Aligning mRNA Progress with Regulatory Streamlining

BioPharm Peer Exchange

Dosage Forms: Roundtable on Oral Solid Dosage Trends

Drug Solutions Podcast: 

Pharmaceutical packaging must advance to adapt to new, complex modalities

Out-of-the-Box Packaging Advancements

From Theory to Reality: Automating Process Development

Drug Digest: 

The Importance of Appropriate Supplier Oversight

Ask the Expert

NÜRNBERG / GERMANY - APRIL 7, 2019: Siemens Logo on an office building in Nürnberg. Siemens is a German engineering company | Image Credit: © filmbildfabrik - stock.adobe.com

Siemens AG has completed its $5.1 billion acquisition of Boston-based Dotmatics, a provider of research and development software for the life sciences sector (1). The deal brings Dotmatics under the umbrella of Siemens’ Digital Industries Software division and marks a significant expansion of Siemens’ artificial intelligence (AI)-driven product lifecycle management (PLM) portfolio into the life sciences domain.

Originally announced in April 2025 (2), Siemens described the transaction as a “strategic milestone” that aligns with structural changes in healthcare—such as aging populations, broader access to medical care, and increasing demand for collaborative, data-integrated R&D environments (1). The acquisition is part of Siemens’ ONE Tech Company strategy, aimed at enhancing digital capabilities across high-growth industrial sectors.

·Siemens’ acquisition of Dotmatics enhances AI-driven drug development, connecting R&D to manufacturing through a unified digital thread.

·Dotmatics’ Scientific Intelligence Platform will streamline pharmaceutical workflows, accelerating discovery, development, and production cycles.

·Pharma manufacturers gain access to Siemens’ expanded digital twin and PLM tools, enabling scalable, data-integrated, and compliant operations.

“By acquiring Dotmatics, we’re strategically strengthening our position in Life Sciences and creating a world-leading AI-powered PLM software portfolio as part of Siemens Xcelerator,” said 

Roland Busch, president and CEO of Siemens

 AG (2). “Artificial intelligence has emerged as a transformative force across various industries, and its application in life sciences is becoming increasingly important.”

Connecting R&D to manufacturing in the pharma value chain

The Dotmatics platform centers around its Scientific Intelligence Platform, Luma, which supports AI-powered, multimodal drug development and data contextualization (1). The software facilitates seamless collaboration, connects previously siloed data across R&D and manufacturing, and creates a continuous digital thread through the pharmaceutical development lifecycle.

“With Dotmatics, we’re building a new era of innovation in Life Sciences,” said Busch. “From research through to production—we’re creating a unique, end-to-end digital thread: We combine Dotmatics’ scientific intelligence with our industrial AI technologies and digital twins. This will allow us to help our customers accelerate breakthroughs, reduce development cycles, and bring life-saving pharmaceuticals faster and more affordably to the market.”

For Siemens, the acquisition opens up an additional $11 billion in total addressable market within industrial software (1). Dotmatics is expected to generate more than $300 million in revenue in fiscal year 2025. Siemens projects medium-term revenue synergies of around $100 million annually, scaling up to more than $500 million in the longer term. The acquisition is expected to be immediately accretive to growth, profitability, and cash flow.

“The acquisition of Dotmatics drives strong revenue synergies and is highly profitable and cash generative,” said 

Ralf P. Thomas, chief financial officer of Siemens

 AG (2). “Financing will be provided primarily through the sale of shares in listed companies, including Siemens Healthineers.”

Siemens’ push into scientific innovation

The transaction also reflects the evolution of Dotmatics itself. Formerly known as Insightful Science, the company rebranded as Dotmatics in April 2022 following its acquisition of Protein Metrics and a period of expansion under the ownership of Insight Partners (2). 

, emphasized the strategic alignment in the press release announcing the deal.

“Following an exciting journey with Insight Partners, where Dotmatics achieved remarkable growth and portfolio expansion, we are thrilled to announce our new chapter with Siemens,” said Swalla (2). “Combining our next-generation scientific intelligence platform and industry-leading scientific applications together with Siemens' digital twin and AI capabilities, we’ll drive a new wave of innovation in life sciences R&D.”

Latest in high-profile software acquisitions

The Dotmatics acquisition follows closely on the heels of Siemens’ $10 billion acquisition of Altair Engineering, completed in April (3). That deal brought new simulation, high-performance computing, and AI capabilities into Siemens’ industrial software offerings and was similarly integrated into the Siemens Xcelerator platform.

“We welcome the Altair community of customers, partners and colleagues to Siemens,” Busch said at the time of that acquisition (3). “Adding Altair’s groundbreaking innovations to the Siemens Xcelerator platform will create the world's most complete AI-powered design, engineering and simulation portfolio.”

Together, these back-to-back deals underscore Siemens’ aggressive push into domains in which digital twin technology, data integration, and AI are reshaping complex product development. With Dotmatics and Altair, Siemens now commands an expanded portfolio capable of supporting highly regulated industries like pharmaceuticals with the digital tools needed to meet rising demand, tighter timelines, and greater product complexity.

Siemens Completes Acquisition of Dotmatics

Siemens Acquires Dotmatics, Extending AI Software Portfolio into Life Sciences

Siemens Acquires Altair to Create Most Complete AI-powered Portfolio of Industrial Software

Articles

Siemens expands AI-driven pharma software portfolio, integrating Dotmatics’ platform to connect drug research, development, and manufacturing digitally.

Siemens Finalizes $5.1B Dotmatics Acquisition

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More

 is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons that hide behind the headlines. 

In episode 20, the panel explores a new wave of developments in CAR-T innovation, biopharma dealmaking, and the evolving role of information in translational medicine. Sascha Berger, private biopharmaceutical investor; Shannon Eaker, CTO of Xcellbio; Edwin Stone, CEO of Cellular Origins; and Bryce Sady, VP of Product Development at PSL Group, unpack key headlines and examine the long-term implications shaping scientific progress and patient access.

CAR-T’s Next Chapter: From Solid Tumors to Regulatory Streamlining

The panel begins by examining the growing promise of CAR-T in solid tumors—a space long considered too complex or hostile for cell therapies. Recent data and development activity are challenging that view: Gilead Sciences reports 62% tumor shrinkage in glioblastoma (1); Affini-T Therapeutics is targeting KRAS mutations (2); and Immatics is advancing its pipeline into PRAME-positive tumors (3).

In parallel, the FDA announced it has removed Risk Evaluation and Mitigation Strategies (REMS) requirements for autologous CAR-T cell therapies. This decision, widely welcomed by the ATMP field, is expected to reduce the reporting burden on healthcare providers, broaden access, and help drive down overall treatment costs (4).

Strategic Acquisitions: AbbVie and Eli Lilly Bet Big

The panelists also explore the rationale behind two major acquisitions. AbbVie announced a $2.1 billion deal to acquire Capstan Therapeutics, strengthening its cell therapy and immunology portfolio (5). Meanwhile, Eli Lilly acquired Verve Therapeutics, whose VERVE-102 program is being positioned as a potential first-in-class in vivo gene editing therapy for cardiovascular disease. According to Lilly’s leadership, the treatment could help shift care from a chronic model to a one-time intervention (6).

The discussion closed with reflections on two systemic shifts: the ongoing talent exodus from the United States—driven in part by cuts to basic research funding—and the transformation of how research findings are shared and applied. Panelists discussed how modern publishing models, data capture technologies, and changes in information flow influence the pace and impact of translational medicine.

Watch the full episode above for more insights into the evolving biopharma landscape and catch up on previous episodes of 

Bagley, S.J., Desai, A.S., Fraietta, J.A. et al. Intracerebroventricular bivalent CAR T cells targeting EGFR and IL-13Rα2 in recurrent glioblastoma: a phase 1 trial.

. Published online June 1, 2025. DOI:10.1038/s41591-025-03745-0

Affini-T Therapeutics presents preclinical data from its programs targeting oncogenic drivers KRAS and TP53 at AACR. Press release. Affini-T Therapeutics. April 24, 2025. 

https://affinittx.com/press-releases/affini-t-therapeutics-presents-preclinical-data-from-its-programs-targeting-oncogenic-drivers-kras-and-tp53-at-aacr/

Immatics IMA203 PRAME cell therapy data presented at 2025 ASCO annual meeting continues to show strong anti-tumor activity and durability in patients with metastatic melanoma. Press release. Immatics. May 31, 2025. https://investors.immatics.com/news-releases/news-release-details/immatics-ima203-prame-cell-therapy-data-presented-2025-asco 

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T Cell Immunotherapies. FDA Safety Communication; June 26, 2025. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor

AbbVie to Acquire Capstan Therapeutics, Further Strengthening Commitment to Transforming Patient Care in Immunology. Press release. AbbVie. June 30, 2025; https://news.abbvie.com/2025-06-30-AbbVie-to-Acquire-Capstan-Therapeutics,-Further-Strengthening-Commitment-to-Transforming-Patient-Care-in-Immunology

Lilly to Acquire Verve Therapeutics to Advance One-Time Treatments for People With High Cardiovascular Risk. Press release. Eli Lilly & Company. June 17, 2025; https://investor.lilly.com/news-releases/news-release-details/lilly-acquire-verve-therapeutics-advance-one-time-treatments

Videos

Sascha Berger, private biopharmaceutical investor; Shannon Eaker, CTO of Xcellbio; Edwin Stone, CEO of Cellular Origins; and Bryce Sady, VP of Product Development at PSL Group go behind the headlines to talk CAR-T advancements, exciting M&A developments, and the impact of lost research funding on innovation. 

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

BIO 2025 - Political Climate Compilation

® Group was able to interview more than a half dozen executives in the biopharmaceutical industry 

 of the Biotechnology Innovation Association (BIO) International Convention, which took place in Boston June 16–19, 2025.

The conference was bookended by major developments with impacts to healthcare within United States government agencies, namely US Health and Human Services Secretary Robert F. Kennedy Jr. 

 of the Advisory Committee on Immunization Practices, a Centers for Disease Control and Prevention-affiliated body responsible for guiding vaccine policy, followed by 

FDA suspending certain new clinical trials,

 pending review, in which US citizens’ living cells are sent to China and other “hostile countries.”

With those policy and personnel changes in mind, the key opinion leaders shaping some of the content presented at BIO were asked how much attention they and their companies were giving to US developments, how those developments figured to impact their business, and the larger implications to their employees and the industry at large.

 in April, there was not one unifying theme expressed by this group; the changes—which by no means are complete—have affected companies small and large, as well as foreign and domestic, in varying ways.

Click the video above to view the responses that were compiled by PharmTech Group.

 is co-founder and chief executive officer, 


Brandon Pence is co-founder and chief operating officer, 

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

® group. As part of our coverage of the Biotechnology Innovation Organization International Convention in Boston in mid-June, we asked key opinion leaders and subject matter experts two questions across the board: To what degree are you keeping your eye on staffing, regulatory, and policy changes within US government agencies, and how do these shifts figure to impact your business? And—how else is the current US political climate impacting you, your company, and the industry overall? As we found out at the earlier INTERPHEX conference in the spring, uncertainty is still looming in the minds of many.

When you wake up every morning to see what's the news, how it's going to impact us. It definitely makes it hard to raise capital.

Depending on the size of a company and its location, some are adjusting their plans and processes, and others are not.

It almost helps to be a small company at this point where we're doing basic research and preclinical research, I don't think anything has changed from our plans based on the macro stuff that's going on right now.

It's definitely pushed us to be more efficient, much more efficient, definitely cutting all the fat that we can. We've had to sit down, review our goals, review our objectives; anything that drives us toward that, those goals, those value creation points, we keep doing. Anything that doesn't, doesn't.

For companies that don't have major operations in the US, they see opportunity,

While changes at the regulatory or federal level may affect how US companies approach partnerships, I believe our strong track records of collaboration with US clients, and the potential and economic stability of Poland and the EU, create a great opportunity for our region. With the right conditions, Poland can be become a key CDMO hub for American biotech, looking for reliable and cost effective partners in Europe.

For those that do business both here and overseas, they feel in general, they are in good position. And say these shifts are not unprecedented.

The way I look at it is, this is a remarkably important and resilient industry, you know, expand a variety of administrations, a variety of approaches.

The good news for Abzena is all of our manufacturing is based in the US, and so, you know, we're definitely seeing the tailwinds. It started with [the] BIOSECURE [Act], you know, in the previous administration; it's moved into a conversation around tariffs, and it's moved into a conversation around intellectual property protection, specifically in China.

FUJIFILM has done a great job of ensuring that it's insulated, in some regard, from various changes that might come up from some of these directives. We've got manufacturing footprints in multiple geographies. We're closely aligned with our customers and supporting their global needs.

Because our manufacturing is primarily in the US, our R&D services are in the UK, we've actually seen, you know, positive benefits from that side of it.

Since the spring, there's been a solid amount of turnover at FDA, both in personnel and policy, and there isn't any way that's gone unnoticed.

One of the areas that we continue to watch carefully is what's happening specifically [at] FDA, and you know, does drug development and approvals and things getting into IND [investigational new drug status], does that slow down because of some of the turmoil there? We haven't seen it yet, but we're certainly concerned about it and worried about it, because a lot of our customers are those early-stage companies.

It has to do with the FDA as well, and I think there are three aspects that probably impact us. One is the staffing changes at FDA, the regulatory agency. The second one has to do with drug pricing, and the third one with funding.

Will these changes slow innovation, especially at the university level? That remains to be seen.

We see, you know, the reduction of some of the, I'll say, funding that used to flow through some of these government agencies, into the universities that drove innovation. You know, a lot of these small companies get spun out of universities. That's worrying, that innovation could slow down, you know, if these grants that are coming through different parts of the federal government don't continue to go into the university systems, that it slows innovation in the US, and so we're obviously worried about that side of the policy. So, you know, there's always pros and cons with every administration, some of the things turn out to be positive, some of them not as much.

In [regards to] funding toward academic institutions, at the end, it's something that's going to impact all of us.

The bottom line has not changed: getting drugs into clinic, then getting them to market, as quickly, safely and effectively as possible.

There's always a question, how is that going to impact the path to the clinic for not only any drug, but in our case, for innovative and platform technologies. And what we've seen today, actually, they've been communicating the right message, that there's quite a bit of support for accelerated approval for rare diseases using validated endpoints that could make it easier, actually, to approve a drug therapy, a gene therapy, or an overall therapy for a rare disease. We want an effective and safe therapy, so that's what we mostly focus on.

Finally, a reminder of the US’s place in pharmaceutical development and hope that the country is able to stay there for the decades ahead.

So while we are certainly paying attention to the directives that are coming, we're listening to our customers, and we know that this industry that's been, you know, a strong growth agent for healthcare over the last 30 years, and will continue to be for the foreseeable future, is one that will require our participation with them.

We'll see what happens. I think people are nervous about some of the anti-science sentiment going on within the government right now, and just the fact that the US clearly has been the leader in biotechnology and pharmaceutical development over the last 50 years, no question. I think what people are nervous about is us, you know, actively giving up that lead and kind of abandoning that area of important high technology and, you know, letting other countries step into a leadership role there. I hope that doesn't happen, but I think that's what the industry at large is nervous [about], that we're going to move in that direction.

In contrast to earlier conferences in 2025, experts interviewed as part of the BIO conference in Boston did not come to a consensus about lasting impacts of recent changes in US government policy.

Key Leaders at BIO 2025 Respond to Continuing Political Shifts

Sterile capsules for injection. Bottles on the bottling line of the pharmaceutical plant. Machine after checking sterile liquids. Interferon, nasoferon. | Image Credit: © neznamov1984 - stock.adobe.com

 a contract development, testing, and manufacturing organization headquartered in Basel, Switzerland, announced on June 30, 2025 that it has joined the “Alliance for RTU,” a partnership launched in September 2024 by primary packaging manufacturers 

 with the intent of advancing technical knowledge and expertise about the sterile manufacturing of ready-to-use (RTU) containers (1).

ten23 health has joined the Alliance for RTU to support advancements in sterile, ready-to-use container technologies for aseptic drug manufacturing.

The collaboration emphasizes standardization and regulatory-compliant development of RTU platforms to improve efficiency in sterile fill/finish processes.

Shifts in sterile manufacturing include isolator tech adoption and packaging tailored to personalized medicine, at-home use, and chronic disease treatments.

In a press release, ten23 health said the Alliance for RTU was formed in response to an increased need in the market for aseptic filling technologies and processes (1). The platform provides a means of technical exchange on high-quality, ready-to-fill primary packaging between pharmaceutical companies, contract manufacturers, and contract development and manufacturing organizations. ten23 health said its role would be to contribute its experience in development, sterile fill/finish, and testing of sterile drug products using RTU containers.

That experience, the company said, is based on a wide range of customer projects aimed at furthering the development and standardization of RTU container platforms, to improve both efficiency and quality while remaining compliant with regulatory standards (1).

Sterile manufacturing, including fill/finish and packaging services, was top of mind for 

 founder and board member of ten23 health, 

 At that time, Mahler said revisions to regulatory guidance were having an impact on fill/finish facilities.

“From my vantage point, I truly believe in isolator technology,” Mahler said in the interview. “So, that’s where I think an isolator in cleanroom, Class C, is probably where you would want to go if you’re building new facilities. And I think a lot of struggles are ongoing with a lot of folks where, they're trying to actually make upgrades from a filling environment, and that obviously comes with a cost, with a shutdown, and with a potential risk ... [Sustainability] has been a key question … and how we want to operate from a footprint perspective.”

 to view the full video interview with Mahler.

Prior to Pharmapack Europe in January 2025, Gerresheimer Global Vice-President Sales Pharma & Biopharma Solutions Stefan Verheyden 

 about various packaging trends, such as those that support at-home therapy and personalized medicine (3).

“[Gerresheimer is] becoming an organization that focuses on solutions in specific domains,” Verheyden said in the interview (3). “We want to make sure … we understand what the market needs, and that we anticipate those needs. And therefore, we think it is very important that we understand very well what happens in specific … disease areas, [for example], chronic disease, … repetitive treatments, oncology, all the diseases where we think a more customized product offering could be of an added value.”

 to view the full video interview with Verheyden.

ten23 health, which is financed through a long-term commitment from the international investment company 3i Group, is named after the Avogadro constant (6.022 × 10

), which represents the number of molecules in a sample of one mol (1).

ten23 health Joins the “Alliance for RTU”—An Association to Advance Technical Exchange for Ready-to-Use (RTU) Containers in Sterile Manufacturing.

 Press Release. June 30, 2025.
2. Thomas, F. 

CPHI Milan 2024: Fill/Finish and Sustainability.

Pharmapack Europe 2025: Packaging Trends.

The partnership was formed in September 2024 in response to increasing demand for aseptic filling technologies and processes.

ten23 health Joins Gerresheimer, SCHOTT, Stevanato Group in ‘Alliance for RTU’

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Hikma Pharmaceuticals USA announced on June 28, 2025 that it is investing $1 billion by 2030 to expand its generic-drug R&D and manufacturing capabilities in its Ohio and New Jersey, United States, facilities. The company has invested $4 billion in the past 15 years to expand its US operations, which began in 1991, and now has an annual domestic capacity to produce 12 billion finished doses of generic medicines.

"We are proud to continue our ongoing investments in US manufacturing and R&D to better serve the needs of American patients," Hafrun Fridriksdottir, president, Hikma Rx, said in a press release (1). "Hikma and our 2300 dedicated US people are committed to supporting healthier communities nationwide by providing Americans with a steady and reliable supply of domestically produced quality medicines.”

“Over the past 15 years Hikma has grown to become a top three US supplier of sterile injectable medicines with more than 180 injectable products in our portfolio and a growing pipeline,” Bill Larkins, president, Hikma Injectables, added. “This new phase of US investment will enhance and expand our sterile injectables production capabilities and enable us to continue providing our broad portfolio of essential medicines to US patients.”

Investment in affordability and community

“As a pharmacist and chairman of the American-Made Medicines Caucus, I understand the crucial role Hikma and other generic manufacturers play in delivering affordable and accessible medicines to Americans. It’s important that we onshore the production of these critical drugs. I will continue working with Hikma to strengthen our national security and public health by making life-saving generic medications here, in America, and applaud them for their announcement today,” US Rep. Buddy Carter, R-Ga., said in the release.

“Hikma continues to invest in American workers, and I am thrilled that they have chosen to continue that commitment here in Columbus. This development will support a critical industry and create more jobs for working families in central Ohio. Additional manufacturing capacity will increase Americans’ access to high-quality, affordable medicines. I am proud to join Hikma here today to support their mission and the Ohioans they employ. I look forward to returning to see the new facility once it is complete,” US Rep. Mike Carey, R-Ohio, said in the release.

In other company news, Hikma published its 2024 Sustainability Report, detailing the company’s approach to sustainability.

"Access to medicines remains at the heart of everything we do at Hikma," said Tim Brooks, the company’s vice-president of Sustainability, in a press release (2). "This sustainability report highlights our belief that providing high-quality medicines is not just our business—it's our responsibility to our people, customers, healthcare professionals, patients and the communities we serve around the world. This year, we have further reinforced access to medicine as the core of our sustainability strategy by leveraging our strong manufacturing presence and working with stakeholders across the healthcare ecosystem.

“This key objective is supported by our commitment to our people, our planet, and our suppliers. Additionally, we have introduced metrics for each of these areas to demonstrate our performance and ensure sustainability remains embedded throughout our corporate strategy,” Brooks added.

Hikma Pharmaceuticals USA Announces $1 Billion of New US Investment to Further Expand its Domestic Manufacturing and Development of Essential Generic Medicines

Hikma Publishes its 2024 Sustainability Report Reinforcing Commitment to Global Access to Medicines

Acting Responsibly. Hikma Sustainability Report 2024.

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.

Hikma Pharmaceuticals Invests $1 Billion to Expand US Generic Drug Capabilities, Releases Sustainability Report

Aenova, a contract development and manufacturing organization, announced on June 27, 2025 that it is expanding its sterile manufacturing facility in Latina, Italy with a new cold chain warehouse that will be connected to the existing facility. The new warehouse will support a wide range of cold chain products without the need for special adaptations for specific APIs or countries and will help the company provide end-to-end integrated supply chain solutions for temperature-sensitive pharmaceutical products.

The new warehouse will be 6500 cubic meters with a total capacity of 1300 pallet spaces.

The warehouse will maintain a controlled, continually monitored temperature range of 2–8 ºC.

An additional 100 pallet spaces will be dedicated to packing, shipping, and final product preparation.

The new warehouse will be 6500 cubic meters, have a total capacity of 1300 pallet spaces, and will maintain a controlled temperature range of 2–8 ºC that will be continuously monitored via a supervisory control and data acquisition system in compliance with current good manufacturing practices (CGMP). An additional area will accommodate 100 pallet spaces dedicated to packing, shipping, and final product preparation.

The warehouse will have the capability to precisely track the location and movement of pallets via a fully automated digital system. An Automated Guided Vehicle system will move goods between production and storage areas. All time-of-refrigerator data will be digitally recorded, and two independent refrigeration systems will ensure uninterrupted operations by backing each other up, therefore providing business continuity. Drug substances will be stored in a dedicated freezer, and state-of-the-art technologies will also enhance energy efficiency and sustainability.

“This expansion significantly enhances our biologics and sterile drug product offering,” Paolo Abbate, managing director at the Aenova site in Latina, said in a press release (1). “By integrating cold chain storage directly into our manufacturing site, we can now offer our customers secure and streamlined logistics; this is a real competitive advantage in terms of speed, reliability, and compliance.”

Construction on the new warehouse began in early 2025, and the company expects the facility to be operational in the first quarter of 2026. An expansion of the Latina site’s fill/finish line for biologics is also planned for the future.

In other Aenova news, the company launched its Aenovation program for the acceleration of drug development in May 2025 (2). The program is designed to fast-track early development of drug formulations, especially to combat bioavailability and solubility challenges. The program deploys a science-based rational selection of formulation and technology and approaches pre-formulation and development in the following three steps:

API profiling and developability classification is done through assessment and testing of the API to determine solubility, permeability, solid-state properties, and powder physical characterization.

The formulation and prototype selection phase uses an API-sparing screening program that uses solubility enhancement technologies and includes process simulation, analytical characterization, accelerated stability assessment programs, and the supply of prototypes for pre-clinical studies.

Clinical-phase material manufacturing includes transfer to GMP lab- and pilot-scale environments, which involves validating analytical methods.

“Aenova’s extended range of development services allows us to support pharmaceutical and biotech companies in accelerating their programs and optimizing their resources,” Florent Bordet, chief scientific officer at Aenova, said at the time in a press release (2). “Our Aenovation program is a reflection of our commitment to innovation and excellence in pharmaceutical development.”

Aenova Expands Cold Chain Capabilities with New State-of-the-Art Warehouse at its Sterile Site in Latina

Aenova Launches Aenovation Program to Accelerate Pharmaceutical Development. 

The new building expands on the company’s supply chain solutions for biologics and temperature-sensitive pharmaceuticals.

Aenova Adds Cold Chain Warehouse to Latina, Italy Site

Close up the media plate on hand medical technicians working on bacterial culture and drug resistance of pathogens in laboratory. | Image Credit: © analysis121980 - stock.adobe.com

 has entered into a licensing agreement with Finnish company Northern Antibiotics that will give Prokaryotics global rights to develop, manufacture, and commercialize a treatment currently known as NAB741, formerly SPR741 (1). NAB741 is a non-bioactive polymyxin that acts as a Gram-negative antibiotic potentiator, designed to increase the permeability of the outer membrane of Gram-negative bacteria—therefore making those bacteria more susceptible to other antibiotics.

The agreement was reached on June 4, 2025, but Prokaryotics publicized the announcement on June 26 (1).

“We are delighted to work with Northern Antibiotics and add NAB741 to the portfolio of first-in-class antibiotics being developed by Prokaryotics,” 

 PhD, founder and chief scientific officer of Prokaryotics, said in a press release (1). “NAB741 demonstrates tremendous activity in enhancing efficacy, expanding spectrum, and reducing spontaneous resistance with each of our mechanistically novel antibiotic lead classes. We believe that combining NAB741 with these agents offers a powerful and de-risked strategy to develop fixed-dose combination agents effective in treating bacterial infections resistant to existing antibiotics.”

Prokaryotics was founded on Merck & Co. (known as MSD outside of the United States and Canada) out-licensed antibiotic assets under development for the treatment of antimicrobial resistant (AMR) infections that are life-threatening (1). AMR is considered an urgent threat to public health and has been projected to contribute to 39 million worldwide deaths by the year 2050; in 2021 alone, 

 an estimated 1.14 million deaths were attributed to bacterial AMR (2). The World Health Organization projects that the impact of antibiotic drug resistance on human health and economic costs will eventually rival that of global warming, and in the next two to three decades, there could be a “pre-antibiotic era” in which existing antibiotics will become largely ineffective in treating serious or life-threatening illnesses (1).

NAB741 was developed by Martti Vaara, MD, PhD, the founder of Northern Antibiotics, who died in 2021 at the age of 68 (1,3).

“Martti always believed that NAB741 is a powerful potentiator with clinical importance,” his brother, Timo Vaara, said in the release (1,3). “Its real value is not in itself, however, but in the uniqueness of its partner antibiotic. Prokaryotics is working on no less than three novel and impressively promising antibiotic lead classes, a perfect match. Martti also always stressed that it is not just about molecules but about people, too. To our collaboration, Prokaryotics has brought extensive antibiotic industry expertise, combined with young-hearted passion and determination. And above all, our partnership has developed to a friendship that is a prerequisite of any genuine progress.”

Complicated intra-abdominal infections (cIAI) are one category of illness can be caused by Gram-negative bacteria, and in February 2025, 

 product, as the first fixed-dose, intravenous monobactam/β-lactamase inhibitor combination antibiotic in the United States, to be used in combination with metronidazole in adults with either limited or no other options for treating cIAI (2).

In a press release at that time, AbbVie identified the Gram-negative microorganisms 

 as potential causes of cIAI, saying that such infections are “among the most challenging” for medical professionals to treat because of their high AMR (2).

Prokaryotics Announces Licensing Agreement with Northern Antibiotics for Novel Gram-negative Antibiotic Potentiator.

 Press Release. June 26, 2025.
2. AbbVie. 

US FDA Approves Emblaveo (aztreonam and avibactam) for the Treatment of Adults with Complicated Intra-Abdominal Infections with Limited or No Treatment Options.

 Press Release. Feb. 7, 2025.
3. Northern Antibiotics. 

Professor Martti Vaara, MD, PhD, 29.3.1953–25.8.2021.

, Aug. 25, 2021 (accessed June 26, 2025).

Prokaryotics will gain worldwide rights to develop, manufacture, and commercialize NAB741, a non-bioactive polymyxin designed to increase permeability of the outer membrane of Gram-negative bacteria.

Prokaryotics Licenses Gram-Negative Antibiotic Potentiator from Northern Antibiotics

3D Rendering of CAR - Chimeric Antigen Receptor Between T-Cell and Cancer Cell | Image Credit: © Alpha Tauri 3D - stock.adobe.com

 a late-stage biopharmaceutical company headquartered in Ireland but also operating in France, has been awarded nearly €1.7 million (approximately US$1.99 million) in non-dilutive funding through i-Nov, an innovation competition and flagship French government program that is part of the 

The funding will support a clinical program revolving around Priothera’s mocravimod, a novel oral sphingosine 1 phosphate (S1P) receptor modulator the company is developing for treatment of hematologic malignancies (1). More specifically, the program will evaluate whether adding mocravimod to commercial chimeric antigen receptor (CAR)-T cell therapies can improve patient outcomes.

In a press release, Priothera noted the potential of CAR-T cell therapies to have strong clinical responses and lasting disease control in patients with acute lymphoblastic leukemia, non-Hodgkin lymphoma, and multiple myeloma (1). However, the company went on to say that as many as 60% of patients treated with CAR-T cells experience “high-grade toxicities,” such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Mocravimod is designed to enhance the effectiveness of CAR-T cell therapy, according to Priothera, with a dual mechanism of action that reduces incidence and severity of CRS and ICANS, as well as improves response rates and durability of treatment.

Priothera is continuing to advance mocravimod in 

 that studies the treatment’s efficacy in patients with acute myeloid leukemia who are undergoing allogeneic hematopoietic cell transplantation (allo-HCT) (1).

“We are honored to receive this i-Nov funding from Bpifrance, which underscores the innovation and therapeutic potential of mocravimod beyond allo-HCT,” said 

 co-founder and CEO of Priothera, in the press release (1). “With its unique immunomodulatory properties, mocravimod is well-positioned to become a key component in the next generation of cell therapy regimens. The MOCART trial represents an exciting expansion of our clinical development into CAR-T therapy, building on our deep expertise in allo-HCT and momentum from our ongoing global Phase III MO-TRANS trial in acute myeloid leukemia.”

On behalf of the French government, Bpifrance manages the French Tech Seed Fund, which was identified as one of the co-leaders of a financing round, also as part of the France 2030 initiative, 

for a new Franco-Belgian biotech venture,

 (2). The company said in June 2025 that it raised €11.25 million (US$12.9 million) in an oversubscribed seed round to advance a novel therapeutic approach targeting treatment-resistant depression.

Meanwhile in Spain, in-house academic CAR-T manufacturing has emerged as a new alternative model, enabled by regulatory flexibility that allows production in Grade C cleanrooms rather than more costly Grade B facilities (3). 

®’s “Behind the Headlines” series explored that and other up-to-the-minute trends in its June 19, 2025 installment.

 to watch that panel discussion in its entirety.

Priothera Secures €1.7 Million i-Nov Funding by Bpifrance for Rare Blood Cancer Clinical Program.

 Press Release. June 24, 2025.
2. Elkedonia. 

Elkedonia Closes EUR 11 Million Seed Round to Advance Neuroplastogens as Novel Therapeutics for Depression and Neuropsychiatric Disorders.

 Press Release. June 11, 2025.
3. Spivey, C. 

Behind the Headlines, Episode 19: CGT Cost Pressures, BioNTech’s CureVac Move, and Spain’s CAR-T Model.

The company’s mocravimod, a novel oral S1P receptor, is being evaluated for its efficacy as an addition to CAR-T cell therapies.

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