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 

TOP NEWS on grunge world map | Image Credit: © Sean K - stock.adobe.com

Saying the combined issues of drugs—namely fentanyl—and illegal immigration constituted an “extraordinary threat” and national emergency in the United States, the Trump Administration announced on Feb. 1, 2025 an implementation of 25% additional tariffs on imports from Canada and Mexico, and a 10% additional tariff on imports from China (1).

But some of those enactments were delayed after President Donald Trump, on February 3, agreed to a 30-day pause with respect to Canada and Mexico when both countries said they would negotiate with the United States about how best to combat the problems Trump is prioritizing, according to the 

also reported that China’s response was not as conciliatory, with that country announcing retaliatory tariffs against the US as well as an antitrust investigation into Google (3).

Whatever the eventual outcome, the administration’s fact sheet on the proposed tariffs listed the overcrowding of hospitals as a residual effect of illegal immigration, and holds both Mexico and Canada responsible for funneling international narcotics distribution through the US (1). Those justifications, however, have not kept the pharmaceutical industry from speculating on the possible consequences of the penalties.

The Brookings Institution, a Washington, D.C.-based nonprofit research firm, predicts that if the 25% tariffs on Canada and Mexico wind up being imposed by the US, pharmaceutical exports from Mexico could fall by 61% (4). Should Canada and Mexico enact retaliatory tariffs, as China has done, Brookings estimates the dropoff to climb to 72%. And the Council on Foreign Relations calculated that US exports of vaccines, blood antisera, toxins, and cultures could collectively be one of the top five export categories most affected by the tariff “war,” to the tune of $5 billion in exports to China, $2 billion to Canada, $994 million to Mexico, and $41 billion to the rest of the world (5).

“We are concerned about the unintended, adverse consequences [the tariffs] may have on the cost of medicines in the US,” Susan A. Cantrell, CEO of the Academy of Managed Care Pharmacy, said on February 3 (6). “Many critical medications and raw materials are sourced internationally, and imposing tariffs risks driving up prices, creating supply disruptions, and impeding patient access to essential treatments.”

John Murphy III, president and CEO of the Association for Accessible Medicines, said drug shortages are already problematic, and that that challenge could continue to grow (7).

“Generic[-drug] manufacturers simply can’t absorb new costs. Our manufacturers sell at an extremely low price, sometimes at a loss, and are increasingly forced to exit markets where they are underwater,” Murphy said. “The overall value of all generic sales in the US has gone down by $6.4 billion in five years despite growth in volume and new generic launches. Tariffs would make this much worse.”

“We respectfully urge caution on instituting tariffs on sectors that will impact medical products,” the Healthcare Distribution Alliance said in a statement (8). “Accordingly, we ask the administration to consider establishing exemptions for pharmaceutical products and long implementation timelines.”

Meanwhile, the 13 Democratic members of the US Senate Finance Committee sent a letter on Jan. 30, 2025 to Department of Health and Human Services Secretary nominee Robert F. Kennedy Jr., asking him not to pause Medicare drug price negotiations, as leading pharmaceutical CEOs have requested (9).

“Medicare drug price negotiation is a powerful tool available right now to President Trump to make good on his long-standing promise to stand up to Big Pharma,” the senators wrote. “On behalf of the tens of millions of Americans who count on Medicare, Democrats on the Senate Finance Committee want to know whether the Trump Administration will follow through.”

1. The White House. Fact Sheet: President Donald J. Trump Imposes Tariffs on Imports from Canada, Mexico and China. 

, Feb. 1, 2025 (accessed Feb. 4, 2025).
2. Boak, J.; Sánchez, F.; and Gillies, R. Trump Agrees to Pause Tariffs on Canada and Mexico After They Pledge to Boost Border Enforcement. 

, Feb. 3, 2025 (accessed Feb. 4, 2025).
3. Moritsugu, K. and Wu, H. China Counters with Tariffs on US Products. It Will Also Investigate Google. 

, Feb. 4, 2025.
4. Meltzer, J. P. Trump’s 25% Tariffs on Canada and Mexico Will Be a Blow to All Three Economies. 

, Feb. 3, 2025 (accessed Feb. 4, 2025).
5. O’Neil, S. K. and Huesa, J. What Trump’s Trade War Would Mean, in Nine Charts. 

, Feb. 1, 2025 (accessed Feb. 4, 2025).
6. Academy of Managed Care Pharmacy. Statement from AMCP CEO Susan A. Cantrell on President Trump’s New Tariffs. Press Release. Feb. 3, 2025.
7. Association for Accessible Medicines. Association for Accessible Medicines Comments on New Tariffs. Press Release. Feb. 2, 2025.
8. Healthcare Distribution Alliance. HDA Statement on Proposed Tariffs of Pharmaceutical Products. Press Release. Feb. 2, 2025.
9. United States Senate Committee on Finance. Wyden, Finance Democrats Press RFK Jr. to Reject Big Pharma Pause on Medicare Negotiation. Press Release. Jan. 30, 2025.

Articles

The tariffs President Trump wants to levy against Canada and Mexico are on hold, for now, but China has already announced it intends to proceed with retaliatory tariffs against the US.

Pharmaceutical Industry Responds to Proposed Trump Administration Tariffs

Feliza Mirasol is the science editor for 

3d rendering of Antibody drug conjugates (ADCs) are targeted medicines that deliver chemotherapy agents to cancer cells | Image Credit: © Love Employee - stock.adobe.com

*Editor's note: article updated on March 3, 2025 to fix typographical errors.

Following a long road to success with antibody-drug conjugates (ADCs), developers today are seeing regulatory approvals for ADCs as a more common occurrence. Better success in the current environment is largely due to technology improvements that have helped minimize risk and enhance therapeutic efficacy for these complicated drugs. However, the manufacturing of ADCs remains a complex process, involving requirements for both the large-molecule and small-molecule components. The linker technology joining the two pieces also has its own requirements. Because of their manufacturing complexity, ADC development and production increasingly requires outsourcing services.

Three major challenges for drug developers trying to bring ADCs to market include lack of capacity, lack of expertise in scaling up, and the complexity of the supply chain, notes Christian Morello, vice-president and head of the Bioconjugates Business Unit at Lonza.

In looking at the overall dynamic of innovation in the ADC space, the majority of innovation is coming from small biotech companies, and those companies are not necessarily well equipped with the internal capacity to produce the product, Morello points out. “There is also a lack of knowledge about the industrialization and the scale up of ADCs,” he says. “And [there is also] the complexity of the supply chain; Indeed [we] within the bioconjugate field, we are bringing different pieces, like a puzzle, to produce the drug substance. It implies [much] complexity [and requires] management of different sourcing in order to make it happen.”

These challenges are what ADC developers have to face and overcome to produce clinical supply or commercial supply, Morello emphasizes. “This is where CDMOs [contract development and manufacturing organizations] bring a lot of benefit, because we have [experience with] different modalities. [Especially at Lonza,] we’re totally integrated, so we offer fully integrated services to make it happen and to accelerate [the developer’s] path to commercialization,” Morello says.

ADCs have unique manufacturing requirements, which is part of their complexity. “With ADC specificity, we are merging two worlds,” explains Morello. “We are merging the water and the solvent, the biologic and the chemistry. So, with this integration of two worlds, it requires specific skills.” Morello also cautions carefulness when dealing with the risks associated with the chemistry involved in ADC manufacture. “You need to take care about potential explosion or flammable risk associated [with] the chemistry, but you also need to take care about the potential contamination due to microbes if you’re not working with adequate procedure for clean environment. So, the operating model is very specific.”

The science of ADCs has evolved significantly over the past 20 years, Morello also points out. Many improvements can be seen in the carrier component (protein or peptide), the linker component, and the payload, all of which makes the conjugation technology more complex.

“There have been a lot of new developments in terms of conjugation and linker technologies,” agrees Nicolas Camper, senior director, Bioconjugation, at Abzena. “There is a definitive move towards site-specific conjugation technologies and away from stochastic conjugation approaches that allows [us] to prepare better-defined antibody-[drug] conjugates,” he says.

Camper also points out another new development that he’s observed over the past few years, which is that linker technology is becoming more sophisticated. “Quite often, when you conjugate cytotoxic drugs, they are quite hydrophobic, and that can impact the performance of your ADC. So, there has been a lot of effort put into developing more hydrophilic linkers,” he explains.

Another noticeable advancement has been in the development of branch linkers. These branch linkers give some options for preparing the ADC and modulating the drug loading. “[T]hat is something relatively new and should have an impact on the performance of ADCs and ultimately result in better ADCs and more programs,” he says.

Technological gaps are one area of unmet need in the ADC space. In Lonza’s case, the CDMO realized it needed a certain technology that would be valuable to its customers, which prompted it to acquire the Netherlands-based Synaffix in 2023 (1). Morello explains that the technology Synaffix brings offers a new way to do the conjugation “where we are connecting the linker at the glycan location on the mAb.”

“That is something that no one else has,” Morello emphasizes. This technology specifically addresses the challenge of how to manage the number of linkers and payload that can be connected to the carrier, the mAb. “So, it brings some solution to address the needs the customer has,” he says.

Morello also notes that Lonza is following the evolution of conjugation technology day-to-day to be able to capture new technologies and bring the best solutions to customers. “We have also created a toolbox [where we] identify very innovative companies/technology outside, bring them into the [Lonza] network, and identify where the customer may require this type of support, and then facilitating, connecting this technology at an early stage,” Morello states.

“When it is confirmed that [a] molecule is really interesting … then [we use] our ability to … master this very breakthrough technology [and bring it] into an industrial and GMP [good manufacturing practice] environment and to scale up this technology to support Phase I, Phase II, or Phase III [development], and then, later on, [scale up to] the commercialization of the drug,” Morello says.

ADC development has a robust future with much potential. Camper points out an important aspect currently driving ADC development: diversification. “I think that we’ve seen a lot of diversification. That’s a key word. The increased diversity can be noticed in the targeting moiety. Smaller targeting fragments, which allow for better penetration into the tumors, are being developed as targeting moieties; that can be nanobodies or fat fragments,” he explains.

“There is also diversity which is encompassed in the use of bispecific antibodies. They allow for targeting more selectively cancer cells,” Camper says. Camper also notes that there is a lot of diversity today in the payloads. “Traditionally, they were cytotoxic payloads, but, now, people are revisiting all potent small molecules, such as potent kinase inhibitors or payloads that have radically different mechanisms of action, such as molecular glues or PROTACs [proteolysis-targeting chimeras].”

Camper additionally observes how, in the past few years, there has been development of bioconjugates outside the area of oncology. “There are lots of antibody-drug conjugates being developed for the treatment of inflammation, for instance, or—something which is extremely hot at the moment—the development of antibody oligonucleotide conjugates for the treatment of genetic disorders,” he states. “Having access to more complex and linked payloads and conjugation technologies—more advanced conjugation technologies—that definitely results in better therapeutic profiles for antibody-drug conjugates, and we’ll see more and more of those in the future.”

“The technology is now at the level of maturity that enable a lot of different things,” adds Morello. For instance, going back to Lonza’s Synaffix acquisition, Synaffix presents another type of linker technology in which the developer can define how many payloads it wants to have per mAb. “That is another possibility that will enable [the developer] to fine tune the benefits/risk ratio for the patient,” Morello states. “We can see [that] today for some cytotoxic compounds for oncology, for sure, but we also have radiolabeled compounds to facilitate diagnosis. [This is] also oncology treatment, but with a different approach.”

“We have nucleotide and mRNA [messenger RNA] that are more and more used for some applications. We have polysaccharides that are also used as a vaccine. So, the applications associated with bioconjugation is much broader than it was in the past,” Morello says.

In addition, Morello points out, when looking at the overall portfolio of clinical trials that are ongoing in the bioconjugates field, half of them is associated with oncology applications and the other half is associated with non-oncology products. The ability to tackle different type of disease is one clear direction where ADC development is heading. Another area is having the ability to improve the benefits/risk ratio to decrease side effects, particularly in oncology, while increasing efficiency. Being able to target a specific ratio of linker to payload to mAb is also an interesting area, he adds. 

“Last but not least is the ability to simplify the process, again, through more integration,” Morello states. “We will need to accelerate the time to market and will accelerate, as well, the time to commercialization.”

1. Lonza. Lonza to Acquire Synaffix and Strengthen Antibody-Drug Conjugates Offering. Press Release. June 1, 2023.

®
Vol. 49, No. 1
January/February 2025
Pages: 29–30

When referring to this article, please cite it as Mirasol, F. Advancing ADCs to the Next Level. 

CDMOs who have integrated technologies can help further the advancement of ADC development.

Advancing ADCs to the Next Level

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Facility Monitoring Systems (FMS), a contamination control solutions provider based in Malvern, United Kingdom, announced on Feb. 3, 2025 that it has joined the calibration services company Trescal. In a company press release, the transaction is referred to as a “strategic acquisition” by Trescal of FMS (1).

“Becoming part of the Trescal family is a transformative opportunity for FMS,” Deborah Haisman, FMS commercial director, said in the press release (1). “We are proud of our strong reputation and the trust our customers place in us. Working with Trescal’s experts and calibration solutions will allow us to enhance our services, expand our reach, and deliver even greater value to our customers in all contamination control sectors in the UK and Ireland.”

Among the benefits FMS said the new partnership would provide to customers in the UK and Ireland are expanded resources and service capabilities, cutting-edge cleanroom contamination control solutions, and a stronger commitment to customer support (1). While FMS has specialized in the design, installation, and maintenance of environmental monitoring systems, Trescal’s focus has been on calibration and metrology services.

“By bringing FMS into the Trescal family, we are boosting our capabilities and strengthening our commitment to serving highly regulated industries,” Karolina Lachi-Kolarova, managing director of Trescal in the UK, Ireland, and Norway, said in the release. “The complementary skills and experience of the two companies is a powerful asset to our global business.”

Astech Ltd is the strategic partner to FMS in Ireland and will continue to be a direct interface for customers in the Irish market, according to the release (1). TSI Inc., of Shoreview, Minn., in the United States, has endorsed the transaction; TSI is a longtime principal to FMS, the Gold Channel Partner for TSI’s contamination products in the UK and Ireland.

“We are confident that its integration with Trescal will unlock new opportunities for innovation and growth,” Simon Tebb, Europe, Middle East and Africa sales manager for Controlled Environments at TSI, said in the release. “TSI looks forward to continuing our collaboration with FMS as part of Trescal to advance contamination control technologies in the UK and Ireland.”

This transaction is just one of several mergers and acquisitions that have been announced so far in 2025. On January 7, Molex, the parent company of Phillips Medisize, said it had 

completed an acquisition of Vectura Group

Telix Pharmaceuticals entered into an asset purchase agreement

 with ImaginAb for a pipeline of next-generation therapeutic candidates, a proprietary and novel biologics technology platform, and a protein engineering and discovery research facility (3). And on January 28, 

 it was acquiring the clinical stage radiopharmaceutical contract development and manufacturing organization Evergreen Theragnostics (4).

1. Facility Monitoring Systems. FMS Acquired by Trescal, Driving Growth and Innovation in the Contamination Control Industry. Press Release. Feb. 3, 2025.
2. Phillips Medisize. Phillips Medisize Expands Its Inhalation Drug Delivery Capabilities. Press Release. Jan. 7, 2025.
3. Telix Pharmaceuticals. Telix to Acquire Next-Generation Therapeutic Assets and Innovative Biologics Technology Platform. Press Release. Jan. 13, 2025.
4. Lantheus. Lantheus to Acquire Evergreen Theragnostics for Upfront Payment of $250 Million to Drive Strategic Evolution into Fully Integrated Radiopharmaceutical Leader. Press Release. Jan. 28, 2025.

While FMS has specialized in the design, installation, and maintenance of environmental monitoring systems, Trescal’s focus has been on calibration and metrology services.

Trescal Acquires Facility Monitoring Systems to Bolster UK Contamination Control Services Market

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Alvogen announced on Jan. 31, 2025 that it is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches because of the potential of multi-stacked patches. It is possible the patches, which were manufactured by Kindeva Drug Delivery, are adhered one on top of the other in a single product pouch. The recalled lot, Lot 108319, 25 mcg/h, has an expiration date of 04/2027 and was distributed nationwide (1).

Fentanyl Transdermal System 25 mcg/h transdermal patches are used to manage severe and persistent pain in opioid-tolerant patients for an extended treatment period with a daily opioid analgesic, and for patients who don’t respond well enough to alternative treatment options. According to Alvogen, application of multi-stacked patches could cause serious or fatal respiratory depression, especially in first-time recipients, children, and the elderly.

While the company has not received any reports of adverse events related to the recalled product, as of the date of the press release, adverse events can be reported to FDA via its 

MedWatch Adverse Event Reporting program.

Final inspection of a product is essential in reducing recalls and ensuring the safety of drug products. In an episode of 

 series, Dirk Margosch, vice president Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, 

 to mitigate risk in future batches of vials during secondary packaging after defective units have been found during an inspection (2). A thorough investigation should be performed to discover the root cause of the defects to prevent future occurrences.

“This [investigation] should involve reviewing all processes related to production. That means aseptic filling, visual inspection, assembly and secondary packaging, of course, always including the relevant packaging components. And then second, define the right preventive action, if the investigation comes, for example, to the conclusion that the defective vials were already present after the filling,” says Margosch.

Recalls are a factor in drug shortages, which can lead to patients not getting the medicines they need. Both FDA and the European Medicines Agency (EMA) have initiatives to monitor drug shortages that require manufacturers to provide information to regulators about things like product recalls and quality problems that might impact the availability of a drug. In January 2025, EMA announced the European Shortages Monitoring Platform is fully functional. This tool was created for marketing authorization holders and national competent authorities to directly report information about the supply, demand, and availability of authorized medicines to EMA during crises situations (3).

FDA. Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System. Press Release. Jan. 31, 2024.

Haigney, S. and Thomas, F. Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging. 

https://www.pharmtech.com/view/ask-the-expert-product-inspection-part-one-risk-mitigation-in-secondary-packaging

EMA. European Shortages Monitoring Platform Fully Operational for Monitoring of Shortages in the EU. Press Release. Jan. 29, 2025.

The company is recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches because of possible multi-stacking of patches.

Alvogen Recalls Fentanyl Transdermal System

Cheryl Barton is director of PharmaVision, 

Landkarte *** Europa | Image Credit: © beugdesign - Stock.adobe.com

On 1 Jan. 2025, the European Medicines Agency (EMA) introduced a new legal framework, fees, and charges for its regulatory activities and services to medicine developers (1). The New Fee Regulation (NFR) is governed by Regulation (EU) 2024/568 which amended Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and the Council (EPC) and repealed Regulation (EU) No 658/2014 and Regulation (EC) No 297/95 (2–5).

Since the EMA became operational in 1995, it has depended on “fees payable” to offset the cost incurred for providing a range of activities and services listed in the Council Regulation (EC) No 297/95. EMA and the National Competent Authorities (NCA) need to receive efficient funding to carry on their activities and “ensure an efficient, responsive, and innovative regulatory system in Europe for human and veterinary medicines,” according to Jean-Michel Mastio, head of the Finance Department at EMA (6). The EMA budget is currently around €0.5 billion, and a large part of this budget is used to support the NCAs; more than 95% of the budget is generated from fees, and the remainder is contributed by the European Union (EU).

The fees were introduced in 1995 and recognize 23 different basic procedural fees including those associated with applications for certificates, marketing authorization applications (MAA), scientific advice (SA), inspections, as well as supplemental authorization of additional strengths and pharmaceutical forms (7). Other fee-related regulations include Regulation (EU) No 658/2014 regarding pharmacovigilance inspection activities, and Regulation (EC) No 2049/2005 for reduced fees associated with non-orphan medicinal products submitted by small and medium-sized businesses (SMEs), medicinal products with orphan designation (OD) or paediatric use, advanced therapy medicinal products (ATMPs), and medicinal products for preparedness against biological agents (8–11).

Since 2015, the European Commission (EC) has been working on reviewing the EMA fee system. The EMA’s user fee system was evaluated in 2019 to assess if the fees were in alignment with the underlying activity cost of the EMA and NCAs, to identify areas for improvement, and to reduce the complexity of the fee system (12). EMA previously amended fees in 1999 and 2005 to ensure there was adequate provision for the services it provides. Fees increase on an annual basis to adjust for inflation, with the last adjustment having been published in April 2022, which resulted in an increase in the fee level by 0.3% for 2020 and 5.3% for 2021 (13).

In December 2022, the EC published a proposal for the revised EMA Fee Regulation, and the EPC agreed on the revised EMA Fee Regulation in September 2023. It was adopted and formally published on 7 Feb. 2024 (6). In 2024, EMA published a working arrangements document that clarified the requirements and terminology of the new regulation, established fee reductions for certain types of services, and provided further details on payment modalities; the working arrangements were adopted by EMA’s Management Board in June 2024 (11). The key principles and objectives for the NFR are: harmonization, flexibility, alignment, and sustainability. The new fees are “proportionate” instead of the previous “standard” or flat-rate fees.

The provisions outlined in Regulation (EU) 2024/568 will apply to all requests validated and starting in January 2025 and will impact human and veterinary medicines. A few examples of the new fees compared with previous fees (2024) are summarized in 

 (14). Applications with OD or drugs for use in paediatrics will be exempt from fees; however, there are some special circumstances where administrative fees will be applicable. Namely, if an applicant submits the application and withdraws it after 24 hours or EMA rejects the application during the validation phase (15). If an applicant applies for certificates, parallel distribution, or SA, EMA will issue an invoice, and once the payment is received it will deliver the service. The application will be cancelled if EMA does not receive payment within 30 days (15).

A few examples of fees payable under New Fee Regulation (NFR) versus previous regulation. MAA is marketing authorization applications.

For veterinary medicine, EMA has adopted a single framework to deliver a streamlined fee system, and the fees payable to EMA will be proportionate to the work carried out based on the complex evaluation, workload, and actual costs for the services delivered by EMA and NCA (6). The key changes to the fee regulations for veterinary medicines are summarized in 

. EMA will charge a fee for certificates, SA, and MAAs, and the amount payable will be dependent on the type of active substance (i.e., new active substance or known active substance). The fee will be calculated after the submission of the application in conjunction with the related fee reductions. For more details, see Annex I, Section 2, or Annex II, Section 1, of the Fee Regulation and Chapter 1.1 of the Fee Regulation Working Arrangements (11,16,17).

High-level changes to fees based on new fee regulation from 1 Jan. 2025.

Overhauling of the EMA fees legislation is long overdue and should provide EMA and NCAs with sufficient funds to ensure they can continue to deliver high-quality services and adapt to future market demands. The simplified proportionate fee structure should be easier to navigate but may lead to significant increases in the fees payable for medicine developers particularly when obtaining or maintaining MAAs from January 2025 onwards (14).

1. EMA. Fees Payable to the European Medicines Agency. 

. 1 Jan. 2025.
2. EMA. Regulation (EU) 2024/568. 

. 4 Feb. 2024.
3. EMA. Regulations (EU) 2017/745. 

. 5 April 2017.
4. EMA. Regulation (EU) 2022/123. 

. 25 Jan. 2022.
5. EMA. Regulation (EU) No 658/2014. 

. 15 May 2014.
6. EMA. New Fee Regulation. Webinar. 20 June 2024.
7. EMA. Council Regulation (EC) No 297/95. 

. 10 Feb 1995.
8. EMA. Regulation (EU) No 658/2014. 

. 15 May 2014.
9. EMA. Regulation (EC) No 2049/2005. 

. 15 Dec. 2005.
10. EMA. Regulation (EC) No 141/2000. 

. 22 Jan. 2000.
11. EMA. Fee Regulation working arrangement. 

. 13 June 2024.
12. EC. Evaluation of the European Medicine Agency’s Fee System. 18 Sep. 2019.
13. AgencyIQ. What You Need to Know about the Status of the Proposed EMA Fees Regulation. 

. 3 Nov. 2023.
14. DLCR. EMA Updated Fees: What Does This Mean for My Applications? 9 Aug. 2024.
15. Vignol, C. EMA – New Fee Regulation (NFR). RPN Group.com. 9 Aug. 2024.
16. EMA. Annex I to Regulation (EU) 2024/568; Q&As. 

. 14 Nov. 2024.
17. EMA. Annex II to Regulation (EU) 2024/568; Q&As. 

Cheryl Barton is director of Pharmavision, info@pharmavision.co.uk.


Vol. 37, No. 1
January/February 2025
Pages: 6–7

When referring to this article, please cite it as Barton, C. Introducing a New Legal Framework, Fees, and Charges. 

EMA introduced its New Fee Regulation in January 2025, but what impact will the new fees and charges have on medicine developers? 

Introducing a New Legal Framework, Fees, and Charges

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

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Adhering to rules and codes around promoting drug products is nothing new for the bio/pharma industry, with many companies agreeing to self-regulation practices that comply with codes set out by industry bodies. However, the increasingly prevalent use of social media by companies and their employees has added another level of complexity to consider and seems to be leading to several code breaches.

In the United Kingdom, for example, advertising of medicinal products is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA), but many companies that operate within the UK also tend to self-regulate in accordance with other codes of practice. For prescription-only medicines, companies should adhere to the Association of the British Pharmaceutical Industry (ABPI) Code of Practice, which is administered by the Prescription Medicines Code of Practice Authority (PMCPA) (1).

The ABPI Code of Practice was first introduced in 1958 and has undergone regular revisions since that time to encompass any relevant amendments or additions that may be necessary to ensure the continued appropriate use of medicines (2). In 2023, PMCPA published a new guidance document that specifically tackles the use of social media by bio/pharma companies and their employees (3).

“We recognize that social media can pose particular challenges for companies under the ABPI Code. With its wide reach and international audience, information on medicines can be seen by audiences it wasn’t intended for,” said Alex Fell, director of the PMCPA, in a press release about the launch of the guidance (3). “I hope this guidance will help companies navigate the potential pitfalls of social media, with more confidence, a clearer knowledge of the principles to follow and the legal requirements.”

While this guidance undoubtedly helps companies within the bio/pharma industry, the social media landscape is still proving to be reasonably tricky to navigate with some companies falling foul of the Code of Practice. Most notably, Big Pharma companies Novartis, GSK, AstraZeneca, and Novo Nordisk have all been found to be in breach of various clauses from the code on the LinkedIn platform (4–7). In all cases, the breaches occurred as a result of employees sharing/reposting and/or ‘liking’ posts, thereby distributing content to a wider, public audience.

A review of the potential impact of pharmaceutical promotional activities on social media has demonstrated potentially wider reaching public health concerns from increasingly covert promotional activities on these platforms (8). With such concerns apparently becoming ever more pressing, further regulatory development to ensure patient safety seems inevitable.

Pharmaceutical Advertising Laws and Regulations England & Wales 2024–2025

ABPI Code of Practice for the Pharmaceutical Industry: Introduction

 (accessed 7 Feb. 2025).
3. PMCPA. PMCPA Launches New Social Media Guidance for Pharmaceutical Companies. Press Release, 26 Jan. 2023.
4. PMCPA. AUTH/3843/11/23 and AUTH/3844/11/23—Complainants v Novartis Alleged Promotion of a Medicine on LinkedIn. Case Completed on 3 Jan. 2025.
5. PMCPA. AUTH/3810/8/23—Complainant v GSK Alleged Promotion of Jemperli (dostarlimab) on LinkedIn. Case Completed on 11 Oct. 2024.
6. PMCPA. AUTH/3774/6/23—Complainant v AstraZeneca Allegations about Conduct on LinkedIn. Case Completed on 21 Oct. 2024.
7. PMCPA. AUTH/3867/12/23 - Complainant v Novo Nordisk Alleged Promotion on LinkedIn. Case Completed on 14 Aug. 2024.
8. Mor, J.; Kaur, T.; Menkes, D.B.; Peter, E.; Grundy, Q. Pharmaceutical Industry Promotional Activities on Social Media: A Scoping Review. 


Vol. 37, No. 1
January/February 2025
Page: 6

When referring to this article, please cite it as Thomas, F. The Social Media Code. 

Bio/pharma companies have a lot to consider when tackling social media communications, especially within Europe.

The Social Media Code

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended eight new medicines for approval, issued a positive opinion on one medicine intended for use outside the European Union (EU), and recommended extensions of therapeutic indications for eight other medicines, among other actions taken at CHMP’s Jan. 27–30, 2025 meeting, according to information provided by EMA (1).

Recommendations for marketing authorizations were granted to two medicines. Capvaxive (pneumococcal polysaccharide conjugate vaccine [21-valent]) is intended for the prevention of invasive disease or pneumonia caused by streptococcus pneumoniae bacteria in adults, and Vimkunya (chikungunya vaccine [recombinant, adsorbed]) is designed to protect adults and children aged 12 and older against disease caused by the Chikungunya virus (1).

The following six other new medicines received positive opinions from CHMP:

Datroway (datopotamab deruxtecan), for treatment of breast cancer

Dyrupeg (pegfilgrastim), to shorten duration of neutropenia (low levels of neutrophils, a type of white blood cell) and prevent febrile neutropenia after chemotherapy

Eltrombopag Accord (eltrombopag), for treatment of adults and children with primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C

Pavblu (aflibercept) and its duplicate Skojoy (aflibercept), indicated for treatment of neovascular age-related macular degeneration and visual impairment

Tivdak (tisotumab vedotin), for treatment of recurrent or metastatic cervical cancer.

Extensions of indication were recommended for the following medications already authorized in the EU: Breyanzi (lisocabtagene maraleucel), Imfinzi (durvalumab), Opdivo (nivolumab), Ronapreve (casirivimab/imdevimab), Rxulti (brexpiprazole), Sivextro (tedizolid), Slenyto (melatonin), and Yervoy (ipilimumab) (1).

Lisocabtagene maraleucel has been approved in the EU for use in adult patients with various forms of white blood cell cancers, and an indication expansion was already granted by EMA in August 2024 for treatment of relapsed or refractory follicular lymphoma (2). Durvalumab was one of two medications to receive a positive recommendation in January 2025 from the National Institute for Health and Care Excellence for treatment of lung cancer in patients in England and Wales (3). A previous extension of therapeutic indication was given to Slenyto by CHMP in July 2024 (4).

In August 2024 in the United States, FDA accepted the combination of nivolumab plus ipilimumab as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma (5).

Ivermectin/albendazole received a positive opinion for treatment of infections caused by several worm parasites—including the tropical disease lymphatic filariasis—having been submitted under the EU-Medicines for all program, which enables EMA to contribute to the protection and promotion of public health beyond the EU (1). In March 2021, EMA advised against the use of ivermectin for prevention or treatment of COVID-19 outside of well-designed clinical trials (6).

Finally, the European Commission has asked CHMP to consider information on the safety of Leqembi (lecanemab) that became available after a positive opinion given in November 2024 was adopted (1,7). And applications for marketing authorizations were withdrawn for two medicines: Datopotamab deruxtecan, for the treatment of adults with non-squamous non-small cell lung cancer, and Nugalviq, intended for the treatment of classic galactosaemia (1).

1. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025. Press Release. Jan. 31, 2025.
2. Bristol Myers Squibb. European Medicines Agency Validates Bristol Myers Squibb’s Application for CAR T Cell Therapy Breyanzi for Relapsed or Refractory Follicular Lymphoma. Press Release. Aug. 19, 2024.
3. AstraZeneca. AstraZeneca Receives Two Positive NICE Recommendations for Lung Cancer Patients Across England and Wales. Press Release. Jan. 22, 2025.
4. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 22–25 July 2024. Press Release. July 26, 2024.
5. Bristol Myers Squibb. Bristol Myers Squibb Receives US Food and Drug Administration sBLA Acceptance for First-Line Treatment of Unresectable Hepatocellular Carcinoma. Press Release. Aug. 21, 2024.
6. EMA. EMA Advises Against Use of Ivermectin for the Prevention or Treatment of COVID-19 Outside Randomized Clinical Trials. Press Release. March 22, 2021.
7. Eisai. Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease. Press Release, Nov. 15, 2024.

Another eight medications already authorized in the EU were recommended for extensions of various indications.

EMA Recommends Eight New Medicines for Approval in January 

Mike Hennessy Jr. is the Chairman and CEO of 

High Angle Shot of a Working Desk of an Successful Person in Office with Cityscape Window View. | Image credit: © Gorodenkoff - stock.adobe.com

In January each year, global healthcare and life sciences industry leaders, investors, and government officials come together in San Francisco, Calif., at the J.P. Morgan Healthcare Conference to discuss market trends that are expected to shape the industry in the near future. For 2025, this annual barometer of the healthcare sector has left industry with a reasonably positive outlook on the potential for M&A activity.

Since the bumper year of 2019, the bio/pharma industry has experienced a slower pace in M&A activity. While there have been some high value deals, such as Pfizer’s acquisition of Seagen in 2023—valued at approximately $43 billion (1)—the overall value and volume of deals have been lower than expected.

According to the EY 2025 Firepower analysis—which found that there was a decrease in deal value of 41% in 2024 compared with 2023—2024 may be considered a “reset year” when bio/pharma companies were turning away from larger deals and looking at smaller strategic ones (2). In 2025, the EY analysts expect a continued focus on smaller and smarter deals (2), with the emerging field of artificial intelligence (AI) proving a popular opportunity, as was demonstrated by NVIDIA’s announcement in San Francisco (3) and discussed in depth in this issue’s cover story on pages 10–13 (4).

Customarily, industry sees a flurry of deals announced during the J.P. Morgan Healthcare Conference, and 2025 proved no different. The biggest deal, announced on day one of the conference, was Johnson & Johnson’s proposed acquisition of Intra-Cellular Therapies for $14.6 billion (5), marking the largest seen at the conference in years.

While unlikely to hit the heights of years gone by, there is an abundance of ‘dry powder’ private equity funding potentially available (6). So, if the conditions prove optimal, the right opportunities are focused on, and policymaking shakes out in a beneficial way, 2025 could well be a prosperous year for deals for bio/pharma.

Pfizer. Pfizer Completes Acquisition of Seagen. Press Release, Dec. 14, 2023.

EY. EY Firepower Report: Life Sciences Dealmaking—Trends in 2025. Featured Thinking, EY.com, Jan. 13, 2025.

Hollan, M. NVIDIA Announces Pharma Partnerships to Expand AI. 

Thomas, F. Expanding Pharma’s Horizons Through AI and Acquisitions. 

J&J. Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc. Press Release, Jan. 13, 2025.

Whaley, E.; Ward Woffenden, T.; Mahoney Jr., P.M. At JP Morgan Conference, Health Care Investors Gear Up for Transformative Legal Developments

Mike Hennessy Jr is President and CEO of MJH Life Sciences®.

®
Vol. 49, No. 1
January/February 2025
Page: 8

When referring to this article, please cite it as Hennessy, M. Dealmaking on the Rise? 

If the conditions prove optimal, 2025 could be a prosperous year for bio/pharma business deals.

Dealmaking on the Rise?

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Q. Artificial intelligence (AI) seems to be everywhere. Are there specific regulations covering AI for the pharma and medical devices industries?

A. There are indeed regulations; however, it is important to note that AI regulations in healthcare are rapidly evolving, and specific regulations can vary significantly between countries and regions. There certainly isn’t yet a unified global approach to regulating AI in the healthcare industry.

Though companies explore a multitude of opportunities to apply AI (e.g., for improving and strengthening the supply chain to prevent drug shortages), these technologies are still in their infancy. That is reflected in the discussion and policy papers published by the various regulators. AI algorithms are created by humans, and it is only logical to assume some level of bias. Addressing bias and ensuring fairness in AI algorithms is one of the common themes across these regulations. Avoiding bias is essential to ensure patient safety. A benefit of AI is that these algorithms are capable of learning and evolving. To avoid anyone blaming the algorithm for when an AI tool, such as an AI-based medical device malfunctions, the regulators are keen to establish clear liability and accountability frameworks.

The use of AI in the healthcare industry invariably impacts patients’ wellbeing. Any application of AI must therefore follow or adhere to ethical principles. Unlike a piece of traditional software that remains static in its output, AI is often intended to evolve and change. Companies may no longer be able to rely on a one-time validation effort to maintain transparency and explainability of AI decision-making processes.

Though the regulators do not wish to prevent the use of AI, considering the assumed benefits for patients, they do have to weigh the risks to protect patient safety, as well as patient data privacy and security. All these concerns are reflected in the current legislation. The following are merely a small number of regulations, guidance documents, and discussion papers from key regulatory agencies.

The World Health Organization (WHO) published Ethics and Governance of Artificial Intelligence for Health in 2021, which addresses the use of AI in healthcare globally (1). Most of the regulations and guidance documents have been issued for medical devices (2–9).

A more detailed overview of these regulations has been published by the Regulatory Affairs Professionals Society, though access is for members only (10).

For the most current and detailed information on AI regulations in specific countries or regions, it is always advisable to consult with regulatory subject matter experts in those areas, particularly as this is such a rapidly evolving regulatory field.

Ethics and Governance of Artificial Intelligence for Health

FDA. Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. 

 updated Aug. 7, 2024 (accessed Dec. 5, 2024).

Discussion Paper on Proposed Regulatory Framework for Modifications to (AI/ML)-Based Software as a Medical Device (SaMD)

FDA. Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles. 

Guidelines on the Responsible Use of Generative AI in Research Developed by the European Research Area Forum

Future of Life Institute. The EU Artificial Intelligence Act. 

MHRA. Software and Artificial Intelligence (AI) as a Medical Device, 

MHRA’s AI Regulatory Strategy Ensures Patient Safety and Industry Innovation into 2030

The National Medical Products Administration (NMPA) (China). 

NMPA Announcement on Guidance for the Classification Defining of AI-Based Medical Software Products.

Kulshreshtha, A.; Bharadwaj, M.S. Global Regulatory Landscape for AI/ML-enabled Medical Devices. 

. 2024;4(3):5-20. Published online Sept. 18, 2024.

Siegfried Schmitt, PhD, vice president, Technical at Parexel.

®
Vol. 49, No. 1
January/February 2025
Page: 34

When referring to this article, please cite it as Schmitt, S. Regulations in AI and Other Digital Technologies. 

AI regulations in healthcare are rapidly evolving, and one should consult with regulatory subject matter experts, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Regulations in AI and Other Digital Technologies

In this episode of the Drug Solutions podcast, Felicity Thomas, Associate Editorial Director, chats with a host of experts about the trends that have impacted the bio/pharma industry in 2024 and those they expect to be impactful in 2025.

This episode is a compilation of comments taken from a series of interviews where experts reveal the trends that have impacted the bio/pharma industry in 2024 and those they expect to be impactful in 2025.

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