Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Chris Spivey

Pfizer re-balances weight loss portfolio with Metsera, Bristol Myers Squibb and Roche make Breast cancer progress, and Keytruda gets under your skin.

Behind the Headlines Episode 26: Clinical Advances, Weight-Loss Deals, and Swiss Startup Strength

Behind the Headlines bi-weekly episodes examine the ongoing trends, factors and fashions that cause pharmaceutical news to happen. Panelists are a mix of consultants, venture capitalists, scientists, patient advocates, journalists and editors. Each episode talks about the current headlines of the preceding weeks that are on everyone’s lips but seeks to highlight the more enduring lessons that hide behind these headlines.

In Episode 26, Sirpa Tsimal, Global Marketing Director, Switzerland Global Enterprise; Philip Just Larsen, MD, PhD, CEO, Six Peaks Bio; and Stephan Emmerth, Director of Business Development & Operations, BaseLaunch, take a close look at recent clinical trial progress, including Bristol Myers Squibb’s successful phase 3 results for relapsed refractory multiple myeloma (1) and Roche’s evERA study on advanced breast cancer (2), alongside Eli Lilly and Company's oral treatment for ESR1-mutated breast cancer (3) and Merck 's FDA approval for subcutaneous keytruda delivery (4).

Because of its very clear importance to Scandinavian countries, this all Swiss-based panel also examined the reasons behind Pfizer’s Metsera acquisition for $4.9Billion (5), a key move to re-shape the weight loss drug landscape, once again.

The panel also discussed what makes for a great set of accelerator business conditions for life sciences and scores Switzerland’s performance for several of the most important factors determining successful outcomes for the life science industry, most especially as they relate to innovative young companies, as well as the university systems that feed them, alongside the big pharma companies that help sustain the momentum being built.

Bristol Myers Squibb Announces Phase 3 EXCALIBER-RRMM Study Evaluating Iberdomide in Combination with Standard Therapies Demonstrated a Significant Improvement in Minimal Residual Disease Negativity Rates in Relapsed or Refractory Multiple Myeloma

Positive Phase III Results Show Roche’s Giredestrant Significantly Improved Progression-free Survival in ER-positive Advanced Breast Cancer

U.S. FDA Approves Inluriyo (Imlunestrant) for Adults with ER+, HER2-, ESR1-mutated Advanced or Metastatic Breast Cancer

FDA Approves Pembrolizumab and Berahyaluronidase Alfa-pmph for Subcutaneous Injection

Pfizer to Acquire Metsera and its Next-Generation Obesity Portfolio. Press Release

Videos

Alvin Jogasuria, ProBio; Matthew Lunning, University of Nebraska Medical Center; and Carl Schoellhammer, DeciBio, go behind the headlines to discuss the need for doing more with less.

Behind the Headlines Episode 25: Major Big Pharma Moves, Pressures of Capital Markets at Intersection with Autologous Versus Allogeneic

Behind the Headlines bi-weekly episodes examine the ongoing trends, factors, and fashions that cause pharmaceutical news to happen. Panelists are a mix of consultants, venture capitalists, scientists, patient advocates, journalists, and editors. Each episode talks about the current of the preceding weeks that are on everyone’s lips but seeks to highlight the more enduring lessons that hide behind these headlines.

In episode 25, Alvin Jogasuria, Head of Marketing, Americas and Europe, ProBio; Matthew Lunning, DO, Professor, University of Nebraska Medical Center (UNMC) Division of Oncology & Hematology; and Carl Schoellhammer, Partner, DeciBio, discuss the need for doing more with less as big pharma consolidates and rationalizes their pipeline. This equates to less waste, duplication, and inefficiency to lower costs, particularly in manufacturing aspects of cell and gene therapy. Layer on this the commercial exigencies of tariffs, Most Favored Nation pricing, rises in raw material and energy costs, and the business need to rationalize supply chain and materials pipelines further increases.

Novartis activity in acquiring Tourmaline Bio for cardiovascular disease treatment (1) and also Monte Rosa Therapeutics for degraders to treat immune-mediated diseases (in a deal worth up to $5.7B) (2) was examined from a portfolio perspective. A Pfizer announcement regarding acquiring Metsera Therapeutics for weight loss treatments with an up to $7.3 billion Metsera buyout (3) was another example of portfolio management via disease that the panel discussed.

Much of the remaining panel time was spent looking at CAR T-cell therapy expanding outside of oncology, as well as other advances in advanced therapy medicinal products, generally speaking, with UNMC patient Jan Janisch-Hanzlik being first in the world to receive a new allogeneic CAR T-cell therapy for multiple sclerosis serving as an example (4).


Novartis Acquiring Tourmaline Bio for Cardiovascular Disease Treatment Pacibekitug

Monte Rosa Therapeutics Announces Collaboration with Novartis for Degraders to Treat Immune-mediated Diseases

Pfizer Doubles Down on Weight-loss Treatments with Up to $7.3 Billion Metsera Buyout

World First: Multiple Sclerosis Patient Treated with Allogeneic CAR T Therapy

In the first-ever “Two-Minute Mysteries: BioPharma Stories,” Agilent’s Ken Boda shares the mystery of a low reading.

Two-Minute Mysteries: BioPharm Stories - Episode 1: The Mysterious Cause of a Low Reading



In this inaugural episode of the “Two-Minute Mysteries: BioPharma Stories” video series--created in partnership with our sister publication

--Ken Boda, a dissolution product specialist at Agilent Technologies, shares the story of a mysterious low reading.

Ken Boda
Dissolution Product Specialist
Agilent Technologies

Ken works primarily with customers in the US and Canada. He has a wide knowledge of analytical methods, method development, validation, and regulations in the pharmaceutical environment. He enjoys educating people on the science of dissolution and helping customers work through their method challenges.

Specialties: Dissolution Method Development and Validation, Dissolution Failure Investigations, HPLC, UV, Physical Testers, well-versed in USP, FDA, and ASTM regulations in regard to pharmaceuticals, nutritional supplements, and medical devices.

Find Ken on 

*Editor’s Note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.



Hi, my name is Ken Boda. I'm a dissolution product specialist with Agilent Technologies. I wanted to share a little, scientific mystery with you. Oftentimes, when we're working with dissolution and we have a failure, these can present as little mini mysteries to try to do a failure investigation, determine what's going on.

One example of a quick mystery is a customer of ours who had a dissolution with baskets and a disintegrant dosage form, and they had unexplained low results on a particular dissolution bath. They asked us to come out and take a look at it. We brought our 280-DS mechanical qualification system to the site to evaluate the system.

We found that the alignment of the system was good. However, we did note that there was some interesting spikes in vibration over time, and it turned out that the vibration was coming from a refrigerator that was on the same bench top as the dissolution. So what was going on? What was causing those low results?

Well, when we have spikes in vibration in a disintegrant dosage form in basket, we can shake that basket out and we end up having the powder land on the bottom of the vessel, and at the bottom of the vessel, we don't have much mixing. And so, as a result, we have a large amount of drugs sitting at the bottom of the vessel where it can't dissolve.

And that leads us to having low results. This is really important to monitor vibration and dissolution, because it can have a lot of interesting effects. We usually think of vibration causing higher and more variable results, but that's not always the case as evidenced by this basket study. So, thank you, and hope you enjoy the rest.

Behind the Headlines Episode 24: Surging Implementation of Sequence Event Reporting in CMC Analytics,

Behind the Headlines is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons that hide behind the headlines.

In episode 24, Aaron B. Cowley, PhD, CSO, Recipharm Advanced Bio; Renee A. Hart, president and CBO, LumaCyte; and Vibha Jawa, PhD, FAAPS, CSO, EpiVax, look at the recent round of Mega-Deals, in part driven by Big Pharma patent cliffs, but also a need to cover-every-technology-and-expertise-base for complex manufacturing of advanced therapy medicinal products.

In this current spate of M&A activity, the panel examines AbbVie’s acquisition of Gilgamesh Pharmaceuticals’ investigational therapy, Bretisilocin, for $1.2 billion (1); Enlaza Therapeutics’ collaboration with Vertex Pharmaceuticals for the development of war-lock drug conjugates and T-cell engagers (worth up to $2 billion) (2); and Argo BioPharma’s agreement with Novartis (a combined potential value of up to $5.2 billion), for “long-acting siRNAs which are designed to deeply and durably target disease-causing proteins represent an important paradigm shift in prevention and treatment of cardiovascular diseases” (3).

Because of its more direct impact on pharmaceutical chemistry, manufacturing, and controls and process analytical technology, the panel spent significant time to understanding the reasons the Waters-Becton Dickinson Mega Deal, valued around $17.5 Billion (4). On balance, it was thought the recurring revenue and regulatory knowledge in precision medicine and diagnostics afforded by Becton Dickson was the largest attraction for Waters to move ahead on this deal.

The panel rounds out the discussion asking what are the bright new technologies arriving, and what we’d wish for in our Christmas stockings come December.

AbbVie. AbbVie to Acquire Gilgamesh Pharmaceuticals' Bretisilocin, a Novel, Investigational Therapy for Major Depressive Disorder, Expanding Psychiatry Pipeline. Press Release. Aug. 25, 2025 

https://news.abbvie.com/2025-08-25-AbbVie-to-Acquire-Gilgamesh-Pharmaceuticals-Bretisilocin,-a-Novel,-Investigational-Therapy-for-Major-Depressive-Disorder,-Expanding-Psychiatry-Pipeline

Enlaza Therapeutics. Enlaza Therapeutics Announces Strategic Collaboration with Vertex Pharmaceuticals to Develop War-Lock Drug Conjugates and T-Cell Engagers for Improved Conditioning and Certain Autoimmune Diseases. Press Release. Sept. 2, 2025, 

https://enlazatx.com/press_release/enlaza-therapeutics-announces-strategic-collaboration-with-vertex-pharmaceuticals-to-develop-war-lock-drug-conjugates-and-t-cell-engagers-for-improved-conditioning-and-certain-autoimmune-diseases/

Argo Biopharma. Argo Biopharma Announces Multi-Asset License and Option Agreements with Novartis for Novel Molecules for Cardiovascular Diseases. Press Release. Sept. 3, 2025 

https://www.argobiopharma.com/news/153.html

Waters. Waters and BD's Biosciences & Diagnostic Solutions Business to Combine, Creating a Life Science and Diagnostics Leader Focused on Regulated, High-Volume Testing. Press Release. July 14, 2025. 

https://ir.waters.com/News--Events/newsroom/news-details/2025/Waters-and-BDs-Biosciences--Diagnostic-Solutions-Business-to-Combine-Creating-a-Life-Science-and-Diagnostics-Leader-Focused-on-Regulated-High-Volume-Testing/default.aspx

Aaron Cowley, Recipharm Advanced Bio; Renee Hart, LumaCyte; and Vibha Jawa, EpiVax, go behind the headlines to delve deeper into recent market deals driven by Big Pharma patent cliffs and the complex manufacturing of ATMPs. 

Behind the Headlines Episode 24: Surging Implementation of Sequence Event Reporting in CMC Analytics, Billion Dollar Deals Push Further Consolidation or Collapse, and an Analytics Wish List

 Benjamin McLeod and Sebastian Lykke Skafte Andersen go behind the headlines to examine the motivations behind recent M&A activity, tariff responses, and more.

Behind the Headlines, Episode 23: Patent Cliff Deals, Tariff Pressures, and the In Vivo Cell Therapy Bet

 is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons that hide behind the headlines.

In episode 23, the panel analyzes how looming patent cliffs, rising trade pressures, and a new wave of in vivo platforms are reshaping the biotech deal landscape. Benjamin McLeod, founder of Convey BIO, and Sebastian Lykke Skafte Andersen, managing director and founder of ClarityNorth Partners, examine how recent headlines signal deeper structural shifts for pharma commercialization and manufacturing strategy.

The panel begins by spotlighting Merck’s $10 billion acquisition of Verona Pharma (1) as a clear example of dealmaking driven by pricing headwinds. With the 

Most-Favored Nation (MFN) executive order

 pushing U.S. drug prices toward European benchmarks, biopharma buyers are racing to acquire late-stage, revenue-generating assets ahead of price compression. As margins come under threat, preemptive M&A is becoming a go-to strategy for portfolio fortification.

In Vivo CAR-T Moves Closer to Center Stage

Attention then turns to the in vivo cell therapy frontier. Gilead’s Kite Pharma recently acquired Interius Biotherapeutics for $350 million (2), adding a modular in vivo CAR-T platform aimed at broadening therapeutic applications and improving scalability. Cindy Perettie, executive vice president at Kite, highlighted the potential for combining Interius’ novel platform with Kite’s established infrastructure to accelerate in vivo therapeutic development.

AstraZeneca’s massive $50 billion U.S. investment

 as a strategic response to escalating U.S. 

, some exceeding 250%. The company’s pivot marks a larger industry trend toward reshoring biomanufacturing as a form of industrial policy, not just portfolio strategy. Beyond portfolio diversification, AstraZeneca’s U.S. expansion includes GLP-1 pipeline growth, CGT infrastructure, and regulatory optimization through increased U.S.-based trials.

Watch the full episode above for more insights into the evolving biopharma landscape and catch up on previous episodes of 

References 
1. Merck to Acquire Verona Pharma, Expanding its Portfolio to Include Ohtuvayre® (ensifentrine), a First-In-Class COPD Maintenance Treatment for Adults and Expected to Drive Growth into the Next Decade. Press Release. Merck. July 9, 2025. https://www.merck.com/news/merck-to-acquire-verona-pharma-expanding-its-portfolio-to-include-ohtuvayre-ensifentrine-a-first-in-class-copd-maintenance-treatment-for-adults-and-expected-to-drive-growth-into-the-next-dec/
2. Kite to Acquire Interius BioTherapeutics to Advance In Vivo Platform. Press release. InteriusBioTherapeutics. August 21, 2025. https://interiusbio.com/press-release/kite-to-acquire-interius-biotherapeutics-to-advance-in-vivo-platform/

Panel discussion addressing shifting policy and its impact on the future of chronic disease, diagnostics, and next-generation cell and gene therapies

Behind the Headlines, Episode 22: Chronic Disease Priorities, Biomarker Breakthroughs, and CGT-RLT Synergies

In episode 22, Jonathan D. Grinstein, PhD, North American Editor for 

; Manfred Scholz, PhD, President of Scholz Consulting Partners; and Erik Wiklund, PhD, CEO of Circio, tackle a shifting policy landscape and what it means for the future of chronic disease, diagnostics, and next-generation cell and gene therapies. They explore what’s rising, what’s receding, and what’s next for precision medicine.

The discussion opens with reflections on a growing realignment in U.S. healthcare priorities—from high-profile acute care innovations toward more long-term strategies for managing chronic illness. The panel agrees that the shift is overdue, citing a large body of data pointing to the long-term burden of untreated and under-managed conditions across the country (1). This shift occurs against a backdrop of geopolitical tensions, including tariffs and widespread staff layoffs affecting the life sciences workforce.

The panel then takes a full-circle look at diagnostics—highlighting both high-opportunity fields and high-need gaps. In addition to established companion diagnostics and biomarker work, attention is turning to emerging tools like dried blood spot testing and acoustic ejection mass spectrometry, which promise faster and more accessible protein biomarker quantification (2).

The regulatory environment for cell and gene therapy continues to evolve. The panel notes the FDA’s recent move to halt Sarepta’s Elevidys distribution and place multiple trials on hold after reported deaths (3), while also citing broader 

 within the agency’s biologics arm. In this climate, in vivo approaches are gaining traction. Examples include Orbital Therapeutics’ non-human primate data for its in vivo CAR-T program in autoimmune disease (4) and ARTBIO’s $132 million Series B raise to advance its radioligand therapy (RLT) platform. While some see RLT as a more promising route for solid tumors, others—like ARTBIO’s Emanuele Ostuni, PhD—suggest that the modalities may work best in tandem. “The alpha particle modality essentially creates a small explosion of antigens in the tumor, which do recruit T cells—a situation ripe with synergistic potential,” he told 

Watch the full episode above for more insights into the evolving biopharma landscape and catch up on previous episodes of 

Combating America’s Chronic Disease Epidemic. Rand. March 5, 2025.  

https://www.rand.org/pubs/commentary/2025/03/combating-americas-chronic-disease-epidemic.html

Van Puyvelde B, Hunter C, Zhgamadze M. “Acoustic ejection mass spectrometry empowers ultra-fast protein biomarker quantification.” 

. 2024 Jun 15;15(1):5114. doi: 10.1038/s41467-024-48563-z

FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold. FDA. News release. July 18, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-requests-sarepta-therapeutics-suspend-distribution-elevidys-and-places-clinical-trials-hold

Orbital Therapeutics Presents Non-Human Primate Data for In Vivo CAR-T Therapy. Orbital Therapeutics. News release. July 22, 2025. 

https://www.orbitaltx.com/orbital-therapeutics-presents-non-human-primate-data-for-in-vivo-car-t-therapy-with-potential-best-in-class-profile-for-autoimmune-disease/

Grinstein, J. “From CAR-T to RLT: Enhancing Precision Oncology with ARTBIO’s Radioligands.” 

https://www.insideprecisionmedicine.com/topics/oncology/from-car-t-to-rlt-enhancing-precision-oncology-with-artbios-radioligands/

Jonathan D. Grinstein, PhD, Manfred Scholz, PhD, and Erik Wiklund, PhD, go behind the headlines to address a shifting policy landscape and what it means for the future of chronic disease, diagnostics, and next-generation cell and gene therapies.

Chris Spivey

Articles