An international team of scientists, headed by a team at Nanyang Technological University, Singapore (NTU Singapore), has discovered a new way that could speed up the healing of chronic wounds infected by antibiotic-resistant bacteria.

Collaborating with researchers at the University of Geneva, the team’s preclinical study showed how a common bacterium, Enterococcus faecalis, actively prevents wound healing. The results of their collective studies in mice and in human cells showed that, unlike other bacteria, which produce toxins when they infect wounds, E. faecalis produces reactive oxygen species (ROS), which impairs the healing process of human skin cells.

The team identified extracellular electron transport (EET) as a previously unrecognized mechanism by which E. faecalis generates ROS, which, in turn, activates the unfolded protein response (UPR) in epithelial cells and impedes their migration following wounding. The study also demonstrated how neutralizing this biological process can allow skin cells to recover and close wounds.

Establishing a direct link between bacterial metabolism and host cell dysfunction, the study points to a potential new therapeutic strategy for chronic wounds. Co-senior and co-corresponding author, NTU associate professor Guillaume Thibault, PhD, at the School of Biological Sciences, and colleagues reported on their findings in Science Advances, in a paper titled “Enterococcus faecalis redox metabolism activates the unfolded protein response to impair wound healing,” in which they concluded, “Our findings establish EET as a virulence mechanism that links bacterial redox metabolism to host cell stress and impaired repair, offering new avenues for therapeutic intervention in chronic infections.”

The study was headed by Thibault and co-senior author Kimberly Kline, PhD, a professor from the University of Geneva, who is a visiting professor at the NTU Singapore Centre for Environmental Life Sciences and Engineering. The paper’s first author is NTU Research Fellow Aaron Tan, PhD.

Worldwide, chronic wounds represent a major health challenge, with an estimated 18.6 million people developing diabetic foot ulcers each year, according to figures cited by the NTU. Such wounds are a leading cause of lower-limb amputations and are frequently complicated by persistent infections that prevent healing. In Singapore, chronic wounds, including diabetic foot ulcers, pressure injuries, and venous leg ulcers, are increasingly common, with over 16,000 cases annually, particularly among older adults and people with diabetes.

E. faecalis is an opportunistic pathogen frequently found in chronic infections such as diabetic foot ulcers. These wounds are difficult to treat and often fail to heal, increasing the risk of complications and amputation. “Enterococcus faecalis is a gut commensal and opportunistic pathogen that causes difficult-to-treat biofilm-associated infections, including catheter-associated urinary tract infection, infective endocarditis, and chronic wound infections,” the authors wrote. “We previously showed that E. faecalis infection impairs wound healing.”

Antibiotic resistance is also an increasing concern in E. faecalis, with some strains resistant to several commonly used antibiotics, making certain infections difficult to treat. While such infections are known to delay healing, the biological mechanism behind this disruption has remained unclear to doctors and scientists. “… the extent to which E. faecalis metabolism actively interferes with host repair mechanisms is poorly understood,” the team further noted.

Through their newly reported research, Thibault and colleagues found that in E. faecalis, a metabolic process known as extracellular electron transport continuously produces hydrogen peroxide, a highly reactive oxygen species that can damage living tissue. Laboratory experiments showed that oxidative stress triggers a cellular defense mechanism known as the unfolded protein response (UPR) in keratinocyte skin cells, which are responsible for skin repair.

The unfolded protein response is normally used by cells to cope with damage by slowing down protein production and other vital activities, so that they can recover. Once activated, the stress response effectively paralyses the cells, preventing them from migrating to close the wound. “E. faecalis is the first example, to our knowledge, where a defined EET system is shown to drive ROS production that directly alters host stress signaling and function,” the scientists commented.

The researchers showed that a strain of E. faecalis genetically modified to lack the EET pathway produced significantly less hydrogen peroxide and was unable to block wound healing. This confirmed that the metabolic pathway was central to the bacterium’s ability to disrupt skin repair.

The team then tested whether neutralizing the hydrogen peroxide could reverse the damage. By treating affected skin cells with catalase, a naturally occurring antioxidant enzyme that breaks down hydrogen peroxide, the researchers reduced cellular stress and restored the cells’ ability to migrate and heal.

This, they suggest, offers a potential approach to tackle antibiotic-resistant E. faecalis strains other than trying to kill or inhibit them with antibiotics. In their paper, they concluded, “These findings not only establish a role for EET in ROS generation but also, through its interaction with the host UPR, establish it as a metabolic virulence mechanism by which E. faecalis disrupts epithelial repair, thereby presenting new opportunities for targeting chronic E. faecalis-driven pathologies.”

Added Thibault, who is also the assistant dean, international engagement, at the College of Science, “Our findings show that the bacteria’s metabolism itself is the weapon, which was a surprise finding previously unknown to scientists. Instead of focusing on killing the bacteria with antibiotics, which is becoming increasingly difficult and leads to future antibiotic resistance, we can now neutralize it by blocking the harmful products it generates and restoring wound healing. Instead of targeting the source, we neutralize the actual cause of the chronic wounds—the reactive oxygen species.”

As the study used human skin cells to demonstrate the mechanism, the findings are relevant to human physiology and may pave the way for new treatments for patients with non-healing wounds. The researchers suggest that wound dressings infused with antioxidants such as catalase could be an effective treatment in the future.

Because antioxidants such as catalase are already widely used and well understood, the scientists believe this strategy could shorten the path from laboratory research to clinical application, compared with developing a new drug. The team aims to move toward human clinical trials after determining the most effective way to deliver antioxidants through ongoing studies in animal models.

In their paper, the scientists suggested, “Future studies should examine the role of EET in vivo, its regulation and contribution within polymicrobial settings, and the potential for targeting redox metabolism to mitigate E. faecalis infections that are increasingly recalcitrant to antibiotic therapy.”

Liver failure claims thousands of lives each year as patients in the United States wait for a donor organ. Now, a research project at the University of California San Diego, funded by the Advanced Research Projects Agency for Health (ARPA-H), aims to change that by developing a fully functional, patient-specific, 3D bioprinted liver. The project, which falls under ARPA-H’s Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) program, provides up to $25,771,771 for a 60-month period.

The multidisciplinary team has the goal of creating “made-to-order” livers grown from a patient’s own cells. The approach could offer a safe, scalable alternative to transplantation that eliminates the need for donor organs and lifelong immunosuppressant drugs.

“When people think about 3D printing, they often imagine making gadgets like cellphone holders or toys, not human organs,” said Shaochen Chen, PhD, professor in the Aiiso Yufeng Li Family Department of Chemical and Nano Engineering at the UC San Diego Jacobs School of Engineering. “But the need for organ transplants is enormous, and 3D bioprinting is uniquely suited to address that challenge, as it allows us to personalize each organ to the patient. Our ultimate goal—the holy grail—is to help solve the organ shortage by printing real, living human organs that can restore health and quality of life.”

Chen and his lab have developed a technology capable of rapidly fabricating high-resolution biological tissues with complex, multi-cellular structures in just seconds rather than hours. Recently, they integrated artificial intelligence into the design and manufacturing process to help engineer sophisticated vascular networks. This, Chen explained, is one of the key challenges in scaling up from small tissue samples to full-sized, living organs.

The project could provide an on-demand source of functional liver tissue for transplantation, potentially saving the lives of more than 12,000 patients in the United States each year who are currently on the transplant waiting list. The approach could also significantly reduce healthcare costs and improve long-term outcomes for patients with chronic liver disease.

“For decades, the transplant community has dreamed of a future where the fate of thousands of patients each year is no longer determined by the scarcity of donor organs,” said Gabriel Schnickel, MD, professor of surgery at UC San Diego School of Medicine, chief of the Division of Transplantation and Hepatobiliary Surgery at UC Dan Diego Health. “This work has the potential to fundamentally change countless lives by moving that vision from aspiration to reality.”

The researchers are collaborating with Allele Biotechnology, an industry partner with expertise in personalized stem cell generation technologies and methods to efficiently produce different types of cells needed to bioprint livers for transplantation. The San Diego company also owns specialized facilities for cell manufacturing that meet regulatory standards. Together, the team plans to advance the process from laboratory-grade to clinical-grade production.

Unlike conventional 3D printing methods, this technology uses digitally controlled light patterns to solidify cell-laden materials layer by layer, allowing researchers to precisely recreate the fine microarchitecture found in living tissues, including intricate networks of blood vessels. Chen and his team launched a startup company, Allegro 3D (now Cellink), to translate the technology beyond the laboratory. As they worked to commercialize the bioprinting platform, they progressively advanced the system from an experimental prototype to an industrial-scale printer capable of producing much larger, more complex structures.

An international research group led by scientists at Pompeu Fabra University has reported new discoveries that help to better understand the nanomachine that controls a process known as constitutive exocytosis, which is the uninterrupted delivery of spherical molecular packages to and fusion with the cell membrane. This is an essential activity present in virtually all organisms to preserve cell fitness and other vital functions such as communication with the cell’s exterior, cell growth and division.

Studying the yeast Saccharomyces cerevisiae the scientists resolved the dynamic architecture of the tiny machine that delivers essential molecular packages to the cell surface. Discovery of this flexible and transient ‘nanocourier’ required the combined power of multiple microscopes and artificial intelligence, yielding unprecedented information of a key process that occurs billions of times per day in our bodies.

Better understanding of exocytosis may have profound implications for the treatment of some infections and rare diseases. Research lead Oriol Gallego, PhD, leader of the Biophysics in Cell Biology Group at the UPF Department of Medicine and Life Sciences (MELIS), said, “despite being one of the largest nanomachines in the cell, its short lifespan and dynamism made it very challenging to capture.”

Gallego and colleagues reported on their findings in Cell, in a paper titled “Continuum architecture dynamics of vesicle tethering in exocytosis.”

“Constitutive exocytosis (hereafter exocytosis), the uninterrupted transport of secretory vesicles to and subsequent fusion with the plasma membrane (PM), is an essential cellular process for nearly all eukaryotes,” the team wrote. “Exocytosis is critical for the preservation of PM homeostasis, cell growth, and cell division.”

Every day, every cell of our body transports between 10,000–100,000 of these spherical packages to the cell surface to fulfill cellular processes that require the release or display of any molecule on the outside of the cell, such as the secretion of enzymes and hormones, repairing wounds on the cell surface or simply because the cell needs to grow, move or change its shape. Therefore, the delivery of packages to the surface is essential because it is linked to many vital processes that the cell undergoes daily. Central to this intricate process is tethering, which is the finely tuned docking of cargo-loaded vesicles with the plasma membrane, the team further explained.

Despite being vital for the cell, studying exocytosis hasn’t previously been possible in detail. Gallego’s lab, in collaboration with Carlo Manzo, PhD, at the Universitat de Vic, Daniel Castaño, PhD, at the Instituto Biofisika, and Jonas Ries, PhD, at Max Perutz Labs, combined advanced light and electron microscopes with image analysis using artificial intelligence, to resolve the 3D organization of this nanomachine, and filmed how it quickly changes its structure during the delivery of spherical packages. Gallego added, “The function of this nanocourier is so important that it is very rare to find it mutated in patients as its alteration would normally impair the viability of the embryo.”

At the core of this nanomachine, the concerted motion of seven protein assemblies known as exocysts builds a flexible ring that holds the spherical packages in place upon their arrival at their destination: the cell surface. “The exocyst, a conserved heterooctameric protein complex, is the main component of tethering,” the authors noted. “We found that seven exocysts form a flexible ring-shaped ExHOS that tethers vesicles at <45 nm from the PM.”

Co-senior Marta Puig-Tintó, PhD, one of the main authors of the study, further explained, “We have named this nanocourier ExHOS, standing for exocyst higher-order structure. The ExHOS features three checkpoints and a mechanism of disassembly that ensures that the delivery of molecular packages continues at the required speed.”

Co-senior author Sasha Meek, PhD, added, “It is as if every time the cell needs to deliver a heavy package, a team of seven strong couriers work together to do so. Because the package is so heavy, they can’t just drop it all at once and have to lower it in three steps. And when they’re finished, they need confirmation of receipt so that the team of couriers can break up and go on to make other deliveries.”

Increasing what is understood about exocytosis goes far beyond the mere desire to know, and could one day affect many fields of applied science. Plants, for example, need the ExHOS to defend cells against microbial invasion. Hence, many phytopathogens have developed mechanisms to attenuate plant immunity by attacking the ExHOS. A good example is Magnaporthe oryzae, also known as rice blast fungus, which causes the loss of up to a third of the world’s rice production.

In humans, several viruses such as SARS-CoV-2, HIV, or pathogenic bacteria, such as Salmonella, behave similarly and hijack exocytosis during infection. “Beyond its canonical role in exocytosis, the exocyst is involved in the secretion of exosomes and herpesviruses,” the researchers stated. “Not limited to secretory processes, it is a key player in autophagy, host invasion by pathogens (e.g., Salmonella typhimurium), and it is both a pathogen target and an immune receptor in plants. Together, these roles highlight the exocyst’s central importance across diverse biological pathways in both biomedical and agricultural contexts.

Even mild alterations of ExHOS components are linked to human diseases. Though infrequent, mutations in components of the nanocourier cause rare diseases related to neurodevelopmental disorders. In other cases the ExHOS participates in cell invasion in metastatic cancers.

“Despite being small in size, the cell interior is a vast space full of enigmatic nanomachines that have never been observed because of the limitations of current microscopy tools,” Marta Puig-Tintó commented. ”But I think that the future lies in integrating various imaging technologies with the power of new computational tools like AI to “make the invisible visible.”

In their report the authors concluded, “Overall, this study provides quantitative insights into the biophysical principles that drive tethering of secretory vesicles. Given the exocyst’s central role across multiple cellular processes and diseases, these insights could help advance our understanding of the exocyst’s mechanism of action across biology more generally.”

Gallego added, “With these new opportunities, we have unveiled a fundamental and vital cellular process. It’s like explaining how oxygen is exchanged during breathing or how the periodicity of the heartbeat is maintained. It might not have an immediate application, but the discovery of this nanomachine will facilitate future research to find solutions to severe biomedical and biotechnological problems.”

Robert Kramer, former CEO of Emergent BioSolutions, allegedly earned more than $10.1 million by executing trades with information related to the company’s manufacturing operations that had yet to be made public.

The New York Attorney General has sued Robert Kramer, former CEO of Emergent BioSolutions, for allegedly engaging in insider trading by selling off stocks before an anticipated dip in the company’s shares.

“Kramer entered into the illegal trades while in possession of material nonpublic information regarding serious and unresolved contamination issues Emergent faced,” the complaint reads. Kramer gained more than $10.1 million in proceeds from these stock trades, the suit alleges. The lawsuit was filed Thursday with the Supreme Court of the State of New York.

At the heart of the lawsuit is a series of partnerships in mid-2020 between Emergent and AstraZeneca, which had an aggregate value of more than $260 million. Under the agreement, Emergent promised to manufacture the pharma’s virus-based COVID-19 vaccine, while also providing other contract development services such as analytical testing and drug substance processing.

Soon after the deals were forged, Emergent ran into “serious manufacturing difficulties,” Thursday’s lawsuit claims, namely the contamination of AstraZeneca’s vaccine. The contract manufacturer encountered “excess bioburden (bacteria) and elevated endotoxin” concentrations in several vaccine batches, which ultimately resulted in “the rejection and destruction of multiple batches.”

Kramer was aware of these issues as early as Oct. 6, 2020, the suit alleges.

Later that same month, the complaint claims, Kramer instructed his investment adviser to put in place a trading plan, which the former CEO executed on Nov. 13, 2020—“still in the midst of an internal investigation of the unresolved contamination and manufacturing problems that had not been disclosed to the public.” Ultimately, Kramer earned more than $10.1 million in proceeds from this trading plan.

Kramer had not engaged in such a trade since 2016, the lawsuit states.

The ex-CEO continued to carry out a handful of similar trades through January and early February 2021, acquiring and then immediately selling Emergent shares. Shortly thereafter, Emergent’s contamination problems became public, sending the company’s share prices on a decline “from which it has not recovered,” according to the lawsuit. Kramer announced his retirement from Emergent in June 2023.

The New York Attorney General is asking the court to direct Kramer to “disgorge all amounts obtained” from the alleged insider trading scheme and to pay all direct and indirect damages related to the incident.

The office has also filed a case against Emergent, but on Thursday announced that it had reached a settlement, with the company agreeing to pay $900,000. Emergent has also promised to bake more protections into its anti-insider trading policies.

Incoming PhRMA Chair Paul Hudson, a day before the White House announcement, pledged to work with the administration as the president turns to insurers as a source of cost savings for prescription medicines.

President Donald Trump unveiled “The Great Healthcare Plan” on Thursday, calling on Congress to enact changes to lower drug prices and insurance premiums and stretch Most Favored Nation drug pricing beyond the 17 pharma companies that were targeted last year.

Speaking with reporters on Wednesday in San Francisco, Sanofi CEO—and PhRMA’s next board chair—Paul Hudson, had pledged to work with the administration on any drug pricing action that targeted insurers. Trump’s actions seem to confirm what Hudson and other leaders suspected would be next from the administration on the drug pricing issue.

The plan outline calls on Congress to codify the Most Favored Nation deal, although details were not provided. On lowering insurance premiums, the plan suggests that money will be sent directly to Americans while insurance companies will be required to disclose rate and coverage comparisons in “Plain English.”

“Instead of putting the needs of big corporations and special interests first our plan finally puts you first and puts more money in your pocket,” Trump said in a statement. “The government is going to pay the money directly to you. It goes to you, and then you take the money and buy your own healthcare… the big insurance companies lose and the people of our country win.”

The day before the announcement, Hudson stressed that the industry wants to be involved in advising on future drug pricing policy, preferably through organizations like PhRMA that can represent the interests of the entire industry.

“I did say this to some of [Trump’s] advisors, when we were in the White House, that I prefer for them to deal with PhRMA, because there’s a large group of companies that don’t have a deal exactly, and what are they left with?” Hudson said.

Over the fourth quarter of 2025, a handful of companies—kicked off by Pfizer—signed individual deals with the Trump administration to lower the cost of certain therapies in their portfolios. The White House also proposed TrumpRx, a direct-to-consumer platform that promises to offer the lowest prescription drug prices in America. The site has yet to launch.

Hudson suspected that there may be a “catch all” policy effort to come that would collect the remaining drug companies that have not signed deals.

Whether The Great Healthcare Plan will do that is unclear. The provisions will require codification from a divided Congress.

Hudson says his goal as incoming chair of PhRMA is to make sure that Most Favored Nation drug pricing negotiations come to an end.

“The things I’m interested in as incoming chair is trying to make sure that this round of MFN is the round, and that we’re vigilant enough to know that we we’ve all paid a price, and hopefully that will be the conclusion.”

Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite assurances of swift reviews under the FDA’s new Commissioner’s National Priority Voucher program.

The FDA has extended its review period for Eli Lilly’s oral obesity drug orforglipron and three other Commissioner’s National Priority Voucher awardees, Reuters reported on Thursday.

The target action date for orforglipron now falls on April 10, 2026, the publication reported, citing internal regulatory documents it was able to review. Reuters had previously named an initial decision date of March 28 for the weight loss pill in an exclusive report published last month, noting that agency leaders wanted to accelerate the drug’s review and release a verdict before the original May 20 deadline.

Aside from orforglipron, the FDA has also pushed back the timeline for Sanofi’s type 1 diabetes therapy Tzield after detecting concerning safety signals, including two seizures, one episode of blood clotting and one death, according to Reuters. Disc Medicine’s bitopertin, being developed for the rare blood disorder porphyria, was also delayed amid questions surrounding its efficacy data and its risk of being abused.

The Tzield delay will extend its review by more than a month, Reuters reported, while bitopertin will have to wait two additional weeks for a verdict.

The FDA has also extended its review for Boehringer Ingelheim’s kinase inhibitor zongertinib, which the company is proposing as a treatment for non-small cell lung cancer. A decision for the drug is now expected in mid-February, according to Reuters, though it’s not clear what the original target action date was.

BioSpace has reached out to the companies involved for comment.

All four drugs were awarded the FDA’s Commissioner’s National Priority Vouchers last year. Launched in June 2025, this priority program sought to drastically shorten regulatory review timelines, from the normal 10–12 months down to 1–2 months. These tickets would be awarded to companies that pledged to comply with certain national priorities set by the government, such as addressing a key unmet need, boosting domestic manufacturing and bringing down drug prices in line with President Donald Trump’s Most Favored Nation scheme.

The FDA handed out the first batch of tickets in October last year, with Tzield and bitopertin among them. Lilly and Boehringer won their tickets during the second cycle of awards in November. The FDA has since proactively handed out a voucher to Johnson & Johnson—the pharma didn’t apply for the award.

Buying vaccine biotech Dynavax was an easy choice for Sanofi despite antivaccine moves by the Trump administration.

“It’s a good time to do vaccine BD and M&A,” according to Sanofi CEO Paul Hudson.

While vaccine sentiment is suffering amid the Trump administration’s rhetoric, Hudson says he’s playing the long game with Sanofi’s acquisition of Dynavax.

“With the uncertainty, if you’re a short-term thinker, you don’t move. If you’re a long-term thinker—which is what we have to be—then there are less people to compete against to make acquisitions,” Hudson told reporters at a media breakfast in San Francisco on day three of the J.P. Morgan Healthcare Conference.

To end 2025, Sanofi offered $2.2 billion to buy Dynavax. The center of that deal is the hepatitis B vaccine Heplisav-B. That the vaccine is for adults could help Sanofi overcome some of the vaccine hesitancy that is rising, particularly in America, Hudson said. “We know that the sensitivities are less in the adult context.”

And it was those sensitivities that set the stage for the French drugmaker to pay what Hudson called an “appropriate price” for Dynavax. Elsewhere on the company’s business development (BD) bingo card, he also pointed to Sanofi’s July 2025 acquisition of Vicebio for $1.6 billion, scooping up a combination vaccine for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).

“Those things will launch 5, 6, 7, 8 years from now. And so we have to assume that there’ll be a new administration or two between now and then,” Hudson said. “We don’t know what their sensitivities will be, but it’s okay, as long as there’s some objectivity in the regulator.”

Hudson hinted that there could be more deals to come in the vaccine space.

Sanofi’s legacy vaccine sales fell 8% in the third quarter and Hudson is predicting similar “softness” in the quarters to come. Hudson reiterated that the sales decline can be pinned on the “misinformation that is going around.” He noted the rise in measles cases as people opt out of vaccines.

“We think it will settle down and we’ll move through it,” Hudson said. Sanofi has not provided guidance for 2026 yet.

Hudson also spoke to recent vaccine schedule updates and other antivaccine actions at the Department of Health and Human Services (HHS). The CEO suggested that people are capable of educating themselves when it comes to vaccines in partnership with their care providers.

“The vast majority of people understand the benefit of vaccines and their lives and generations of their family have been protected that way,” Hudson said. “Not everybody looks to the top of the HHS to get people with their guidance on how to live their lives.”

He continued: “So I think people should be respectful of all guidance given, but I think talking to their own healthcare professional is still probably the best thing to do.”

The Next Moment

Vicebio and Dynavax’s programs may be years out from FDA review, but Sanofi’s flu-COVID combo, licensed from Novavax, is not. Hudson expects regulatory review to happen in 2027 or 2028.

That shot is “going to be the next moment, I think, for an acceleration on vaccine utilization,” Hudson said. The product will offer convenience with a one-and-done approach for both infectious diseases. And it will be the only non-mRNA COVID shot available in the U.S. for those who do not want to receive a shot featuring that technology.

“We think people are still very vaccine literate. We think they understand the reactogenicity or the tolerability challenges of mRNA,” Hudson said. Those post-vaccine reactions may have been tolerated during the global pandemic, but that’s not the case anymore, the CEO explained. He expects Sanofi will garner the over-55 and over-65 markets, particularly as the combo can offer a high dose needed for older people, who are at higher risk of death from the flu.

“While there may be debates on Facebook and other places, the over-65s, I think, are highly motivated to get protected,” Hudson said, “because they know they are the ones that are most vulnerable.”

Primarily known as an immunology and neuroscience company, AbbVie wanted to put the biopharma world on notice during its J.P. Morgan presentation: its oncology portfolio is underappreciated. This week, the Illinois-based company dove into the sizzling PD-1/VEGF space with a licensing deal with China-based RemeGen.

It’s a poorly kept secret in biopharma that AbbVie intends to become the leading neuroscience company in the near future. It was a point the Illinois-based behemoth reiterated during its J.P. Morgan presentation on Wednesday.

“We anticipate being the largest neuroscience player in the industry soon,” Scott Reents, the company’s chief financial officer, said during the presentation.

But this wasn’t the only point the company wanted to highlight. “And then the oncology pipeline is something we’re also very excited about that probably isn’t as appreciated as we’d like it to be,” Reents said.

AbbVie took significant strides earlier this week to drive this point home, kicking off JPM26 with a licensing deal potentially worth nearly $5 billion for ex-China rights to RemeGen’s PD-1/VEGF bispecific. The pact—which will see AbbVie front $650 million—puts the company squarely in the middle of the hottest new trend in immuno-oncology, on which peers Bristol Myers Squibb, Pfizer and Merck have collectively bet more than $20 billion biobucks.

“We feel that can be a very nice complement to our c-MET franchise,” Reents said. AbbVie’s Emrelis, a c-Met-directed antibody and microtubule inhibitor conjugate, was approved by the FDA last May for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression.

When asked about AbbVie’s overall approach to oncology R&D, Roopal Thakkar, executive vice president of research & development and chief scientific officer, said the company has “a very strong pipeline internally in a very active research group. . . . So we get assets out of that, a fairly consistent stream.”

Indeed, AbbVie currently has 18 investigational drugs in various stages of clinical development listed in its pipeline.

However, pointing to the RemeGen deal, Thakkar said, “I think you could anticipate from us looking externally for ways to complement the ADC franchise and on the [hematology] side as well.”

The RemeGen pact is far from the only oncology deal AbbVie has inked in recent months. Earlier this month, the company committed more than $1 billion in milestones for the ex-China rights to a Phase III DLL3xDLL3 T cell engager from Suzhou Zelgen Biopharmaceuticals that could challenge Amgen’s Imdelltra. And heading into JPM, AbbVie was one of two companies rumored to be interested in buying Revolution Medicines and its pipeline of targeted drugs for RAS-driven cancers. AbbVie has since denied the rumor.

While AbbVie is a well-diversified company with a significant presence in oncology and neuroscience, as well as eye care and aesthetics, it is possibly best known for its success in the immunology space, and the company’s executives spent half the presentation discussing its megablockbusters.

Now three years past the Humira loss of exclusivity cliff, AbbVie provided 2027 guidance of $31 billion inclusively for successor products Skyrizi ($20 billion) and Rinvoq ($11 billion). AbbVie plans to provide 2026 guidance for the two drugs when it presents its full-year 2025 earnings on Feb. 4.

Reents expressed confidence in the immunology duo’s revenue potential throughout the next several years.

“The runway is really significant still through the end of the decade and even into the 2030s as we go forward,” he said. “And that’s based on a certain way these immunology markets are structured and the breadth and depth that we have with both of those assets.”

Speaking to BioSpace at the J.P. Morgan Healthcare Conference, Novartis’ chief dealmaker Ronny Gal explains why the Swiss pharma hasn’t acquired a GLP-1, and why it probably won’t.

Novartis doesn’t have a GLP-1. But it’s not for lack of trying on the part of intrepid biotechs.

“I will not tell you the number of emails or conversations I had around, ‘Wouldn’t you like to have a GLP-1 with 2% better efficacy than the existing leading compounds? My product is a month-long versus a week-long, things like that,” Ronny Gal, Novartis’ chief strategy and growth officer, told BioSpace on the sidelines of the J.P. Morgan Healthcare Conference on Tuesday.

But Novartis doesn’t want to just be a ‘me-too.’ Gal likens the situation with GLP-1s to what’s happening in China, where a burst of innovation has led to concerns about the real gains being made there and whether many drugs are simply offering incremental improvements over existing options, particularly in oncology.

“The trap of me-too is not unique to China,” Gal said, holding up his can of Pepsi—the ultimate me-too product—for emphasis.

Every industry gets into a cycle of me-too products once one is successful. For a company like Novartis, acquiring such a product can be okay—Gal is not ruling out picking up an asset that offers a small improvement. But “it’s a harder strategy to follow and be successful with,” he said.

Gal said drug program acquisitions typically involve one of three types of risk: scientific, developmental and commercial.

A me-too product can lower the first two types of risk. With an existing product to point to, drug developers have a clinical precedent and lessons learned. The regulatory leg work has also been done if the first product is already approved.

But marketing a product that has a major competitor raises the commercial risk. Will patients or providers switch? Is there enough of a market left over to find a niche? That commercial risk can take much longer to show up, whereas development and R&D risk is “very binary,” Gal explained. That’s why Gal and his team at Novartis are careful about me-too products.

“As a pharma company, we want to make sure that the leadership team at Novartis does our jobs to make sure we balance out those risks,” he said. “So me-too is something that we will do, but we will basically do less commonly, because we do not want to be in a situation where all our risk is commercial risk.”

That’s not to say that Novartis has written off the GLP-1 class or weight loss altogether. To get Gal interested, he said an asset would have to demonstrate substantial benefit over existing options—mainly, Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy.

“But it is an area that is very well served by existing companies,” Gal said. “We are yet to see a transaction in that area that makes sense for us to go into.”

Another factor is pricing. Novo and Lilly have both lowered the cost of their therapies to a few hundred dollars a month, broadening access even as payers continue to balk at coverage. Gal pointed to the consumer impact that has made that possible.

“The argument that the core demand of patients is not being met is not what we’re convinced about,” he said. “I think [for the] majority of patients, the current generation of GLP-1s are probably good enough.”

Still, Gal noted that there are about 30 similar compounds in the clinic right now. Novo just launched a pill version of Wegovy. That therapy is being marketed with a simple ad around San Francisco—a hand holding a small, round tablet with text that reads, “The Pill Is Here.”

While obesity is a common disease, Gal said another limiting factor is that it’s mostly a single disease. In oncology, for example, there are many niche indications to be found across tumor types, stages and gene expression. GLP-1s have been shown to work for almost anyone that takes them, he said—aside from tolerability concerns that can vary between patients.

Now, companies are battling for incremental changes or product features, Gal continued—improvements in tolerability, slight single-percent increases in weight loss achievement.

“What’s the saying? A smart person can get out of trouble. A wise person wouldn’t walk into [it]. . . . We simply try to be thoughtful about the kind of risk we’re taking, and that one, we just can’t find an asset that makes sense for us.”

Acadia Pharma’s Catherine Owen Adams has formed a group of small- to mid-cap biotechs to advocate against a ‘peanut butter blanket’ approach to drug pricing for small companies.
After a year of watching major pharma companies in the Trump administration’s hot seat for drug pricing, Acadia Pharmaceuticals CEO Catherine Owen Adams isn’t taking any chances.

The CEO has formed a lobbying group with her peers to seek carve-outs to any proposed Most Favored Nation drug pricing–style policy that could emerge. That hasn’t happened yet, and the Trump administration has not indicated an interest in imposing the policy on any companies beyond the 17 Big Pharmas that received letters in July.

“I don’t think the administration is out to target small pharma or small biotech particularly. And what we’re trying to do is make sure that they understand that a peanut butter blanket approach to MFN probably would not be the best for U.S. innovation,” Owen Adams said in an interview on the sidelines of the J.P. Morgan Healthcare Conference in San Francisco on Monday.

It’s not just Owen Adams and her immediate peers that are raising concerns about small- to mid-cap biotechs. Greg Graves, a senior partner in McKinsey’s life sciences practice, recently told BioSpace that MFN drug pricing will be a big risk for these companies in 2026.

So Owen Adams and her peers are getting ahead of the matter.

“There’s a group of about 10 of us who are looking to specifically help the administration understand that if you disrupt small biotech innovation in the U.S. by putting MFN around us in terms of constraints, then you’re really suffocating U.S. innovation,” Owen Adams said.

Owen Adams is also involved in other policy and advocacy groups with the same mission, including at BIO. The goal is to ensure that if such a policy is imposed, small biotechs—particularly those, like Acadia, working on rare disease—are exempted. The Inflation Reduction Act included these kinds of carve-outs, Owen Adams noted.

“We’re continuing to be the voice of small biotech,” Owen Adams said. “It’s really important that they don’t lump us in with the large pharma companies who have the ability to make different choices. They have much larger portfolios in which to weigh their decisions than us.”

The matter is particularly critical for Acadia, which is expecting a decision for Rett syndrome therapy Daybue in Europe by the end of the first quarter. Any disruption to pricing in the U.S. could impact those same conversations across the pond, Owen Adams explained.

“If I can’t launch Daybue in Europe because of MFN, it’s a big, big impact on Acadia,” she said. The company still intends to go ahead with that launch, Owen Adams stressed. It’s one of the key milestones she expects for Acadia in a catalyst-rich year.

As Big Pharmas came under President Donald Trump’s microscope, CEOs such as AstraZeneca’s Pascal Soriot began to shift the narrative to suggest that other nations needed to pay more to cover innovation, rather than just dropping prices in the U.S. While the U.K. has agreed to adjust its reimbursement rate, there has been no such decision for the EU at this point.

Owen Adams is skeptical that European nations are going to suddenly agree to pay more for their medicines.

“I think it’s a nice try, but I’m not sure Europe’s ready to raise their prices just because of the situation or the direction from the U.S.,” she said.

The changes in the U.K. were welcome though, Owen Adams said, as country had not changed its reimbursement level in nearly 30 years. “It’s been a while, so their commitment to increase the NICE [National Institute for Health and Care Excellence] reimbursement levels is definitely positive.”

Despite her planning, Owen Adams said that she has not gotten a sense that the Trump administration is working on policy that would impose MFN on smaller companies. In fact, she believes Trump and his team are “keen on U.S. innovation and ensuring that the biotech industry thrives here and has a good foothold.”

Part of the conversation with Trump administration officials has been pointing out that China is ready to step up if the U.S. biotech industry is hamstrung.

“If we don’t have that innovation here, China’s going to move into the space real quick. And we’ve been very specific about how we talk about that and giving illustrative examples,” Owen Adams said.

“I’m hoping that the voice of smaller [and] middle-sized pharma is heard.”