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Thursday, May 8, 2025

Duffy plots multi-billion-dollar overhaul of US air traffic control by 2028

 Transportation Secretary Sean Duffy unveiled a plan Thursday to revamp the nation’s failing air traffic control system by 2028 — following a deadly plane crash outside Washington, DC and thousands of radar and communications outages that have spooked officials, lawmakers and passengers alike.

“This is bold, this is gonna be challenging, but we absolutely can do it,” Duffy declared of his plan, which calls for at least six new air traffic control centers replacing 1960s-era facilities; swapping out old-fashioned copper wiring for fiber-optic, wireless and satellite technology at 4,600 locations; and replacing 25,000 radios and more than 600 radar installations.

Mid-presentation, the cabinet secretary phoned President Trump, who said he’d like to give the top bidding company “one, big beautiful contract” for the “complete rebuilding and modernization of America’s air traffic control system.”x/SecDuffy

Though Duffy’s plan didn’t come with an exact price tag, the secretary hinted it would cost “tens of billions” of dollars.

Meanwhile, the Republican-led House Transportation and Infrastructure Committee has already floated a proposal for the air traffic control system’s upgrade that amounts to $12.5 billion.

The Trump administration has also put in a $4 billion initial budgetary request for fiscal year 2026 to update the technology and facilities.

“We should be using fiber, but it’s copper. We use radar from the 1970s,” Duffy explained. “Some of them are from the 1980s, but most of them are from the 1970s, so this technology is 50 years old that our controllers use to scan the skies and keep airplanes separated from one another.”

A Federal Aviation Administration (FAA) official and other airline industry insiders warned earlier this week that roughly 1,000 telecom outages were plaguing the industry every week — and airports should be expecting “more and more” without a significant upgrade.

That caution came after a 90-second blackout hit controllers overseeing Newark Liberty International Airport last week, when a frayed piece of copper wire caused flight disruptions and some FAA workers to take “trauma leave,” according to CNN.

“Everything from digging ditches to the most sophisticated stuff,” Trump teased of the air traffic control system overhaul, saying “reliable service … is long overdue.”Gripas Yuri/ABACA/Shutterstock

“I think Newark has been a great example,” Duffy said Thursday. “The backup line didn’t fire and so we had that 30 to 90 seconds of a blackout, which is frightening if we don’t actually accomplish the mission that we’re announcing today.”

“It’s long past time when we need to fix this problem,” acting FAA Administrator Chris Rocheleau added.

Mid-presentation, the cabinet secretary phoned President Trump, who said he’d like to give out “one, big beautiful contract” for the “complete rebuilding and modernization of America’s air traffic control system.”

The president also paused to recognize victims’ families from the January mid-air collision of an Army Black Hawk helicopter and a passenger plane at Reagan National Airport, killing 67.REUTERS

“Everything from digging ditches to the most sophisticated stuff,” Trump teased, saying “reliable service … is long overdue.”

The president also paused to recognize victims’ families from the Jan. 29 mid-air collision between an Army Black Hawk helicopter and a passenger plane on approach to Ronald Reagan Washington National Airport, which killed 67.

“What a horrible thing that was,” Trump said to the family members in the audience. “Earlier this year, if they had a system in there, we wouldn’t have had a problem, but you know, the people have devoted themselves to making the skies safer, and we’re going to make them totally safe.”

“It’s long past time when we need to fix this problem,” acting FAA Administrator Chris Rocheleau added.REUTERS

Duffy also predicted hardware and software updates to facilities like air traffic control towers and floated a new flight management system to include electric air taxis, known as eVTOLs, which he said have sometimes been called “Ubers in the air.”

“All new hardware, all new software is going to be built into this brand new air traffic control system, and some of you might say, ‘Well, how are you going to do that in any reasonable amount of time?'” the secretary asked.

“I’ve told you we’re going to do this in three or four years,” he added. “I’m going to ask the Congress for up-front appropriations to give us all the money.”

Duffy also forecast hardware and software updates to facilities like air traffic control towers and floated a new flight management system to include electric air taxis, known as eVTOLs, which he said have sometimes been called “Ubers in the air.”AP

Trump’s transportation head compared the plan to upgrading to a smartphone from a flip phone.

The head of the largest trade association for passenger and cargo planes cheered Duffy’s announcement.

“I’ve been holding up floppy disks and paper strips for about nine years now, and I wasn’t going to bring them, but yesterday the secretary encouraged me to bring them along,” Airlines for America CEO Nicholas Calio said.

“Here they are,” Calio said brandishing the antiquated tech. “People can never believe this, but here’s the good news: What’s happening here today is going to put these things out of business for good.”

“I want to thank Secretary Duffy for presenting a plan that begins to address a decades-long problem in the manner in which he’s attempting to do it because we’ve seen failure in the past,” he added. “This one will not.”

Airlines for America, in a separate statement called for an additional $18.5 billion in emergency supplemental funds over the next three years to speed up the overhaul.

https://nypost.com/2025/05/08/us-news/transportation-secretary-sean-duffy-calls-for-multi-billion-dollar-overhaul-of-failing-air-traffic-control-system-by-2028/

Tyra Biosciences Q1 results, highlights

 - BEACH301 study of TYRA-300 for Pediatric Achondroplasia (ACH) Open for Enrollment -

- Initiated patient dosing in SURF431 study of TYRA-430 for hepatocellular carcinoma (HCC) -

- Cash, cash equivalents, and marketable securities of $318.9 million at Q1 2025; runway through at least 2027 -

"In 2025, we are focused on clinical execution across our portfolio of next-generation precision therapies for oncology and skeletal dysplasia.  We continued to advance TYRA-300 for ACH and intermediate risk non-muscle invasive bladder cancer and will begin dosing in BEACH301 and SURF302 in the second quarter," stated Todd Harris, CEO of TYRA.  "In addition, our SURF431 study is now underway, and we dosed the first HCC patient with TYRA-430, our oral FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers."

https://finance.yahoo.com/news/tyra-biosciences-reports-first-quarter-200500962.html

PacBio Q1 consumable growth offsets instrument revenue decline

 Pacific Biosciences of California (NASDAQ:PACB) reported mixed first-quarter results on May 8, 2025, with total revenue of $37.2 million, slightly below the $38.8 million recorded in the same period last year. The genomic sequencing technology company faced headwinds from academic funding uncertainty and newly implemented tariffs between the U.S. and China, prompting a strategic restructuring and adjusted revenue guidance.

PacBio’s stock closed at $1.20 on the day of the earnings release, up 6.19% from the previous close, but traded down 2.5% in after-hours trading as investors digested the mixed results and lowered guidance.

Quarterly Performance Highlights

PacBio reported first-quarter product and service revenue of $37.2 million, with consumables showing strong growth while instrument sales declined significantly year-over-year. The company shipped 12 Revio systems and 28 Vega systems during the quarter, with approximately 50% of these placements going to new customers.

"We had a solid start to 2025, though we remain cautious given the macro environment, especially academic funding and trade policy," said Christian Henry, President and CEO of PacBio.

Consumable revenue grew 26% year-over-year to $20.1 million, while service and other revenue increased 59% to $6.0 million. However, instrument revenue declined 42% to $11.0 million compared to Q1 2024, which the company attributed to academic funding uncertainty.

https://in.investing.com/news/company-news/pacbio-q1-2025-slides-consumable-growth-offsets-instrument-revenue-decline-93CH-4819906

Illumina Cuts Guidance on Threat From Tariffs and China Ban

 


Illumina Inc. cut its full-year adjusted profit guidance for the second time in three months as it grapples with the impact of tariffs and China banning imports of its gene-sequencing machines.

The maker of DNA sequencing machines now expects adjusted earnings of $4.20 per share to $4.30 per share for the fiscal year, it said in a statement. That’s a reduction from its March forecast of $4.50 a share, which was down from the $4.50 per share to $4.65 a share it offered in February.

'Banning PFAS Would Jeopardize Millions of Medical Devices'

 A key component of life-saving medical devices has been placed in the crosshairs by government regulators, jeopardizing care for millions of Americans.

State and federal policymakers are targeting a class of 15,000 chemicals known as perfluoroalkyl and polyfluoroalkyl substances, or PFAS. Best known for waterproofing and nonstick treatments, these chemicals have been widely used because of their durability, friction resistance, and ability to withstand fire and other temperature extremes. Teflon and Scotchgard are two well-known products that contain PFAS.

The issue is that some of these chemicals have been linked to health concerns. As a result, certain state, federal, and European regulators have taken action to limit PFASopens in a new tab or window while others are considering sweeping bans on all 15,000 types of PFAS.

But these chemicals play an essential role in healthcare: they are crucial to the proper functioning of a broad range of medical devices such as stents, catheters, surgical mesh, pacemakers, heart patches, CPAP machines, prosthetics, surgical instruments, and asthma inhalers. Because there are not yet any clear alternatives to PFAS in the manufacturing and safe operation of many medical devices, regulators should carve out an exemption for the continued use of the chemical for healthcare.

A Brief History of PFAS

Discovered by accident in 1938 by a DuPont Company chemistopens in a new tab or window in New Jersey, PFAS initially was used for the most urgent concern in the U.S. at that time -- helping to build the first atomic bomb for the Manhattan Projectopens in a new tab or window. After World War II, PFAS became a signature component of modern life, with widespread use in cooking pans, food packaging, clothes, carpet, furniture, sheets, pillows, mattresses, cosmetics, and sunscreen. The chemicals helped put humans on the moon via Apollo space missions, in the clouds via jet manufacturing, at sea through shipbuilding, and all across the Earth via cars, trucks, bicycles, and more. Products containing these chemicals became key ingredients in firefighters' foam, jackets, pants, and gloves.

One other major use was healthcare. A subset of PFAS made possible the development of medical devices for millions of people with no other alternative. Today, an estimated 32 million Americans liveopens in a new tab or window with an implanted medical device, and approximately one in every 10 Americansopens in a new tab or window will have a device inside their bodies at some point in their lifetimes.

Over time, however, evidence mounted that various forms of PFASopens in a new tab or window were accumulating in the environment and posing health risks. What started as a miracle material is now referred to more often as a forever chemical and environmental hazard.

Scientists have detected these chemicals in the bodies of 98% of Americansopens in a new tab or window. In 40 studies over 5 yearsopens in a new tab or window, every mother's umbilical cord sample tested positive for PFAS -- nearly 30,000 samples -- meaning that humans begin their life today with the chemical in their bodies. The Environmental Working Group estimates that more than 200 million Americansopens in a new tab or window are drinking water tainted with PFAS.

As a result, the Environmental Protection Agency has dramatically increased PFAS restrictions in the past two decades. The chemical behind Teflon was eliminated by 2014opens in a new tab or window, and in recent years 30 states have approved 155 PFAS policiesopens in a new tab or window, with many banning once-common uses in clothing, cookware, cosmetics, and menstrual products. Last year, the federal government also imposed limits on PFAS in drinking wateropens in a new tab or window. Faced with mounting regulatory and courtroom pressure, 3M, one of the biggest U.S. manufacturers, has announced it is exiting the PFAS manufacturing businessopens in a new tab or window by the end of 2025.

PFAS in Medical Devices

The issue is that banning all PFAS from medical devices would threaten care for the Americans who receive 300,000 newly implanted pacemakersopens in a new tab or window or defibrillators per year; 75 million annual endoscopiesopens in a new tab or window4.8 million laparoscopic proceduresopens in a new tab or window per year; as well as the 1.7 million Americansopens in a new tab or window with amputated limbs who rely on prosthetics.

An outright ban on all PFAS would be a high-stakes case of throwing out the baby with the bathwater -- eliminating a clear medical good while trying to prevent an environmental bad.

Many of these medical devices are made possible with fluoropolymers, a chemically distinct subset of PFAS. Studies suggest fluoropolymers, when used in medical devices, are more biologically benign. Clinical studiesopens in a new tab or window of patients with implanted medical devices that used fluoropolymers have found no chronic toxicity or links to cancer, and no reproductive, developmental, or endocrine toxicity.

Other studies concludedopens in a new tab or window fluoropolymers are nontoxic, do not bioaccumulate, and "have very different physical, chemical, environmental, and toxicological properties when compared with other PFAS." While research suggestsopens in a new tab or window emissions during fluoropolymer production, processing, and disposal may pose health or environmental risks, there is no evidence linking these substances in medical devices to adverse health effects.

Because sweeping PFAS bans would have such dire consequences for medical care, policymakers and public health regulators should include an exception that allows the crucial chemicals to continue to be used in medical devices -- at least until alternatives can be developed and tested.

The medical industry is researching chemical alternativesopens in a new tab or window, but the process is lengthy and complicated. Many medical devices must be approved by the FDAopens in a new tab or window, and replacement of PFAS with another substance may require extensive testing by the device manufacturer and detailed study by regulators.

The European Union (E.U.) considered a sweeping ban on PFASopens in a new tab or window, but scientists foundopens in a new tab or window that there currently are no feasible chemical alternativesopens in a new tab or window for many types of equipment. As a result, E.U. regulators are weighing plans to enact a PFAS ban while carving out an exception of 5-12 yearsopens in a new tab or window for implanted medical devices. That would give manufacturers and regulators more time to see if PFAS alternatives are possible.

Similar exceptions for medical devices have been approved by several states. Maineopens in a new tab or window, for example, in 2021 announced the world's first sweeping PFAS ban covering all consumer goods, but amended it 2 years lateropens in a new tab or window to allow exemptions for medical devices. Minnesotaopens in a new tab or window and New Mexicoopens in a new tab or window also carved out exceptions for medical devices.

Patient safety should always be the overarching concern for medical devices. Regulators should focus PFAS restrictions on uses that pose the most robust risks to health and the environment, not the uses in medical devices that save lives.

Roberta Dressen, MBA, is CEO and president of Medical Alleyopens in a new tab or window, a Minnesota-based healthcare trade group that represents 800 partner organizations with more than 500,000 employees. Several of the partner organizations are medical device manufacturers.

https://www.medpagetoday.com/opinion/second-opinions/115448