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Pfizer announced that FDA has granted accelerated approval to its multiple myeloma treatment, Elrexfio (elranatamab-bcmm), on Aug. 14, 2023. The treatment is approved for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-cluster of differentiation 38 monoclonal antibody. According to a company press release, approval was based on a Phase II trial (MagnetisMM-3), and continued approval is contingent upon verification of clinical benefit in a confirmatory trial.

Elranatamab-bcmm is a subcutaneously delivered B-cell maturation antigen (BCMA)-cluster of differentiation three (CD3)-directed bispecific antibody immunotherapy. The treatment is designed to bind to BCMA on myeloma cells and CD3 on T-cells, bringing them together and activating the T-cells to kill myeloma cells.

According to the press release, data from the Phase II study showed meaningful responses among heavily pretreated RRM patients who received elranatamab-bcmm as their first BCMA-directed therapy. Among patients who received four or more lines of therapy prior to elranatamab-bcmm, overall response rate was 58%, with 82% maintaining the response for at least nine months.

“[Elranatamab-bcmm] reflects our ongoing commitment to developing scientific breakthroughs that meaningfully improve outcomes for people with cancer. Discovered at Pfizer, we advanced this therapy from a first-in-patient trial to approval in less than five years, because we know that time is life for people living with multiple myeloma,” said Angela Hwang, chief commercial officer and president, Global Biopharmaceuticals Business, Pfizer, in the release. “With significant responses in a patient population with highly refractory disease, we believe [elranatamab-bcmm] is poised to potentially become the new standard of care for multiple myeloma, as we plan to build upon this indication with continued development across the … MagnetisMM program.”

“Most multiple myeloma patients will experience relapse or resistance of their disease to treatment, often facing increased symptom burden and lowering their chance of surviving longer with each attempted line of therapy,” said Ajay Nooka, director of the Multiple Myeloma Program at Winship Cancer Institute of Emory University and MagnetisMM clinical trial investigator, in the release. “By offering durable clinical response with an established safety profile and the convenience of subcutaneous administration, [elranatamab-bcmm] provides a much-needed new option for heavily pre-treated multiple myeloma patients who are struggling with relapsed myeloma.”

Prior to this accelerated approval, elranatamab-bcmm received breakthrough therapy and orphan drug designations from FDA. The FDA review was conducted under Project Orbis, a framework for concurrent submission and review of oncology drugs among international partners to potentially expedite approvals; five countries (Switzerland, Brazil, Canada, Australia, and Singapore) are currently participating. The Japanese Ministry of Health, Labour and Welfare is currently evaluating a new drug application for elranatamab-bcmm, and the European Medicines Agency is evaluating a marketing authorization under the Priority Medicines scheme.

Articles

FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

FDA Grants Accelerated Approval to Pfizer’s Multiple Myeloma Treatment

AGC Biologics announced a new agreement with Asahi Kasei Pharma Corporation on Aug. 15, 2023 to produce clinical drug substance for antibody-based therapies for Asahi Kasei at the AGC Biologics’ Seattle manufacturing site. The agreement also lists that AGC Biologics will leverage the company’s monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei drug substance, according to the press release.

The Seattle location features multiple mammalian current good manufacturing practice manufacturing lines at various scales and serves as a center of excellence for formulation. A recent expansion added a new microbial-based manufacturing line system. The scientists at the Seattle manufacturing site are planning to support process optimization during the clinical phase, including product qualification, process development, analytical, and regulatory document to further support the manufacture of the product for late-phase preparation.

“Our company has a strong history of antibody production, and we pride ourselves on offering the flexibility and the technical expertise to meet any drug substance need at this critical clinical phase,” said JB Agnus, chief business officer, AGC Biologics, in a press release. “We look forward to partnering with Asahi Kasei Pharma to help achieve their goals with this important project.”

The Seattle facility serves as a hub for formulation and can provide the latest fed-batch and perfusion manufacturing processes. It also recently expanded with new microbial-based manufacturing line system, according to the press release.

The agreement also lists that AGC Biologics will leverage the company’s monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei drug substance.

AGC Biologics Partners with Asahi Kasei on Clinical Antibody Project

Feliza Mirasol is the science editor for 

China-based HitGen, a drug discovery technology platform company, announced on Aug. 10, 2023 that it has entered into a research service agreement with Nested Therapeutics (Nested), a US-based biotechnology company specializing in a next-generation precision medicine platform for hard-to-treat cancers. Under the agreement, HitGen will use its DNA-encoded library (DEL) technology platform to identify hits against targets in which Nested is interested.

HitGen’s technology platform is centered around the design, synthesis, and screening of DELs. The company applies its technology to early stage small-molecule drug discovery. Its platform includes more than 1.2 trillion small molecules generated by its DEL technology, which streamlines the screening process.

“We look forward to working with the research teams at Nested to generate novel starting points for their research programs to help address the unmet needs of patients with cancer. As one of HitGen’s four core technology platforms, our … DEL platform is an efficient ‘engine’ to advance drug discovery and has enabled hit identification and lead generation for many innovative discovery programs by our customers and partners. We look forward to delivering useful outcome[s ]for Nested’s research programs,” said Jin Li, chairman of the board and CEO of HitGen, in the press release.

HitGen has entered into a research service agreement with Nested Therapeutics for use of HitGen’s DNA-encoded library for drug discovery.

HitGen and Nested Therapeutics Sign Research Service Agreement for DNA-Encoded Library

Alpha Teknova (Teknova), a US-based producer of critical reagents for novel therapies, vaccines, and molecular diagnostics, has opened its newest good manufacturing practice (GMP)-certified production facility in Hollister, Calif., which increases its capacity for custom, high-quality reagents for use in life sciences. The facility is expected to enable faster bioprocessing and gene therapy development, bringing products to the clinic faster, according to an Aug. 9, 2023 company press release.

The new facility, which was previously operational for research-grade production, now adds more than 10,000 ft2 of GMP-certified ISO cleanrooms. Teknova gets a three-fold increase in overall manufacturing capacity with expanded formulation, dispensing, cleanroom, and warehouse space. The facility also includes increased automation to support single-use needs and offers animal-free and endotoxin-controlled environments.

“Our team has worked tirelessly over the past two years to build our new GMP-certified production facility here in Hollister, and its opening represents a momentous milestone in our company’s evolution,” said Stephen Gunstream, Teknova’s president and CEO, in the press release. “We kept hearing from our customers that they wanted a partner who could support them with custom reagent manufacturing as they scale from research, through process development, and into clinical trials, particularly in batch volumes of less than 2000 liters. We built this facility to do just that [and] we look forward to leveraging our facility's modular manufacturing capabilities to continue supporting our customers throughout various stages of their lifecycle.”

The launch of Alpha Teknova’s new manufacturing facility in Hollister, Calif., increases its capacity for custom reagents for life sciences applications.

Teknova Opens New GMP Manufacturing Facility for Life Sciences Reagents 

Gilead Sciences and Tentarix Biotherapeutics, a biopharmaceutical company focused on targeted, multifunctional, conditional therapies, announced three multi-year collaborations on Aug. 15, 2023. The collaborations will use Tentarix’s Tentacles platform to discover and develop multifunctional, conditional protein therapeutics for oncology and inflammatory diseases. According to a company press release, these molecules will have the potential to conditionally target immune cells related to disease pathways without activating other immune cells that may create adverse events.

Tentarix will receive upfront payments and an equity investment from Gilead totaling $66 million across all three collaborations. Additionally, Gilead has the option to acquire up to three select Tentarix subsidiaries containing the programs developed under the collaborations for $80 million per subsidiary, placing the total value of the deal at approximately $306 million.

“At Gilead, a key area of our research strategy is addressing immune dysregulation in oncology and inflammatory diseases,” said Flavius Martin, executive vice-president, Research, Gilead Sciences, in the release. “This early-stage collaboration with Tentarix will be highly synergistic to our ongoing efforts, building upon our growing strength in protein therapeutics, and may provide access to next-generation, multi-specific biologics.”

“This collaboration is part of our strategy to join forces with innovators, like Gilead, who can help us rapidly advance new medicines to the clinic,” said Paul Grayson, president and CEO, Tentarix Biotherapeutics, in the release. “Our technology has great promise and collaborating with Gilead to build out this pipeline helps broaden the development of multi-functional, antibody-based therapeutics, providing an excellent mechanism to validate our science with the ultimate goal of bringing these potential medicines to patients faster.”

Gilead and Tentarix established three multi-year collaborations to discover and develop multi-functional, conditional protein therapeutics for oncology and inflammatory diseases. 

Gilead and Tentarix Strike Three Cancer And Inflammation Partnership Deals

CPHI, a pharmaceutical conference covering everything in the pharma spectrum from ingredients to packaging, announced on August 15, 2023 that it would be returning to Milan, Italy in 2024. The global pharma exhibition will be hosted at the Fiera Milano from October 8-10, 2024.

According to a press release from Informa, the event organizers, the 2024 event is expected to see record attendance due to a large number of international visitors and a rapid increase in attendees from major Asian pharma hubs. The event was previously held at this location for CPHI 2022.

“We are delighted to be returning to Fiera Milano, as Italy and the Lombardy region are widely known as one of the key pharma manufacturing centers in Europe,” said Adam Anderson, executive vice-president, Pharma, at Informa. “There are very few global locations with such a depth and breadth of local and regional talent. We expect a large international attendance and will marry this with local and regional manufacturing insights. I am excited to bring CPHI … back together with the industry in Milan.”

“Fiera Milano is the ideal venue for a global event like CPHI, which is an important tenet of this industry and central to the world economy, with the Lombardy region being a leading producer of pharmaceuticals,” said Roberto Foresti, deputy general manager of Fiera Milano, in the release. “What makes Milan so attractive is that the city has world-class infrastructure and is well connected to European, Asian, and North American countries. It’s why Fiera Milano continues to attract massive international events.”

CPHI 2024 will return to the Fiera Milano in Milan, Italy.

CPHI to Return to Milan in 2024

Caroline Phares, global head of Health and Life Sciences at Domino Data Lab, speaks with Grant Playter, associate editor, on integrating data processes into pharma operations. Topics of discussion include trusted research environments, the proper balance between data accessibility and privacy, how pharma will use artificial intelligence in the future, and more.

For more from Caroline, we encourage you to read her piece on interoperability difficulties stemming from the skills gap within statistical programming organizations. The piece can be read in full 

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Caroline Phares, global head of Health and Life Sciences at Domino Data Lab, speaks on integrating data processes into pharma operations.


Diving into Data Integration with Caroline Phares

Harmony Biosciences announced a definitive agreement to acquire Zynerba Pharmaceuticals on Aug. 14, 2023, where Harmony will acquire all outstanding shares of Zynerba for a price of $1.1059 per share in cash, or $60 million in the aggregate, according to the press release.

“This is an important step in Harmony’s strategy to build a diversified portfolio of innovative assets to address unmet medical needs and drive our long-term growth. This acquisition affords us the opportunity to advance the development and delivery of a potentially transformative treatment for the symptoms of Fragile X syndrome and other rare neuropsychiatric disorders,” said Jeffrey M. Dayno, MD, president and chief executive officer at Harmony Biosciences, in a press release. “In addition to the strength of our core business in narcolepsy and our current life cycle management programs, led by idiopathic hypersomnia, we are excited to continue to diversify our portfolio beyond sleep/wake by adding Zynerba’s clinical development programs to our pipeline. The team at Zynerba has been dedicated to these programs and we are confident that our combined efforts could have a profound impact on individuals living with rare neuropsychiatric disorders and their families."

Zygel is the first and only pharmaceutically manufactured, synthetic cannabidiol that is formulated as a patient-protected permeation-enhanced gel for transdermal delivery, according to the press release. It is not extracted from a cannabis plant, but rather, a synthetic process in a current good manufacturing practice facility, and can be a nonscheduled product if approved. Additionally, it is being evaluated in a Phase III clinical trial for patients living with FXS in the RECONNECT trial.

“Harmony’s development and commercial expertise, technologies, people and focus on rare neurological diseases are an excellent strategic fit with Zynerba,” said Armando Anido, chairman and chief executive officer of Zynerba, in a press release. “I am very proud of Zynerba’s accomplishments with Zygel to date. With Harmony’s scale, resources, and proven commercial excellence, they are well positioned to potentially bring to market the first pharmaceutical product indicated for the treatment of behavioral symptoms of Fragile X syndrome and to maximize the value of Zygel.”

Zygel is the first and only pharmaceutically manufactured, synthetic cannabidiol that is formulated as a patient-protected permeation-enhanced gel for transdermal delivery.

Harmony Biosciences to Acquire Zynerba Pharmaceuticals

Novo Nordisk has agreed to acquire Inversago for up to $1.075 billion in cash if certain development and commercial milestones are achieved, the company announced on Aug. 10, 2023. The acquisition of the latter includes the company’s lead development asset INV-202, an oral CB1 inverse agonist which is designed to block the receptor protein CB1. According to the press release, CB1 plays an important role in metabolism and appetite regulation in the peripheral tissues, like the kidneys and liver.

INV-202 will continue to be investigated under Novo Nordisk as a potential treatment for obesity and obesity-related complications.

“The acquisition of Inversago Pharma will further strengthen our clinical development pipeline in obesity and related disorders,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk, in a press release. “This promising class of medicine pioneered by the Inversago team could lead to life-changing new treatment options for those living with a serious chronic disease and, in particular, may offer alternative or complementary solutions for people living with obesity.”

François Ravenelle, chief executive officer of Inversago Pharma, emphasized the delight he feels in joining forces with a global leader in the obesity and metabolic disorder space. “We believe this combination will help unlock the full medical potential of our CB1 blockers and may one day expand treatment options for people living with metabolic syndrome, obesity and related complications,” he said in a press release. “Novo Nordisk has world-class research facilities, significant global reach and a rich culture of collaboration seeking to bring our therapeutic treatments to market.”

The closing of the acquisition is expected to happen before the end of 2023, according to the press release.

The acquisition of the latter includes the company’s lead development asset INV-202, an oral CB1 inverse agonist which is designed to block the receptor protein CB1. 

Novo Nordisk to Acquire Inversago Pharma

Eli Lilly and Company (Lilly) has announced the completion of several previously announced acquisitions: Versanis Bio (Versanis), Sigilon Therapeutics (Sigilon), and DICE Therapeutics (DICE), all of which were concluded in August 2023.

The Versanis acquisition includes that company’s lead asset, bimagrumab, a monoclonal antibody currently in Phase IIb development for treating obesity. Under the agreement, Versanis shareholders stand to receive up to $1.925 billion in cash, which includes an upfront payment and subsequent payments based on the achievement of certain development and sales milestones, according to an Aug. 14, 2023 company press release. Lilly had announced its intent to acquire Versanis Bio in July 2023 (1).

"Combining our current incretin portfolio, including tirzepatide, with activin receptor blockers such as bimagrumab, could be the next major step in innovative treatments for those living with cardiometabolic diseases, [such as] obesity," said Ruth Gimeno, group vice-president, diabetes, obesity, and cardiometabolic research, Lilly, in the company press release. "The wealth of knowledge that our new colleagues from Versanis will bring to Lilly will propel our research and development efforts forward, ultimately benefiting patients around the world."

The Sigilon acquisition, first announced by Lilly in June 2023 (2), boosts Lilly’s R&D capabilities in encapsulated cell therapies for treating type 1 diabetes and includes a lead candidate, SIG-002. According to a company press release, Lilly offered $14.92 per share of Sigilon common stock, an aggregate of approximately $34.6 million (2).

Finally, the $2.4 billion ($48 per share) DICE acquisition, 

 (3), expands Lilly's immunology portfolio. It adds DICE's novel oral therapeutic candidates for treating chronic diseases in immunology, including oral interleukin-17 (IL-17) inhibitors, to Lilly’s pipeline. The IL-17 inhibitors are currently in clinical development, according to a company press release.

1. Eli Lilly and Company, Lilly to Acquire Versanis to Improve Patient Outcomes in Cardiometabolic Diseases. Press Release, July 14, 2023.
2. Eli Lilly and Company, Lilly to Acquire Sigilon Therapeutics. Press Release, June 29, 2023.
3. Eli Lilly and Company, Lilly to Acquire DICE Therapeutics to Advance Innovation in Immunology. Press Release, June 20, 2023.

The completion of three acquisitions of Versanis Bio, Sigilon Therapeutics, and DICE Therapeutics boosts Eli Lilly and Company’s product pipeline in obesity, diabetes, and immunology.

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

Behind the Headlines Episode 28

Ask the Expert

Drug Digest December 2025

A “Plan, Prevent, Prove” Approach