suit against Pfizer, the British pharma was seeking monetary damages or royalties and potentially a permanent injunction on the commercialization of Pfizer’s RSV vaccine in the U.S.

Meanwhile, the two companies still appear to be locked in a patent battle around mRNA COVID vaccine technologies. 

https://www.fiercepharma.com/pharma/gsk-pfizer-end-rsv-patent-feud-entire-vaccine-market-faces-volatility

OPKO Health Doubles Current $100 Million Share Repurchase



OPKO Health (NASDAQ: OPK) has announced a $100 million increase to its existing share repurchase program, bringing the total program capacity to $200 million. The company has already repurchased approximately $41 million of common stock since the program's initial authorization in July 2024.

The expanded buyback program, representing about 14% of shares outstanding at current price levels, will be executed through various methods including open market purchases, block trades, and accelerated share repurchase transactions. OPKO had approximately 671.6 million shares outstanding as of February 24, 2025.

The company plans to fund the repurchases from existing cash reserves and future cash flows. The program has no time limit and can be modified or suspended at management's discretion based on market conditions and other factors.

Daiichi and AstraZeneca’s Enhertu gains EC approval for breast cancers



The European Commission (EC) has approved Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) for use as a single agent to treat adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) low or ultralow breast cancer.

The approval is for those who have undergone a minimum of one endocrine treatment in the metastatic setting and are deemed unsuitable for further endocrine therapy.

Following this EU approval, Daiichi Sankyo will receive a milestone payment of $125m from AstraZeneca for the HER2 low and HER2 ultralow chemotherapy-naïve breast cancer indication.



Daiichi Sankyo discovered this HER2-directed antibody-drug conjugate (ADC) and is co-developing and commercialising it along with AstraZeneca. It is tailored leveraging Daiichi’s DXd ADC technology.

The ADC has gained approval based on the Phase III DESTINYBreast06 trial’s outcomes. This follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use.

In DESTINYBreast06, the ADC demonstrated a significant minimisation in the disease progression or mortality risk against chemotherapy in subjects with chemotherapy-naïve HR positive, HER2-low metastatic breast cancer.

866 subjects were enrolled across Oceania, Asia, North America, South America and Europe.

The median progression-free survival for subjects treated with the ADC was 13.2 months versus 8.1 months for those receiving chemotherapy.


The safety profile of Enhertu in the DESTINYBreast06 trial is consistent with previous trials, with no safety concerns observed.

Daiichi Sankyo CEO, president and oncology business global head Ken Keller stated: “Today’s approval expands the use of Enhertu to now include an earlier treatment setting of HER2 low metastatic breast cancer and broadens the patient population eligible for treatment to those with HER2 ultralow disease.”

Enhertu’s approval extends to 75 nations, inclusive of the EU, for individuals with HER2 low metastatic breast cancer who have previously received systemic therapy or experienced disease recurrence shortly after adjuvant chemotherapy.

In October 2023, the EC approved Enhertu for treating advanced non-small cell lung cancer patients with a HER2 mutation.

https://www.pharmaceutical-technology.com/news/ec-daiichi-astrazeneca-enhertu/

Committee Recommends EU Trials of Sarepta’s Elevidys Continue, Day After Holds

 

One day after the European Medicines Agency requested that three clinical trials of Elevidys be placed on hold after the death of a U.S. teenager, a data monitoring committee concluded that they should continue unchanged.

The holds placed in the EU on three clinical trials for Sarepta and Roche’s gene therapy Elevidys may soon lift after a data monitoring committee determined that the benefit-risk ratio favors their continuation without changes.

On March 18th, Sarepta announced that a patient who had been treated with Elevidys had died of acute liver failure. According to a statement released by Sarepta on Friday, an independent data monitoring committee (DMC) convened Thursday, the same day the holds were announced. EU member states had requested the committee meet to review the death.

The committee “concurred that based on the totality of evidence, the overall benefit-risk profile remains favorable to continue dosing in the paused clinical trials without changes to the study protocols.”

Sarepta and Roche plan to submit the committee’s conclusion to EU regulators within a week and Sarepta said Friday it does not anticipate a “material impact” on the timeline for the affected trials.

Original story published April 3, 2025.

Sarepta’s Duchenne Gene Therapy Placed on Hold in Europe Pending Death Investigation

The European Medicines Agency has requested that Sarepta Therapeutics and partner Roche pause a trio of clinical trials of their Duchenne muscular dystrophy gene therapy Elevidys in response to a patient death that occurred outside the scope of the studies.

In a letter addressed to the World Duchenne Organization and dated March 31, Roche shared that it was pausing Phase IPhase II and Phase III trials all studying the gene therapy for treating Duchenne muscular dystrophy (DMD).

The European Medicines Agency (EMA) asked for the trials to be paused until the exact cause of death of a U.S. teenager, who had suffered acute liver failure (ALF) after taking Elevidys, can be precisely determined. Sarepta announced last month at the time of the patient’s death that it would update Elevidys’ label to reflect the safety signal.

Analysts at BMO were nonplussed by the trial pause. “We view the requested clinical hold as an administrative step, pending [data monitoring committee] meeting, that can be resolved within ~6mo given Elevidys benefit/risk in the context of DMD being a universally fatal disease,” the analysts wrote in a note late Wednesday (emphasis theirs).

Other analysts were more mixed. “On one hand, the risk of fatal ALF is rare (0.125%) and our experts affirm the news is unsurprising to them. However, we’ve felt the death should not be fully dismissed unless [Sarepta management] can provide color on some outstanding questions,” Jefferies analysts wrote Wednesday.

The connection between biopharmas working on DMD and the patient community is especially tight knit. Following the patient’s death, Sarepta sent a letter directly to the DMD patient community, pledging transparency and sharing data as the company investigates the death.

The sentiment mirrors those reflected in Roche’s letter earlier this week to the DMD community. The company signed off saying, “We truly appreciate your leadership and the opportunity to work together with you in these efforts.”

The patient death after taking Elevidys is one of a series of deaths from DMD gene therapies. Two patients died, one in 2021 and another in 2024, while taking Pfizer’s investigational gene therapy fordadistrogene movaparvovec. That program was later scrapped. In 2022, a CRISPR-based Duchenne therapy led to another patient death, potentially caused by the viral vector used.

https://www.biospace.com/drug-development/sareptas-duchenne-gene-therapy-placed-on-hold-in-europe-pending-death-investigation