Trump could use the findings of the probe to impose certain trade restrictions on pharma products, including tariffs.

The U.S. Department of Commerce has formally launched an investigation into the importation of pharmaceutical products and the potential national security threats posed by the global supply chain, according to a Federal Register notice on Monday.

The probe will cover “pharmaceuticals and pharmaceutical ingredients,” according to the registry notice, such as “finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items.”

The federal agency launched the investigation on April 1 and is seeking public comments on the matter, which should be filed within 21 days of the notice’s publication.

Analysts at Leerink Partners said Monday that the probe was “expected.” After all, President Donald Trump over the past few weeks has signaled his intent to impose tariffs on the pharma industry. “The surprise was that the Federal Register notice indicated that [the investigation] was initiated on April 1,” Leerink wrote, nearly two weeks before the notice was published.

Trump’s first tariff threat on pharma came in February, when he told industry leaders that he would slap additional duties on their products unless they relocate their manufacturing operations to the U.S.

Last week, Trump doubled down on his threats, saying that “major” pharma tariffs are coming “very shortly.” In an interview with ABC News over the weekend, Commerce Secretary Howard Lutnick said that the pharma tariffs will hit “in the next month or two.”

Analysts warn that these levies would be a blow for the industry. BMO Capital Markets in a note last week wrote that tariffs “will likely do little to shift manufacturing back to the U.S.,” especially since many major players already have “robust” biomanufacturing and fill-finish footprints in the country.

“Given the complexity of the pharma supply chain, we do not expect the industry to make any major changes,” BMO wrote. “These tariffs will only threaten public health and access to crucial treatments.”

Monday’s investigation is being carried out under Section 232 of the Trade Expansion Act of 1962, which allows the Commerce Department to look into certain imports and their effects on national security. The probe will culminate with a report to the president, within 270 days of initiation, who will then make the decision to impose certain trade restrictions, including tariffs.

In his first term, Trump used findings of Section 232 investigations to impose tariffs on copper and timber imports. He again relied on Section 232 probes to expand steel and aluminum tariffs last month.

In a Phase Ib trial, VERVE-102 showed it could lower bad cholesterol across doses, setting up an opt-in decision for Eli Lilly and a showdown with Novartis.

Verve Therapeutics’ in vivo base editing therapy, VERVE-102, lowered bad cholesterol in Phase Ib, the company announced Monday morning, leaving the company’s partner, Eli Lilly, with a decision to make.

Analysts from both William Blair and BMO Capital Markets pointed to the asset’s “clean” safety profile in notes to investors Monday morning. Safety was the trial’s primary outcome.

VERVE-102 targets and permanently shuts off the PCSK9 gene specifically in the liver, with the aim of reducing low-density lipoprotein cholesterol (LDL-C, so-called “bad” cholesterol) to treat heterozygous familial hypercholesterolemia (HeFH), where high cholesterol can lead to strokes and heart attacks.

The therapy is part of a $60 million deal with Eli Lilly signed in 2023, where the larger pharma can opt-in to take over development of the therapy after Phase I trials are completed.

VERVE-102 showed dose-dependent reductions in LDL-C, with the lowest dose eliciting a 21% average reduction while the highest led to a 53% reduction, with one patient in the highest dose cohort seeing a 69% reduction.

These data from the highest-dose cohort “numerically [beat] the LDL-C lowering bar for a long-acting PCSK9 inhibitor set by [Novartis’] Leqvio,” which elicited a 39.7% LDL-C lowering for HeFH patients, William Blair analysts said Monday. Verve could also differentiate itself from Leqvio in another way: VERVE-102 is a one-time therapy, while Leqvio is given twice per year.

Verve reported “no treatment-related [serious adverse effects], no dose-limiting toxicities, and no cardiovascular events observed,” according to its press release.

“We believe the absence of dose-dependent changes in [adverse effects] points to a wide VERVE-102 therapeutic index,” BMO wrote.

VERVE-102’s continuing development sets it up for a showdown with Leqvio, an siRNA treatment that also targets PCSK9. Novartis licensed the drug from Alnylam in 2020, winning FDA approval in 2021. The William Blair analysts also compared VERVE-102 to Merck’s investigational PCSK9 drug MK-0616, which has achieved similar LDL-C-lowering numbers, while noting that food consumption lowers its bioavailability. AstraZeneca also has a drug candidate in the running, AZD0780, though William Blair noted that daily dosing might be a disadvantage.

Monday’s results may come as a relief to Verve. A year ago, the company halted development of a similar PCSK9 gene editor, VERVE-101, due to Grade 3 drug-induced thrombocytopenia. The company at the time attributed those abnormalities to the lipid nanoparticle delivery system used by VERVE-101. Verve then pivoted to VERVE-102, which uses a different nanoparticle. Two months ago, Vertex severed a $400 million agreement signed with Verve in 2022 to co-develop gene therapies together.

Health and Human Services employees aren’t the only ones out of work. Thousands of private-sector biopharma professionals lost their jobs in the first quarter.

At the end of March, news hit that the Department of Health and Human Services had put 10,000 jobs on the chopping block. Those cuts began April 1, generating a flurry of media coverage about who’d lost their jobs and how they’d received that news. Some people, for example, found out when they went to start their workday and their security badges didn’t work. It was an ugly scene, to be sure. And yet . . .

Biopharma professionals are painfully familiar with this reality, as layoffs have hit the industry hard in recent years. In just the first quarter of 2025, about 4,015 employees were laid off, according to BioSpace tallies. Jobs are rarely safe, certainly not for years or decades. That kind of job security was only found at government agencies—until now.

Many of these laid-off biopharma employees are still looking for work. As highlighted in BioSpace’s job market report that went to Career Insider newsletter subscribers Thursday, job applications submitted through our website jumped 91% during the first three months of 2025. With thousands of life sciences–focused professionals suddenly being dismissed from HHS agencies including the FDA, NIH and CDC, how much harder is it going to be for the unemployed to find work?

Unfortunately, in addition to the sudden uptick in job seekers, the number of available positions is dropping. Bureau of Labor Statistics data released April 1 showed that U.S. job openings in February declined by 877,000 over the year. And in biopharma specifically, BioSpace data show a 20% dip in job postings live on our website in Q1 2025 as compared with Q1 2024.

In a job market like that, how much more stress is being placed on biopharma professionals looking for work now that they may have increased competition from former HHS workers? How much longer might it take to get a job? It’s not always a quick process, after all. In a BioSpace survey late last year that informed our 2025 U.S. Life Sciences Employment Outlook report, we found that 45% of unemployed respondents had been between roles for at least six months and 20% for over a year.

Some biopharma professionals have taken jobs they likely wouldn’t have before they found themselves laid off. According to a March BioSpace LinkedIn poll, 44% of respondents had recently taken a biopharma role they were overqualified for. In a recent BioSpace article, our recruitment manager, Greg Clouse, shared a story about a senior manager of a manufacturing function who became a supply chain manager simply because he needed a job.

Some senior-level biopharma professionals have turned to fractional roles where they work as part-time leaders for companies. Last year, Eric Charsky, president of Charsky Group, an executive search firm, told BioSpace that he’d seen more candidates he works with turn to fractional work in 2024 compared to 2023. That trend could very well continue this year.

Layoffs are tough whether you’re a public- or private-sector employee. HHS workers’ job loss may be garnering national headlines right now, but let’s not forget about the biopharma professionals who were already out of work, and those that join them every week.

Hopefully that market turns around soon for the sake of everyone out there looking for their next role.

According to analysts at Jefferies, legislation such as the newly proposed bills that aim to streamline regulatory processes would be a positive for the biotech industry.

Scientists from Conceivable Life Sciences, a biotechnology company, said that the first baby conceived using its fully automated, digitally controlled intracytoplasmic sperm injection (ICSI) system has been born. Full details are available in a new paper in Reproductive Biomedicine Online titled, “A digitally controlled, remotely operated ICSI system: case report of the first live birth.”

Conceivable combines AI and robotics to automate more than 200 steps required to create embryos for IVF. Its workstation automates each of the 23 steps of the standard ICSI procedure. The ICSI system was developed and adopted into widespread use in the 1990s and is now routinely used for assisted conception. It achieves fertilization by injecting a single sperm cell into the center of a mature egg. Historically, ICSI procedures are performed manually by skilled embryologists operating microinjection systems, which can introduce variability in the fertilization process.

Besides standardizing ICSI procedures, Jacques Cohen, PhD, Conceivable’s CSO and a trained embryologist, noted that Conceivable’s automated approach also has the potential to improve egg survival and to optimize the timing of the injection. The steps can be controlled either by using artificial intelligence or a remote operator. In this latest iteration of the system, the scientists used AI to position the sperm cell in the injection pipette and direct the microinjection itself within the egg. Essentially, the system’s AI “autonomously selects sperm and precisely immobilizes its midsection with a laser ready for injection,” explained Gerardo Mendizabal-Ruiz, PhD, the company’s lead engineer.

The birth reported in the paper was accomplished in a 40-year-old female who was referred for treatment with donor eggs at Hope IVF Mexico in Guadalajara, Mexico. The patient was referred following a previously unsuccessful IVF attempt which had produced only one mature egg and no embryos. In the study cycle, five eggs were assigned to fertilization with automated ICSI, and three as controls with standard manual ICSI. The automated system was set up on site but after that remote operators, in the Guadalajara clinic and in New York, issued commands via a digital interface to perform each of the 23 microinjection steps for each egg—a total of 115 steps. Overall, the entire procedure took an average of 9 minutes 56 seconds per egg, a little longer than routine manual ICSI because of its experimental nature, but in the future, the team expects “to reduce procedure time significantly,” said Mendizabal-Ruiz.

Four of the five injected eggs in the automated system achieved normal fertilization and all three in the manual control group. One high-quality embryo that progressed to the blastocyst stage in culture had been fertilized with the automated system under remote control in New York. When this blastocyst was transferred in a subsequent cycle, a pregnancy was established which continued normally to the delivery of a healthy male baby. The treatment was provided under review board oversight at Hope IVF, a fertility clinic in Guadalajara, Mexico, as part of a pilot investigation into various processes of automation in the fertility laboratory.

Successfully achieving a live birth using the automated ICSI procedure is a significant step toward the adoption of a fully automated IVF laboratory, Alejandro Chavez-Badiola, MD, Conceivable’s co-founder and chief product officer, noted. However, applying the system more broadly will depend on its safe performance in more cases, he said.

Earlier this year, Conceivable raised $18 million in a Series A financing round led by ARTIS Ventures with participation from several new investors including Atlantic Health Venture Studio, Muse Capital, and Scrub Capital. Existing investors include ACME Capital, Black Opal Ventures, Cadence Healthcare Ventures, Future Positive Capital, Stride.VC, and Time BioVentures.

Cancer diagnoses traditionally require invasive or labor-intensive procedures such as tissue biopsies. Researchers at the Ludwig-Maximilians-Universität München (LMU) have now reported on a method that uses pulsed infrared light to identify molecular profiles in blood plasma that could indicate the presence of some common cancers. In a proof-of-concept study, the team used machine learning to analyze blood plasma from more than 2,000 participants and link molecular patterns to lung cancer, extrapolating a potential “cancer fingerprint.”

Mihaela Žigman, PhD, at the Max Planck Institute of Quantum Optics (MPQ) is corresponding author of the team’s published paper in ACS Central Science, titled “Electric-Field Molecular Fingerprinting to Probe Cancer.” In their report, the team concluded, “Our study demonstrates that electric-field molecular fingerprinting is a robust technological framework broadly applicable to disease phenotyping under real-world conditions.”

Various physiological states, and some diseases, may be reflected in the molecular makeup of biofluids such as blood and plasma, which is the liquid portion of blood depleted of any cells, the authors explained. Plasma carries diverse molecules such as proteins, metabolites, lipids, and salts throughout the body and some molecules carried by blood plasma indicate potential health conditions. For example, unusually high levels of prostate-specific antigen are used to screen for prostate cancer. Theoretically, a medical test that measures a broad range of molecules could identify a pattern specific to different cancers, leading to quicker diagnoses and reduced costs.

The use of sensitive and specific analytical methods in the fields of proteomics and metabolomics has led to the discovery of various molecular “biomarker candidates” the authors noted. “However, current omics techniques are often still limited in the range of molecular species that they can probe at once. They often require complex, target-specific preanalytical workflows for sample preparation.”

A technique known as molecular fingerprinting, “… where phenotype detection is based on patterns of change across the entire molecular landscape,” could represent an alternative approach, the researchers continued. “If a specific pattern shows a robust correlation with a particular physiological state, it may contribute to the detection of a phenotype.”

For their newly reported study, Žigman and colleagues tested a technique called electric-field molecular fingerprinting (EMF), which uses pulsed infrared light, to profile complex molecular mixtures in blood plasma and look for telltale chemical patterns of cancer.

First, the researchers used the electric-field molecular fingerprinting technique to send ultra-short bursts of infrared light through plasma. They analyzed samples from 2,533 study participants, including people with lung, prostate, breast, or bladder cancer and those without cancer. For each sample, they recorded the pattern of light emitted by the molecular mixtures in the plasma, the “infrared molecular fingerprint.” Using these complex patterns from individuals with and without cancer, the researchers taught a machine learning model to identify molecular signatures associated with the four types of cancer.

The computer model was tested on a separate subset of participants’ samples to see how well the model could perform on unseen test data. The analytical technique demonstrated a convincing level of accuracy (up to 81%) in detecting lung cancer-specific infrared signatures and differentiating them from control samples obtained from individuals without cancer. “In an independent held-out test data set, designed to reflect different experimental conditions from those used during model training, we achieved a lung cancer detection ROC AUC of 0.81… This independent testing allows us to assess the generalizability of our technique beyond a single measurement campaign, revealing that our lung cancer detection model remains robust under realistic measurement shifts, maintaining its diagnostic performance and demonstrating its potential reliability,” they noted.

The computer model’s performance did demonstrate lower success rates in detecting the other three cancers. The observed discrepancies, particularly in the capacity to detect the other three cancer entities, the authors noted, “… highlight the need for improving the reproducibility of EMF measurements and for further validation of this approach in additional patient populations.”

Nevertheless, they wrote, “Our findings indicate that patterns in infrared fingerprints can reliably be associated with physiological states … In conclusion, the current findings provide compelling evidence underscoring the potential of electric-field molecular fingerprinting for minimally invasive disease detection.”

In the future, the team aims to expand and test the approach to identify additional cancer types and other health conditions. “Future enhancements, such as broader spectral coverage, increased detection sensitivity and specificity, multidimensional measurements, and interferometric subtraction, could further boost biomedical potential,” they stated. “Expanding clinical studies to larger cohorts, focusing on early disease states and independent clinical testing, and exploring various disease phenotypes and their combinations will be crucial for developing a reliable diagnostic platform to improve cancer outcomes.”

Žigman added, “Laser-based infrared molecular fingerprinting detects cancer, demonstrating its potential for clinical diagnostics. With further technological developments and independent validation in sufficiently powered clinical studies, it could establish generalizable applications and translate into clinical practice—advancing the way we diagnose and screen for cancer today.”

According to analysts at Jefferies, legislation such as the newly proposed bills that aim to streamline regulatory processes would be a positive for the biotech industry.

Senators Todd Young (R-IND) and Alex Padilla (D-CA) on Thursday filed a bill to help revitalize biotech in the U.S. as a key component of national security and economic productivity. The bill seeks to establish the National Biotechnology Coordination Office (NBCO), which would reside under the Office of the President and be responsible for harmonizing federal initiatives on biotech and for streamlining regulatory pathways.

Representatives Stephanie Bice (R-OK) and Ro Khanna (D-CA), meanwhile, have introduced a parallel version of the bill in the House.

“We see strong support for optimizing regulatory processes and eliminating unnecessary bureaucracy” as a positive for the industry, Jefferies analysts wrote to investors Thursday evening, which in turn could lead to “quicker approvals.” The group referenced the new bills as one example but also noted “we will watch for other bills to come starting in the next few months which could touch more on incentives, supply chain onshoring, investment restrictions etc. [plus] other issues investors remain concerned about.”

Thursday’s proposed legislation, dubbed the National Biotechnology Initiative Act of 2025, is one of the principal recommendations from the recent National Security Commission on Emerging Biotechnology (NSCEB) report that warned the government that China is growing “dangerously close” to overtaking the U.S. as the global leader in biotech innovation. Young is the chair of the NSCEB, while Padilla, Bice and Khanna are commissioners.

Jefferies noted that across the industry, “onshoring manufacturing [continues] to be a major theme of conversation.” At the head of this push are Big Pharma players like Eli Lilly, Johnson & Johnson and Novartis, who in the face of President Donald Trump’s ongoing tariff threats have unveiled multibillion-dollar investments in the U.S.

Still, Jefferies warned that China is unlikely to play passive and instead could enact a “retaliatory strategy that does not just utilize tariffs but takes advantage of other strategies such as cutting off API [active pharmaceutical ingredient] supply.” China holds about 90% of API production, as per the analysts.

The NSCEB report outlines some 50 recommendations that the U.S. government can take to maintain and widen its lead in biotech. One of these is the establishment of the NBCO to help ease what Young and Padilla called “regulatory burdens” on well-characterized products. The NCBO would also be in charge of the overall biotech strategy in the U.S.

The director of the NCBO would serve as principal biotech advisor to the president. It remains unclear who the prime candidates for this position would be.

Novartis plans to build seven new facilities in the U.S., touting the creation of up to 1,000 new jobs at the company. The new facilities will include a biomedical research hub in California, two radioligand plants, and four manufacturing sites.

Biotech companies are already seeing regulatory delays and plenty of uncertainty after around 3,500 FDA employees were cut by the Trump administration.

The biotech industry is already feeling the regulatory impact of dramatic staff cuts at the FDA, according to a letter sent by executives, patient advocates and investors to Sen. Bill Cassidy (R-LA).

Cassidy oversees the Health, Education, Labor, and Pensions (HELP) Committee that conducted the hearings for new FDA chief Marty Makary. The executives urged the senator toward action to ensure the agency can continue its core mission.

“Most small companies don’t engage the agency frequently enough to know yet how their drug candidates or their research timelines will be affected by recent changes at the FDA; while some problems crop up quickly, others will take months or even years to emerge,” said the letter, which was posted by the advocacy group No Patient Left Behind. “The companies that happen to be engaging with the FDA right now are our leading indicators—and some of us have already encountered regulatory difficulties that we believe are the consequences of the FDA’s loss of experienced staff.”

No Patient Left Behind is an advocacy group founded by RA Capital’s Peter Kolchinsky, that aims “to protect and promote the biotech social contract that provides society with affordable biomedical innovation.” The letter to Cassidy was signed by dozens of biotech executives, investors and patient advocates, including the CEOs of Ovid Therapeutics, Seaport Therapeutics, ReCode Therapeutics, Verto Therapeutics, Delphia Therapeutics and many more.

The FDA has been hit hard by several rounds of layoffs spurred by President Donald Trump’s Department of Government Efficiency (DOGE). The cuts have rolled through rank-and-file employees and felled top leaders, such as Center for Biologics Evaluation and Research (CBER) Director Peter Marks.

The letter asked Cassidy to find out where the FDA’s capabilities have been stunted to preserve and restore its core functions, re-hire key officials with institutional knowledge that cannot be easily replaced and lift the FDA hiring freeze to ensure the agency can get back to work.

“The operating plans and development milestones of biotech companies leave little room for missing critical regulatory timelines due to unforeseen FDA delays,” the letter said. “Our companies have already faced delays in scheduling routine meetings and receiving routine agency feedback that guides drug development. Many have concerns that approval decision deadlines will be missed.”

Companies have also faced a tumultuous few weeks in the stock market, with biotechs in particular battered after a prolonged post pandemic downturn.

The letter cites an unnamed California biotech that is turning to European regulators to run a clinical trial due to concerns about the FDA’s ability to meet timelines. The company is “effectively ‘offshoring’ capital and investment dollars away from the U.S.,” according to the letter.

Another example from a Massachusetts biotech explains that a dispute resolution process was canceled because the FDA counterpart was not sure there would be enough staff available to handle the matter. A separate Boston-based biotech trying to overcome a clinical hold doesn’t even know if the FDA managers they had previously been working with are still with the agency.

The letter also points to the leadership gap at the agency. A BioSpace analysis found that more than half of senior leaders have left or been fired from the agency in the past six months.

“With these individuals now gone, companies fear we are entering a period of years to build back up an experienced workforce,” the letter says. “One biotech recently experienced conflicting feedback from the review team—a situation where someone senior should step in to make a determination of agency position, which did not happen.”

The letter authors acknowledged that there is room for improvement at the FDA but argued that the agency’s core functions must continue while that review process is happening.

“FDA has never been monolithic; we’ve always had something to complain about but also something to admire,” the letter says. “The current uncertainty surrounding the FDA’s ability to function creates downstream uncertainty from investors who will question whether the FDA can do its job as it is being reinvented.”