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In her end-of-the-year message, Emer Cooke, executive director of the European Medicines Agency (EMA) promoted the agency’s successes in 2024, including the recommendation of 114 drugs for approval, collaborations with EU Member States and regulators from other regions, and efforts to combat drug shortages.

The marketing authorization recommendations made in 2024 by EMA included 48 new active substances, 16 of which were for rare diseases. “It is the first time since 2009 that we have been able to deliver more than 100 positive opinions,” Cooke stated in the press release (1). “This is good news for patients, but also a very encouraging indication of the competitiveness of the European pharmaceutical sector.”

Noteworthy marketing authorization recommendations went to the first Alzheimer’s disease medication in the European Union to slow progression of the disease and the first Chikungunya vaccine for adults. A new antibiotic was also approved to fight infections caused by multidrug-resistant bacteria, which is a positive development as antimicrobial resistance continues to be a threat to public health.

EMA collaborated with a variety of partners in 2024 to deal with multiple industry challenges. The agency worked with EU Member States to transition ongoing clinical trials to the Clinical Trials Information System. “Ten thousand applications have been submitted in the system since January 2022. This marks the end of a three-year transition period that began when the Clinical Trials Regulation became applicable,” Cooke stated in the release. The agency also worked with the African Medicines Agency to share experience and knowledge and to support a pilot program for joint evaluation of drugs in Africa.

To combat the ever-present problem of drug shortages, EMA worked with EU Member States in 2024 to ensure medicines were available to patients. Efforts included recommendations to keep the supply of critical vulnerable drugs strong. Communication was increased regarding key drugs, such as glucagon-like peptide-1 receptor agonists. In addition, the European Shortages Monitoring Program was established so that information regarding drug shortages can be exchanged quickly and efficiently between regulators and pharma companies. The Task Force on Availability of Authorised Medicines for Human and Veterinary Use, established in 2016, also concluded its work in 2024. “Fast forward to today, and one pandemic later, the activities started by the group have been enshrined in law and added to our public health mandate. The Task Force can be incredibly proud of what it has achieved, including the just published second version of the Union list of critical medicines,” Cooke stated.

“In 2025, EMA will continue its mission to protect public and animal health—with determination, with enthusiasm and passion. We are tirelessly working on reinventing and improving ourselves,” Cooke said in the release. “Next year, the Agency will maintain its focus on accelerating and optimizing the assessment of key medicines, improving both accessibility and availability of medicines, as well as working on approaches to future-proofing medicines regulation in the EU [European Union] in preparation for the new pharmaceutical legislation. I am expecting 2025 to be another exciting year for medicines regulation.”

1. EMA. Emer Cooke, EMA’s Executive Director: 2024 Achievements in Medicine Regulation. Press Release. Dec. 17, 2024.

Articles

Emer Cooke, executive director of EMA, is encouraged by the competitiveness of the European pharmaceutical market.

Innovation, Collaboration, and Performance Were Highlights for EMA in 2024

In a press release posted on FDA’s website on Dec. 20, 2024, Endo USA, Inc. announced it was voluntarily recalling all lots of Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP) 30 mg/30 mL (1 mg/mL) 30 mL vials. The recall was issued because the product, which is a vasoconstrictor for topical application that predates the 1938 Federal Food, Drug & Cosmetic Act, was never approved by FDA. The product was also found to be misbranded by FDA with a misleading label that is similar to one for an FDA-approved drug, Adrenalin (epinephrine injection, USP) (1 mg/mL) 30 mL vial, which is also produced by Endo. The approved Adrenalin (epinephrine injection, USP) (1 mg/mL) 30 mL vial has not been recalled.

According to FDA, the labeling similarity makes telling the difference between the non-sterile topical product and the sterile injectable product difficult. This could lead to administration errors.

“Intravenous administration of the unapproved non-sterile topical Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP), instead of the approved sterile Adrenalin (epinephrine injection, USP) (1 mg/mL) 30 mL vial for injection, would result in non-fatal serious and/or severe, health outcomes related to delayed or inadequate treatment of the underlying condition (anaphylaxis, hemodynamic instability, hypotension) or infection due to intravenous administration of a non-sterile product,” the press release stated (1). “In addition, there is a high probability that intravenous administration of the nasal product will result in patients receiving the wrong dose of epinephrine in emergency situations for serious, life-threatening conditions such as the treatment of anaphylaxis, blood pressure support, and cardiac arrest. If these events are not treated with the correct dose of epinephrine, patients may be at risk for death.”

The recalled lots are packaged as 30 mL vials in individually packed cartons under national drug code number (NDC) #42023-103-01 that say, “Nasal Solution USP” and “For Topical Application” on the package. The following lots of Adrenalin Chloride Solution (EPINEPHrine Nasal Solution, USP) for topical application 30 mg/30 mL (1 mg/mL), which were distributed nationwide from Oct. 10, 2023 through Dec. 11, 2024, are recalled:

NDC 42023-103-01. Lot 82809. Expiry date: 03/2026

NDC 42023-103-01. Lot 79637. Expiry date: 11/2025

NDC 42023-103-01. Lot 77776. Expiry date: 07/2025

NDC 42023-103-01. Lot 74716. Expiry date: 05/2025

NDC 42023-103-01. Lot 71835. Expiry date: 01/2025

NDC 42023-103-01. Lot 72916. Expiry date: 01/2025.

Notification is being provided by the company to direct consumer accounts. Wholesalers are advised to discontinue the recalled lots immediately. Endo states in the press release that the company has not reported adverse events associated with the product in the past five years. Adverse reactions may be reported to FDA through its MedWatch Adverse Event Reporting program.

This is not the first recall for Endo in 2024. In July, the company recalled one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets (also seen as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 mg tablets 60-count) because an incorrect strength appeared on the cartons of some packs (2). The product strength was listed as 0.125 mg and not 0.25 mg. The inside blister strips, however, had the correct strength of 0.25 mg noted. The error was made by a third-party packager.

1. FDA.Endo USA, Inc. Issues Voluntary, Nationwide Recall of Adrenalin Chloride Solution (EPINEPHrine Nasal Solution, USP) Due to the Potential for Administration Errors. Press Release. Dec. 20, 2024. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-adrenalinr-chloride-solution-epinephrine-nasal


2. FDA. Endo USA, Inc. Issues Voluntary, Nationwide Recall of One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number 550147301 Due to Mislabeling: Incorrect Strength on Product Carton. Press Release, July 17, 2024. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-one-lot-clonazepam-orally-disintegrating-tablets-usp

The company is voluntarily recalling all lots of Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP) 30 mg/30 mL (1 mg/mL) 30 mL vials due to misleading labeling and its status as an unapproved drug. 

Endo Recalls Adrenalin Chloride Solution 

Dr Rupa Pike, Sr. Director & Global Head Strategic Alliances and Field Scientists for Cell Therapy, Catalent, shares insight on de-risking cell therapy programs using streamlined development and manufacturing platforms.

From Early Development to Commercialization: Strategies for Successful Cell Therapy Manufacturing

Manufacturing is a critical component in the development of cell therapies, and implementing de-risking strategies early in the process is essential to ensure product safety, efficacy, and alignment with regulatory requirements. De-risking encompasses identifying and addressing potential safety and manufacturing challenges, such as variability in raw materials or inefficiencies in processes, to reduce technology transfer issues and clinical development setbacks. Early-stage strategies like Quality by Design (QbD) principles, gap assessments for regulatory compliance, and thoughtful planning around vendor selection, raw materials, and manufacturing technologies contribute to smoother clinical progression and commercial readiness. These measures also lead to time and cost savings, ultimately improving the likelihood of successful IND approval and clinical manufacturing initiation.

To address manufacturing challenges specific to CAR-T therapies, Catalent has developed the UpTempo℠ CAR-T platform, a flexible and customizable solution built from experience with over 500 manufactured batches across 20+ cell therapy programs. This platform leverages GMP-compliant manufacturing equipment, ready-to-use raw materials, and a robust suite of analytical tools to streamline processes and ensure quality. It supports two approaches: transferring existing processes into the UpTempo℠ ecosystem for optimization or utilizing Catalent’s standardized workflows for efficient manufacturing. The platform's flexibility and instrument-agnostic design enable integration of the latest technologies, reducing costs, accelerating timelines, and enhancing therapy accessibility.

Navigating regulatory requirements throughout the manufacturing process requires early and proactive engagement with authorities like the FDA. Interact and pre-IND meetings provide critical feedback on product development expectations, including manufacturing and quality controls. Sponsors benefit from guidance on preclinical models, CMC readiness, and expedited approval pathways, which have been instrumental in bringing commercial cell therapies to market. Maintaining compliance through clinical phases and addressing country-specific regulatory requirements are crucial to ensuring product safety, quality, and consistency. Catalent’s global regulatory affairs team supports sponsors from pre-IND submission through commercialization, ensuring adherence to evolving regulatory standards.

Integrating advanced analytics and data-driven insights into cell therapy manufacturing enhances efficiency and decision-making by enabling real-time monitoring of critical process parameters (CPPs) such as cell health, proliferation, and functional properties. Catalent’s UpTempo℠ platform incorporates innovations like microfluidics-based automated flow cytometry and rapid sterility strategies, reducing analytical testing time and accelerating batch release. Emerging technologies such as non-invasive sample analysis, cloud-connected inline tools, and embedded sensors further optimize monitoring and control. The application of AI and machine learning is also beginning to play a role in predictive modeling, complementing current tools to accelerate product release and improve manufacturing outcomes. This data-driven approach supports process optimization, quality assurance, and commercialization efforts, paving the way for broader accessibility of cell therapies.

Videos

Dr Rupa Pike, Sr. Director & Global Head Strategic Alliances and Field Scientists for Cell Therapy, Catalent, shares insight on de-risking cell therapy programs using streamlined development and manufacturing platforms.


David McErlane, Group President of Biologics, Catalent, reacts to trends in cell and gene therapy development and manufacturing and comments on Catalent's ESG strategy to support people, the environment, and communities.

The Evolution of Cell & Gene Therapy: Development and Manufacturing Insights and the Role of CDMOs

Contract Development and Manufacturing Organizations (CDMOs) play a critical role in advancing the field of cell and gene therapies by providing specialized expertise, state-of-the-art facilities, and scalable manufacturing solutions. Their technical knowledge and ability to adapt to evolving regulatory standards enable faster development timelines and ensure compliance, supporting biotech companies in bringing life-changing therapies to patients more efficiently. By leveraging their established infrastructure, CDMOs also offer cost-effective solutions that allow biotech firms to focus resources on groundbreaking R&D while reducing the need for significant investment in in-house production facilities. This combination of expertise, flexibility, and cost efficiency ultimately accelerates the path to market for innovative treatments.

As cell and gene therapies continue to revolutionize the treatment of previously untreatable diseases, key trends are shaping the future of manufacturing in this field. Streamlined regulatory approval processes, such as the anticipated FDA Platform Technology Designation Program, aim to reduce the time and complexity of bringing therapies to market. Advancements in automation, artificial intelligence, and digitalization enhance the efficiency, scalability, and reliability of manufacturing processes, reducing costs and barriers to patient access. Additionally, innovations in supply chain management improve reliability and traceability, ensuring timely delivery of these highly individualized therapies.

Looking ahead, the balance between insourcing and outsourcing in cell and gene therapy manufacturing is likely to shift, with many biotech companies prioritizing funding for core innovation rather than maintaining in-house production capacity. CDMOs with phase-appropriate expertise and facilities are positioned to become essential partners, particularly as companies seek to offset high development costs and manage the complexities of production. Allogeneic cell therapies, with their streamlined requirements, are especially well-suited to outsourcing, further underscoring the growing importance of CDMOs in the industry.

The commitment to Environmental, Social, and Governance (ESG) principles is another area where CDMOs like Catalent can demonstrate leadership. By fostering a diverse and inclusive workplace, minimizing environmental impact through science-based targets, and giving back to local communities, CDMOs align their operations with the broader goals of sustainability and social responsibility. Sustainable manufacturing practices, ethical sourcing, and robust governance frameworks further reinforce their dedication to ethical and environmentally conscious operations. This holistic approach not only builds trust with stakeholders but also supports healthier communities and a more sustainable planet.

Want to learn more? Watch episode 3 of this series 

David McErlane, Group President of Biologics, Catalent, reacts to trends in cell and gene therapy development and manufacturing and comments on Catalent's ESG strategy to support people, the environment, and communities.


Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Pharmaceutical Technology chats with Roger Viney from ICE Pharma about bile acids in detail, including how they are useful in helping to improve drug solubility and absorption.

Improving Solubility and Bioavailability with Bile Acids

Poor solubility and bioavailability are becoming increasingly problematic for drug developers as more complex molecules are entering the development pipeline. “Bile acids are nature’s surfactants, their primary role is to promote the absorption of fat-soluble nutrients,” says Roger Viney, PhD, chief commercial officer for ICE Pharma—a bile acid expert. “So, depending on the bile acid, you can vary the hydrophilic lipophilic balance [and] improve bioavailability of poorly soluble drugs.”

“Furthermore, the bile acids can play a role as enhancer of permeability,” Viney continues. “[Bile acids are] able to modulate the cell membranes to allow certain drugs to cross the biological barriers more effectively. So, we have examples today, existing examples of oral and injectable applications formulations that use bile acids as excipients, and we are expecting to see this expand into things like transdermal and even nasal applications.”

Bile acids have been used in traditional forms of medicine for thousands of years; however, they did not enter modern and Western medicines until the 1960s, Viney notes. “The past 20 years have seen a very significant amount of research done into bile acids and their recognition that they're more than nature's surfactants, that they're, in fact, signaling molecules that have metabolic function,” he adds. “And so, this kind of research has opened up a whole new field where bile acids can potentially treat oncology, liver diseases, even neurodegenerative diseases.”

Roger Viney, PhD, is the chief commercial officer for ICE Pharma and is responsible for the global commercial functions. Roger has a 30-year career, starting in R&D and then moving across to sales, marketing, key account management, and business and product management for the pharma market.

In this episode of the Drug Solutions podcast, Felicity Thomas, Associate Editorial Director, chats with a host of experts about artificial intelligence (AI) and the potential impact AI and machine learning may have on the global bio/pharma industry in the near future.

 is chief scientific officer for Biorelate—an AI platform company that provides data solutions to pharma companies

 is CEO of Qinecsa Solutions, which is a UK headquartered but international pharmacovigilance technology and services solution provider.

 is vice president of Regulatory Quality and Compliance, Arriello—a life sciences consultancy.

 is CEO of Autolomous, which uses smart technology to help ATMP manufacturers.

is COO of Unbiased Science and vice-president of the Medical Information Leaders in Europe (MILE).

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

This episode is a compilation of comments taken from a series of interviews where experts are discussing how AI might impact the global bio/pharma industry in the future.

Drug Solutions Podcast: Realizing AI’s Potential 

Feliza Mirasol is the science editor for 

Orexo, a Sweden-based commercial-stage pharmaceutical company, announced on Dec. 17, 2024, that it has entered into a collaboration with Abera Bioscience (Abera), a Sweden-based platform and vaccine developer. Under the agreement, the companies will use AmorphOX, Orexo’s powder-based drug delivery technology, to develop mucosal vaccine candidates based on Abera's vaccine platform. This collaboration will be funded by Abera through grants it has previously received, mainly from the Coalition for Epidemic Preparedness Innovation (CEPI).

The AmorphOX technology is designed to improve properties of new or existing drugs. The technology aims to develop formulations that aid in significantly stabilizing active ingredients to enable alternative and more effective routes of administration. AmorphOX-based formulations are applicable for a range of active ingredients, from small molecules and peptides to larger biomolecules, such as vaccines, according to a company press release (1).

Orexo and Abera’s partnership will develop powder-based intranasal vaccine candidates with a focus on Abera's influenza vaccine candidate. Because an intranasal influenza vaccine has potential to easily and effectively reduce the spread of infections and prevent disease, they can play a significant role in controlling potential future pandemics.

“Influenza is a family of viruses that could mutate and cause the next pandemic, but seasonal influenza is already a major problem where vaccines are often not effective enough. Orexo has an impressive knowledge and technology for powder formulations of medicines that perfectly complements our expertise in vaccine development. Their innovative technology, AmorphOX, has shown to improve the properties of a wide range of different active ingredients. There is therefore great potential in this area, and we will be able to take many important development steps in the coming year,” said Maria Alriksson, CEO, Abera Bioscience, in the press release (1).

In a historical context, an influenza pandemic in 1918 caused at least 20 million deaths (2). Controlling another influenza pandemic will depend on innovations in vaccine production, according to researchers (3). A long-term goal for influenza vaccination should rely on a more universal vaccine, but there remains debate as to what exact traits a universal vaccine should have. A universal vaccine against all epidemic and pandemic viruses is not realistic, however, but having a vaccine that covers more drift variants may mean there could be less need for vaccine updates and a reduced need for yearly vaccinations, researchers note (4).

“Abera has an innovative and promising vaccine platform for the development of mucosal vaccines, as confirmed by their recent funding from CEPI. The collaboration is fully in line with our strategic development of the AmorphOX platform, and, through collaborations, we can showcase the potential and value of our technology. We look forward to working with Abera, where our experience and technologies are highly complementary,” said Robert Rönn, senior vice-president and head of R&D at Orexo, in the press release (1).

1. Orexo. Orexo Enters into Collaboration with Abera to Develop Nasal Powder Vaccines Based on the Amorphox Technology. Press Release. Dec. 17, 2024.
2. Crosby, A.W. 

America’s Forgotten Pandemic: The Influenza of 1918

; Cambridge University Press, 1989.
3. Kilbourne, E. D. Influenza Pandemics: Can We Prepare for the Unpredictable? 

 (3). DOI: 10.1089/vim.2004.17.350
4. Kim, H.; Webster, R. G.; Webby, R. J. Influenza Virus: Dealing with a Drifting and Shifting Pathogen. 

The companies will use Orexo’s powder-based drug delivery technology to develop mucosal vaccines in an inhaled formulation.

Orexo and Abera Partner to Develop Nasal Powder Vaccines

In this episode of Drug Digest, industry experts discuss their experiences in dealing with the challenges of developing and manufacturing next-generation biotherapeutics as well as triumphs that move the industry as a whole forward.

Challenges and Triumphs in Next-Generation Biotherapeutic Development

The development of next-generation biotherapeutics is in full swing, which means that developers and biomanufacturers are tackling new challenges in the drug development and manufacturing lifecycle. Two areas of focus are in the maintenance of an aseptic environment throughout the manufacturing process and the search for solutions to establishing alternative drug delivery methods that don’t require a parenteral route of administration. In this episode of 

, experts from N4 Pharma and Cellular Origins discuss their experiences in dealing with these challenges, as well as triumphs in creating innovations to move the industry as a whole forward.

Nigel Theobald is CEO of N4 Pharma, a specialist pharmaceutical company developing novel delivery systems for oncology, gene therapy and vaccines. Theobald has over 25 years’ experience in healthcare, in building businesses, strategy development and implementation, and in a strong network covering all aspects of pharmaceutical product development and commercialization. He was the head of healthcare brands at Boots Group plc in 2002 before leaving to set up a series of successful businesses, including Oxford Pharmascience Group plc, which he grew over five years into an AIM-quoted company with a market capitalization of £40 million (US$53 million) upon departure. Theobald formed N4 Pharma in 2014.



Dan Strange, PhD, Chief Technology Officer, Cellular Origins

Dan Strange has been working at the intersection of engineering and biology for almost 15 years, and he is an inventor on 20 patents. After completing a PhD in regenerative medicine at the University of Cambridge, he moved to TTP where he developed complex drug delivery devices. He was instrumental in the creation of multiple technology platforms successfully licensed to large pharma in deals worth over $100 million. For the past four years, Strange has focused on cell therapy manufacturing equipment. Strange is an active member of various automation working groups and was a reviewer on the Alliance for Regenerative Medicines A-Cell report on cell therapy manufacturing.

Drug Digest is a tech talk video series with the 

® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

Innovations in Biopharmaceutical Development

Drug Digest: Challenges and Triumphs in Next-Generation Biotherapeutic Development

Scinai Immunotherapeutics (Scinai), an Israel-based biopharmaceutical company focused on developing inflammation and immunology biological products, announced on Dec. 16, 2024 the establishment of a US-based subsidiary for its contract development and manufacturing organization (CDMO) services. The company provides CDMO services through its Scinai Bioservices business unit. This US subsidiary, incorporated in Delaware, will operate under the name Scinai Bioservices Inc.

The Scinai Bioservices CDMO business unit was launched in 2024 and operates from the company's site in Jerusalem, Israel. The Jerusalem facility comprises 1850 square meters (approximately 20,000 square feet) of clean rooms and laboratories, which operate under current good manufacturing practice (CGMP) conditions in compliance with European Medicines Agency (EMA) and FDA requirements, according to a company press release (1).

"We are thrilled and energized by the opening of our new subsidiary in the [United States]. Last week, we signed our first contract with US customer, Serpin Pharma, to support their clinical manufacturing,” said Amir Reichman, CEO of Scinai, in the press release (1). “I believe that our expanded presence in the US will significantly enhance the prospects of our CDMO unit."

From its launch, the CDMO unit has executed drug development projects for nine different biotech companies, which included upstream and downstream process development, scale-up, analytical methods development, and drug manufacturing for pre-clinical and clinical supplies. The company has also partnered with Ayana Pharma, an Israel-based pharmaceutical company specializing in liposomal therapeutics for treating cancer, under which Scinai will provide liposomal encapsulated drug development services.

The Scinai Bioservices unit operates on projects at the early stage, where the company noted in its press release capacity is strained because of the complex manufacturing processes associated with biologics. “Additionally, the BIOSECURE Act, introduced in January 2024, aims to prevent ‘foreign adversary biotech companies’ from receiving US federal funding,” the company stated in its press release (1).

Scinai's new US subsidiary aims to serve US-based early stage biotech companies with the goal of providing required CDMO services that are currently in short supply. The US subsidiary will also allow early stage biotech startups, which are supported by US government grant funding, to use their grant money in contract with Scinai, which would allow them to avoid concerns related to the BIOSECURE Act, Scinai stated in its press release.

To put the situation into context, Parviz Shamlou, senior vice-president of Science and Technology, Abzena, spoke to the PharmTech Group during BIO 2024 this past June about the impact the act will have on the bio/pharmaceutical industry and how the industry is preparing for it. “We appreciate that [the BIOSECURE Act] is an important act designed to protect the health of citizens of this country. And we know we must do everything we can to avoid any unintended, potentially harmful use of our services as highlighted in the act. [We] have put in place a robust contingency plan as well as a CMC [chemistry, manufacturing, and controls] strategy that are designed to mitigate any such risk to supply chain and the development of the assets that our clients bring to us,” Shamlou stated in the interview (2).

1. Scinai Immunotherapeutics. Scinai Immunotherapeutics Establishes US Subsidiary for CDMO Business Unit, Scinai Bioservices Inc. Press Release. Dec. 16, 2024.
2. Haigney S. 

Impact of Biosecure Act on the Pharma Industry (BIO 2024)

Scinai Bioservices Inc. has been established in Delaware as the company's new US-based subsidiary, which will serve biotech companies in early stage drug development.

Scinai Immunotherapeutics Establishes US CDMO Business Unit

AbbVie has signed a definitive agreement to acquire Nimble Therapeutics, a biotechnology company specializing in oral peptide therapeutics, which would add Nimble’s lead asset, an investigational oral peptide interleukin 23 receptor (IL23R) inhibitor that is in preclinical development for treating psoriasis. to AbbVie's immunology pipeline. In addition to the lead asset, AbbVie would also acquire a pipeline of other novel oral peptide candidates that show potential across several autoimmune diseases, AbbVie announced in a Dec. 13, 2024 company press release.

With the acquisition, AbbVie also gains Nimble's peptide synthesis, screening, and optimization platform. This platform uses proprietary technology to facilitate rapid discovery and optimization of peptide candidates for a range of targets.

Under the agreement, AbbVie will pay $200 million in cash at the close of transaction, which is subject to certain customary adjustments. AbbVie will also pay certain interim funding payments, and Nimble's shareholders will be eligible to receive potential payment upon the achievement of a development milestone, according to the press release (1).

"The addition of Nimble's pipeline to AbbVie's existing pipeline, combined with our deep clinical and translational expertise in immunology, represents an important growth opportunity," said Jonathon Sedgwick, PhD, senior vice-president and global head of discovery research, AbbVie, in the press release (1). "Together, AbbVie and Nimble have the potential to help address the significant unmet medical need for people living with autoimmune diseases."

Nimble's lead candidate, which targets IL23R, has potential in the treatment of psoriasis and inflammatory bowel disease (IBD). According to AbbVie, IL23R is a clinically validated therapeutic target in certain autoimmune diseases and is known to be a major contributing factor in psoriasis and IBD pathogenesis as well as progression by way of increased inflammation and amplified immune responses (1).

"Nimble Therapeutics is committed to transforming the discovery of oral peptide-based medicines. With AbbVie's … expertise in developing and commercializing medicines on a global scale, Nimble's novel oral therapies will be well-positioned to reach more people living with autoimmune diseases," said Jigar Patel, PhD, founder and chief executive officer, Nimble Therapeutics, in the release. "The talented, passionate, and dedicated team at Nimble has made great progress over the past few years, and we are pleased that AbbVie has recognized the tremendous potential of our proprietary platform and emerging immunology pipeline."

Nimble is the latest in a series of acquisitions that AbbVie has conducted this year. Also in December 2024, AbbVie completed its 

$1.4 billion acquisition of Aliada Therapeutics

$8.7 billion acquisition of Cerevel Therapeutics

, both of which strengthen AbbVie’s neuroscience pipeline (2,3). In June 2024, AbbVie 

acquired Celsius Therapeutics for $250 million in cash

, which included an antibody drug candidate in clinical development for IBD (4). In May 2024, AbbVie completed its acquisition of Landos Biopharma for approximately $137.5 million in cash, which included that company’s lead asset, NX-13, an oral nucleotide oligomerization domain-like receptor family member X1 agonist in clinical development for treating ulcerative colitis and Crohn's disease (5).

1. AbbVie. AbbVie to Acquire Nimble Therapeutics, Further Strengthening Immunology Pipeline. Press Release. Dec. 13, 2024.
2. AbbVie. AbbVie Completes Acquisition of Aliada Therapeutics. Press Release. Dec. 11, 2024.
3. AbbVie. AbbVie Completes Acquisition of Cerevel Therapeutics. Press Release. Aug. 1, 2024.
4. AbbVie. AbbVie Acquires Celsius Therapeutics. Press Release. June 27, 2024.
5. AbbVie. AbbVie Completes Acquisition of Landos Biopharma. Press Release. May 23, 2024.

AbbVie's latest acquisition target is Nimble Therapeutics, which will give AbbVie a lead asset, an oral peptide for treating psoriasis.

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