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Sunday, May 11, 2025

Radiopharma Powerhouses Push Frontiers With New Indications, Innovation

At the intersection of radiation and precision, Novartis, Bayer, AstraZeneca and more hope to cash in on a radiopharmaceuticals market that could top $16 billion by 2033.

For years, chemotherapy and radiation therapy formed the backbone of oncology care, despite their steep burden of side effects. Then came precision medicine, which sought to improve the safety and tolerability of cancer therapy by tailoring treatment to the patient’s specific needs and using certain molecules to deliver cancer-killing chemicals directly to the tumor, sparing the surrounding tissues.

Now, armed with recent advancements in targeting technologies, the pharmaceutical industry is applying the principles of precision medicine to radiation, unlocking a new paradigm of oncology called radiopharmaceuticals.

Currently, Novartis enjoys market dominance with its two FDA-approved therapies: Lutathera, indicated for gastroenteropancreatic neuroendocrine tumors, and Pluvicto, for metastatic castration-resistant prostate cancer (mCRPC). In 2024, Novartis reported over $2.1 billion for these products combined.

Its closest challenger is Bayer, which owns Xofigo, a radium-223 based radiotherapy that according to Dominik Ruettinger, global head of research and early development for oncology, “was the first alpha emitting [targeted radionuclide therapy] approved.” It won the FDA’s blessing in 2013, while Novartis’ Lutathera cleared regulatory hurdles roughly five years later, in 2018. But despite its first-to-market advantage, Bayer has fallen far behind. The company didn’t even bother to report Xofigo’s sales figures last year.

Behind these two pioneers, AstraZeneca, Eli Lilly, Bristol Myers Squibb and more are scrambling to capitalize on a market opportunity that by some estimates could top $16 billion in value by 2033.

In order to compete, however, they will need to innovate on the modality—improving the technology and optimizing the composition of the radiotherapy itself and push into new indications and earlier treatment settings. In a Feb. 7 note to investors, Jefferies analysts said that this year, companies will likely “explore more modalities, isotopes, and $1B+ cancer targets.”

Seeking Alpha Power

Very broadly speaking, targeted radiotherapies are composed of three parts: the actual radionuclide that delivers cancer-killing radiation, the targeting molecule and a linker that binds these two components. Each piece of the radiopharma molecule presents an opportunity for drugmakers to improve on, but experts told BioSpace most of the innovative effort is presently focused on the first two elements.

First, the radioactive payload. The current standard in the space is the emission of beta particles, which are small, highly energetic particles—essentially electrons or positrons—that bombard the target tumor cell, weakening and, ultimately, destroying it. Lutathera and Pluvicto are beta-emitters, underscoring the therapeutic efficacy of this class of radioisotopes.

But the field is already quickly moving away from beta and testing newer, more powerful alpha-emitting isotopes. Unlike their beta counterparts, alpha particles are orders of magnitude larger—nearly 8,000 times larger, according to Oliver Sartor, director of Radiopharmaceutical Clinical Trials at the Mayo Clinic—which lends to their stronger cancer-killing activity.

The most common alpha-emitter being studied right now is actinium-225, which “holds the promise of being a next-generation radioisotope in cancer treatment,” Puja Sapra, AstraZeneca’s senior vice president for Biologics Engineering and Oncology Targeted Discovery, told BioSpace in an email. Actinium-225 “delivers greater radiation dose over shorter distance, with potential for more targeted delivery and potential to reduce damage to surrounding healthy tissue compared to beta emitters,” she said.

AstraZeneca has two clinical-stage radiopharma assets, both of which are actinium-225-based. The more mature of the two is FPI-2265—the star of the $2 billion acquisition of Fusion Pharmaceuticals in March 2024—which targets the prostate-specific membrane antigen (PSMA) and is in Phase IIb development for mCRPC. A readout from this study is expected this year, Sapra told BioSpace in March.

The Fusion buy also gave AstraZeneca AZD2068, another actinium-225-based radioconjugate that targets the EGFR and cMET proteins. The asset is in early-stage studies for solid tumors, with results expected in 2026.

Bayer is also investing in actinium-225, which forms the heart of what it calls a “targeted alpha therapy” program. An advantage of this approach, according to Ruettinger, is its “high energy and a short penetrating range,” which damages the DNA of cancer cells and triggers their death. “At the same time, because the energy travels a short range, damage to nearby normal tissues is much reduced,” he told BioSpace in an email. Bayer’s Xofigo is an alpha-emitter.

Like AstraZeneca, Bayer’s clinical pipeline consists of two actinium-225-based molecules, BAY 3546828 and BAY 3563254, both of which target PSMA. BAY 3546828 is currently recruiting for a Phase I trial, while BAY 3563254 is being studied in a first-in-human trial that launched in March 2024. Bayer is proposing both molecules for mCRPC.

Beyond actinium-225, however, the company is also “open to using other isotopes,” Ruettinger said. To this end, Bayer has several preclinical programs exploring various payloads, with a particular focus on different half-lives.

“A fast-growing tumor with a high cell division rate may require treatment with an isotope with short half life, while an isotope with longer half life may be better suited for patients with low tumor burden, such as in an adjuvant setting,” Ruettinger explained.

Precision Targeting

Another area of active innovation in radiopharma involves the targeting moiety, which is used to deliver the therapeutic element to the cancer cells. “There are largely three flavors of ways to target the radioisotopes to the tumor,” Shiva Malek, Novartis’ global head of Oncology, told BioSpace in an interview. These include peptides, small molecules and biologics, including antibodies.

Though different in how they work, all three share a goal: to direct the payload to the target tumor, precisely deliver a cancer-killing dose of radiation and, crucially, minimize toxic off-target effects.

Of these three “flavors,” Novartis has chosen to focus on peptides, which Malek said is due to their favorable pharmacokinetic properties. “They’re rapidly cleared from the body,” she explained. “You don’t want an RLT [radioligand therapy] sitting in your bone marrow or circulating for a long time. You want it cleared pretty rapidly.”

Of course, Malek continued, “you want to have really high affinity for your tumor antigen,” so the therapy reaches the tumor. For Novartis, peptides achieve a good mix of safety and targeting efficacy.

For Lilly, however, the process of selecting a targeting ligand isn’t so straightforward. “The optimal ligand will be the one that has excellent performance for a specific target,” Daniel Pryma, the company’s vice president for Global Clinical Development, Radioligand Therapy, told BioSpace in an email. The payload is also a big consideration, according to Pryma, who noted that the pharma’s discovery efforts take into account “rational pairing” between “target, ligand, isotope and patient populations.”

Lilly has two radiopharma assets in the clinic, both from its $1.4 billion acquisition of Point Biopharma in October 2023. The lead candidate is PNT2001, which targets PSMA and uses a small molecule ligand, also directed against PSMA, according to Lilly’s pipeline page. The pharma is additionally developing PNT2002—Point’s lead asset—which is also designed to seek out PSMA but uses a peptide ligand.

A Regimen that is ‘Greater Than Its Parts’

Aside from improving the structure of the radiopharma molecule itself, some companies are looking to package targeted radiotherapy into combination regimens as a way to break into clinical practice.

Such an approach, according to Malek, could elevate the efficacy of radiopharma therapies even further, particularly when combining them with agents that can “exacerbate DNA damage,” such as chemotherapy and T cell engagers.

“We don’t fully understand where we’re going to get the best combinations,” Malek said, but this is a question that Novartis has already started to chip away at. The pharma is running a handful of combination studies testing its current radiotherapies—which Malek said have “clear monotherapy activity”—with standard of care and immunotherapies, in prostate cancer.

AstraZeneca is similarly exploring combination approaches, Sapra said, with an eye toward making its radioconjugates “the backbone for novel cancer therapies.” The company’s focus is on developing combination regimens “that can attack a tumor from multiple angles” and offer superior selectivity to and efficacy against specific cancer types.

For instance, Sapra explained that targeted radiotherapies could work well with antibody-drug conjugates (ADCs) by opening up new tumor types or tumor locations that ADCs would otherwise not be able to access. Similarly, she theorized that radioconjugates, which damage the DNA, might be synergistic with anti-cancer therapies that prevent the cells’ DNA repair mechanism.

Ultimately, AstraZeneca’s goal with combinations is to demonstrate improved efficacy and clinical utility, in turn achieving a regimen whose overall value is “greater than its parts.”

A Fertile Field

The radiopharma space is still in its infancy, with high potential for growth.

One area of growth, according to William Blair, is a move into earlier treatment settings. Recent dosing optimization studies “show that radiation can still be used further up, and we’re not going to [negatively] impact the quality of life too much,” analysts told BioSpace.

In this regard, Novartis appears to be leading the pack. In March, the pharma won a label expansion pushing Pluvicto into an earlier treatment setting in prostate cancer—even before classic chemotherapy—which would “basically triple the total addressable market for Pluvicto,” the analysts noted.

New indications are also ripe for radiopharma expansion, according to William Blair, an opportunity many of the main players are leaning into. Bayer, for instance, is working on an asset that targets the GPC3 protein to treat hepatocellular carcinoma (HCC). “GPC3 is an oncofetal protein overexpressed in 70-75%of HCC lesions,” Ruettinger said, noting that this asset will also carry the alpha-emitting actinium-225.

BMS is also targeting HCC, according to Ben Hickey, president of RayzeBio, a BMS company. The pharma’s RYZ801, which also targets GPC3 and carries actinium-225, is part of BMS’ mid-term plans for its radiopharma pipeline. Farther out on the horizon, BMS is also planning to target the CA9 protein—typically highly expressed in malignant kidney tissues—to treat renal cell carcinoma. This program is still in the preclinical phase, Hickey said.

There’s also the prospect of using the radiopharma platform beyond cancer. “Autoimmune conditions could be one of these applications,” William Blair analyst Andy Hsieh told BioSpace in an email. Hsieh was quick to qualify, however, that use in this field remains “theoretical at the moment.”

There is at least some precedent, however. “We’ve seen some ADCs, antibodies, or T cell engagers expanding from cancer to autoimmune conditions,” Hsieh said, adding that targeted radiotherapy could follow suit. But even at this theoretical stage, there are already barriers, such as the “high-risk nature” of autoimmune drug development, and the “complex supply chain” in this market.

“The efficacy bar would need to be exceedingly high . . . in order for Big Pharma to invest in” the autoimmune potential of radiopharma, according to Hsieh. “We see the prospect of that as an unlikely event.”

https://www.biospace.com/drug-development/radiopharma-powerhouses-push-frontiers-with-new-indications-innovation

Biopharma Targets an HIV Cure

As the Trump administration slashes funding for HIV-related research and infrastructure, Gilead, Immunocore and more are targeting the next goalpost: a cure.

Since Donald Trump took office in January, the National Institutes of Health has seen its funding cut for numerous HIV studies, alarming researchers and likely reducing the chances of achieving the president’s own 2019 goal of ending HIV in the U.S. by 2030. Against this backdrop, biopharma companies such as Gilead Sciences and Immunocore are pursuing the holy grail—a cure.

Medicine has made considerable strides against HIV since the advent of the epidemic in 1981. The death rate from HIV in the U.S. fell from 16.2 per 100,000 infected people in 1995 to 1.3 per 100,000 in 2022, according to Statista, as antiretroviral therapy (ART) controlled the virus in people with HIV and, more recently, pre-exposure prophylaxis (PrEP) allowed high-risk individuals to protect themselves against infection in the first place.

This progress could be in danger, however. As of April 11, the NIH had cancelled approximately 770 active research grants, Scientific American reported. Of the projects axed as of that date, 29% were related to HIV/AIDS, according to the publication. These programs and those focused on COVID-19 made up a disproportionate amount of the culled research, accounting for 46% of halted projects despite these areas garnering less than 4% of 2024 NIH grants.

Martin Rhee, director of clinical research at Gilead, said that NIH funding is key to HIV research. “Federal funding is really, really important, for scientific innovation, but also at the level of implementation as well,” he told BioSpace. Rhee pointed to the AIDS Clinical Trials Group (ACTG) and the HIV Prevention Trials Network (HPTN) as two federally funded groups that have “really played an important role” in bringing drugs to the market. Gilead, whose ART Sunlenca (lenacapavir) earned FDA approval in December 2022, has partnerships with ACTG for clinical trials.

As this arm of the HIV space is challenged by cuts under the new administration, Gilead and other private sector players are carrying on the mission. Industry “also [has] a very, very important role to play in drug development,” Rhee said, “and we will continue to focus on scientific innovation and really bringing important scientific discoveries to patients who need them.”

Now that the virus is largely under control in the U.S., the focus is on keeping it that way with PrEP and discovering a cure for the now decades-old threat.

Going for a Cure

Near-term, the goal in the HIV space is to offer options that require less frequent dosing. “When you look at the underlying reasons why [disease in] some people may not be suppressed, often what comes up is the stigma of daily pill-taking and also just the sheer burden of having to take a pill every day,” Rhee explained.

Currently approved for as a twice-yearly injection, Gilead is looking to reduce that frequency to once per year. At the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in March, Gilead presented Phase I data showing that two novel once-yearly formulations of lenacapavir led to higher plasma concentrations of the drug than were needed to show efficacy in Phase III trials of patients treated twice a year. The company expects to launch a Phase III trial for once-yearly lenacapavir in the second half of 2025, according to a March press release.

Alongside Gilead, GSK and ViiV are also working on long-acting antivirals. But the ultimate goal is to totally rid patients of the virus such that treatment is not necessary at all.

“Cure will always be, I think, the final goal post in some ways,” Rhee said. The challenge, he continued, is that HIV has never been cured naturally. “We have elite controllers, but really no good example of a naturally cured infection.”

There have been cases, however, that have spurred hope for a curative HIV treatment. The most famous is probably that of Timothy Ray Brown, aka “the Berlin patient.” Brown, who was diagnosed with HIV in 1995, developed acute myeloid leukemia 12 years later. Brown received a bone marrow transplant from a donor who was naturally resistant to HIV thanks to a rare mutation in the CCR5 gene. Miraculously, the virus was undetectable in his system just three months later despite the fact that Brown had stopped taking his antiviral medicine the day of the procedure. From then until his death from cancer in September 2020, the HIV was never detected again.

Unfortunately, bone marrow transplants aren’t feasible for every patient. “That’s been the major, major challenge within the HIV cure field, because we want to develop an intervention and regimen that is scalable,” Rhee said. But the virus doesn’t make it easy. “Biologically and scientifically, it is very, very challenging because of the diversity of the virus [and] also the way it evades the immune system and goes undetected . . . through a reservoir,” he explained.

Historically, no one has been able to show any impact on the reservoir, David Berman, EVP of research and development at Immunocore, told BioSpace. But that doesn’t mean biopharma is giving up. While antiretroviral therapies block the HIV from replicating, they do not eliminate the reservoir. Although fully eradicating the virus from the body—what might be called a true cure—is still a lofty goal, researchers are focused on a functional cure, or remission, where the reservoir has shrunk to a smaller size and immune control is induced for what remains.

Devi SanGupta, head of Gilead’s HIV cure strategy, said that, most likely, “a combination of agents will be required both really for a functional cure, or a complete cure.” Among those agents could be Gilead’s bispecific T cell engager GS-8588. One arm of the molecule targets HIV that is expressed on infected cells, while the other targets T cells, explained SanGupta. “It’s actually trying to bring the T cells together with the infected HIV infected cells, so that those T cells can then destroy the infected cells.”

Pennsylvania and Maryland–based Immunocore is also developing a bispecific T cell engager. In January 2022, Kimmtrak was approved by the FDA for uveal melanoma, becoming the first T cell receptor therapy to win the regulator’s greenlight. “Now we’re turning to HIV,” Berman said. “I think the dream has always been to have some type of immunotherapy approach where you can harness the immune system to target the virus.”

At CROI, Immunocore presented data from a Phase I/II trial showing that its candidate, IMC-M113V, elicited “signals of dose-dependent viral control after antiretroviral treatment (ART) is interrupted,” according to a March press release.

Typically, one in a million T cells in the blood will have the virus in them, so a key data point for Immunocore was looking at the level of HIV RNA in the T cells. And reductions were seen, “so we believe the mechanism may be working,” Berman said.

In the trial, 16 patients with HIV taking ART were given weekly IV infusions of IMC-M113V for 12 weeks. After stopping all treatment, three participants given the highest dose of 300 micrograms saw an initial rebound in viral load, “and then it went back down,” Berman said. Immunocore will continue to monitor these patients to see if the virus will “start to burn itself out.” The company also plans to test higher dose levels.

Meanwhile, Excision is taking a CRISPR-based approach, claiming on its website to have “demonstrated the first functional therapeutic treatment for HIV in animals.” In May 2024, the biotech presented data from a Phase I/II study of EBT-101, showing “important clinical evidence that a gene editing treatment modality can be safely delivered for targeting the HIV DNA reservoirs in human cells,” Rachel Presti, professor of Medicine at Washington University School of Medicine in St. Louis and a principal investigator on the trial, said in a statement.

Achieving a functional cure for HIV is important for three reasons, Berman stressed. First, even with the virus suppressed, the reservoir can cause mild but chronic inflammation, which can have an impact on the cardiovascular system, he said. “So there’s a need to get that chronic inflammation under control.” Second, with ART, there is a risk of resistance, particularly when people are inconsistent with treatment. And finally, there’s a social stigma when somebody has transmissible levels of HIV.

Unfortunately, it may be this very social stigma that weakens one of HIV research’s prime funding sources.

“I can only predict that [the NIH cuts are] because of the population that it affects,” John Meade, senior program manager for Policy at the AIDS Vaccine Advocacy Coalition (AVAC), told BioSpace. “HIV research has always been based on the marginalized and the most vulnerable populations, and cutting those will only hurt those populations, which I think is the goal of this administration.”

Whatever the reason, the HIV space is feeling the pressure, and SanGupta emphasized the role that Gilead and its peers play in ensuring the research continues. “It’s an ecosystem,” she said, “and we’re doing our best in that ecosystem to keep things moving and also making sure that we’re engaging with the lawmakers as appropriate.”

https://www.biospace.com/drug-development/biopharma-targets-an-hiv-cure-as-nih-funding-cuts-threaten-to-derail-progress

Medicaid Work Requirements Sought in Bill to Fund Trump Tax Cuts

House Republicans want to impose work requirements on some Medicaid recipients up to 64 years old and impose more costs on some beneficiaries to help pay for President Donald Trump’s planned sweeping tax package.

The moves, unveiled by Republican leaders in draft legislation Sunday night, are described as ways to better protect coverage to people who most need it. Critics counter that millions of recipients will have trouble navigating complex reporting systems and lose coverage. Proposed cuts to the federal health insurance program that offers coverage for poor and disabled Americans are shaping up as one of the most contentious fights in the fiscal package.

The bill offered by the Energy and Commerce Committee also includes a menu of other moves, ranging from raising millions of dollars by reauthorizing FCC spectrum auctioning to retaining some unspent climate-related spending — which the committee’s chairman, Brett Guthrie of Kentucky, calls “Green New Deal-style waste.”

The committee Republicans didn’t include the president’s request to force drugmakers to accept lower payments for prescriptions covered by Medicaid by tying them to prices the companies charge foreign governments. Trump, separately on Sunday, said he plans to unveil an executive order on drug pricing Monday morning that would mandate Americans pay no more than people in whatever country has the lowest price.

A public hearing by the panel is set to begin Tuesday afternoon to advance its proposals.

While a final cost estimate of the package wasn’t immediately available, the committee was assigned to come up with at least $880 billion in cuts or savings over 10 years to help pay for Trump’s tax package. Committee spokesman Matt VanHyfte said the panel’s text would meet that target.

Medicaid represents a substantial chunk of the panel’s jurisdiction.

The work requirements target so-called “able-bodied adults without dependents.” Broadly written, it would exclude parents with dependent children, pregnant women, those with a disability and people with substance abuse disorders.

Republicans are also proposing expanding the fees that some poor and disabled enrollees pay for health care services. The plan also includes a measure that would cut federal funding for states that use their own funds to cover health services for undocumented immigrants.

Guthrie in an op-ed in the Wall Street Journal published Sunday characterized the changes as addressing “Medicaid waste and abuse.” He highlighted that the legislation would roll back regulations on Medicaid eligibility and enrollment practices established under President Joe Biden, saving the federal government $172 billion over a decade.

“When so many Americans who are truly in need rely on Medicaid for life-saving services, Washington can’t afford to undermine the program further by subsidizing capable adults who choose not to work,” Guthrie said.

Democrats have attacked the idea of curtailing health coverage to help defray tax cuts they portray as skewed toward wealthier taxpayers. Some moderate Republicans from swing districts have warned they won’t go along with Medicaid cuts they consider too deep.

The plan unveiled by the committee Sunday night was already being criticized by Democrats as going far beyond simply attacking waste and fraud, implementing measures that could make it difficult for even people who qualify to maintain coverage.

“The overwhelming majority of the savings in this bill will come from taking health care away from millions of Americans,” said Frank Pallone, the top Democrat on the committee. “Nowhere in the bill are they cutting ‘waste, fraud, and abuse’ — they’re cutting people’s health care and using that money to give tax breaks to billionaires.”

The cumulative paperwork burden could be substantial. Beyond proving some enrollees work at least 80 hours per month, Republicans also want to implement more frequent checks on whether some people in the Medicaid program are actually qualified to receive benefits. Checks would occur for people insured through the Affordable Care Act’s expansion population every six months, instead of annually.

The committee also proposes limiting states’ ability to pay their share of Medicaid by placing a moratorium on new or increased taxes on medical providers. Some states tax health care providers such as hospitals to help raise money for state Medicaid budgets. States would also be limited from seeking new payments for providers that exceed Medicare payment rates.

Critics say limiting provider tax rates would simultaneously limit states’ ability to pay their higher tab as a result of the reductions to federal matching funds.

Health care industry groups that represent insurers and hospitals have lobbied opposing the Medicaid cuts. Hospitals face higher uninsured rates if spending cuts result in more people losing insurance coverage, and insurers that manage Medicaid programs make less money if fewer people are enrolled. Insurers Centene Corp., Elevance Health Inc., UnitedHealth Group Inc., Molina Healthcare Inc., and CVS Health Corp. are major players in administering Medicaid plans.

Senior pharmaceutical executives mounted a furious lobbying campaign to stop Trump’s drug pricing proposal, which the industry’s largest trade group told lawmakers could cost drug companies as much as $1 trillion in revenue over a decade. The industry got a surprise win in the form of a tweak to the Inflation Reduction Act which would allow drugs to be exempt from Medicare’s drug price negotiation program if they are approved to treat multiple rare diseases.

https://financialpost.com/pmn/business-pmn/medicaid-work-requirements-sought-in-bill-to-fund-trump-tax-cuts

Newark, Atlanta airports experience more terrifying air traffic control outages

Almost 80 flights have been cancelled and more than 60 delayed at Newark airport after yet another equipment outage brought more chaos to the the NYC-area hub.

A 45-minute ground stop was ordered on Sunday morning by the FAA following the outage at Newark’s ATC facility, officials told WABC.Then, a short time later a different outage hit Atlanta’s Hartsfield-Jackson Atlanta International Airport — the busiest in the country.

“Runway equipment issues” resulted in delays and ground stops for nearly all flights arriving at Atlanta.

The FAA said “technicians are working to address the problem” after the problem slowed arrivals about 10:30 a.m.

“An equipment outage at ATL’s Air Traffic Control Tower is currently causing delays for inbound and outbound aircraft. For further details please contact the FAA. In the meantime, we encourage passengers to contact their respective airlines and visit ATL.com for further information on their individual travel itineraries,” an FAA spokesperson told 11Alive.

At Newark, the problem was yet again the Philadelphia-based air traffic control center that controls the airport.

“There was a telecommunications issue at Philadelphia TRACON Area C, which guides aircraft in and out of Newark Liberty International Airport airspace,” the FAA said in a statement. “The FAA briefly slowed aircraft in and out of the airport while we ensured redundancies were working as designed.”

No flights were diverted during Sunday’s outage as of 11 a.m., according to flight tracking website, FlightAware.

It comes after a radar malfunction on Friday morning brought Newark to a standstill briefly on Friday morning.

The 90-second-long radar and radio outage at the TRACON facility was just days after a similar incident on April 28, which led to five air traffic controllers taking leave on trauma grounds.

Controllers are entitled to at least 45 days away from the job and must be evaluated by a doctor before they can return to work.

More than 1,000 flights were canceled in the face of the staff shortages.

The number of flights in and out of the airport will be reduced for the “next several weeks,” Transportation Secretary Sean Duffy told NBC’s “Meet the Press,” following travel chaos triggered by a shortage of air traffic controllers.

“We want to have a number of flights that if you book your flight, you know it’s going to fly, right?” he said.

A meeting with all airlines flying out of Newark Liberty International is expected to be called this week to determine the reduction, Duffy added.

However, he insisted that “it is” safe to fly out of New Jersey’s busiest airport, despite admitting that it uses an “old” system.

“In the next several weeks, we’re going to have this reduced capacity at Newark,” he said. “I’m convening a meeting of all the airlines that serve Newark, get them to agree on how they’re going to reduce the capacity. So you book, you fly.

“We are building a new line that goes directly from Newark to the Philly Tracon, which controls the New York airspace.”

Duffy insisted that the new line be completed by the end of the summer.

A 20% up-front bonus will be offered to new air traffic controllers to try to plug the gaps left by staff shortages, he added.

https://nypost.com/2025/05/11/us-news/newark-airport-experiences-another-terrifying-air-traffic-control-outage-bringing-flights-to-a-standstill/

'Trump Tower Damascus? Syria seeks to charm US president for sanctions relief'

A Trump Tower in Damascus, a detente with Israel and U.S. access to Syria's oil and gas are part of Syrian leader Ahmed al-Sharaa's strategic pitch to try to get face time with U.S. President Donald Trump during his trip to the Middle East, according to several sources familiar with the push to woo Washington.

Jonathan Bass, an American pro-Trump activist, who on April 30 met Sharaa for four hours in Damascus, along with Syrian activists and Gulf Arab states has been trying to arrange a landmark - if highly unlikely - meeting between the two leaders this week on the sidelines of Trump's visit to Saudi Arabia, Qatar and the United Arab Emirates.

Syria has struggled to implement conditions set out by Washington for relief from U.S. sanctions, which keep the country cut off from the global financial system and make economic recovery extremely challenging after 14 years of grinding war.

Bass hopes that getting Trump into a room with Sharaa, who still remains a U.S-designated terrorist over his al-Qaeda past, could help soften the Republican President and his administration's thinking on Damascus and cool an increasingly tense relationship between Syria and Israel.

Part of the bet for the effort is based on Trump's history of breaking with longstanding U.S. foreign policy taboos, such as when he met with North Korean leader Kim Jong Un in the demilitarized zone between North and South Korea in 2019.

"Sharaa wants a business deal for the future of his country," Bass said, noting it could cover energy exploitation, cooperation against Iran and engagement with Israel.

"He told me he wants a Trump Tower in Damascus. He wants peace with his neighbours. What he told me is good for the region, good for Israel," said Bass.

Sharaa also shared what he saw as a personal connection with Trump: both have been shot at, narrowly surviving attempts on their lives, Bass said.

Syrian officials and a presidency media official did not respond to a request for comment.

Sharaa spoke with Saudi Arabia's de facto ruler Crown Prince Mohammed bin Salman on Sunday, according to the Syrian presidency.

A person close to Sharaa said afterwards a Trump-Sharaa meeting remained possible in Saudi Arabia, but would not confirm whether Sharaa had received an invitation.

"Whether or not the meeting takes place won't be known until the last moment," the person said.

'PUSH UNDERWAY'

To be clear, a Trump-Sharaa meeting during the U.S. president's visit to the region is widely seen as unlikely, given Trump's packed schedule, his priorities and lack of consensus within Trump's team on how to tackle Syria.

A source familiar with ongoing efforts said a high-level Syria-U.S. meeting was set to take place in the region during the week of Trump's visit, but that it would not be between Trump and Sharaa.

"There is definitely a push underway," said Charles Lister, head of the Syria Initiative at the Middle East Institute.

"The idea is that getting to Trump directly is the best avenue because there are just too many ideologues within the administration to get past."

Washington is yet to formulate and articulate a coherent Syria policy, but the administration has increasingly been viewing relations with Damascus from a perspective of counterterrorism, three sources including a U.S. official familiar with the policy-making said.

That approach was illustrated by the make-up of the U.S. delegation in a meeting last month between Washington and Syrian Foreign Minister Asaad al-Shibani in New York, which included a senior counterterrorism official from the State Department, two of the sources said.

U.S. officials conveyed to Shibani that Washington found steps taken by Damascus to be insufficient, particularly on the U.S. demand to remove foreign fighters from senior posts in the army and expel as many of them as possible, the sources said.

The U.S. Treasury has since conveyed its own demands on the Syrian government, bringing the number of conditions to more than a dozen, one of the sources said.

The U.S. State Department declined to disclose who attended the meeting from the U.S. side and said it does not comment on private diplomatic discussions.

White House National Security Council spokesperson James Hewitt said the actions of Syria's interim authorities would determine the future U.S. support or possible sanctions relief.

'OLIVE BRANCH'

A key aim of Syria's overtures to Washington is communicating that it poses no threat to Israel, which has escalated airstrikes in Syria since the country's rebels-turned rulers ousted former strongman Bashar al-Assad last year.

Israel's ground forces have occupied territory in southwestern Syria while the government has lobbied the U.S. to keep Syria decentralised and isolated.

Israel has said it aims to protect Syrian minority groups. Syria has rejected the strikes as escalatory.

Sharaa last week confirmed indirect negotiations with Israel aimed at calming tensions, after Reuters reported that such talks had occurred via the UAE.

In a separate effort, Bass said Sharaa told him to pass messages between Syria and Israel that may have led to a direct meeting between Israeli and Syrian officials.

But Israel soon resumed strikes, including one near the presidential palace, which it framed as a message to Syria's rulers to protect the country's Druze minority amid clashes with Sunni militants.

"Sharaa sent the Israelis an olive branch. Israel sent missiles," Bass said.

"We need Trump to help sort this relationship out."

https://www.aol.com/news/trump-tower-damascus-syria-seeks-185225385.html

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