Organon acquired regulatory and commercial rights in the United States for TOFIDENCE™, a biosimilar to ACTEMRA®, for intravenous infusion from Biogen. TOFIDENCE, the first approved tocilizumab biosimilar entrant in the U.S. market, was launched in May 2024 and is indicated in certain patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

“Biosimilars continue to be a key growth driver for Organon, and this acquisition complements our existing business, enabling us to expand our immunology portfolio,” said Kevin Ali, Organon’s CEO. “We believe that by leveraging our commercial expertise and market access capabilities, there is considerable growth potential for this product.”

The agreement includes an upfront payment to Biogen, with Organon assuming the obligation to pay tiered royalty payments based on net sales and tiered annual net sales milestone payments owed by Biogen to Bio-Thera Solutions.

Large growth market

The biosimilars market is forecasted to grow from $29.4 billion in 2023 to $66.9 billion by 2028, driven by a CAGR of 17.8%, according to a report by MarketsandMarkets. The market, focusing on drug classes such as monoclonal antibodies, insulin, erythropoietin (EPO), and anticoagulants, is poised for substantial growth driven by increasing demand for cost-effective treatments amid rising chronic disease rates and the patent expirations of major biologics, noted the report. A key trend cited includes the rapid approval and adoption of biosimilars, particularly in oncology.

Challenges include complex manufacturing processes and regulatory obstacles, which are countered by opportunities in less regulated markets like Asia Pacific, noted the report, which cites players such as Novartis, Pfizer, and Amgen as pivotal in shaping industry dynamics through innovation and strategic expansions.

Ethris and Lonza agreed to collaborate on the development of room-temperature stable, spray-dried formulations of mRNA-based vaccine candidates, designed for mucosal delivery to combat respiratory diseases.

Room-temperature stability aims to address significant supply chain challenges associated with some mRNA vaccines, including the dependence on ultra-low-temperature storage and complex delivery systems, according to Carsten Rudolph, PhD, CEO, Ethris. Overcoming these challenges will simplify production, reduce costs, and support rapid, scalable vaccine development, he added, noting that spray-dried formulations of mRNA-based vaccine candidates aim to enable needle-free nasal administration, potentially achieving mucosal immunity.

“Together, I believe we are well positioned to create promising noninvasive mucosal vaccine candidates that could potentially transform how respiratory diseases are prevented globally,” Rudolph said.

The initial focus of the collaboration is to develop a first-in-class mRNA vaccine candidate against influenza delivered nasally. This noninvasive approach is designed to provide localized immune responses with an immune effect comparable to intramuscular vaccines and could reduce virus transmission by generating mucosal immunity at the site of virus entry.

Lonza will provide spray-drying and particle engineering for vaccine candidates based on Ethris’ stabilized non-immunogenic mRNA (SNIM® RNA) and stabilized lipid nanoparticles (SNaP LNP) platform at its Bend, OR, site, which specializes in addressing bioavailability challenges and modulating pharmacokinetics to meet target product profiles.

“Spray-drying represents a well-established technique that addresses solubility and other manufacturing and stability challenges,” pointed out Jan Vertommen, head of commercial development, advanced synthesis. “However, its application in the field of DNA and RNA-based products represents a highly innovative approach, with another level of complexity introduced by the presence of LNPs.”

President Donald Trump’s exemption of pharmaceuticals from the “reciprocal” tariffs he announced Wednesday limited the declines of biopharma stocks as financial markets tanked late last week—but the specter of future industry-specific tariffs and import duties still hanging over the industry means that shares of biotech and pharma drug developers are hardly out of the proverbial woods.

Biopharma stocks mostly showed declines this past week, buffeted first by the sudden departure of Peter Marks, MD, as director of the FDA’s Center for Biologics Evaluation and Research (CBER), which pushed shares mostly downward on March 31—especially developers of cell therapies, gene therapies, other biologics, and vaccines, all overseen by CBER. The following day, the U.S. Department of Health and Human Services (HHS) began a staggering shrinkage of its workforce, eliminating some 10,000 jobs at the FDA, NIH, and U.S. Centers for Disease Control and Prevention (CDC).

A day later, Trump effectively ended the age of “free trade” by announcing a 10% minimum baseline tariff rate on all imports from all countries effective Saturday—plus reciprocal tariffs set at individual rates for more than 180 countries and territories with which the United States has run the largest trade deficits, including China (34% added to 20% tariff imposed in February), and the European Union (20%). The reciprocal tariffs take effect on April 9.

According to investment research and management firm Morningstar, last year the United States exported $95 billion in pharmaceutical products—but imported more than double that amount, about $200 billion.

“With roughly $200 billion in pharmaceutical imports in 2024, a 10% tariff could amount to a $20 billion headwind across the industry, with the biggest firms seeing potential annual tariffs as high as $1 billion,” predicted Karen Andersen, equity director with Morningstar, in a research note Thursday.

Figuring out which biopharmas face the greatest impact from future tariffs is a challenge, she added.

“While we have some information on which major products are manufactured in which countries, they are often produced in multiple geographies, making it difficult to determine the exact percentages being produced in the United States and whether finishing might be done in another country,” Anderson wrote.

While a future global pharmaceutical tariff could potentially lower gross margins while raising long-term tax rates, Andersen added: “We expect firms to be able to adapt their manufacturing, and nearly all large-cap biopharma firms continue to hold wide economic moats.”

Manufacturing plans “could help offset” tariff risks

Richard de Chazal, macroeconomic analyst with William Blair, noted in a report Thursday that several biopharma giants have announced plans for new U.S. manufacturing facilities over the past 12 months—including Amgen ($1 billion second drug substance manufacturing plant in Holly Springs, NC); Eli Lilly (four sites totaling $27 billion); Novo Nordisk ($4.1 billion second fill and finishing facility in Clayton, NC); and Johnson & Johnson (four plants totaling $55 billion-plus). Those plans, according to de Chazal, signal “a continued goal of globalized infrastructure that could help offset longer-term tariff risks.”

However, de Chazal cautioned that an earlier Trump threat of biopharma tariffs potentially 25% or higher “suggests the industry’s relief will be short-lived.

“If—or perhaps more appropriately, when—pharma-specific tariffs are rolled out, there will not be a material direct impact on most pharmaceutical outsourcing and services companies,” de Chazal observed. “That said, since tariffs would pressure margins for commercial drugs and likely make developing drugs more expensive, the taxes could potentially discourage investments in research and development, which in turn would lead to a more challenging demand environment for our coverage list.”

He said the brunt of any future tariff impacts on biopharma would likely be felt by pharma giants—“but it would also add to a large pile of unsettling news creating uncertainty around biotech funding and ultimately demand from smaller innovators.”

Among contract research organizations (CROs) and providers of tech-enabled services, de Chazal added, Charles River Laboratories (NYSE: CRL) would have the most direct exposure to tariff impacts, since about 18% of revenue is tied to non-pharmaceutical product sales, while Lonza Group (SIX Swiss Exchange: LONN) would also be negatively impacted by a slowdown in R&D spending, but to a lesser extent than other companies tracked by William Blair, since Lonza generates 70% of its contract development and manufacturing organization (CDMO) revenue from Phase III and commercial drugs. Lonza also has some potential direct exposure to tariffs through its capsules and health ingredients (CHI) segment, which accounted for 16% of 2024 revenue, the analyst noted.

“On the bright side, we believe Lonza is extremely well positioned to benefit from increased demand for U.S. manufacturing capacity” given its its $1.2 billion acquisition of Genentech’s large-scale biologics manufacturing site in Vacaville, CA, from parent company Roche last year, de Chazal added.

“Liberation” and engagement

During his “Liberation Day” ceremony Wednesday announcing the baseline and reciprocal tariffs, Trump didn’t mention his administration’s earlier threat of industry-specific tariffs. But he lamented what he called a dearth of U.S. drug making and predicted increased domestic manufacturing activity for biopharma would result from his policies.

“The United States can no longer produce enough antibiotics to treat our sick,” Trump said, adding: “We’re going to produce the cars, ships, chips, airplanes, minerals, and medicines that we need right here in America.”

“The pharmaceutical companies are going to come roaring back. They are coming roaring back. They are all coming back to our country because if they don’t, they got a big tax to pay. And if they do, I’ll be very happy,” Trump added.

Trump’s administration has specified the composition of pharmaceuticals exempted from the reciprocal tariffs in an annex to the executive order under which they were enacted. The exemption appeared to represent early success for biopharma leaders following weeks of engagement with Trump and his administration aimed at staving off tariffs and promoting other industry-friendly policies:

• Pfizer Chairman and CEO Albert Bourla, DVM, PhD—who is also chair of industry group Pharmaceutical Research and Manufacturers of America (PhRMA)—said last month his company could carry out additional drug production in the United States, where it operates 13 manufacturing sites, in order to get around tariffs.

• Bourla and PhRMA president and CEO Stephen J. Ubl led a February 20 meeting of industry leaders with Trump

• David A. Ricks, Lilly chair and CEO, and Amgen chairman and CEO Robert A. Bradway in recent weeks have both publicly credited Trump’s 2017 tax cuts with enticing them to build their manufacturing sites in the United States

“He delivered the tax reform and we delivered the investment in creating high-paying attractive science-based jobs as a result,” Bradway said at the groundbreaking for Amgen’s Holly Springs manufacturing expansion.

Biopharma funds slide with Wall Street

The tariff announcements sparked headline-grabbing stock selloffs in financial markets worldwide that led to low- to mid-single-digit declines Thursday of 2.8% (Japan’s benchmark Nikkei 225 index), 4% (Dow Jones Industrial Average), 4.8% (S&P 500), and 5.97% (Nasdaq Composite). The U.S. markets finished with their worst one-day declines since March 16, 2020, days into the COVID-19 pandemic. The Wall Street slide continued into Friday with declines of 2.75%, 4.96%, 5.5%, and 5.48%, respectively.

However, five of the top six biotech electronic transfer funds (ETFs) as ranked by VettaFi finished last week with double-digit losses between March 28 and Friday. The largest ETF, iShares Biotechnology ETF (NASDAQ: IBB) fell 10.1% from $130.29 to $117.16, compared with a 12.8% loss for the second largest ETF, SPDR S&P Biotech ETF (NYSE Arca: XBI), from $84.40 to $73.63.

The third-largest biotech ETF, First Trust NYSE Arca Biotechnology Index Fund (NYSE Arca: FBT) slid 10.2%, from $170.12 to $152.75, while the fourth-largest, ARK Genomic Revolution ETF (CBOE: ARKG) slipped 11.8% from $21.55 to $19.

Two notable exceptions arose at both ends of the price spectrum. Falling worse than the top four ETFs was the number five ETF, Direxion Daily S&P Biotech Bull 3X Shares (NYSE Arca: LABU), which nosedived nearly 36%, from $69.07 to $44.45. Faring best among the top six ETFs was VanEck Pharmaceutical ETF (NASDAQ: PPH), the sixth largest biopharma ETF, which consists of the shares of 25 pharma giants. PPH shares dropped about 7.5% from $90.65 to $83.89.

“We await potential future pharma sector tariffs in the next month or so and subsequent developments,” Risinger added.

He said those future tariffs will show significant impacts on biopharma manufacturers including 21 companies spotlighted by Leerink in a March 30 report.

Biopharma stock declines could intensify, some analysts warned, if Trump follows through on his earlier talk about levying biopharma tariffs, and especially if his administration imposes import duties—an additional possibility that emerged from news reports that the U.S. Department of Commerce may launch an investigation under Section 232 of the Trade Expansion Act of 1962 into whether drug imports by multinational biopharmas threaten national security.

“President Trump could announce pharma sector tariffs, possibly in the next month or so. When potential sectoral tariffs are announced, we’ll have to see if there are specific company exemptions (potentially those committing to significant investments in the United States),” David Risinger, a senior managing director and senior research analyst covering diversified biopharmaceuticals with Leerink Partners, cautioned in a research note.

Reciprocal risks as China, EU respond

“Additionally, if pharma sector tariffs are announced, we see risks from reciprocal actions by ex-U.S. countries.”

China responded Friday, as its Customs Tariff Commission of the State Council imposed an additional 34% tariff on all U.S.-origin goods effective April 10, and the country’s Ministry of Commerce filed a lawsuit with the World Trade Organization (WTO) challenging the reciprocal tariffs.

“China urges the United States to immediately remove unilateral tariffs and resolve differences with trade partners through dialogue,” a Ministry of Commerce spokesperson said in remarks reported by Global Times, an English-language newspaper published by People’s Daily, the official newspaper of the Chinese Communist Party. “China firmly opposes this and will resolutely take countermeasures to safeguard its own rights and interests.”

“There is no winner in a trade war, and protectionism leads nowhere,” the spokesperson added.

Ursula von der Leyen, president of the European Commission, which oversees the European Union, said the EU will take countermeasures against U.S. tariffs in coming days should talks with Trump administration officials fail. The EU is drafting a set of tariffs on up to €26 billion ($28.4 billion) of U.S. goods set to take effect later this month, after Washington enacted tariffs on steel and aluminum on March 12.

“President Trump’s announcement of universal tariffs on the whole world, including the European Union, is a major blow to the world economy,” von der Leyen stated. “The global economy will massively suffer. Uncertainty will spiral and trigger the rise of further protectionism.”

EU member Ireland, where numerous U.S. biopharmas have manufacturing operations, says it continues to engage with the Trump administration under the working assumption that Washington will levy pharma-specific tariffs in the future.

Pharmaceutical exports account for 79% or about €58 billion (nearly $64 billion) of the €72.6 billion ($79.6 billion) in products that Ireland exported to the United States last year. IDA Ireland, the republic’s foreign investment attraction agency, said the Emerald Isle is home to more than 90 pharmaceutical companies that employ 45,000 people. Of those, around 30,0000 work for U.S.-based companies, according to the industry group Irish Pharmaceutical Healthcare Association (IPHA).

“We’re making the point that actually about 80% of what we produce in companies here that goes into the United States, from a pharma point of view, aren’t finished products,” Ireland’s Deputy Prime Minister or Tánaiste Simon Harris, the country’s Minister for Foreign Affairs and Trade, told Irish broadcaster RTE. “They’re commodities that actually go back into U.S. factories, create jobs for people to pay taxes there.”

Leaders and laggards

• Aldreya Therapeutics (ALDX) shares cratered 73% from $5.33 to $1.42 Thursday after the company announced that the FDA sent the company a complete response letter in response to its second submission of the New Drug Application (NDA) of reproxalap, a candidate designed to treat dry eye disease. The FDA contended that the NDA “failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye” should be conducted. The letter also cited methodological issues with trial data, including a difference in baseline scores across treatment arms. “Pending positive results from the ongoing clinical trials and discussions with the FDA, we look forward to a potential NDA resubmission mid-year 2025,” stated Todd C. Brady, MD, PhD, Aldreya’s president and CEO. The FDA rejected Aldreya’s first NDA for reproxalap in 2023.
• Allakos (ALLK) shares surged 45% from 22 cents to 32 cents Wednesday, after the company said it had entered into a definitive merger agreement with Concentra Biosciences, which agreed to acquire Allakos for 33 cents a share cash. Allakos’ board has approved the deal, which is subject to the tender of Allakos common stock representing at least a majority of the total number of outstanding shares, the availability of at least $35.5 million of cash (net of transaction costs, wind-down costs, and other liabilities) at closing, and other customary closing conditions. Allakos had been considering strategic alternatives since January.

Antibiotic resistance tends to stabilize over time, according to Sonja Lehtinen, PhD, from the University of Lausanne and colleagues. The team published its study, “The evolution of antibiotic resistance in Europe, 1998–2019,” in PLOS Pathogens.

Antibiotic resistance is a major public health concern, contributing to an estimated five million deaths per year, point out the scientists. Understanding long-term resistance patterns could help public health researchers to monitor and characterize drug resistance as well as inform the impact of interventions on resistance.

In this study, researchers analyzed drug resistance in more than three million bacterial samples collected across 30 countries in Europe from 1998 to 2019. Samples encompassed eight bacteria species important to public health, including Streptococcus pneumoniae, Staphylococcus aureus, Escherichia coli, and Klebsiella pneumoniae.

They found that while antibiotic resistance initially rises in response to antibiotic use, it does not rise indefinitely. Instead, resistance rates reached an equilibrium over the 20-year period in most species. Antibiotic use contributed to how quickly resistance levels stabilized as well as variability in resistance rates across different countries. But the association between changes in drug resistance and antibiotic use was weak, suggesting that additional, yet unknown, factors are at play.

“The evolutionary dynamics of antibiotic resistance are not well understood, particularly the long-term trajectories of resistance frequencies and their dependence on antibiotic consumption. Here, we systematically analyze resistance trajectories for 887 bug-drug-country combinations in Europe across 1998–2019, for eight bacterial species with a considerable resistance-associated public health burden,” wrote the investigators.

Analytical support for model

“Our analyses support a model in which, after an initial increase, resistance frequencies reach a stable intermediate equilibrium. The plurality (37%) of analyzed trajectories were best described as ‘stable’ (neither increasing nor decreasing). 21% of trajectories were best described as ‘stabilizing,’ i.e., showing a transition from increasing frequency to a stable plateau; 21% as decreasing and 20% as increasing.

“The antibiotic consumption in a country predicts both the equilibrium frequency of the corresponding resistance and the speed at which this equilibrium is reached. Moreover, we find weak evidence that temporal fluctuations in resistance frequency are driven by temporal fluctuations in hospital antibiotic consumption. A large fraction of the variability in the speed of increase and the equilibrium level of resistance remains unexplained by antibiotic use, suggesting other factors may also drive resistance dynamics.”

The study highlights that continued increase in antibiotic resistance is not inevitable and provides new insights to help researchers monitor drug resistance.

“When we looked into the dynamics of antibiotic resistance in many important bacterial pathogens all over Europe and in the last few decades, we often found that resistance frequency initially increases and then stabilizes to an intermediate level,” said Francois Blanquart, PhD, senior author and a researcher at the French National Center for Scientific Research (CNRS). “The consumption of the antibiotic in the country explained both the speed of initial increase and the level of stabilization.”

“In this study, we were interested in whether antibiotic resistance frequencies in Europe were systematically increasing over the long-term,” added Sonja Lehtinen, PhD, senior author and an assistant professor at the computational biology department at the University of Lausanne. “Instead, we find a pattern where, after an initial increase, resistance frequencies tend to reach a stable plateau.”

Syngenta Biotechnology China-led research, with partners in the U.S., France, the UK, Chile, the Netherlands, Argentina, and across China, has discovered that sunflowers can form viable haploid seeds through parthenogenesis in the absence of pollination. This discovery opens the possibility of a scalable doubled haploid system in sunflowers, a technique that could reduce the time needed to produce fully inbred lines from six years to ~10 months.

Some animals, including certain birds, reptiles, fish, and crustaceans like Daphnia, can reproduce without fertilization through a process known as facultative parthenogenesis. In these species, females can produce offspring without male involvement. Charles Darwin first documented unusual reproductive patterns in plants, but many aspects of plant reproduction remain poorly understood.

In most flowering plants, seed formation depends on a process called double fertilization. This involves one sperm fertilizing the egg and another fertilizing a separate cell that forms the endosperm, a tissue that nourishes the embryo. Without fertilization, viable seeds rarely develop.

Sunflower is one of the world’s most important oilseed crops, producing nearly 55 million metric tons globally in 2023. Because sunflower is a hybrid crop, improving its traits requires creating inbred parent lines, which typically takes six years through repeated self-pollination.

In the study, “Haploid facultative parthenogenesis in sunflower sexual reproduction,” published in Nature, researchers examined how sunflowers can form haploid seeds without fertilization. The team conducted a combination of genetic, chemical, and environmental experiments to identify the factors that enable parthenogenesis and support a scalable doubled haploid breeding system.

Researchers tested sunflower plants under controlled greenhouse, growth chamber, and field conditions to identify genetic backgrounds capable of producing haploid seeds without fertilization.

Experiments included chemical treatments, manual and hormonal suppression of pollen, and variation in environmental factors such as light intensity and temperature. Flow cytometry and genetic analysis confirmed haploid seed formation. Tissue culture and chromosome doubling techniques were applied to regenerate fertile, doubled haploid plants.

Formation of haploid seeds was first noticed during experiments using a chemical phospholipase inhibitor on pollen. Researchers observed small, shriveled seeds and initially attributed them to the chemical’s effects. Later trials showed the same seeds forming even in the complete absence of pollen, leading to the discovery of spontaneous parthenogenesis.

Genetic analysis confirmed the seeds were maternally derived and lacked paternal DNA. Parthenogenesis occurred across multiple sunflower lines, with some producing over 100 haploid seeds per flower head. High-intensity light significantly increased haploid yield, while blue or red light alone had no effect.

Maize pollen combined with boron improved haploid formation in certain genetic backgrounds. Germination trials showed a 40% success rate in soil.

Imaging showed that many haploid embryos which formed without fertilization had irregular shapes or multiple axis-like centers. Each seed still contained a single embryo, but some developed multiple shoot-like structures after germination. Tissue culture was used in regenerating healthy seedlings from these atypical forms.

Chromosome doubling produced fertile, seed-setting plants, with some individuals generating up to 188 seeds.

Unlike most flowering plants, sunflower embryos survived and germinated using nutrient reserves stored in the cotyledons, bypassing the usual requirement for endosperm development. This bypass of the endosperm requirement is highly unusual.

Discovery of parthenogenesis in sunflower introduces a previously unrecognized reproductive pathway in a major global crop. Researchers demonstrated that haploid seeds can develop without fertilization and be converted into fully fertile plants, offering a faster route to inbred line development.

The results provide a foundation for a scalable doubled haploid breeding system in sunflower, with the potential to accelerate crop improvement and expand global breeding capabilities.

A method using free software and a drone with a low-cost camera has made it possible to select drought-tolerant corn plants. The tool contributes to the selection of plants that can better withstand water stress, one of the impacts of climate change on agriculture.

The results of the experiments were published in an article in the Plant Phenome Journal.

The authors are associated with the Genomics for Climate Change Research Center (GCCRC), an Engineering Research Center (ERC) at the State University of Campinas (UNICAMP), in the state of São Paulo, Brazil.

“Experiments with genetically modified plants are expensive. This method allowed us to assess the plants’ tolerance to drought in a relatively small area, using free software and a simpler RGB camera that captured the parameters of the experiment more effectively than the more expensive multispectral camera,” says Helcio Duarte Pereira, a researcher at the GCCRC.

The method allowed for optimized, faster and cheaper data collection. Conventional methods require manual measurements, sometimes with expensive equipment and slow processes. In addition, some characteristics can only be measured at the end of the plant’s life cycle. With the drone, the work that would otherwise take days can be done in a few hours, allowing plants to be assessed at different stages of growth.

The approach also makes it possible to follow the development of the plants throughout their growth cycle. “The continuous analysis, at different stages of the plant’s life cycle, was essential to understand how they respond to water stress, as well as making it possible to predict how they’d behave in other areas,” explains Juliana Yassitepe, a researcher at the GCCRC and EMBRAPA Digital Agriculture, who coordinated the study.

Water stress parameters

During the dry season of 2023, between April and September, the researchers carried out a series of flights at an experimental site in Campinas. The site was planted with 21 varieties of corn, three conventional and 18 genetically modified to overexpress genes potentially associated with resistance to water stress.

In the experiment, the only treatment difference between the plants was that half received irrigation throughout their lifecycles, while the other half was subjected to drought.

Each flight lasted 10 minutes and yielded 290 images. The researchers selected 13 flights done with the multispectral camera, which captures non-visible spectra such as infrared, and 18 with the RGB camera, which is much cheaper and captures three colors or bands: red, green and blue.

The images were analyzed using free software that allowed the bands obtained in the images to be cross-referenced. To determine what the color differences in the images indicated, the researchers took a series of conventional measurements of the plants on the ground. From there, they were able to define the water stress parameters and calibrate the predictive models.

The results presented from the images from the cheaper camera proved to be more reliable and accurate, making the technology accessible for large-scale breeding programs.

As well as reducing operating costs, the method allows studies to be conducted in smaller areas, which is especially useful in projects with limited resources. “We don’t always have enough seeds to plant in very large areas, which is a bottleneck in this type of research,” says Yassitepe.

The researchers also point out that the drone’s lower flights allow it to obtain high-resolution images, which is justified in smaller experimental areas, helping to obtain more accurate data.

Finally, although it is not the main goal of the group, the breakthrough opens the way for other research groups or startups to develop applications directly aimed at producers or breeding companies.

“There are applications on the market that allow you to assess, for example, the chlorophyll in the plant and thus determine the nitrogen levels. This makes it possible to adjust fertilization as needed,” says Pereira.

For Yassitepe, the indices evaluated in the study can serve as a basis for the development of applications that make automated measurements of water stress in different agricultural or forestry crops.

Antibiotic resistance tends to stabilize over time, according to Sonja Lehtinen, PhD, from the University of Lausanne and colleagues. The team published its study, “The evolution of antibiotic resistance in Europe, 1998–2019,” in PLOS Pathogens.

Antibiotic resistance is a major public health concern, contributing to an estimated five million deaths per year, point out the scientists. Understanding long-term resistance patterns could help public health researchers to monitor and characterize drug resistance as well as inform the impact of interventions on resistance.

In this study, researchers analyzed drug resistance in more than three million bacterial samples collected across 30 countries in Europe from 1998 to 2019. Samples encompassed eight bacteria species important to public health, including Streptococcus pneumoniae, Staphylococcus aureus, Escherichia coli, and Klebsiella pneumoniae.

They found that while antibiotic resistance initially rises in response to antibiotic use, it does not rise indefinitely. Instead, resistance rates reached an equilibrium over the 20-year period in most species. Antibiotic use contributed to how quickly resistance levels stabilized as well as variability in resistance rates across different countries. But the association between changes in drug resistance and antibiotic use was weak, suggesting that additional, yet unknown, factors are at play.

“The evolutionary dynamics of antibiotic resistance are not well understood, particularly the long-term trajectories of resistance frequencies and their dependence on antibiotic consumption. Here, we systematically analyze resistance trajectories for 887 bug-drug-country combinations in Europe across 1998–2019, for eight bacterial species with a considerable resistance-associated public health burden,” wrote the investigators.

Analytical support for model

“Our analyses support a model in which, after an initial increase, resistance frequencies reach a stable intermediate equilibrium. The plurality (37%) of analyzed trajectories were best described as ‘stable’ (neither increasing nor decreasing). 21% of trajectories were best described as ‘stabilizing,’ i.e., showing a transition from increasing frequency to a stable plateau; 21% as decreasing and 20% as increasing.

“The antibiotic consumption in a country predicts both the equilibrium frequency of the corresponding resistance and the speed at which this equilibrium is reached. Moreover, we find weak evidence that temporal fluctuations in resistance frequency are driven by temporal fluctuations in hospital antibiotic consumption. A large fraction of the variability in the speed of increase and the equilibrium level of resistance remains unexplained by antibiotic use, suggesting other factors may also drive resistance dynamics.”

The study highlights that continued increase in antibiotic resistance is not inevitable and provides new insights to help researchers monitor drug resistance.

“When we looked into the dynamics of antibiotic resistance in many important bacterial pathogens all over Europe and in the last few decades, we often found that resistance frequency initially increases and then stabilizes to an intermediate level,” said Francois Blanquart, PhD, senior author and a researcher at the French National Center for Scientific Research (CNRS). “The consumption of the antibiotic in the country explained both the speed of initial increase and the level of stabilization.”

“In this study, we were interested in whether antibiotic resistance frequencies in Europe were systematically increasing over the long-term,” added Sonja Lehtinen, PhD, senior author and an assistant professor at the computational biology department at the University of Lausanne. “Instead, we find a pattern where, after an initial increase, resistance frequencies tend to reach a stable plateau.”

Organon acquired regulatory and commercial rights in the United States for TOFIDENCE™, a biosimilar to ACTEMRA®, for intravenous infusion from Biogen. TOFIDENCE, the first approved tocilizumab biosimilar entrant in the U.S. market, was launched in May 2024 and is indicated in certain patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

“Biosimilars continue to be a key growth driver for Organon, and this acquisition complements our existing business, enabling us to expand our immunology portfolio,” said Kevin Ali, Organon’s CEO. “We believe that by leveraging our commercial expertise and market access capabilities, there is considerable growth potential for this product.”

The agreement includes an upfront payment to Biogen, with Organon assuming the obligation to pay tiered royalty payments based on net sales and tiered annual net sales milestone payments owed by Biogen to Bio-Thera Solutions.

Large growth market

The biosimilars market is forecasted to grow from $29.4 billion in 2023 to $66.9 billion by 2028, driven by a CAGR of 17.8%, according to a report by MarketsandMarkets. The market, focusing on drug classes such as monoclonal antibodies, insulin, erythropoietin (EPO), and anticoagulants, is poised for substantial growth driven by increasing demand for cost-effective treatments amid rising chronic disease rates and the patent expirations of major biologics, noted the report. A key trend cited includes the rapid approval and adoption of biosimilars, particularly in oncology.

Challenges include complex manufacturing processes and regulatory obstacles, which are countered by opportunities in less regulated markets like Asia Pacific, noted the report, which cites players such as Novartis, Pfizer, and Amgen as pivotal in shaping industry dynamics through innovation and strategic expansions.

A genomic study of hydrogen-producing bacteria has revealed entirely new gene clusters capable of producing large volumes of hydrogen.

Vibrionaceae are a family of marine bacteria famous for their bioluminescence, but also notorious for including the cholera pathogen among their number.

Vibrionaceae have not been attractive subjects in biofuel production, but another unique feature of the family—their ability to generate large volumes of hydrogen gas by breaking down a substance called formate into carbon dioxide and hydrogen through fermentation—has now emerged as a potential solution for green energy.

Now, a team including Professor Tomoo Sawabe at the Faculty of Fisheries Sciences, Hokkaido University; Ramesh Kumar Natarajan at the National Institute for Interdisciplinary Science and Technology, India; and Fabiano Thompson at the Federal University of Rio de Janeiro, Brazil, has used genome sequencing to investigate the mechanism behind this biochemical feat.

Their findings are published in the journal Current Microbiology.

The researchers examined all 16 known species of Vibrionaceae, which are often found in symbiotic relationships with deep-sea animals. They focused on the sequence and structure of the Hyf-type formate hydrogenlyase (FHL) gene cluster.

The hydrogenase enzyme from this gene cluster catalyzes the breakdown of formate into hydrogen and carbon dioxide. This complex is also found in Escherichia coli, another bacterium which can generate hydrogen through fermentation, though in much smaller amounts than Vibrionaceae.

“These analyses reveal unexpected diversity of FHL gene clusters and relationships between gene clusters and function in hydrogen production ability,” Sawabe explains.

The team discovered two new types of FHL gene clusters among Vibrionaceae, bringing the total number of FHL gene clusters in these bacteria to six. They suggest that this diversity in the structure of the cluster is the result of speciation among the Vibrionaceae as they adapted and evolved to occupy a range of ecological niches.

The study also found differences in hydrogen fermentation and production associated with the different FHL gene clusters. Vibrio tritonius, a marine species, and Vibrio porteresiae, found in mangrove-dwelling wild rice, showed the highest levels of hydrogen production, while Vibrio aerogenes and Vibrio mangrovi showed the lowest.

There was a correlation between levels of hydrogen production and how well the bacteria were able to take up formate back into their cells.

“These genotypes strengthen formate metabolism as a possible key factor in maintaining fermentative hydrogen production in specific groups of vibrios,” Sawabe concludes.

The findings support the researchers’ proposal that some species were driven to evolve higher hydrogen production because of their need to detoxify formate from the environment—what they call the formate detoxification hypothesis.

The findings could also shed light on the evolution of hydrogen fermentation in other bacterial species, such as E. coli.

Scale Biosciences, Inc. (Scale Bio), a leader in highly scalable single cell technologies, today announced its participation in the Chan Zuckerberg Initiative’s (CZI) Billion Cells Project at the Chan Zuckerberg Biohub New York Affiliate Symposium. Scale Bio joins technology partners 10x Genomics and Ultima Genomics in this landmark effort to generate an unprecedented one billion cell dataset to fuel rapid progress in cell biology through AI model development. This collaboration represents a significant expansion of the data generation capabilities for the Billion Cells Project.

Scale Bio is a demonstrated leader in advancing large-scale single cell studies, having leveraged its QuantumScale technology in its “100 Million Cell Challenge,” supported by CZI, Ultima Genomics, NVIDIA, and BioTuring, which helped lay important groundwork for the broader Billion Cells Project. The integration of Scale Bio’s technology with the Billion Cells Project will further accelerate the generation of high-quality, diverse cellular data to fuel advances in biological understanding.

“At Scale Bio, we are focused on accelerating scientific progress through the power of scale to improve human health. For too long, technological limitations have constrained what’s possible in single cell research,” said Giovanna Prout, President and CEO at Scale Bio. “With our QuantumScale and ScalePlex technologies, we’ve reimagined single cell analysis to drive unprecedented scalability, enabling researchers to conduct experiments previously considered infeasible, overly cumbersome, or too expensive. We are proud to collaborate again with CZI and participating researchers on the Billion Cells Project to push the boundaries of single cell omics, helping to generate data across diverse biological models at the scale needed to power new discoveries and develop impactful AI models. We’re excited to see our technologies contribute to such a monumental initiative.”

“Scale Bio will be a valuable partner to help us achieve our grand scientific challenge of building an AI-based virtual cell model to predict and understand cellular behavior,” said Jonah Cool, PhD, Senior Science Program Officer for Cell Science at CZI. “This collaboration will allow researchers to answer specific biological questions about cells and derive high-quality data with unprecedented scale and accessibility. We hope this partnership with Scale Bio is just the beginning of how innovative technologies can remove barriers to data generation, enabling researchers to build more comprehensive AI models that could provide insights into health and disease.”

Scale Bio’s QuantumScale Single Cell RNA kits, which were made available early to 100 Million Cell Challenge winners, are now commercially available in five configurations to academic and commercial customers around the world. The technology is a dramatic improvement over existing solutions, as it can capture and process up to 4 million cells in one short workflow without specialized partitioning instrumentation. Additionally, leveraging ScalePlex technology, researchers can multiplex up to 9,216 samples or conditions per run, making it uniquely suited for large-scale projects.

“With support from CZI and in partnership with interlocking efforts across HuBMAP and the Human Cell Atlas, we’re working to build a comprehensive cellular map of diseases that affect the inhalation interface—from the oral cavity through the upper airway and into the lung,” said Kevin Matthew Byrd, DDS, PhD, Researcher at Virginia Commonwealth University and recipient of a 100 Million Cell Challenge grant. “Chronic conditions like sarcoidosis and Sjögren’s disease impact this entire cul-de-sac of breathing. Scale Bio’s QuantumScale technology allows us to map millions of cells across these connected niches, uncovering shared mechanisms and opening the door to new diagnostic and therapeutic insights.”

Large-scale single cell analysis projects, such as the CZI Billion Cells Project, are critical to building a comprehensive understanding of cellular diversity. These initiatives accelerate understanding of cellular behavior and gene function while fueling the development of AI models that reflect diverse biology. Once completed, this single cell dataset will bring critical new data and resolution to multiple domains of biology that need comprehensive resources, enabling researchers to train AI models and make transformative discoveries across precision medicine and functional genomics.