Behind the Headlines Episode 27

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

Artificial intelligence, machine learning, and novel instruments are helping drug developers.

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

J.P. Morgan Report Lists Biologics, Obesity, China

Top Trends Reshaping Pharma R&D

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Hand shaking which print screen on wooden cube block in front of human icon for business deal and agreement concept. | Image Credit: © Dilok - stock.adobe.com

The National Institute for Bioprocessing Research and Training (

), an Irish-based center of excellence in biopharmaceutical manufacturing; 

, a United Kingdom-based software consultancy; and 

, a product design, engineering, and development specialist with offices in the UK and Ireland, are joining 

, a co-location center of EIT Health, which is a part of the European Union’s European Institute of Innovation and Technology (1).

EIT Health is a 100-member strong network of organizations in various fields—business, education, government, research, and health services delivery—that work together to address healthcare challenges across Europe with collective technological knowledge and innovation (1).

NIBRT, Firefinch Software, and eg technology have joined EIT Health Ireland–UK to foster collaboration in healthcare innovation across Europe.

Membership provides access to a pan-European innovation network, supporting bioprocessing training, product development, and accelerated tech adoption.

The partnership highlights a trend of increased collaboration among European pharma and tech sectors, despite ongoing geopolitical uncertainties.

“We are delighted to welcome NIBRT, Firefinch, and eg technology to the EIT Health Ireland-UK network,” said 

 managing director at EIT Health Ireland–UK, in a press release (1). “Each brings a unique strength to our network. From world-class bioprocessing training and market-ready product design to expert solutions that can accelerate innovation adoption, their expertise enhances our collaborative mission to create meaningful, scalable healthcare solutions for Europe.”

By joining the network, NIBRT, Firefinch, and eg technology gain access to what EIT Health referred to as a pan-European innovation base. Opportunities will be available to the three new network members to contribute to the EIT Health Think Tank and other EU-supported initiatives.

“At NIBRT, we are committed to advancing excellence in bioprocessing through training and research that meets the evolving needs of the biopharma sector,” 

 chief scientific officer and director of Research and Innovation at NIBRT, said in the release (1). “Being part of this vibrant European network opens up exciting opportunities to work with like-minded partners and bring meaningful, scalable health solutions to patients across Europe.”

“We are thrilled to be joining such an exciting and dynamic community as EIT Health,” said Isabel Vincent, market development manager, Firefinch Software, in the release (1). “From university spin outs to large multi-nationals, we are keen to work with innovative companies that want to improve health outcomes across Europe.”

“Our continued partnership with EIT Health reinforces eg technology’s commitment to accelerating healthcare innovation across Europe,” Rouzet Agaiby, director at eg technology, said in the release (1). “By further supporting high-potential start-ups and contributing to cutting-edge medical technology development, we can continue to play an active role in the delivery of meaningful improvements to patient outcomes.”

®’s “Industry Outlook 2025” series, 

 discussed European political impacts on the pharmaceutical industry at large, and the pharma supply chain in particular. Those interviews can be viewed in full at the links provided 

EIT Health Ireland–UK said it is still hoping to grow its membership further to connect more healthcare stakeholders. Interested parties can learn more at 

NIBRT, Firefinch and eg technology Join EIT Health Ireland–UK Network to Boost Pan-European Health Innovation.

 Press Release. June 12, 2025.
2. Thomas, F. and Haigney, S. 

Industry Outlook 2025: European Geopolitical Impact on Pharma.

, Apr. 30, 2025.
3. Thomas, F. and Haigney, S. 

Industry Outlook 2025: European Political Impacts on the Supply Chain.

Articles

NIBRT, Firefinch, and eg technology will join the center, adding to its collective of healthcare innovators.

EIT Health Ireland–UK Expands European Network with Three New Members

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

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

 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 this episode, three experts from across the advanced therapy ecosystem examine the commercial growing pains of cell and gene therapies (CGTs), ongoing efforts to drive down costs, and what BioNTech’s recent bid for CureVac reveals about the messenger RNA (mRNA) landscape. Fabian Gerlinghaus, CEO of Cellares; Alexander Seyf, co-founder and CEO of Autolomous; and Knut Steffensen, director of the Karolinska Institutet and University Hospital ATMP Center, offer their perspectives on the urgent need for better integration across the therapeutic value chain.

Fragmentation and redundancy in CGT manufacturing

The panel highlights persistent inefficiencies in CGT manufacturing, including duplicated facilities, fragmented digital workflows, and increasing strain from external cost pressures such as energy prices and tariffs. The lack of shared infrastructure and harmonized systems continues to hamper scalability and access, while high manufacturing costs remain a major barrier for both developers and patients.

Academic CAR-T and the Spanish hospital model

Turning to alternative models, the panel discussed the emergence of in-house academic chimeric antigen receptor (CAR)-T manufacturing in Spain, enabled by regulatory flexibility that allows production in Grade C cleanrooms rather than more costly Grade B facilities. This approach—used in Spanish hospital centers—has reduced the per-treatment cost to under €100,000, in contrast to commercial products exceeding US$400,000. The academic model also benefits from a more integrated, “bench-to-bedside” design that improves coordination between research, manufacturing, and clinical care (1).

The discussion concluded with the implications of BioNTech’s proposed acquisition of CureVac (2). While some speculate the move is related to an ongoing patent dispute, the panel suggested the transaction also reflects broader strategic concerns, including a cooling vaccine market and a desire to bolster oncology capabilities and mRNA manufacturing scale. The CureVac deal may signal a shift in acquisition strategies across the mRNA sector as companies look to shore up competitive advantages in a rapidly evolving field.

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

1. Li, F. Spain’s Hospital-Based CAR-T Goes Global: A Therapy, a System, or a New Paradigm? April 14, 2025, 

2. BioNTech. BioNTech Announces Strategic Transaction to Acquire CureVac in Public Exchange Offer. Press Release. 

Videos

Fabian Gerlinghaus, Alexander Seyf, and Knut Steffensen go behind the headlines and dive into the advanced therapy ecosystem. 

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

BASF announced on June 17, 2025 that it has opened a good manufacturing practice (GMP) facility in Wyandotte, Mich. as part of the company’s commitment to providing a reliable supply of bioprocessing ingredients and excipients to the biopharma and pharmaceutical industries. The facility expands on BASF’s existing network of GMP sites. BASF Pharma Solutions is a manufacturer of excipients and APIs.

The new facility will feature state-of-the-art cleanroom packaging and high-sensitivity analytical testing capabilities. These will allow the company to customize chemistries for product development and provide more tightly controlled parameters beyond compendial limits and a validated control system, according to a press release (1).

“Our new GMP Solution Center exemplifies BASF’s dedication to understanding and addressing the evolving needs of our customers in both the biopharma and pharmaceutical industries,” Marion Kuhn, vice president of business management, BASF Pharma Solutions, said in the press release. “This state-of-the-art facility will play a fundamental role in enabling us to collaborate closely with our customers worldwide on product development and GMP manufacturing in ways that are unique to the industry, further strengthening our position as an innovator in the pharmaceutical sector.”

“Wyandotte’s new GMP Solution Center is a key example of BASF’s commitment to innovative excellence,” added Benjamin Knudsen, vice president of research North America at BASF Corporation. “This expansion not only showcases our dedication to developing customized solutions, but it also highlights our ability to adapt and innovate in response to our customer’s needs. Together, we are paving the way for new innovative solutions.”

The quality of pharmaceutical ingredients is imperative for ensuring a robust and safe drug supply chain. Poor-quality APIs that do not meet standards may destabilize drug formulations, creating quality control problems and regulatory actions that result in drug recalls (2).

“From a supply chain perspective, poor-quality APIs increase the likelihood of production interruptions, which disrupt the supply to the market,” Qixuan Lu, vice-president of Process Chemistry at BioDuro, said in an interview about API quality with 

® (2). “Because of the poor-quality API, additional quality control measures become necessary, driving up costs and diminishing profit margins. If such issues arise repeatedly, they can harm a company’s reputation and undermine market confidence in its products. Beyond these commercial setbacks, manufacturers also face considerable legal and regulatory risks if they fail to meet the standards required for pharmaceutical quality and patient safety.”

 video interview, experts discussed key trends impacting small-molecule APIs and excipients, the importance of supply chain resilience, ways in which advanced manufacturing approaches can prove beneficial, and potential hurdles facing companies seeking to secure their small-molecule API and excipient supply chains (3).

BASF. BASF Strengthens Its Commitment to the Biopharma and Pharmaceutical Ingredients Industries through a New Investment in North America. Press Release. June 17, 2025.

Haigney, S. Poor API Quality Threatens a Healthy Supply. 

https://www.pharmtech.com/view/poor-api-quality-threatens-a-healthy-supply

Thomas, F. Drug Digest: Securing the Supply Chain for Small-Molecule APIs and Excipients. 

https://www.pharmtech.com/view/drug-digest-securing-the-supply-chain-for-small-molecule-apis-and-excipients

The new facility offers cleanroom packaging and high-sensitivity analytical testing.

BASF Opens GMP Manufacturing Facility in Michigan

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

FDA announced on June 17, 2025 that it has created the Commissioner’s National Priority Voucher (CNPV) program to help shorten the review times for drug approvals. The program provides a voucher that drug developers can redeem so they may participate in a novel priority program that will shorten the final drug application submission review time from 10–12 months to one to two months. The program will begin in 2025 with a one-year pilot phase. The number of vouchers will be limited in the first year of the program to “companies aligned with US national priorities” (1,2).

Experts from FDA offices will meet for a “team-based review” as part of the new CNPV process, with a multidisciplinary team of physicians and scientists reviewing clinical information and pre-reviewing submitted information in a one-day “tumor board style” meeting.

Participants in the program may also be granted accelerated approval if applicable legal requirements are met. In addition, the program will offer enhanced communication between the agency and the sponsor.

To qualify for the program, applicants must meet the following criteria:

must address a health crisis in the United States

must deliver more innovative cures for the American people

must increase domestic drug manufacturing as a national security issue.

Applicants must submit the chemistry, manufacturing, and controls part of their application and the draft labeling at least 60 days before submitting their final application. Sponsors are expected to be available for prompt, ongoing communications with the agency during the CNPV review. “FDA reserves the right to extend the review window if the data or application components submitted are insufficient or incomplete, if the results of pivotal trial(s) are ambiguous, or if the review is particularly complex,” the agency stated in the press release.

FDA may direct vouchers to specific investigational new drugs or grant a voucher to a company as an undesignated voucher, which would allow the voucher to be used for a new drug at the sponsor company’s discretion. Vouchers, however, are non-transferrable to other companies but will remain valid through changes in company ownership. Vouchers must be used within two years of receipt (2).

“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” said FDA Commissioner Marty Makary in a press release (1). “As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a one-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”

“This approach capitalizes on frequent communication with sponsors, which can be a powerful tool in reducing wasted time. We are confident this more efficient process can be achieved without cutting any corners on safety or scientific evaluation,” said FDA Principal Deputy Commissioner Sara Brenner.

FDA’s existing Priority Review Voucher (PRV) program will continue as is and is separate from the new CNPV. PRV will have a different timeline for review (2).

FDA. FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests. Press Release. June 17, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests

FDA. FAQs: Commissioner’s National Priority Voucher Program. 

https://www.fda.gov/news-events/press-announcements/faqs-commissioners-national-priority-voucher-program

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for shortened drug approval review time.

FDA Voucher Program Provides Shorter Drug Application Review Time

Cancer detection and screening as a treatment for malignant cells with a biopsy or testing caused by carcinogens and genetics with a cancerous cell as an immunotherapy symbol | Image Credit: © freshidea - stock.adobe.com

 a Poland-based contract development and manufacturing organization (CDMO) with a focus in biotechnology, is using the occasion of the Biotechnology Innovation Organization (BIO) International Convention, being held in Boston from June 16–19, 2025, to announce a €500,000 (US$574,119) oncology services contest that will culminate at another conference, CPHI Frankfurt, Oct. 28–30, 2025 (1).

Mabion launched a €500,000 oncology services contest to accelerate recombinant protein-based cancer therapy development.

The contest aims to foster long-term partnerships and offers winners end-to-end CDMO services credit.

Entries will be judged on scientific merit, feasibility, and patient impact, with finalists announced at CPHI Frankfurt 2025.

The contest, Mabion said in a press release, has a goal of accelerating development of recombinant protein-based cancer therapies, with the winner receiving the monetary credit toward Mabion’s end-to-end CDMO services. The company said it hopes the contest will foster a long-term partnership, either with the winner or, potentially, runner-up entries (1,2).

"Despite unprecedented scientific advances, many oncology treatments still face hurdles at the funding stage," said 

 PhD, Mabion chief operating officer (1). "This contest is our invitation to innovators who just need the right partner. We’re offering more than a prize; we’re offering a path to impact.”

Balcerek will be among an independent jury of experts that is tasked with evaluating entries in several criteria—such as scientific merit, feasibility, and the potential impact to patients:

Tadeusz Pietrucha, professor, Medical Biotechnology Department, Medical University of Łódź, Łódź, Poland

Przemysław Juszczyński, professor, Department of Experimental Hematology and Transfusionology, Lazarski University, Warsaw

Gestur Vidarsson, professor, principal investigator and head of Immunoglobulin Research at Sanquin Research, Utrecht University (Utrecht, Netherlands), and Chair of the Immunoglobulin Biotherapeutics group

Alicja Santos, PhD, CEO, Polonium Foundation, Warsaw.

At Mabion’s booth (#2445) at BIO 2025, a QR code will be available to access a simplified entry process for the contest, including a dedicated landing page (1). Mabion’s business development team will assist selected entrants with pre-qualification, non-disclosure agreements, and shaping of a proposal.

At CPHI Milan in October 2024, Jakub Knurek, Mabion business development specialist, 

 “Building the Future Pharma Workforce” (3). There, discussing the rise of women in leadership positions in the pharmaceutical industry, Knurek noted the change by saying the panel was comprised of more women than men.

“In every gender, [to] have that passion for biotech, for improvement that's really challengeable for all companies, how [can we] search, I think, more about headhunting, talent acquisition from that perspective?” Knurek said (3).

There has been a similar change, Mabion said, in the Polish city of Łódź, once a textile hub but now a rising power in life sciences.

"Wherever you’re based, this is your chance to accelerate your breakthrough program with Mabion’s financial support and world class services," Balcerek said in the June 17 press release (1). "Mabion is proud to help turn scientific ambition into clinical reality.”

Mabion encourages interested applicants to get more information at 

 for all of our coverage of BIO 2025, and check back for an interview 

conducted as part of that coverage with Mabion Director of Business Development Bartlomiej Czubek.

1. Mabion. Mabion Launches €500,000 Services Contest to Support Next-Gen Oncology Breakthroughs. Press Release. June 17, 2025.
2. Comment received via email correspondence, June 17, 2025.
3. Thomas, F. and Lavery, P. 

CPHI Milan 2024: What Does the Future Pharma Workforce Look Like?

The contest, which aims to accelerate the development of recombinant protein-based oncology therapies, will culminate at CPHI Frankfurt in October 2025.

Mabion Announces Oncology Services Contest at BIO 2025

Stainless steel door and walls, clean room | Image Credit: © Alexandr - stock.adobe.com

 a good manufacturing practice (GMP)-ready space and service provider with facilities in Massachusetts and North Carolina, has officially launched following a strategic ownership investment and the acquisition of facility assets from Azzur Group, a press release from the new company said on June 16, 2025 (1).

Chrysalis offers flexible, GMP-compliant cleanroom spaces with rapid access (four to six weeks), supporting life science innovators’ varied technical needs.

The model allows companies to maintain process control and IP while scaling operations, minimizing risk, and avoiding long-term expense burdens.

Chrysalis plans rapid expansion to meet growing demand for adaptable GMP spaces, amid industry trends toward complex, personalized medicines and advanced cleanroom technologies.

The acquired assets provide the company with GMP-compliant cleanroom spaces that Chrysalis said will be flexible and able to be tailored to life science innovators and biopharmaceutical companies, with entry times as short as four to six weeks (1). As the companies work to clear key milestones to get transformative therapies to clinic, Chrysalis’ involvement permits these innovators to retain full ownership of their programs so that they can meet individual timelines and technical requirements.

“Our model is particularly valuable for programs where retaining process control, protecting IP [intellectual property], and minimizing risk are crucial considerations,” said Sarah Stevens, Chrysalis CEO, in the press release (1). “Our approach gives our customers flexibility to take only the space and services they need, when they need it. By providing rapid access to GMP-compliant space and operational support, we empower our customers to advance on their own terms, transforming scientific promise into real progress without the burden of scheduling constraints or unnecessary ongoing expense.”

In the press release, Chrysalis listed among its partners early-stage biotechnology companies, contract research organizations, top-10 pharmaceutical firms, and various other life sciences stakeholders (1). The company’s facilities are intended to accommodate a range of needs and therapeutic modalities.

“Whether clients are navigating early development or preparing for commercialization, we’re here to grow with them,” Stevens said (1). “We don’t just provide space, we build partnerships grounded in collaborative operational excellence and a deep understanding of what it takes to operate in a GMP environment.”

examined the evolution of cleanroom procedures

 in the context of a shift in the market toward personalized medicines, listing the challenges in maintaining sterile environments (2).

“The evolving regulatory requirements over the years as well as the increasing biopharmaceutical complexity and growing demand for aseptic processing have prompted significant advancements in cleanroom technologies and analytical testing methods,” the article says (2). “These innovations have been driven by the need for faster, more accurate contamination detection, improved environmental monitoring, and greater flexibility in biomanufacturing. Innovations include rapid microbiological methods, next-generation sequencing, real-time environmental monitoring, and the use of digitalization and artificial intelligence in cleanroom analytics.”

Chrysalis said it plans to scale rapidly following its launch, enhancing infrastructure and expanding into other geographical areas (1).

Chrysalis Launches with Acquired Cleanroom Assets to Deliver Flexible Manufacturing Solutions.

 Press Release. June 16, 2025.
2. Mirasol, F. 

Evolving Cleanroom Procedures and Sterility Challenges.

Chrysalis lists among its partners early-stage biotechnology companies, contract research organizations, top-10 pharmaceutical firms, and various other life sciences stakeholders.

New Company Chrysalis Launches After Acquisition of Cleanroom Assets

BIO 2025: Pulmonary Drug Delivery

PharmTech Group spoke with Andy Burns, vice-president of MDI Business Development at Kindeva, about trends he is observing in the pulmonary drug delivery field as part of our preview of the BIO International Convention, which is being held from June 16–19, 2025 in Boston.

According to Burns, sustainability is a focus of a lot of pharmaceutical companies and stakeholders. “A lot of our clients and customers have their own well-developed set of policies and procedures that they wish their partner organizations to subscribe to, and certainly very progressive in Europe and the UK and also in the [United States],” Burns says. “So, sustainability and the impact on supply chains, both within Big Pharma, but also their associated contract manufacturers, is certainly a theme that I've seen developing over the past the past few years.”

Click the video above the watch the interview.

Andy Burns, vice-president of MDI Business Development at Kindeva.

PharmTech Group spoke with Andy Burns, vice-president of MDI Business Development at Kindeva, ahead of BIO 2025 to find out what’s new in pulmonary drug delivery.

South San Francisco, CA, USA - February 24, 2021: Closeup of a AstraZeneca building corporate office, a British-Swedish pharmaceutical, biotechnology company with its headquarters in Cambridge, England | Image Credit: © Valeriya Zankovych - stock.adobe.com

In a press release on June 13, 2025, AstraZeneca announced its entry into a strategic research collaboration with CSPC Pharmaceuticals Group, based in Shijiazhuang City, China (1). The two companies plan to work together to advance discovery and development of novel oral candidates for multiple high-priority targets.

In the press release, AstraZeneca said these oral therapies—which include a small molecule candidate for immunological diseases—have a collective potential to treat diseases across numerous chronic indications (1).

AstraZeneca partners with CSPC to accelerate AI-powered small molecule drug discovery, targeting chronic diseases with novel oral therapies developed in China.

The collaboration expands AstraZeneca's R&D footprint in China, following its $2.5 billion investment to establish a Beijing-based global innovation hub earlier in 2025.

CSPC can receive up to $5.33 billion in milestone and sales payments, plus royalties, while AstraZeneca secures global rights to license and commercialize resulting candidates.

The new agreement calls for CSPC to conduct the research at its Shijiazhuang City campus using its artificial intelligence (AI)-driven, dual-engine efficient drug discovery platform (1). According to the release, the platform leverages the power of AI to analyze binding patterns of target proteins with existing compound molecules and carry out targeted optimization, with the end goal of selecting small molecules that are not only highly effective but also showcase excellent developability.

“This strategic research collaboration underscores our commitment to innovation to tackle chronic diseases which impact over 2 billion people globally,” 

 AstraZeneca executive vice-president and head of BioPharmaceuticals R&D, said in the release (1). “Forming strong collaborations allows us to leverage our complementary scientific expertise to support the rapid discovery of high-quality novel therapeutic molecules to deliver the next-generation medicines.”

As AstraZeneca noted in the release, the partnership with CSPC further strengthens AstraZeneca’s footprint in China. 

 that, as part of a strategic partnership with the Beijing Municipal Government and the Beijing Economic-Technological Development Area Administrative Office, and including agreements with biotech companies Harbour BioMed, Syneron Bio, and BioKangtai, it planned to invest $2.5 billion in Beijing in the next five years (2,3). The ultimate purpose of the investment is to establish a global strategic R&D center supporting major research and manufacturing agreements to further advance life sciences in the country.

 AstraZeneca agreed to acquire Belgium-based EsoBiotec, a biotechnology company specializing in 

 cell therapies, at an initial payment price of $425 million by AstraZeneca upon the closing of the deal (4).

The financial terms of the agreement between AstraZeneca and CSPC stipulate that the latter is receiving an upfront payment of $110 million and will be eligible to receive up to $1.62 billion in potential payments for development milestones, plus an additional maximum of $3.6 billion in sales milestone payments (1). Potential single-digit royalties may also be paid, based on annual net sales of products. AstraZeneca, meanwhile, retains worldwide rights to exercise options for exclusive licenses to develop and commercialize candidates.

AstraZeneca Enters Strategic Collaboration with CSPC Pharmaceuticals Focused on AI-Enabled Research.

 Press Release. June 13, 2025.
2. AstraZeneca. 

AstraZeneca to Invest $2.5 Billion in New Global Strategic R&D Centre, Biotech Agreements and Manufacturing in Beijing.

 Press Release. March 21, 2025.
3. Mirasol, F. 

AstraZeneca Invests $2.5 Billion to Establish Global Strategic R&D Center, Support Biotech Agreements, and Boost Manufacturing in China.

AstraZeneca to Acquire EsoBiotec to Advance Cell Therapy Ambition.

The collaboration will focus on identifying pre-clinical candidates for high-priority targets, including a small molecule oral therapy for immunological diseases.

AstraZeneca Partners on AI-Enabled Research with CSPC Pharmaceuticals

mainz,Rhineland-Palatinate /germany - 16 07 2022: the biontech company building and flags in mainz germany | Image Credit: © Tobias Arhelger - stock.adobe.com

In a move to reportedly consolidate and expand its capabilities in messenger RNA (mRNA)-based medicine, BioNTech has announced plans to acquire CureVac through an all-stock transaction valued at approximately $1.25 billion (1). The acquisition aims to accelerate the development and manufacturing of next-generation mRNA immunotherapies for oncology and infectious diseases by combining the strengths of the two German-based biotechnology companies.

Strategic fit to strengthen BioNTech’s oncology pipeline

This acquisition forms a cornerstone of BioNTech’s long-term oncology strategy. The company intends to integrate CureVac’s proprietary mRNA platforms and advanced research infrastructure, particularly its R&D and manufacturing facilities in Tübingen, Germany, to complement existing efforts across BioNTech’s immunotherapy programs (1).

·BioNTech's acquisition of CureVac strengthens mRNA cancer immunotherapy R&D and supports its next milestone in oncology strategy execution.

·The deal enhances BioNTech’s proprietary mRNA design, delivery, and manufacturing technologies for advanced therapeutic development.

·CureVac's integration expands BioNTech’s mRNA platform, optimizing formulation and production for future oncology pipeline growth.

“This transaction is another building block in BioNTech’s oncology strategy and an investment in the future of cancer medicine,” said 

, CEO and co-founder of BioNTech (1). “We intend to bring together complementary capabilities and leverage technologies with the goal of advancing the development of innovative and transformative cancer treatments and establishing new standards of care for various types of cancer in the coming years.”

CureVac’s scientific expertise and its progress in mRNA design and lipid nanoparticle delivery systems are expected to support BioNTech’s pan-tumor immunotherapy candidates, including its lead PD-L1xVEGF-A bispecific antibody, 

“To me, this transaction is more than a business decision, it represents a shared commitment to leverage the full potential of mRNA as a disruptive technology to develop transformative therapies with greater scale and speed,” said 

, MD, CEO of CureVac (1). “For more than two decades, both companies have operated with related ambitions, often tackling challenges from different angles. This transaction aims at combining complementary scientific capabilities, proprietary technologies, and manufacturing expertise in the mRNA field under one roof.”

Expanding the mRNA platform in oncology and infectious disease

BioNTech’s acquisition of CureVac reflects a broader ambition to dominate the mRNA therapeutic landscape beyond COVID-19 (1). While BioNTech is best known for co-developing the first approved mRNA vaccine with Pfizer, the company continues to invest heavily in mRNA research targeting various solid tumors and infectious diseases.

CureVac adds to this effort with an R&D pipeline that includes off-the-shelf and personalized mRNA cancer vaccines, and prophylactic vaccine candidates (1). Its technology platforms are built to enhance immunogenicity while maintaining low-dose efficiency—a key factor for scalability and safety. By combining assets, both companies aim to streamline mRNA drug development pipelines and manufacturing workflows, potentially reducing timelines for delivering clinical-stage therapies to patients. The integrated platform will be positioned to support mRNA applications from discovery to commercialization.

The deal, approved unanimously by the boards of both companies, is expected to close in 2025, pending customary regulatory clearances and a minimum 80% share acceptance rate from CureVac shareholders—although BioNTech retains the option to reduce this threshold to 75% (1).

This news comes just 10 days after BioNTech announced a global co-development and co-commercialization agreement valued at up to $11.1 billion for 

 (2). Under that deal, BMS will provide BioNTech with an upfront payment of $1.5 billion and an additional $2 billion in non-contingent anniversary payments through 2028. 

 is also eligible to receive up to $7.6 billion in development, regulatory, and commercial milestones.

BioNTech Announces Strategic Transaction to Acquire CureVac in Public Exchange Offer

BioNTech to Receive Up to $11.1 Billion in Deal with BMS to Develop Immuno-Oncology Agent.

The acquisition boosts BioNTech’s mRNA design and manufacturing capabilities, accelerating development of next-gen cancer immunotherapies.

CureVac to Be Acquired by BioNTech in $1.25B Deal to Advance mRNA Cancer Therapies

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS). | Image Credit: © Tada Images - stock.adobe.com

In a June 10, 2025 update, FDA posted seven updated Warning Letters, issued between the beginning of 2025 and the present, to its 

 which stores more than 3400 such letters dating back to 2020 (1). The warnings encompassed various forms of lack of compliance in the agency’s view, including product mislabeling, false or misleading claims on packaging, and shortfalls in current good manufacturing practice (CGMP) standards found during laboratory inspections.

Highlights of five of the seven letters, the companies they were addressed to, and the significant red flags found by FDA are presented below.

American Behavioral Research Institute (ABRI) was inspected in April and May 2024 relative to its capacity as the sponsor of a clinical investigation of an investigational drug, Relaxium Sleep (Protocol ABRI-002, “A Study to Evaluate the Effects of Relaxium in Subjects with Sleep Disorder”) (2). While ABRI did respond to FDA correspondence following this inspection, dated May 24, 2024, FDA said the institute failed to submit an Investigational New Drug application for the conduct of a clinical investigation, such as the one described, subject to Title 21 of the Code of Federal Regulations, part 312. However, FDA acknowledged that there may have been misrepresentation as to whether Protocol ABRI-002 was intended as a drug or a dietary supplement, and has given ABRI more time to reply.

FDA cited CGMP violations in multiple facilities, including inadequate quality systems, lack of equipment cleaning procedures, and missing production records.

Companies marketing unapproved or misbranded products, such as dietary supplements and topical analgesics, were warned for noncompliance with labeling and authorization rules.

Improper or misleading promotional claims, particularly on social media, led to FDA scrutiny and warning letters regarding drug representation and investigational compliance.

FDA charged numerous violations with respect to pain relief creams, ointments, and sprays produced under the brand umbrella “Amish Origins Deep Penetrating” (3). The violations ranged from CGMP standards, to misbranded or unapproved new drugs marketed as external analgesics, to misbranded drugs sold as sunscreen. Among the CGMP violations were failures to conduct testing to verify the identities of certain components of drug products, notably glycerin, and to adequately prepare and perform batch production and control records, as well as quality control. FDA suggested that Amish Origins retain a consultant to address its CGMP issues, and that some of the company’s products may be classified as cosmetics, which fall under different sets of regulations.

Pointe-Claire, Quebec, Canada – May 29, 2025

The warning letter to this Canadian manufacturing facility also deals with CGMP violations, in this instance tied to regulations for finished pharmaceuticals; according to FDA, these products include over-the-counter drug products such as sunscreens and other skin protectants, as well as hand sanitizer (4). In addition to the same recommendations regarding a CGMP consultant and cosmetics designation made to Amish Origins, FDA said Laboratoire Druide’s quality systems were inadequate, and that the Pointe-Claire facility failed to establish, and then follow, appropriate written procedures for the cleaning and maintenance of its equipment.

An Instagram post by Sprout Pharmaceuticals’ CEO, Cindy Eckert, was the impetus for this warning letter. FDA alleges that the post, which was reviewed by the agency’s Office of Prescription Drug Promotion but also received complaints through FDA’s Bad Ad Program, was false or misleading when it came to the effects of the oral tablet flibanserin, marketed as Addyi, within the meaning of the federal Food, Drug, and Cosmetic Act (FD&C Act) (5). Among other claims, the post referred to Addyi as “the sex pill for women”; while it has been indicated for treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), it is not intended for postmenopausal women, or men, with HSDD, and is not indicated to enhance sexual performance.

Two products offered for purchase through Bio Wellness 444’s website and Instagram account, both varieties of vaginal douches, are available without prescriptions (6). FDA says these are unapproved new drugs that were introduced, or delivered for introduction, into interstate commerce, in violation of multiple sections of the FD&C Act. The products, labeled “Silver Bullet elite douche” and “Silver D elite douche,” contain colloidal silver intended for use in treating vaginal infections. As such, FDA said, the products would be deemed new drugs and require new drug applications, but no FDA-approved applications are currently in effect for those products. Bio Wellness 444 has been asked to respond to FDA with its plan for how to address the violations alleged.

While FDA warning letters generally do not authorize the execution of any definitive actions by the agency, they do specify actions that may be taken if FDA’s suggestions and requests are not adhered to, usually to be communicated by a company within a window of 15 business days of receipt of FDA’s letter. After that period of time, measures cited by FDA may be enacted, or further warnings can be issued.

, last updated June 10, 2025 (accessed June 12, 2025).
2. FDA. 

Warning Letter—American Behavioral Research Institute, LLC.

, last updated June 10, 2025 (accessed June 12, 2025).
3. FDA. 

Warning Letter—Amish Origins Management, LLC.

, last updated June 10, 2025 (accessed June 12, 2025).
4. FDA. 

The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.

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