CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More

Behind the Headlines, Episode 20

ICH Q12 and Post-Approval Changes

The quickly evolving development of biopharmaceuticals is impacting innovation in the industry overall.

Advancements in Biopharma Spur Innovation

What Pharma Manufacturers Need to Know

Every Pharmaceutical Manufacturing Professional Should Know

Feliza Mirasol is the science editor for 

Beckman Coulter Life Sciences, a provider of laboratory automation and innovation and an operating company of Danaher Corporation, has launched the CytoFLEX mosaic Spectral Detection Module, the industry’s first modular spectral flow cytometry solution, the company announced on March 18, 2025 (1).

The CytoFLEX mosaic Spectral Detection Module offers substantially greater fluorescence sensitivity when connected to the CytoFLEX LX or S Flow Cytometers. The solution addresses challenges with dim and complex multicolor experiments because it can detect nanoparticles as small as 80 nm. The instrument provides two unmixing algorithms and up to 10 autofluorescence channels, with up to 88 detection channels. As a result, richer data can be generated from spectral analysis that can help untangle the complexities of biological systems and diseases faster. It also allows for a nuanced understanding of immune cell subsets and their functions and interactions by simultaneously detecting multiple markers.

“As a central feature of the CytoFLEX platform, this innovation is focused on pairing ease-of-use with powerful, sensitive acquisition technology to remove the intimidation encountered in many flow cytometry instruments,” said Matthew Goff, product manager, Beckman Coulter Life Sciences, in a company press release. “Investigators can now easily switch between their true conventional detection system and this advanced spectral detection system, while maintaining a familiar sample management and user experience, all without having to invest in a separate instrument. Along with experimental continuity and evolution offered by a more flexible approach, this delivers a unique solution for sustainability needed by many institutions.”

Compared to conventional flow cytometry (2), spectral flow cytometry acquires the full emission spectrum of each antibody-associated fluorophore across all lasers, rather than just measuring the peak of emission. This advanced ability delivers a more detailed and precise characterization of cellular properties, which can then advance the understanding of complex biological systems and diseases within each sample compared to older, traditional approaches, according to the company in the release.

The CytoFLEX mosaic spectral detection module runs on a unique algorithm that is capable of improving resolution compared to other available methods. It also offers unmixing accuracy checks for ensuring efficiency. Accompanying the instrument is the CytExpert software, used in spectral cytometry to reduce the need for extensive training, which can thus speed up the transition to spectral technology. The module also comes with tools to ease the full spectral workflow and offers access to the FluoroFinder panel builder and a Cytobank premium license that provide all the tools needed to transition from sample preparation to analysis of complex spectral data in an easy manner.

“I found the software very easy to learn and was able to start my first experiments in only a few hours,” said Tamar Tak, coordinator of the Flow Cytometry Facility at Leiden University Medical Center, in the press release. “A feature I really like is that it allows me to do an extensive QC [quality control] of the unmixing. You get a plot with all the normalized spectra of your fluorochromes and a table with similarity indices. This allows me to see if a tandem dye has degraded, or perhaps the wrong antibody was added. The autofluorescence settings are another highlight, allowing flexibility depending on your samples—from human tissue to complex samples of microorganisms.”

The new module is available in two configurations, the CytoFLEX mosaic 88 for the CytoFLEX LX Flow Cytometer and the CytoFLEX mosaic 63 for the four-laser CytoFLEX S Flow Cytometer.

Beckman Coulter Life Sciences Launches Industry-First Modular Spectral Flow Cytometry Solution

. Press Release. March 18, 2025.
2. McKinnon, K. M. Flow Cytometry: An Overview. 

Articles

The CytoFLEX mosaic Spectral Detection Module offers up to 88 channels for detection.

Beckman Coulter Life Sciences Launches Modular Spectral Flow Cytometry Module, First of Its Kind in Industry

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

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

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended five new medicines for approval, according to a summary of CHMP’s March 24–27, 2025 meeting (1). Another seven medicines were recommended for extensions of their therapeutic indications.

A recommendation for a marketing authorization was given to Xoanacyl (ferric citrate coordination complex) for the treatment of concomitant hyperphosphatemia and iron deficiency in adults with chronic kidney disease (1). CHMP also gave a positive opinion to Ryjunea (atropine), intended for slowing progression of myopia in children aged 3 to 14 years.

Three biosimilars also received positive opinions: Jubereq (denosumab), for prevention of skeletal-related events in adults with advanced malignancies involving bone and treatment of adults and skeletally mature adolescents with giant cell tumor of bone; Qoyvolma (ustekinumab), for treatment of plaque psoriasis in adults and children and psoriatic arthritis, Crohn’s disease, and ulcerative colitis in adults; and Osvyrti (denosumab), for treatment of osteoporosis in women who have been through menopause, men with prostate cancer who are at increased risk of fractures with bone loss linked to hormone ablation, and those whose bone loss is linked to long-term treatment with systemic glucocorticoids (1).

Recommended for extensions of indications were made for the following medicines already approved in the European Union: Bosulif (bosutinib), Calquence (acalabrutinib), Flucelvax (influenza vaccine—surface antigen, inactivated, prepared in cell cultures), Opdivo (nivolumab), Tevimbra (tislelizumab), Tremfya (guselkumab), and Xydalba (dalbavancin) (1).

Negative opinions were issued regarding two medicines. A recommendation was made not to grant a marketing authorization for Kisunla (donanemab), for the treatment of early Alzheimer’s disease, with CHMP saying that the benefits of the medicine were not enough to outweigh its risks of potentially fatal events due to amyloid-related imaging abnormalities (1). CHMP also recommended to refuse extending the marketing authorization for Pemazyre (pemigatinib), for treatment of myeloid/lymphoid neoplasms with fibroblast growth factor receptor 1 rearrangement.

For Opdivo, CHMP recommended a new pharmaceutical form as well as a new strength for subcutaneous administration (1).

“Preventing disease recurrence and improving long-term outcomes for patients with NSCLC [non-small cell lung cancer] earlier in the treatment journey is critical to addressing unmet needs and is one of our top priorities,” said Dana Walker, MD, vice-president, Opdivo global program lead, Bristol Myers Squibb, in a company press release (2). “With today's positive opinion from the CHMP, we are pleased that our second Opdivo -based regimen for certain patients with resectable NSCLC whose tumors have PD-L1 [programmed cell death ligand 1] expression ≥1%, is one step closer to being approved in the European Union.”

Applications for initial marketing authorizations for two medicines were withdrawn: Insulin Human Rechon (insulin human), for treatment of patients with diabetes who need insulin to control their blood glucose levels, and Cinainu (liquid ethanolic extract 30% [W/W] of Allium cepa fresh bulb and Citrus limon fresh fruit/dry aqueous extract of 

 seed), an herbal medicine for treatment of moderate-to-severe alopecia areata (1). Also, an application to extend the use of Amyvid (florbetapir [18F]) in adults, to monitor their response to treatments reducing beta amyloid plaques, was withdrawn.

CHMP said it finalized a review of Orexigen Therapeutics Ireland’s Mysimba (naltrexone/bupropion), used for weight management in adults with obesity or who are overweight, because of concerns about potential long-term cardiovascular risk, but concluded that more information must be provided from an ongoing study on the medicine’s cardiovascular effects in patients treated for more than one year (1).

1. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24–27 March 2025. Press Release. March 28, 2025.
2. Bristol Myers Squibb. Bristol Myers Squibb Receives Positive CHMP Opinion for Perioperative Regimen of Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo for Resectable Non-Small Cell Lung Cancer in Patients with Tumor Cell PD-L1 Expression ≥1%. Press Release. March 28, 2025.

Three of the five are biosimilars, and seven additional medicines received recommendations for indication extensions.

EMA Recommends Five New Medicines for Approval

Safe, Smart, and Sustainable Packaging for the Healthcare Industry

Lon Johnson, Sr. VP of Sales at Colbert Packaging, knows that the pharmaceutical healthcare industry has unique packaging needs. In this video, Johnson explains how the company leverages equipment, procedures, and approaches that sync with the pharma industry to adopt a customer-centric business model. Watch this video to learn more about:

How Colbert Packaging takes a customer-centric approach in its standard operating procedures;

Colbert’s commitment to sustainability with safe, smart, and sustainable 100% paperboard-based packaging;

Specific initiatives the company is taking, including its goal to have zero waste.

Videos

Colbert Packaging specializes in safe, smart, and sustainable paperboard packaging for the pharmaceutical and healthcare industries, differentiating itself through industry-focused investments and a commitment to environmental responsibility.


Sherwin-Williams Protective & Marine (Sherwin-Williams), a supplier of high-performance flooring, wall systems, and coatings for pharmaceutical, life sciences, and biotech facilities, will showcase its latest pharmaceutical cleanroom innovations at INTERPHEX 2025, occurring April 1–3 in New York City. In particular, the company will highlight its new high-performance coating systems at the conference, according to a March 20, 2025 company press release (1).

The company’s high-performance coating systems are designed to ensure safe, sterile, and efficient pharmaceutical manufacturing environments. The systems contain solutions that are tailored to meet the specialized needs of cleanrooms and critical production spaces. The company’s advanced coatings portfolio includes coatings for floors, walls, ceilings, and other surfaces, all of which are designed to minimize downtime while maximizing protection against contamination and wear (1).

By design and through engineering, these advanced coating systems are geared toward supporting the rigorous demands of pharmaceutical manufacturing facilities. Features of the advanced coating systems include:

durability, with high resistance to harsh chemicals, abrasion, and heavy wear for long-term reliability

sterility, by offering seamless, durable surfaces that minimize cracks, with the aim of reducing contamination risks in sterile environments

efficiency, such as fast-curing systems that reduce installation time and downtime to ensure continuous production and development

sustainability, including solutions that are free of Red List chemicals (2) and that are designed to meet Leadership in Energy and Environmental Design compliance (3).

“This industry is a constant balance of compliance and innovation,” said Michael Durbin, market segment manager for Pharmaceutical at Sherwin-Williams Protective & Marine, in the press release (1). “Our precision-engineered coating solutions empower manufacturers to maintain that balance while creating environments critical to life-saving advancements. INTERPHEX is a great opportunity for us to continue to connect with industry leaders and showcase how our coatings contribute to the next generation of pharmaceutical manufacturing.”

At the conference, Sherwin-Williams will also highlight innovative solutions aimed at enhancing efficiency, safety, and compliance in pharmaceutical environments, including:

A floor visualizer tool: the company will exhibit an interactive touchscreen floor visualizer with which attendees can engage; this tool will allow users to explore and customize flooring solutions in real time and helps pharmaceutical manufacturers select the ideal flooring system based on their facility’s unique requirements.

A grout and topcoat technology (Accelera One): this technology offers rapid cure times, chemical resistance, and cost-saving efficiency to help facility owners protect their investments as well as maintain safe and sterile manufacturing environments.

Thermal insulative coating solutions (Heat-Flex): These coating solutions are designed to be used with coolers, freezers, and high-temperature equipment to aid in the prevention of condensation buildup, reduction of thermal losses and enhancement of site safety; these solutions also offer protection to personnel by reducing the risk of burns and injuries, in compliance with Occupational Safety and Health Administration regulations concerning thermal insulation on metallic equipment.

Attendees can visit Sherwin-Williams at booth #2569 at INTERPHEX.

1. Sherwin-Williams Protective & Marine. 

Raising the Bar: Sherwin-Williams Highlights Next-Gen Coatings for Pharma Cleanrooms at INTERPHEX 2025

. Press Release. March 20, 2025.
2. Green Building Alliance. Product and Building Materials Red List. 

 (accessed March 28, 2025).
3. US Green Building Council. LEED Rating System. 

Sherwin-Williams’ advanced coating systems are designed to ensure safety, sterility, and efficiency in pharma manufacturing environments. 

Sherwin-Williams to Showcase Next-Gen Coatings for Pharma Cleanrooms at INTERPHEX 2025

Novotech, which provides biotech and small- to mid-size pharmaceutical companies an accelerated path to market, has been named the best contract research organization (CRO) in Australia at the Asia-Pacific Biopharma Excellence Awards (ABEA) 2025 (1).

ABEA recognizes industry standouts in clinical trials as well as organizations, experts, and technologies that are helping to drive innovation (1). Voting is done 100% within the industry, according to a press release, to ensure that winners will be recognized by their peers.

"We thank the Asia Pacific Biopharma Excellence Awards for this recognition,” Chris Chong, Novotech senior director of Clinical Services, said while accepting the award at a ceremony in Singapore (1). “This award reflects the dedication of our teams worldwide who support biopharma innovation. Our clients and partners entrust us with their research, and we take pride in accelerating the development of new therapies. Novotech remains committed to advancing clinical research, strengthening partnerships, and maintaining high standards in biopharma development.”

Novotech has more than 30 offices globally with partnerships with more than 5000 trial sites, and, according to the press release, has been honored with Frost & Sullivan’s CRO Company of the Year award for 19 consecutive years (1).

Elsewhere in Australia so far in 2025, the Australian nonprofit Genetic Cures for Kids 

 with United States-based CRO/contract development and manufacturing organization (CDMO) PackGene Biotech and the Belfer Gene Therapy Core Facility at Weill Cornell Medicine, to deliver an accessible, custom-tailored gene therapy solution for treating hereditary spastic paraplegia type 56, an ultra-rare neurological disease (2).

Also in January, North Melbourne-based Telix Pharmaceuticals announced it had 

 with ImaginAb, an antibody engineering company, giving Telix a pipeline of next-generation therapeutic candidates, a proprietary and novel biologics technology platform, and a protein engineering and discovery research facility located in California (3).

In February, Sydney-based AdvanCell, a clinical-stage radiopharmaceutical company specializing in the development of cancer therapeutics, 

 an oversubscribed, $112 million round of Series C financing (4). And on February 20, Cosette Pharmaceuticals of Bridgewater, NJ, said it had 

 to buy all remaining shares of Australia-based Mayne Pharma Group with two state-of-the-art, FDA-approved manufacturing sites to be operational as a result of the merger, in Salisbury, South Australia, and in Lincolnton, NC, in the United States (5).

1. Novotech. Novotech Named Best Contract Research Organization in Australia at Asia-Pacific Biopharma Excellence Awards 2025. Press Release. March 25, 2025.
2. PackGene Biotech. A Global Alliance to Save Lives: How Two Parents and PackGene Are Redefining What’s Possible in Gene Therapy with Help from Weill Cornell Medicine. Press Release. Jan. 8, 2025.
3. Telix Pharmaceuticals. Telix to Acquire Next-Generation Therapeutic Assets and Innovative Biologics Technology Platform. Press Release. Jan. 13, 2025.
4. AdvanCell. AdvanCell Successfully Completes an Oversubscribed US$112M Series C Financing. Press Release. Feb. 3, 2025.
5. Cosette Pharmaceuticals. Cosette Pharmaceuticals Announces Acquisition of Mayne Pharma, Transforming Company into a Leader in Women’s Health and Dermatology. Press Release. Feb. 21, 2025.

Winners are selected entirely through industry voting, with those honored representing recognition by their peers.

Novotech Named Best Australian CRO at Asia-Pacific Biopharma Excellence Awards

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

In this exclusive Drug Digest video interview John McQuaid from Almac Pharma Services and Sridevi Khambhampaty from Shilpa Biologics delve into the evolution of the bio/pharma outsourcing market and look at how service-providers’ strategies have adapted to meet demand. 

Strategic Partnerships 

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, 

Group, interviews experts about strategic partnerships in the bio/pharma industry. During the discussion, various experts will detail how the bio/pharma outsourcing market has evolved, how service providers have adapted to meet the shifting industry demands, the benefit of ‘integrated services’ and the potential challenge to providing such services while also being flexible, and potential trends that may shape the outsourcing market in the coming years.

John McQuaid, President & Managing Director, Almac Pharma Services

John first joined Almac Group in 1994 and has held a number of management roles during his tenure. In 2011 he was appointed to Vice President of Technical Operations within Almac Pharma Services where he was responsible for overseeing the strategic growth and development of the Pharmaceutical Development & Manufacturing service offering.

John, who holds a BSc Honours degree, was promoted to President and Managing Director, Almac Pharma Services, in 2022 and is responsible for the strategic, financial and operational leadership of global business. He has extensive product development, quality assurance and validation experience with direct experience of hosting product pre-approval inspections by multiple regulatory authorities.nt. Dr. Kane received his Bachelors, Masters and PhD degrees from the Bombay College of Pharmacy, University of Bombay, India, and served as a post-doctoral fellow at the School of Pharmacy, University of Cincinnati, Ohio. He has also earned an executive MBA from Richard Ivey School of Business, University of Western Ontario, Canada. Dr. Kane is a member of various international pharmaceutical professional organizations and is often asked to speak about scientific topics on formulation, technology and other technical aspects at major industry events. He has also published many articles in international journals and delivered many talks at meetings and conferences across the globe.

Sridevi Khambhampaty, CEO at Shilpa Biologics

Dr. Sridevi Khambhampaty is presently the CEO of Shilpa Biologics. She has an impressive 20 plus-year career in the biopharmaceutical and biotechnology sector. Dr. Sridevi has a PhD from NCBS-TIFR Bangalore, and after completing a postdoctoral fellowship at Stanford University, California, she has served in various leadership roles in at Syngene International, Intas Pharmaceuticals and Dr. Reddy’s Laboratories, prior to her present assignment at Shilpa Biologics.

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: Strategic Partnerships 

FDA’s Center for Drug Evaluation and Research (CDER) issued a 

 to India-based Aspen Biopharma Labs (Aspen) in March 2025 following its inspection of the company’s facility in Malakpet Village, Rangareddy, in Hyderabad, India. The inspection took place Sept. 16–21, 2024. According to the warning letter, FDA inspectors found significant deviations from current good manufacturing practice (CGMP) in the production of APIs (1).

“Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B),” FDA stated in its March 5, 2025 letter (1).

Deviations found during the inspection include, but are not limited to:

a failure in the design and construction of the buildings and facilities used to manufacture the API in a way that minimizes potential contamination and facilitates appropriate cleaning, maintenance, and operations

failure to demonstrate that the company’s manufacturing process can manufacture an API in a reproducible manner while meeting its predetermined quality attributes and failure to adequately validate written procedures for the cleaning and maintaining equipment

failure to provide records, either originals or copies, that are readily available and promptly retrievable during the retention period

failure to design a documented, ongoing stability testing program that monitors the stability characteristics of API and to use the results for confirming appropriate storage conditions as well as for retest or expiry dates (1).

FDA’s warning to Aspen is the latest in a series of warning letters the agency has issued this year to India-based API manufacturers. In February 2025, the agency separately issued warning letters to 

 (Tyche) regarding deviations from CGMP for APIs (2,3).

In the warning letter to Jagsonpal, FDA based its observations on an inspection conducted on March 20, March 27, and April 3, 2024 at the company’s facility in Bhiwadi Dist., Alwar, in Rajasthan, India. During its inspection, the agency observed a failure of the company’s quality unit to exercise its responsibility to ensure compliance with CGMP in the manufacture of the API produced at the company’s contract facility. In addition, the inspector was denied entry by persons present at the site upon arrival on March 15, 2024, only to be granted entry on March 20, 2024; however, during inspection, access to requested documents was limited. Finally, a (b)(4) drug was manufactured at an unregistered facility and was not listed by the company as required under 

)Title 21, Part 207.41(a) (4), which caused the (b)(4) drug to be misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o).

“[F]ailure to provide current listing information in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p),” FDA stated in the letter (2).

Meanwhile, the warning letter to Tyche was based on an inspection conducted at this company’s Sarpavaram, Kakinada, India, manufacturing plant on Aug. 12–16, 2024. In this letter, the FDA inspector observed several deviations, including but not limited to:

a failure to record all quality-related activities at the time these are performed

failure to clean equipment and utensils to prevent contamination or carry-over of any material that can alter the quality of the APIs produced beyond the official or other established specifications

failure to test the identity of each batch of incoming production material (3).

Warning Letter: Aspen Biopharma Labs Private Limited

, March 5, 2025 (accessed March 27, 2025).
2. FDA. 

Warning Letter: Jagsonpal Pharmaceuticals Limited

 Title 21, 207.41(a) (Government Printing Office, Washington, DC), 

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-207/subpart-D/section-207.41

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

FDA Issues Warning Letter to Aspen Biopharma Labs for API Manufacturing Deviations

The latest tariffs to be announced by President Donald Trump’s administration, on March 27, 2025, are a 25% tax on auto imports, adding to 25% tariffs on Mexico and Canada—with a lower 10% tax on Canadian energy products—a 20% import tax on China, and 25% tariffs on steel and aluminum imports (1).

 the Administration may be targeting pharmaceutical drugs, along with computer chips, lumber, and copper, as one of its next areas where stiff taxes may be imposed.

Just before the new auto import tariffs were announced, the Biotechnology Innovation Organization (BIO), a Washington, DC-based trade association, released on March 26, 2025 results of a membership survey evaluating the health of the global biomedical supply chain as it relates to the potential for higher tariffs (2).

In analyzing the responses to the survey, BIO said that almost 90% of biotech companies based in the United States said they rely on imported components for at least half of their products that are FDA approved (2). Given that statistic, a press release from BIO outlined three key tariff concerns expressed in the survey:

 This was an across-the-board concern in the survey, as 94% of biotech firms said they anticipated “surging” manufacturing costs if tariffs are imposed on imports out of the European Union (EU).

 Proposed tariffs on the EU could also, according to the survey, force approximately half of companies to find new research and/or manufacturing partners—with half of survey respondents saying they would either have to redraw or possibly delay their regulatory filings.

 Four out of five (80%) biotech firms surveyed say they would need at least a year to find alternate suppliers, and nearly half (44%) report that they would theoretically need two years or more (2).

"This survey demonstrates the far-reaching and potentially damaging impacts of the proposed tariffs on our biotechnology industry, on biomedical research and on patients,” BIO President and CEO John F. Crowley said in the release. “We fully support strong policies and programs that incentivize the manufacture of medicines here in America. Re-onshoring key parts of the biotechnology supply chain to the US and our allies and strengthening the American manufacturing base should be a high priority for both national and economic security. It will take years, though, for this shift, and we need to be mindful of the negative consequences of these proposed tariffs. We look forward to working with the Administration and Congress to develop incentives and policies that drive private sector dollars to spur a renaissance of US biotech manufacturing."

® took a look at how the industry might respond to tariffs 

 of the new Trump Administration (3). Since then, more experts have weighed in.

 Joseph Principe, chief commercial officer at Abzena, discussed the impact of the geopolitical climate on the bio/pharma industry (4). That interview can be viewed in full at 

 series, from March 20, takes a look at these impacts (5). 

1. Boak, J. Trump Places 25% Tariff on Imported Autos, Expecting to Raise $100 billion in Tax Revenues. 

, March 27, 2025.
2. Biotechnology Innovation Organization. New Survey: U.S. Biotechs Warn Tariffs Could Impede Access to Cures, Stifle Innovation. Press Release. March 26, 2025.
3. Lavery, P. 

Pharmaceutical Industry Responds to Proposed Trump Administration Tariffs.

DCAT Week 2025: Impact of Geopolitical Climate on Biopharma.

Behind the Headlines: Episode 13; Budget Cuts, Reshoring, and Biotech Buyouts.

The Biotechnology Innovation Organization’s new membership survey said that 90% of US biotech companies rely on imported components for at least half of their FDA-approved products.

BIO Survey: Tariffs May Reduce Access, Delay Innovation, Create Red Tape

Novartis has strengthened its presence in Slovenia following the official opening in February 2025 of a new viral vector production facility (VIFA One) in Mengeš. Novartis invested €40 million (US$43 million) into the facility, which is the company’s first specialized viral vector manufacturing facility in Europe (1). With this investment, Novartis significantly expands its research and production capabilities in the biopharmaceutical sector.

The facility will support the production of viral vectors for breakthrough cell and gene therapies (CGTs) developed for treating certain autoimmune and genetic diseases and cancers. The facility features a fully automated production environment, including advanced robotics, designed to ensure precision and efficiency at all stages of the production process under one roof. The facility also introduces a state-of-the-art methodology aimed at setting a new industry standard but also significantly increasing Novartis’ capabilities to deliver breakthrough therapies under the highest quality standards (1).

Construction on the new facility began in 2023 and represents a significant boost to both the Slovenian economy and the country’s scientific community. "Novartis investments, which are among the leading foreign direct investments in the country, have made a significant contribution to the development of Slovenian science over the past two decades,” said Igor Papič, PhD, Minister of Higher Education, Science, and Innovation of the Republic of Slovenia, during the facility’s opening ceremony in February, where he was the keynote speaker (1). “I am pleased that Novartis is successfully cooperating with universities and scientific research institutions, and that it places great emphasis on developing young talent and transferring knowledge into practice. Cooperation between business and science and a stimulating scientific research and innovation environment, which is also supported by the State with generous funding, are key to the successful development of Slovenian society. They also create an environment that will be even more attractive to foreign investment."

The opening of the Mengeš facility follows a cycle of intense investment by Novartis in Slovenia. In 2024, Novartis’s investments in the country had a total value of €257 million (US$277 million) and mainly focused on the construction of new facilities and the introduction of new technologies (2).

A combination of the new investments and growth in business activity resulted in the need for new employees, leading to a growth in workforce in Slovenia in 2024. In that year, Novartis hired more than 560 new staff in Slovenia, bringing its total workforce in the country to more than 3900 employees by year’s end. Novartis also signed a strategic partnership with the University of Ljubljana, which further strengthened the company’s cooperation with academia and contributes to the joint development of knowledge and innovation (2).

“Novartis globally invested US$9.3 billion in research and development in 2024,” said Aymeric Royere, Novartis Slovenia country president, in a Jan. 31, 2025 company press release (2). “This shows our commitment to continue bringing new innovative medicines to patients worldwide in therapeutic areas where there are still significant unmet treatment needs. At Novartis in Slovenia, we also ensured that all key Novartis medicines, including the newly launched innovative medicines, have been available to patients in Slovenia.”

Slovenia’s Ljubljana and Mengeš locations support more than half of Novartis priority medicines in various stages of development, production, or services, Novartis noted in its Feb. 5, 2025 press release (1). "Slovenian experts significantly contribute to technological advancement and innovation in the research, development, and production of Novartis innovative medicines, addressing the greatest health challenges in society,” said Steffen Lang, PhD, member of the executive committee, and president, Operations, Novartis, in the press release (1). “Their knowledge, expertise, and achievements have been recognized and valued by Novartis from the very beginning and represent the fundamental reason for continuous further investments in Slovenia. One of these is the new viral vector production facility, which, as the only such Novartis production facility in Europe, has significant strategic value.”

Since entering the Slovenian market, Novartis has invested approximately €3.5 billion (US$3.8 billion) in the country, aimed primarily at research, development, and production capacities as well as sustainable environmental technologies. Investments totaling approximately €500 million (US$541 million) are currently underway at the Ljubljana and Mengeš locations, furthering the company’s growth in Slovenia.

In Slovenia, Novartis Opens Its First Specialized Viral Vector Production Facility in Europe

. Press Release. Feb. 5, 2025.
2. Novartis. Novartis in Slovenia Sees a Growth in Workforce and an Enhanced Role in the Global Novartis Network in 2024. Press Release. Jan. 31, 2025.

With a completed €40 million (US$43 million) investment in Slovenia, Novartis has opened its first specialized viral vector production facility in Europe, following earlier significant investments in R&D that has led to the growth of Slovenia’s workforce.

Novartis’ Steady Investments in Slovenia Result in New Viral Vector Manufacturing Facility and a Growing Work Force

The US Department of Health and Human Services (HHS) announced on March 27, 2025 that it is restructuring the organization in response to a Trump Administration Executive Order. HHS states the restructuring will include the reduction of its workforce by 10,000 full-time employees; however, the total amount of workforce reduction will be closer to 20,000 when combined with other agency efforts such as early retirement and Fork in the Road (1).

The restructure plans are to streamline functions and remove redundant units. These areas will be consolidated into 15 new divisions, such as a new Administration for a Healthy America (AHA), and core functions will be centralized. HHS will reduce regional offices in half from 10 to 5. “The restructuring will improve Americans’ experience with HHS by making the agency more responsive and efficient, while ensuring that Medicare, Medicaid, and other essential health services remain intact,” the agency stated in a press release.

As part of the restructuring, FDA’s staff will be reduced by approximately 3500 full-time employees, with a HHS fact sheet stating the reduction will not impact drug, device, or food reviewers or inspectors (2). Instead, HHS states the changes will streamline operations and centralize administration functions. In addition, the staff of the National Institutes of Health will be reduced by approximately 1200 employees.

The new AHA will combine the Office of the Assistant Secretary for Health (OASH), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), Agency for Toxic Substances and Disease Registry (ATSDR), and National Institute for Occupational Safety and Health (NIOSH). “Transferring SAMHSA to AHA will increase operational efficiency and assure programs are carried out because it will break down artificial divisions between similar programs,” the agency stated in the release.

TheAdministration for Strategic Preparedness and Response (ASPR), which is responsible for national disaster and public health emergency response, will transfer to the Centers for Disease Control and Prevention (CDC), and the Assistant Secretary for Planning and Evaluation (ASPE) will merge with the Agency for Healthcare Research and Quality (AHRQ) to create the Office of Strategy.

“We aren't just reducing bureaucratic sprawl. We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic,” HHS Secretary Robert F. Kennedy, Jr., stated in the press release (1). “This Department will do more—a lot more—at a lower cost to the taxpayer. Over time, bureaucracies like HHS become wasteful and inefficient even when most of their staff are dedicated and competent civil servants. This overhaul will be a win-win for taxpayers and for those that HHS serves. That’s the entire American public, because our goal is to Make America Healthy Again.”

HHS. HHS Announces Transformation to Make America Healthy Again. Press Release. March 27, 2025.

HHS. Fact Sheet: HHS’ Transformation to Make America Healthy Again. HHS.gov (accessed March 27, 2025).

 https://www.hhs.gov/about/news/hhs-restructuring-doge-fact-sheet.html

In response to a presidential Executive Order, the Department of Health and Human Services is planning to reduce its workforce, including cutting FDA staff by 3500 full-time employees, and reorganize some key departments.

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