Susan Haigney

PharmTech Weekly Roundup - April 10, 2026

 took a look at the shift toward proactive, data-driven contamination control, the adoption of advanced material science to solve manufacturing hurdles, and an evolving regulatory environment that is accelerating the market entry of complex generics and biosimilars. The industry is also seeing a move toward modular collaboration, where large-scale manufacturers leverage specialized external platforms to drive innovation in gene therapy and oncology.

The generic-drug market saw an expansion this week with the 

FDA’s approval of the first generic version of dapagliflozin tablets

, introducing significant competition into the US type 2 diabetes market, requiring manufacturers to strictly adhere to specific safety labeling and bioequivalence standards. This milestone underscores the importance of production readiness as multiple generic applicants enter the market simultaneously.

the first interchangeable denosumab biosimilars

 in the US, leveraging an evolving regulatory landscape to provide affordable alternatives for treating serious bone conditions while maintaining rigorous safety monitoring. Regulatory shifts are now reducing the requirements for comparative efficacy and switching studies, potentially accelerating future biosimilar competition.

Bristol Myers Squibb and Oxford BioTherapeutics

 announced a partnership this week to leverage specialized external platforms for identifying high-precision oncology targets. Oxford BioTherapeutics will use its OGAP-Verify platform to find specific targets in solid cancers and create new T-cell engager molecules. Bristol Myers Squibb will then lead subsequent research, development, and commercialization activities.

Affinia Therapeutics has received clinical trial approval for AFTX-201,

 an investigational gene therapy targeting BAG3-associated dilated cardiomyopathy. Advances in capsid engineering are enabling more efficient cardiac gene delivery at significantly lower doses, improving both manufacturing economics and safety margins for treating inherited cardiomyopathies. These proprietary capsids allow for comparable delivery at doses 5 to 10 times lower than conventional vectors, easing downstream purification constraints.

Industry experts offered input on a variety of topics. Wilber Cruz, Wilbur Hightower, and Vaishali Shah, from Abzena 

detailed how modern contamination control strategies are shifting quality control microbiology

 from a reactive end-product testing role to a proactive, data-driven function integrated across the entire biopharmaceutical lifecycle. This evolution is supported by Rapid Microbiological Methods (RMMs) and real-time environmental monitoring, which move micro-testing from simple compliance to an operational decision-making tool.

IPEC-Americas provided an explanation on how co-processed excipients

 provide engineered, multifunctional solutions that enhance manufacturability and performance beyond simple physical blends, specifically supporting advanced techniques like continuous manufacturing. By integrating excipients at the particle level, CPEs improve flow and compressibility, helping formulators overcome traditional batch processing limitations.

advice for mitigating carcinogenic nitrosamine risks

, including a comprehensive strategy involving careful excipient selection, manufacturing process optimization, and the use of chemical scavengers to ensure patient safety. Industry leaders are now utilizing low-nitrite excipients and avoiding high-risk conditions like wet granulation to comply with global acceptable-intake limits.

From the integration of predictive analytics in the cleanroom to the precision engineering of delivery vectors, these advancements highlight an industry focused on efficiency and patient safety. Staying ahead of these technical and regulatory shifts is essential for any professional in the development and manufacturing space.

Be sure to visit PharmTech.com to read more about these and other pharma industry developments.

Videos

This week, PharmTech discussed proactive, data-driven contamination control, solving manufacturing hurdles, and the market entry of complex generics and biosimilars. 

The integrity of the pharmaceutical supply chain is an ever-evolving landscape. Predictive modeling and digital simulations are being used in transport validation to identify problem areas such asextreme temperature fluctuations and varying transit durations. Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with 

 about the variety of tools being utilized to protect the supply chain.

PharmTech: How are pharma companies using predictive modeling or simulation to design and validate transport conditions?

 Pharma companies are really relying on digital simulations to support transport validation, not to completely replace the physical studies, but the simulated data in general is being used a lot alongside the real-world qualification to be predictive, but also to understand what are the drivers of risk, what sort of stress conditions there are, and try and simulate those worst-case scenarios.

A lot of digital predictive tools are applied to simulate the extremes, whether they are about the temperature or variability in the conditions or the durations, and so on. But one of the things I heard was that hybrid qualification strategies are more prevalent than simulated results.

As digital authentication technologies (eg, serialization, smart labels, mobile/QR, or NFC-based verification) mature, what criteria are used to evaluate which solutions are truly scalable and GMP-ready?

[There is] a lot of talk about all the different types of digital tools, including use of AI, 2D barcodes, and phone apps to sort of scan and authenticate, for the patient at point in time. So, a lot of those are being worked upon in the industry.

It looks like having something in the hands of the patient, like a phone app that you can open your camera and scan a barcode on the product to authenticate it,

Everyone has an Android, everyone has a smartphone, or an Apple phone. So, having those apps is definitely going to be probably the easiest, most scalable approach.

But alongside those, there are a lot of other technologies where they're trying to look at labels, making sure that the labels are verified, digitally, or they're using AI to predict the types of counterfeit areas that the people who try to counter-counterfeit would be using.

I think what we heard was that QR codes are going away, because it's easier to sort of counterfeit those, but 2D barcodes with digital footprints inserted into those 2D barcodes is something that a lot of organizations are moving into.

I think one of the biggest challenges even with using digital tools is the education and the awareness aspect. Because even if you have all of these tools, the mindset of the patient and doctors [might not be is] this product not authentic. I mean, when I take a medication, I'm not thinking whether or not it's authentic. I'm assuming it.

So, if I wasn't educated to actually use these digital tools, I wouldn't even be trying to authenticate the product.

So, there's some challenges even with the digital tools.

What can you tell us about the presentation you moderated at PDA Week in March 2026?

Well, there were two topics. One of them was talking about how do we get ahead of the game and be a little bit more predictive when it comes to tackling with counterfeit products.

We saw how, in a lot of parts of the world, especially some of the developing countries, where drug products are being counterfeited, you can see them being sold on websites like eBay, which are local to those countries.

And, they're getting smarter. The counterfeit folks are getting very, very smart with the way they counterfeit. They're using the same serial numbers as the original manufacturers, similar, expiration dates, same labels. They're using a lot of the available technology to make sure that the product appears to be sort of authentic, when it's not.

That's a big challenge, especially in some of those countries, and it's not always easy to partner with local authorities to crack that down.

From the other session, we also learned that there were 104 respondents for the PDA transport validation survey, and they unanimously agreed about the need for coming to an aligned solution as to what to do around transport validation.

But there's some challenges where regulators are slow to adapt.

The specific types of discussions around whether or not to use simulated studies, real-world data, those types of discussions are still where we're seeing less alignment.

So, there's a need for call to action, for the broader industry to sort of take this survey and, and act upon it and, and come up with some sort of a white paper or something like that.

Articles

Pharmaceutical manufacturers are increasingly pairing digital simulations with physical transport qualification to predict excursions, identify risk drivers, and stress-test worst-case temperature and duration variability. Scalable anti-counterfeiting strategies are gravitating toward patient-facing smartphone authentication, while more robust 2D barcodes with embedded digital footprints are favored over easily replicated QR codes. Counterfeit operations are advancing by mimicking legitimate serials, labels, and expiry dating, especially in developing markets with limited enforcement collaboration. Industry feedback signals urgency for harmonized transport validation approaches amid slow regulatory adaptation.

Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about efforts in anticounterfeiting and the use of predictive modeling to validate transport conditions. 

Techniques for Securing the Supply Chain and Combating Counterfeit Medicines

PharmTech Weekly Roundup - April 3, 2026

Current trends across the pharmaceutical landscape reveal a decisive shift toward integrated process intelligence and regulatory agility. We are seeing a move away from isolated pilot projects toward building permanent digital infrastructure—from AI-driven discovery platforms to dynamic contamination control strategies. Simultaneously, regulatory bodies are setting new precedents for speed, utilizing accelerated review programs and virtual modeling to condense development timelines.

In manufacturing, digital capability is becoming as critical as physical scale. 

AI and digital twins are transitioning from pilots to core infrastructure across process development, tech transfer, and manufacturing design

. This is further supported by major investments, such as 

Eli Lilly’s $2.75 billion collaboration with Insilico Medicine

, which signals a significant commitment to integrating generative AI into the core of the drug discovery and development pipeline.

FDA’s 50-day approval of the oral GLP-1 Foundayo

 highlights a new era of accelerated regulatory pathways and simplified small-molecule manufacturing. While this introduces new oral options for GLP-1s, competition remains high; 

suggests oral semaglutide may offer superior weight loss and tolerability compared to the newly approved GLP-1 from Lilly.

a high-dose regimen of Biogen’s SPINRAZA

 for the treatment of spinal muscular atrophy this week. The approval of a high-dose nusinersen regimen demonstrates successful pharmaceutical lifecycle management through dose optimization while presenting new manufacturing and supply chain complexities.

European Medicines Agency’s CHMP recommended five new drugs 

for approval at its March 2026 meeting, including novel treatments for bladder and lung cancers.

Compliance standards are evolving from static to dynamic models. Revised EU 

necessitate a shift from static documentation to a dynamic, data-driven Contamination Control Strategy across the product lifecycle. Innovation is even reaching preclinical stages. The EMA and FDA are advancing 

 to replace traditional animal control groups with virtual models in preclinical studies.

Eli Lilly acquired Centessa Pharmaceuticals

 for $6.3 billion, which gives Lilly full ownership of Centessa's pipeline of orexin receptor 2 agonists, a class of compounds designed to directly modulate the neurobiological system governing the sleep-wake cycle.

The industry is seeing a shift toward integrated process intelligence and new regulatory pathways.

Workplace modern laboratory for molecular biology test | Image Credit: ©JacobST - stock.adobe.com

The European Medicines Agency (EMA) announced on March 31, 2026 that it’s Committee for Medicinal Products for Human Use (CHMP) has issues a draft qualification opinion

 for a preclinical research methodology to reduce the use of animals in specific dose-range finding studies.

 The new approach method (NAM) would replace standard animal control groups with virtual groups, and once qualified, would allow CHMP to accept evidence generated from virtual control groups in medicine approval applications.

EMA states that reduction in animal testing will be gradual. The first qualification opinion for a NAM used in toxicity assessment will create a “blueprint” for future applications, and potential versions of the NAM could be qualified in the future for toxicological studies that require routine control groups. “Replacing control groups with ‘virtual animals’ in such studies would have a substantial impact on reducing the total numbers of animals used,” the agency stated in the press release.

To create a virtual control group, control data are characterized, and appropriate virtual comparator animals are identified, in line with a standard operating procedure and a statistical approach complemented by expert judgement.

The use of virtual control groups is part of EMA’s and the International Coalition of Medicines Regulatory Authorities’ commitment to replace, reduce, and refine the use of animals in the development and regulation of drugs. According to the agency, NAMs can contribute to these efforts, and the agency supports the integration of NAMs into various mechanisms to enable regulatory acceptance and foster innovation without the use of animals.

“Through the integration of virtual control groups, EMA also seeks to improve the relevance and predictability of non-clinical testing, which supports both more efficient and more ethically responsible medicines development,” the agency stated in the release.

 “A key requirement for the implementation of virtual control groups is the assurance that their use does not compromise study outcomes or pose a threat to human safety in later clinical trials.”

Public consultation on the draft opinion is open from March 31 through May 12, 2026. Input from the scientific community and stakeholders can be sent to 

How Is FDA Making Similar Moves in the US?

On March 18, 2026, FDA issued a draft guidance document on how to validate NAMs to replace animal testing in drug development.

 The document provides recommendations for validating NAMs when nonclinical NAMs data are provided.

 Drug sponsors are required to submit nonclinical pharmacology and toxicology data before an investigational drug can go to clinical trial.

The guidance document established 4 validation principles:

Context of use that provides a clear definition of the NAMs’ intended regulatory purpose

Human biological relevance to demonstrate how NAMs can assess toxicity

Technical characterization to establish scientific confidence through robust, reliable, and reproducible methods

Fit-for-purpose to provide assurance that NAMs help in regulatory decision-making (eg, drug review and potential approval).

“Technological advances are allowing us to move beyond animal testing in drug development, which has a poor track record of predicting safety and efficacy in humans,” said FDA Commissioner Marty Makary, MD, MPH, in a press release.

 “This guidance will facilitate the adoption of modern alternatives to animal testing in regulatory submissions.”

Draft Qualification opinion for Virtual Control Groups (VCG) to replace Concurrent Control Groups (CCG) in rat non-GLP Dose-Range Finding (DRF) studies. EMA. March 31, 2026. Accessed April 1, 2026. 

https://www.ema.europa.eu/en/documents/other/draft-qualification-opinion-virtual-control-groups-vcg-replace-concurrent-control-groups-ccg-rat-non-glp-dose-range-finding-drf-studies_en.pdf

EMA consults on virtual control groups to help reduce animal use in medicines development. EMA. Press release. March 31, 2026. Accessed April 1, 2026. 

https://www.ema.europa.eu/en/news/ema-consults-virtual-control-groups-help-reduce-animal-use-medicines-development

FDA releases draft guidance on alternatives to animal testing in drug development. FDA. Press release. March 18, 2026. Accessed April 1, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-releases-draft-guidance-alternatives-animal-testing-drug-development

General considerations for the use of new approach methodologies in drug development. Draft guidance.

 FDA. March 19, 2026. Accessed April 1, 2026. 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-considerations-use-new-approach-methodologies-drug-development

The agency has issued a draft qualification opinion on a new preclinical research methodology.

EMA Seeks Opinion on Animals Used in Drug Development

3d rendered medically accurate illustration of lung cancer | Image Credit: ©Sebastian Kaulitzki -stock.adobe.com

The European Medicines Agency (EMA) announced on March 27, 2026 that its Committee for Medicinal Products for Human Use (CHMP) recommended 5 new drugs for approval at its March 2026 meeting.

 These approvals were for treatments of cancers, activated phosphoinositide 3-kinase delta syndrome, and different types of oedemas. CHMP also recommended extending the indication of 13 medicines and confirmed its rejection of a change for tasimelteon.

What Were the 5 Approval Recommendations?

CHMP granted conditional marketing authorization to Adstiladrin (nadofaragene firadenovec), for the treatment of adult patients with Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

Two lung cancer treatments were recommended: a new treatment for relapsed extensive-stage small cell lung cancer (ES-SCLC), Imdylltra (tarlatamab), addresses an unmet need for adults with limited treatment options; and a maintenance treatment, Zepzelca (lurbinectedin), for patients with (ES-SCLC) whose disease has not progressed after first-line induction therapy.

Imdylltra (tarlatamab) is a monotherapy to adults with ES-SCLC that has relapsed during or after initial treatment with platinum-based chemotherapy. The treatment options for these patients are limited.

 Tarlatamab is a bispecific antibody that acts as a T-cell engager that binds to the DLL3 protein on tumor cells and the CD3 protein on T cells, activating T cells and leading to the production of inflammatory cytokines and the release of cytotoxic proteins. This leads to tumor cell death. Results from a phase 3 study showed significant improvement in median overall survivor rate of 13.6 months in patients treated with Imdylltra compared to 8.3 months with the usual standard of care.

A positive opinion was granted under exceptional circumstances to Joenja (leniolisib), for the treatment of the rare, inherited condition, activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more. APDS is a progressive condition of the immune system that may be life threatening.

Pediatric-use marketing authorization was given to Bopediat (furosemide) for the treatment of cardiac or renal oedema as well as hepatic oedema and hypertension in children from birth to under 18 years of age with chronic kidney disease. The product’s sponsor submitted a hybrid application that relies on pre-clinical tests results and clinical trial results of an already-authorized reference product as well as new data.

CHMP recommended extensions for the following 13 drugs:

However, the committee, after reexamination, refused to change the marketing authorization for Hetlioz (tasimelteon) to include the treatment of nighttime sleep disturbance in adults and children aged 3 to 15 years with Smith-Magenis syndrome.

CHMP also finalized its review of the antiviral, Tecovirimat SIGA (tecovirimat), to treat smallpox, mpox, and cowpox.

 The committee concluded that Tecovirimat SIGA should not be used to treat mpox, a viral infection that can lead to serious illness in children, pregnant people, and those with weakened immune systems. The recommendation was in response to data from 4 studies that showed Tecovirimat SIGA did not heal lesions faster, relieve pain, or clear the virus from the body faster when compared to a placebo.

“At the time of approval, it was not possible to carry out studies in infected people, as the viruses rarely circulated,” EMA stated in a press release.

 “Therefore, the approvals of Tecovirimat SIGA for mpox, as well as for smallpox, cowpox and complications from smallpox vaccines, were based on results from an animal model of mpox infection. The animal data demonstrated antiviral activity and a survival benefit when treatment was started early and a reduced efficacy if treatment was initiated later after exposure to the virus.”

Additional data on the benefits and risks of Tecovirimat SIGA were considered from programs in the United States and Africa, a epidemiological study in the European Union, animal studies, laboratory data, and published scientific research. The review did not identify any new safety concerns.

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026. EMA. Press Release. March 27, 2026. Accessed March 30, 2026. 

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-march-2026

New treatment for relapsed extensive-stage small cell lung cancer. EMA. Press Release. March 27, 2026. Accessed March 30, 2026. 

https://www.ema.europa.eu/en/news/new-treatment-relapsed-extensive-stage-small-cell-lung-cancer

EMA recommends restricting use of Tecovirimat SIGA. EMA. Press Release. March 27, 2026. Accessed March 30, 2026 

https://www.ema.europa.eu/en/news/ema-recommends-restricting-use-tecovirimat-siga

During its March 2026 meeting, the agency’s Committee for Medicinal Products for Human Use approved treatments for Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer, relapsed extensive-stage small cell lung cancer, activated phosphoinositide 3-kinase delta syndrome, and oedema of cardiac, renal, hepatic origin, and hypertension in children.

EMA Recommends Five New Drugs, Including Lung Cancer Treatment

PharmTech Weekly Roundup-March 27, 2026

Merck’s multi-billion-dollar acquisition of Terns Pharmaceuticals 

reinforces the industry’s focus on allosteric inhibition as a primary strategy to overcome drug resistance in oncology.The deal centers on TERN-701, an investigational oral drug candidate.

neurologic symptoms via surrogate endpoint, signaling evolving rare disease development standards, demonstrating a growing regulatory flexibility toward using biochemical surrogate endpoints to fast-track treatments for ultra-rare diseases.

In conference news, PDA Week saw discussions on a variety of topics. Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda moderated a session on 

the adoption of digital simulations for transport validation

 and 2D barcodes with digital footprints to combat increasingly sophisticated global counterfeiting. Ryan Murray of ValSource spoke about the 

use of a holistic contamination control strategy,

 supported by innovative far-UVC technology and robust environmental monitoring, for maintaining a consistent state of compliant control was also featured. Richard Jaenisch and David Jaenisch highlighted how 

 are enabling adaptive, competency-focused workforce training that ensures no learner falls behind during intensive technical workshops; and a 

Human-AI Training Parallelization framework

 provides a transparent method for integrating generative AI into existing workflows while strictly protecting sensitive intellectual property. Check out 

 to watch interviews with some of the PDA Week session speakers.

, manufacturers announced commitments to expanding domestic finished-dose capacity and specialized technologies like high-potency spray drying to mitigate global supply chain risks. 

are building end-to-end manufacturing chains for antibody-drug conjugates while pioneering sustainable, methanol-free fermentation processes at an industrial scale.

New content on PharmTech.com this week included a 

look at advancements in ensuring drug product quality.

 Quality was a key topic this week with the latest episode of 

discussing how preventing high-level recalls requires a proactive quality unit that regularly walks the shop floor to identify systemic vulnerabilities and human errors before they reach the patient. Columnist Cheryl Barton also took a look at 

how Europe is implementing its most significant pharmaceutical legislation

 in two decades, introducing joint clinical assessments to harmonize evaluations and expedite patient access.

USP’s Tony Lakavage provided his thoughts on 

 and gave insight on how the US Pharmacopeia is utilizing its 

to identify geographic concentration risks and advocate for the adoption of advanced manufacturing technologies.

Partha Anbil, a cognitive enterprise transformation leader with IBM’s Healthcare and Life Sciences practice, 

 have become essential for balancing the massive computational power of the public cloud with the private infrastructure required for GxP compliance and IP security.

And Denis Beckford Vera, head of Radiopharmacology, Champion Oncology, explained how 

requires bridging the preclinical-clinical gap by utilizing patient-derived xenograft models to provide more accurate clinical predictions.

Whether through the integration of Pharma 5.0 automation or the onshoring of critical ingredients, the goal remains the same: ensuring a resilient supply of high-quality medicines. Staying informed on these integrated strategies is no longer optional—it is a requirement for modern pharmaceutical leadership.

 to watch this week’s interviews and read the latest news and technical articles.

This week, three core themes have emerged: the digital transformation of quality systems through AI and hybrid cloud architectures; the pursuit of supply chain resilience via onshoring and advanced mapping; and a regulatory push toward real-time data and flexible approval pathways. 