Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

Ask the Expert

Closing the Gap in Modern Process Control and Automation for QC/QA

Drug Digest December 2025

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

Pharma M&A reflects not only corporate growth strategies, but also regulatory environments, scientific capability, and capital allocation across regions. To understand how acquisition activity and value are being distributed globally, we at FounderNest recently looked at 1,489 pharma M&A transactions worldwide with disclosed deal values totaling $660 billion.

The results point to a highly concentrated market. The United States remains the dominant player, while Europe is showing how smaller, mature markets can generate outsized deal values. At the same time, Asia is emerging as a meaningful third hub, reflecting a shift in long-term strategic priorities.

Let’s take a closer look at the numbers.

Global Pharma M&A Landscape | Created with NotebookLM

Our data show that global pharma M&A is becoming more selective and strategically targeted. While North America remains the dominant market, Europe’s concentration of high-value transactions and Asia’s increasing role reflect different approaches to risk, regulation, and innovation investment.

A key insight from the data is that deal volume and deal size do not necessarily move together. Some regions specialize in frequent, smaller acquisitions, while others concentrate value into fewer, transformative transactions. These differences reflect regulatory environments, market maturity, and strategic objectives.

For industry leaders, these patterns highlight the importance of geographic focus in M&A strategy. Future value creation in pharma will depend not only on doing more deals, but on placing the right bets in the right markets.

Articles

Pharmaceutical mergers and acquisitions (M&A) are influenced by corporate growth strategies, regulatory environments, scientific capabilities, and regional capital allocation. An analysis of 1,489 global pharma M&A transactions, totaling $660 billion, reveals a concentrated market with the United States as the leader. Europe demonstrates how mature markets can achieve high deal values, while Asia is emerging as a significant hub. The data indicates that global pharma M&A is becoming more selective, with regional differences in deal volume and size reflecting varying approaches to risk, regulation, and innovation investment.

Felix Gonzalez, FounderNest, offers a data-driven view of where pharma consolidation is occurring, where capital is being deployed, and how regional M&A strategies differ.

The Global Pharma Merger and Acquisition Landscape

2025 pharma disruption hinged on three themes: political pricing/tariffs, tough quality scrutiny (FDA warnings), and innovation vs. changing standards (patient focus.

Pharma Disruption in 2025: A Recap of Our Top 10 Articles

Diving through our top 10 articles of 2025, we found that the pharmaceutical industry was largely characterized by disruption, spanning from high-level politics to plant floor production standards, setting an intense stage for the coming year. The defining events of the year coalesced around three major themes impacting global biopharmaceutical operations.

The first major theme involved significant political intervention in drug pricing and regulation. The Trump administration aimed to force drug manufacturing back home by proposing a 

. This proposal compelled companies to make a critical decision: either build manufacturing capacity within the US or face massive costs. Pressure on drug pricing also intensified through the implementation of 

Most Favored Nation deals, a regulatory pricing mechanism that AstraZeneca agreed to

, becoming the second major player to sign on. Compounding this regulatory environment was substantial turnover and volatility at key federal agencies, including 

. These departures created considerable uncertainty and prompted questions regarding the future integrity of science-based policymaking in the US.

The second thematic area focused on heightened scrutiny of manufacturing quality and process controls. Regulatory oversight became much tougher, signaled by specific actions such as an 

FDA warning issued to a Novo Nordisk plant

 for recurring issues. The findings detailed in the warning were described as "incredibly specific," underscoring the intensified scrutiny. Such quality failures introduce significant risks to a company's reputation, drug approvals, and overall business operations. In response, the 

FDA issued new guidance mandating much stricter process controls

The final theme explored the clash between rapid innovation and changing standards. While innovation flourished, particularly in the 

 for liver disease, which experienced an "explosion," evolving regulatory landscapes presented new challenges. Key approvals for this notoriously difficult-to-treat condition were characterized as an absolute game changer. Conversely, a debate flared regarding TiO2 (titanium dioxide), an ingredient present in thousands of medications. 

 that while alternatives exist, none currently really measure up. Furthermore, a philosophical shift brought 

the patient’s voice into the regulatory process

, signaling a move toward a more holistic, patient-focused view of a drug's value.

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


Let's jump in. We're breaking down the biggest pharma tech stories that really defined 2025. We've boiled it all down to three huge themes that shaped the entire year for pharma, and really 2025 is all about disruption from politics to the plant floor and everywhere in between. So our first theme, it's all about how politics really shook up drug pricing and regulation.

A proposed a hundred percent tariff on imported drugs. Yeah, that was a huge move to force manufacturing back home. So companies had a big choice to make build in the US or get hit with massive costs. The administration also turned up the heat on pricing with so-called most favored nation deals, and it was a big deal when AstraZeneca signed on becoming the second major player to do so.

On top of that, you had this massive turnover at key agencies creating a ton of uncertainty. I mean, just look at this timeline. You can really see the volatility at the FDA and CDC. These departures raised some serious questions about the future of science-based policymaking in the us. Okay, let's switch gears.

Theme number two is all about manufacturing and quality under the microscope. Case in point, a Novo Nordisk plant got hit with an FDA warning for some recurring issues, and the findings were incredibly specific, which was a clear signal of much tougher regulatory scrutiny for companies. This stuff is a huge deal.

It risks your reputation, approvals, and the whole business. So in response, the FDA dropped new guidance that basically calls for much stricter process controls. Alright, our final theme, this one covers the clash between rapid innovation and changing standards. You wanna see innovation. The market for MSS treatments for liver disease is just exploding.

A few key approvals for this notoriously tough to tree condition. Were in absolute game changer. But at the same time, a big debate flared up over TI O2 an ingredient in thousands of medicines. And here's the problem, the European regulators found that, yeah, alternatives exist, but none really measure up.

We also saw a huge philosophical shift really bringing the patient's voice into the regulatory process. This quote says it all, it's a move toward a more holistic, patient-focused view of a drug's value. So when you put it all together, these three forces are what really define the pharma world in 2025.

This all sets a pretty intense stage for next year, leaving us with one big question. What's coming next?

Videos

Industry Outlook 2026: The Impact of Novel Therapies

 preparation for the new year, the editors speak with experts in the industry to find out which trends happened in the past year that they think impacted the industry the most and will, they believe, continue into the new year. Campbell Bunce, chief scientific officer at Abzena, pointed to two trends in 2025 that stood out: the influx of novel therapies and onshoring of manufacturing facilities to the United States.

Next-generation biologics, such as bispecifics, fusion proteins, and multi-specifics, have multiple functionalities that provide “more bang for your buck in one molecule”. There have also been more approvals of antibody drug conjugates (ADCs) in the past year, according to Bunce, which creates excitement in the industry.

“But one thing that's particularly exciting, I would say, on the sort of drug type front, is antibody-oligo conjugates [AOCs],” Bunce says. “They're particularly driven by companies like Avidity and Dyne, who are really spearheading these next generation by conjugates, where we're using antibodies to target oligonucleotides into cells that will impact certain sort of disease inducing pathways. We're seeing particular excitement around using these types of drugs for muscular dystrophies.”

Bunce points out Novartis’ acquisition of Avidity Biosciences, a biopharmaceutical company located in San Diego that focuses on drugs that enable RNA delivery to muscle, in October 2025 as an example of the excitement surrounding these therapies. Avidity is pioneering AOCs, according to Novartis, for genetic neuromuscular diseases and will provide programs to advance Novartis’ neuroscience strategy (1).

On the onshoring front, Bunce sees a shift toward manufacturing drugs closer to home. “Onshoring manufacturing capabilities in the US has been something that we've seen significant activity around,” Bunce explains. “Abzena built into the US some years ago, kind of deliberately as a deliberate promise to a shareholder base at the time, and we find ourselves really well positioned to sort of capture a lot of the benefits that we're seeing in that sort of migration of manufacturing into the US, particularly around ADCs.”

Novartis. Novartis Agrees to Acquire Avidity Biosciences, an Innovator in RNA Therapeutics, Strengthening its Late-Stage Neuroscience Pipeline. Press Release. Oct. 26, 2025. https://www.novartis.com/news/media-releases/novartis-agrees-acquire-avidity-biosciences-innovator-rna-therapeutics-strengthening-its-late-stage-neuroscience-pipeline

My name is Campbell Bunce, I'm the Chief Scientific Officer at Abzena. Abzena is CDMO with significant front end sort of R and D capability that supports discovery, design, the candidate selection for for manufacture. And you know, as a CDMO, we can support that manufacturer through to clinical studies, and we are planning now to build out interface three and commercial capabilities as well. Our focus very much is on biologics and by conjugates. So a lot of what we're seeing these days is, you know, next generation molecules from essentially building on the on the shoulders of the success of antibodies, as well as ADCs, antibody drug conjugates that are going to be extremely successful in cancer. I've been with the business 10 years prior to that, I spent 18 years or so in biotech, and I came to Abzena when we were starting to build out from early R and D capability and into our GMP manufacturing capabilities. And we do that, of course, two territories, one in the UK for the front end R and D services, and two sites in the US and one in Bristol, near Philadelphia, for chemistry and ADC manufacture, and one in San Diego, where we do biologics scale manufacture there as well.

Which trends Did you see or experience in 2025 that you believe impacted the pharmaceutical industry the most? 

I think there are two trends in the pharmaceutical industry that we've noticed have an impact on the industry in general. One is the evolution of drugs. Drug development itself, you know, the types of drugs.

So as I mentioned, you know, we're seeing sort of next generation biologics. So bispecifics, fusion proteins, multi specifics that build into the biologic multi functionalities. So you know, bigger bang for your buck in the one molecule. And so we're seeing evolution of those, as well as the continuing excitement around antibody drug conjugates. So a few more approvals over the last year or so in that area, and we are really well positioned to support that, both from the design all the way through to manufacturing, GMP manufacture of those complex molecules, where we're bringing chemistry and sort of biology together. But one thing that's particularly exciting, I would say, on the sort of drug type front, is antibody oligo conjugates. We're seeing a lot of exciting activity. They're particularly driven by, you know, companies like avidity and dying, who are really spearheading these next generation bioconjugates, where we're using antibodies to target oligonucleotides into cells that will impact certain sort of disease inducing pathways. So we're seeing particular excitement around using these types of drugs for muscular dystrophies. And actually that's led to a guest, Novartis recently in the news, acquiring avidity for $12 billion so that's a significant amount of money, which kind of I think, goes to the sort of exciting nature of utilizing this type of approach for difficult to treat disease indications. So that's one thing. The other is, of course, across the geopolitical side of things, where we are seeing a genuine shift towards where folks are looking to manufacture drugs. Big focus in the US, of course. So on shoring manufacturing capabilities in the US has been something that we've seen significant activity around for us at Abzena, you know, this is, you know, part look, but part by design. You know, we built into the US some years ago, kind of deliberately as a deliberate promise to a shareholder base at the time, and we find ourselves really well positioned to sort of capture a lot of the benefits that we're seeing in that sort of migration of manufacturing into the US, particularly around ADCs. And there's not a lot of folks can actually manufacture ADCs to scale,and we're one of those companies that can do that, right?

PharmTech spoke with Campbell Bunce, chief scientific officer, Abzena to find out which trends in 2025 impacted the industry the most.

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Jason Bryant Interview - Part 2

In this second of a three-part series, an 

, senior vice-president of Product Management—AI at 

, continues a discussion on the adoption of agentic AI in the pharmaceutical industry, particularly regarding the roles played by autonomy and accountability when it comes to handing over a degree of control to these agents.

Autonomy is not a binary option, Bryant said in the first part of this video interview with 

®, and can work in concert with accountability even if it seems like the two characteristics are not analogous. In this second video, Bryant expands on that viewpoint and adds that autonomous agentic AI cannot and will not usurp all processes.

“I said it's not binary, and what I mean by that is that full autonomy is really a no-go zone for pharmacovigilance,” Bryant says. “And frankly, full autonomy is undesirable or it will even be prohibited where things matter, like choice or ethics or law. It is suitable in some domains. It's suitable in domains where outcomes are reversible, I would say that's the primary characteristic.”

Bryant also says these agents excel at discovery via inference as opposed to look-up.

“For us, that enhances safety teams, because you can now explore different possibilities, especially from weak signals,” he says. “But these weak signals might carry a world of insight. So we're moving now beyond that pattern matching, which, as I said before, still incredibly valuable, incredibly powerful, but we're really moving now into true insight generation.”

The second part of Bryant’s interview can be viewed above. Watch the first part 

The three articles written by Bryant are available 

I said it's not binary, and what I mean by that is that full autonomy is really a no-go zone for pharmacovigilance. And frankly, full autonomy is undesirable or it will even be prohibited where things matter, like choice or ethics or law. It is suitable in some domains. It's suitable in domains where outcomes are reversible, I would say that's the primary characteristic. And there are rich examples of that, like scientific discovery is an example of that where outcomes are reversible.

But the critical piece here is that there's coordination that is done by an orchestrator. The orchestrator has autonomy that coordinates the capabilities, that manages the context, decides when to invoke or escalate or stop entirely the transition control to a human. And that bounded autonomy ensures that, yes, you can anticipate some variability, but for good reason, because you're going to get more value from it, but it's controlled, so it makes a genetic behavior governable, and that's really important in drug safety. So autonomy and accountability. It does sound like a paradox, but for us, it can be resolved, and they can absolutely coexist.

It's happening quickly. These capabilities are not slowing down. We don't see a plateau forming at this point. And here we're really in the domain where machines are thinking, and they're not doing look-up anymore. You mentioned that they're reasoning, they're absolutely reasoning, but in reasoning, they're simulating, they're thinking ahead, they're exploring options, and they're generating pathways that I think are fundamentally very creative.

And these creative pathways are not encoded in instructions, and they're not explicit in the source material that's being discovered, and that's one of the critical pieces for discovery, and that it can't be so machines that think, I think that that might have sounded like science fiction quite a while ago, but here we have it in our everyday life, you can access the consumer tools and see long-chain reasoning. You can see this deeper reflection. You can see this exploration of scenarios and agents.

Ultimately, they test hypotheses as well. They can think through these pathways, and they can anticipate problems and weigh trade-offs. So it's very data-rich, but it's also a very creative process, and it's not just retrieval anymore. They're connecting sparse and cross-domain signals. This is what I mean by discovery, that you just can't get from a single source. It can't be encoded within it directly.

So that is really discovery through inference, not look-up, because it's extending what's possible from finite inputs, inference and not look-up. And for us, that enhances safety teams, because you can now explore different possibilities, especially from weak signals. But these weak signals might carry a world of insight. So we're moving now beyond that pattern matching, which, as I said before, still incredibly valuable, incredibly powerful, but we're really moving now into true insight generation.

Generation already excels at human-level writing. I mean, LLM stands for a large language model, that shouldn't be a surprise, that it's good with language. And so they're excellent there. We don't see an agentic lift in that sense. And as I mentioned, they're narrow, narrow-scope agents. Like our major coding agent, for example, is perfect for just delivering huge advances in really expert-level reasoning, and that's going to be highly valuable.

But when you start thinking about enterprise processes that involve multiple roles and multiple goals and multiple decisions and that interconnectivity, this is where the multi-agent systems with orchestration are really going to unlock that potential, and it's the orchestrator that will ensure this continuity across the agents. I'm sure we'll come on to that later, but it's going to deliver context. It's going to ensure it understands goals, the rationale for achieving those things, and it's going to stay low across process steps.

ArisGlobal’s Jason Bryant continues a video supplement to his series of articles on the adoption and implementation of AI agents.

Full Autonomy Is a ‘No-Go Zone’: Setting Parameters for Agentic AI in Pharma

Dividing cancer cells - 3D illustration | Image Credit: ©peterschreiber.media - stock.adobe.com

The field of cancer treatment saw a variety of advancements in 2025, from new dedicated centers to approved treatments to novel therapies. In this overview, 

 takes a look back at significant oncology news in 2025.

What cancer drug development and approvals happened in January?

The focus on lung cancer was particularly sharp, highlighted by the European Commission’s (EC) approval on January 21 of 

Johnson & Johnson’s Lazcluze (lazertinib) combined with Rybrevant (amivantamab)

 (1). This chemotherapy-free regimen was authorized as a first-line treatment for adults with advanced non-small cell lung cancer (NSCLC) (1).

Further advancing lung cancer care, the National Institute for Health and Care Excellence in England and Wales issued positive recommendations on January 22 

 (2). Imfinzi (durvalumab) was recommended for adults with untreated extensive-stage small cell lung cancer when added to standard chemotherapy, having shown a sustained overall survival benefit (2). Tagrisso (osimertinib) was recommended as an adjuvant treatment option following complete tumor resection for adults with stage IB to IIIA NSCLC who have the specific EGFR mutations (2).

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) also 

 for approval in January in the European Union (3). These included Datroway (datopotamab deruxtecan) for breast cancer and Tivdak (tisotumab vedotin) for recurrent or metastatic cervical cancer (3).

 announced a collaboration on January 2 to advance IBI3009, a novel delta-like ligand 3-targeted antibody drug conjugate candidate for advanced SCLC (4).

How did access to cancer drugs expand in February?

The clinical-stage radiopharmaceutical company 

 an oversubscribed $112 million Series C financing round in February (5). This funding was to be used to accelerate clinical development of its radionuclide therapy pipeline and expand the company's manufacturing capacity.

AstraZeneca’s Lynparza (olaparib) was accepted

 for use within National Health Services Scotland by the Scottish Medicines Consortium. This acceptance provided a new treatment option for adults with human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer who possess germline BRCA1 or BRCA2 mutations and have previously undergone chemotherapy (6).

What regulatory approvals were granted in the spring?

 for extension of their therapeutic indications (7). Notably, a positive opinion was issued for Opdivo (nivolumab) for a perioperative regimen, including neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo, for resectable NSCLC in patients with PD-L1 expression. CHMP also extended indications for the cancer treatments Bosulif (bosutinib) and Calquence (acalabrutinib). The biosimilar Jubereq (denosumab) received a positive opinion for preventing skeletal-related events in adults with advanced malignancies involving bone.

full approval to Bayer’s Vitrakvi (larotrectinib

), a first-in-class tropomyosin receptor kinase (TRK) inhibitor (8). This approval is specifically for treating solid tumors in both adult and pediatric patients with a neurotrophic TRK gene fusion.

What infrastructure investments occurred in May?

On May 1, 2025, Aviva Capital Partners and Socius announced a 

 to develop a new cancer research and treatment center in Sutton, London, located at the London Cancer Hub (9). The project aims to accelerate cancer research and contribute to the discovery and development of new diagnostic technologies and cancer drugs.

AstraZeneca announced on May 6, 2025, that 

Calquence (acalabrutinib) received approval in the EU

 (10). Acalabrutinib, a second-generation Bruton’s tyrosine kinase (BTK) inhibitor, was approved in combination with bendamustine and rituximab for treating adults with previously untreated mantle cell lymphoma who are ineligible for an autologous stem cell transplant.

CellCentric completed a $120 million Series C funding round

 to advance inobrodib, a potential first-in-class oral p300/CBP inhibitor for multiple myeloma. This agent targets the reduction of transcription factors MYC and IRF4 to address therapy resistance in patients with relapsed or refractory multiple myeloma (11).

2025 Oncology Milestones: A Year of Breakthroughs (Created using NotebookLM)

BioNTech announced plans on June 12, 2025, to acquire CureVac

 in an all-stock transaction valued at approximately $1.25 billion (12). This acquisition aimed to accelerate the development and manufacturing of next-generation messenger RNA (mRNA) immunotherapies for oncology by combining the strengths of the two German biotechnology companies.

 included the following recommendations for market authorization (13):

• Zemcelpro (dorocubicel/unexpanded umbilical cord cells) received conditional marketing authorization for treating adults with hematological malignancies who require allogeneic hematopoietic stem cell transplantation when no other suitable donor cells are available.

• The orphan drug Ogsiveo (nirogacestat) was approved for the treatment of adults with progressing desmoid tumors.

• The biosimilar Vivlipeg (pegfilgrastim) received a positive opinion for reducing the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.

Priothera was awarded nearly €1.7 million

 in non-dilutive funding via a French government innovation competition (i-Nov) (14). This funding will support a clinical program evaluating its novel oral S1P receptor modulator, mocravimod, as an addition to commercial CAR-T cell therapies for hematologic malignancies.

 oncology services contest at the BIO 2025 convention in June (15). The contest aims to accelerate the development of recombinant protein-based cancer therapies, offering the winner credit toward Mabion’s end-to-end CDMO services.

Were there advancements in radiopharmaceutical therapies?

 concerning oncology therapeutic radiopharmaceuticals (RPTs) (16, 17). 

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development

 was created to help drug sponsors identify an optimized dosage for RPTs used in oncology indications during clinical development.

Radiopharmaceuticals have evolved from treating superficial tumors to treating internal tumors. FDA's 

 an increasing need for drug sponsors to demonstrate a better understanding of pharmacodynamics, potential toxicity liabilities, and the therapeutic window for these new systemically injected therapies, alongside designing clinical trials to gather data on dosimetry (17).

 that it entered into agreements with Hengrui Pharma to develop treatments for several therapeutic areas, including new therapies for GSK’s oncology pipeline (18).The collaboration included 11 programs for which Hengrui Pharma will lead development through the completion of Phase I trials.

What strategies for research and manufacturing happened?

In September, the Phase IIa clinical trial for the small-molecule immunotherapy drug HTL0039732 was launched by 

 (19). This investigational therapy targets the EP4 receptor to address tumor-mediated immunosuppression, aiming to boost responses in resistant solid tumors. Also focused on novel approaches, 

Medicines Discovery Catapult (MDC) and Crown Bioscience

 announced a strategic partnership to create an integrated platform to accelerate the development of radiopharmaceuticals (20).

 for medications to treat breast, bladder, and gastric cancers (21). Studies include arms of trials for trastuzumab deruxtecan (Enhertu), a Phase III trial of datopotamab deruxtecan (Datroway), and final overall survival results for perioperative durvalumab (Imfinzi).

What developments were at the end of the year?

United Kingdom National Nuclear Laboratory and MDC

 co-led a project focused on developing next-generation cancer treatments known as Targeted Alpha Therapies (22).

 (teclistamab-cqyv), used in combination with daratumumab for relapsed or refractory multiple myeloma, was awarded FDA’s Commissioner’s National Priority Voucher (23) one day after Phase III MajesTEC-3 trial data were released showing the Tecvayli combination produced superior outcome. This voucher offers the opportunity to accelerate drug review to just 1-2 months.

Indivumed and the Wilmot Cancer Institute

 at the University of Rochester Medical Center launched a joint venture to accelerate the development of novel cancer therapeutics (24). This collaboration focuses on patient-centric R&D, initially targeting advanced solid cancers.

Johnson & Johnson. European Commission Approves Lazcluze (lazertinib) in Combination with Rybrevant (amivantamab) for the First-Line Treatment of Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer. Press Release. Jan. 21, 2025.

AstraZeneca. AstraZeneca Receives Two Positive NICE Recommendations for Lung Cancer Patients Across England and Wales. Press Release. Jan. 22, 2025

EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025. Press Release. Jan. 31, 2025. 

Innovent Biologics. Innovent Enters into Exclusive Global License Agreement with Roche for Novel DLL3 Antibody Drug Conjugate. Press Release. Jan. 2, 2025. 

AdvanCell. AdvanCell Successfully Completes an Oversubscribed US$112M Series C Financing. Press Release. Feb. 3, 2025. 

AstraZeneca. Lynparza (olaparib) Accepted for Use in Scotland to Treat Germline BRCA-Mutated HER2-Negative Locally Advanced or Metastatic Breast Cancer After Chemotherapy. Press Release. Feb. 10, 2025. 

EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24–27 March 2025. Press Release. March 28, 2025.

Bayer. US FDA Grants Full Approval of Vitrakvi (larotrectinib) for Adult and Pediatric Patients with NTRK Gene Fusion-Positive Solid Tumors. Press Release. April 10, 2025. https://www.pharmtech.com/view/bayer-announces-fda-s-first-full-approval-of-ntrk-inhibitor

Aviva. Aviva Capital Partners and Socius Submit Plans for £1 Billion Development to Create the World’s Leading Centre for Cancer Research and Treatment. Press Release. May 1, 2025. 

AstraZeneca. Calquence Plus Chemoimmunotherapy Approved in the EU as First and Only BTK Inhibitor for 1st-Line Mantle Cell Lymphoma. Press Release. May 6, 2025. 

CellCentric Secures $120 Million Investment to Advance Inobrodib for Treating Multiple Myeloma.

BioNTech Announces Strategic Transaction to Acquire CureVac in Public Exchange Offer

EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 16–19 June 2025. Press Release. June 20, 2025. 

https://www.pharmtech.com/view/six-biosimilars-part-of-ema-s-authorization-recommendations-in-june

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

Mabion. Mabion Launches €500,000 Services Contest to Support Next-Gen Oncology Breakthroughs. Press Release. June 17, 2025. 

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development. Draft Guidance for Industry

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-therapeutic-radiopharmaceuticals-dosage-optimization-during-clinical-development

Haigney, S. The Impact of FDA’s Guidance on Clinical Trials for Radiopharmaceuticals. 

https://www.pharmtech.com/view/the-impact-of-fda-s-guidance-on-clinical-trials-for-radiopharmaceuticals

GSK. GSK and Hengrui Pharma Enter Agreements to Develop Up to 12 Innovative Medicines Across Respiratory, Immunology & Inflammation, and Oncology. Press Release. July 28, 2025. 

Nxera Pharma and Cancer Research UK Announce First Patient Dosed in Phase 2a Trial of Investigational Cancer Immunotherapy HTL0039732

Haigney, S. MDC and Crown Bioscience. Medicines Discovery Catapult and Crown Bioscience Form Strategic Global Alliance for Radiopharmaceutical Innovation. Press Release. Sept. 11, 2025. 

AstraZeneca Furthers Ambition to Redefine Cancer Care with First Data from Four Major Pivotal Trials at ESMO.

UK Nuclear Revolution Powers Next-Generation Precision Cancer Therapies.

FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results. News release. FDA. December 15, 2025. Accessed December 15, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-proactively-awards-national-priority-voucher-based-strong-phase-3-study-results

Indivumed and University of Rochester Medical Center Expand Collaboration for Patient-Centric Discovery of Novel Therapeutics.

In 2025, significant advancements in oncology included new drug approvals, infrastructure investments, and strategic collaborations. Key developments involved the approval of Johnson & Johnson's Lazcluze and Rybrevant for NSCLC, AstraZeneca's Imfinzi and Tagrisso for lung cancer, and Bayer's Vitrakvi for TRK gene fusion-positive tumors. Infrastructure investments included a £1 billion cancer research center in London. Strategic collaborations, such as BioNTech's acquisition of CureVac, aimed to enhance mRNA immunotherapies. The FDA issued guidance on radiopharmaceuticals, and new initiatives focused on expanding oncology pipelines and innovative cancer therapies.

In this overview, PharmTech takes a look back at significant news in the development and approval of cancer treatment in 2025.

A Year of Advancements in the Treatment of Cancer

PharmTech connected recently with Henrik Johanning, senior vice president, Quality & Strategy, Epista Life Science, to look back at 2025 and ahead into 2026. Johanning details major European regulatory and manufacturing trends transitioning from 2025 into 2026, focusing on the operationalization of modern quality risk management (QRM) and tangible upgrades required for facilities to achieve sustained compliance with European Union (EU) good manufacturing practice (GMP) Annex 1. The conversation explores the rising expectations for digital Good Manufacturing Practice (GMP) driven by Annex 11 and Annex 22, the reconfiguration of supply chains due to geopolitical factors, and the ongoing convergence of global standards under International Council for Harmonisation (ICH), Pharmaceutical Inspection Co-operation Scheme (PIC/S), and EU GMP.

PharmTech: What trends are shaping the transition from 2025 into 2026?

Johanning: From a European regulatory and manufacturing perspective, several converging trends stand out:

 following ICH Q9. Companies are moving from theoretical risk assessments toward genuinely risk-based prioritization of controls, remediation, and capital investment.

 Many sterile facilities are discovering that procedural compliance is insufficient; sustained compliance requires tangible upgrades to contamination control strategies, facility design, and utilities, particularly water and HVAC-systems.

, driven by EU GMP Annex 11 and Annex 22.

Annex 11 is driving stronger expectations around lifecycle management of computerized systems, data integrity, supplier oversight, and continued validation in increasingly complex and cloud-based IT architectures.

Annex 22 reinforces that digital tools, automation, and data used across development and manufacturing must be governed under the pharmaceutical quality system, with clear roles, accountability, and traceability from development into commercial production.

 is accelerating as manufacturers respond to geo-political uncertainty, rising tariffs, and single-source dependencies. We see increased focus on regionalization, dual sourcing, and closer alignment between manufacturing footprint decisions and global regulatory convergence under EU GMP, ICH, and PIC/S.

Continued convergence across EU GMP, ICH, and PIC/S

, resulting in less tolerance for regional interpretation gaps, particularly during inspections of global manufacturing and supply networks.

What trends do you see in AI and digital technology?

AI and advanced analytics are already improving efficiency in such areas as process monitoring, deviation handling, and documentation.

The main barriers to broader adoption are regulatory and organizational rather than technical (Figure): non-GMP-ready data, uncertainty around how to validate and govern AI/ML within Annex 11 expectations, and a shortage of hybrid profiles combining quality, engineering, and data expertise.

What trends do you see in pharmaceutical professional skills and talent?

Digitalization is widening the gap between traditional GMP roles and newer automation- and data-driven roles.

Leading organizations are investing in structured upskilling linked to concrete initiatives (e.g., manufacturing execution systems, continued process verification, digital quality management systems), developing hybrid quality, engineering, and data profiles, and using clearer career pathways as a retention lever.

What trends do you see in facilities, competitiveness, and sustainability?

Margin pressure, patent cliffs, and pricing reforms are forcing tighter alignment between network strategy, quality risk, and capital expenditure decisions. Sustainability is increasingly shaping facility and process design, especially HVAC, water systems, and cleaning strategies, where environmental performance, operational robustness, and cost efficiency are beginning to converge into the same business case.

What should pharma manufacturers plan for in 2026?

Manufacturers should prepare for regulatory-driven digitalization under Annex 11 and Annex 22, continued modernization of legacy sterile and biotech facilities, and a shift from isolated IT or engineering projects toward integrated people, process, technology programs, with QRM, data integrity, lifecycle governance, and supply chain resilience built in from the outset.

European regulatory and manufacturing trends are evolving, with a focus on modern quality risk management and compliance with EU GMP Annex 1. The transition from theoretical to risk-based prioritization is emphasized, alongside the need for tangible facility upgrades. Digital GMP expectations are rising, driven by Annex 11 and Annex 22, necessitating robust lifecycle management and data governance. Geopolitical factors are prompting supply chain reconfiguration, while global standards are converging. AI and digital technology adoption face regulatory and organizational barriers, and digitalization is reshaping pharmaceutical professional skills and facility design.

Henrik Johanning, Epista Life Sciences, takes a European perspective on what will be required of pharma developers and manufacturers in 2026.

Navigating Digitalization, QRM Maturity, and Global Compliance Convergence into 2026

A look back at the top 10 PharmTech videos of 2025 reveals several overarching themes dominating the pharmaceutical industry landscape, primarily centered on advancing complex therapeutic modalities, navigating stringent regulatory environments, and accelerating development through technological integration. A significant focus across these videos was on specialized medicines, including gene therapies using 

high-concentration biologics formula tion

 for targeted cancer treatment. These advanced therapies necessitate novel manufacturing strategies, 

such as the adoption of the "CGT 2.0" paradigm for cell and gene therapy (CGT)

, which emphasizes flexibility, scalability, automation, and data analytics to overcome bottlenecks and ensure commercial viability.

Crucially, these advancements are underpinned by a strong emphasis on 

regulatory compliance, and digital transformation

The pharmaceutical industry in 2025 is characterized by advancements in complex therapeutic modalities, regulatory navigation, and technological integration. Key areas of focus include gene therapies using AAV vectors, high-concentration biologics, and radiopharmaceuticals for targeted cancer treatment. These therapies demand innovative manufacturing strategies like the "CGT 2.0" paradigm, emphasizing flexibility and automation. Quality systems, regulatory compliance, and digital transformation are crucial, with AI and machine learning optimizing workflows. The industry's dual focus on biological science and data technology aims to deliver faster, safer, and more personalized medicine.

The top 10 PharmTech videos of the year cover advanced therapies, high-concentration biologics, major mergers and acquisitions, AI use, and regulatory challenges.

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