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Donaldson Company, a US-based provider of filtration products and solutions, announced its acquisition of Univercells Technologies, a Belgian biotechnology company specializing in biomanufacturing solutions for cell and gene therapy research, development, and commercial manufacturing, on June 29, 2023. According to a company press release, Donaldson acquired Univercells for €136 million (US$148 million) on a cash-free, debt-free basis.

Univercells’ current product line includes the scale-X single-use structured fixed-bed bioreactor, which is designed for the intensified production of viruses for use in cell and gene therapies, viral vaccines, and various other therapeutics. The company also has the automated NevoLine upstream platform, which uses industry-standard filtration to provide integrated up- and mid-stream processing capabilities.

“The acquisition of Univercells Technologies represents an important next step in Donaldson’s life sciences strategy, as we continue to expand our product portfolio aimed at providing customers with a comprehensive, differentiated offering,” said Tod Carpenter, chairman, president, and CEO, Donaldson, in the release. “Univercells Technologies’ engineered systems provide close adjacencies with our previous life sciences acquisitions as well as with our growing organic product suite.”

“We are extremely excited to join Donaldson as we grow our portfolio of ... biomanufacturing platforms and increase our market penetration and related installed base of equipment," said Mathias Garny, CEO, Univercells Technologies, in the release. “Our technology, complemented by Donaldson’s filtration excellence and existing life sciences capabilities is part of a larger vision to bring end-to-end solutions to market for advanced therapies.”

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Donaldson Company’s €136 million (US$148 million) acquisition of Univercells is designed to broaden its portfolio of biomanufacturing solutions.

Donaldson Company Acquires Univercells Technologies for €136 Million 

In this video interview, Mason Ailstock, CEO of the Rowen Foundation, talked to Grant Playter, associate editor, on the topic of incubators and their potential to promote innovation. 

Rowen is a knowledge community in Metro Atlanta focused on fostering collaboration across industries, including those in the medical, environmental, and agricultural fields. In this interview, Mason touches on the current status of the Rowen Foundation, the importance of fostering collaboration in this manner, and how it can promote innovation in the biopharma industry.

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Mason Ailstock, CEO of the Rowen Foundation, discusses incubators and their potential to promote innovation.

Investigating Incubators & Innovation with Mason Ailstock

FDA announced approval of Rystiggo (rozanolixizumab-noli) as a treatment for generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive on June 27, 2023. Rozanolixizumab-noli is a subcutaneous administered, humanized monoclonal antibody injection designed to accelerate the catabolism of antibodies and reduce the concentration of pathogenic immunoglobulin G (IgG) autoantibodies. The approval was granted to Union Chimique Belge (UCB), a Belgian biopharmaceuticals company.

According to a UCB press release, gMG is a rare, chronic, autoimmune disease characterized by dysfunction and damage at the neuromuscular junction (NMJ). Pathogenic IgG autoantibodies can impair synaptic transmission at the NMJ by targeting specific proteins on the post-synaptic membrane, disrupting the ability of nerves to stimulate the muscle; this ultimately results in weaker muscle contractions.

FDA approval was based on data from the Phase III MycarinG study, whose primary efficacy endpoint was comparison of the change from baseline between treatment groups in the MG-ADL total score, a measurement tool which assesses the impact of gMG on daily functions, at Day 43. A statistically significant difference favoring rozanolixizumab-noli over placebo (-3.4 to -0.8) was observed in the MG-ADL total score change from baseline.

“No two people living with gMG experience the disease in the same way, so we can’t take a ‘one size fits all’ approach to disease management,” said Iris Loew-Friedrich, executive vice-president and chief medical officer, UCB, in the press release. “Disease management should be based on the clinical needs and preferences of the individual patient, and the aim of treatment is to help restore that patient’s ability to carry out activities of daily living. The approval of rozanolixizumab-noli means doctors have an additional approved treatment option for their gMG patients who have not yet found a treatment that meets their needs.”

FDA reviewed rozanolixizumab-noli under the priority review indication. The treatment is also currently being evaluated by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.

FDA Approves UCB Generalized Myasthenia Gravis Treatment

Tower Cold Chain, a pharmaceutical thermal protection specialist, has completed its new headquarters in the Americas region, it announced on June 27, 2023. The facility will officially open on Sept. 12, 2023, according to a company press release.

The building, located in Philadelphia, Pa., is the latest facility offering design, laboratory, and testing capabilities in the development of its temperature-controlled solutions. Further, Tower Cold Chain hopes this expansion will serve as a hub of innovation and expertise and a place for stronger partnerships to develop in the cold chain logistics industry.

“We are thrilled to inaugurate our Cent[er] of Excellence in Philadelphia, which demonstrates our unwavering commitment to the Americas market,” said Niall Balfour, chief executive officer, Tower Cold Chain, in the press release. “This marks a significant step in Tower’s growth trajectory. As demand for robust, reliable, reusable pharmaceutical logistics continues to surge, our investment in strategic locations enables us to provide essential support for the seamless transportation of temperature-sensitive pharmaceutical and life-science products.”

Tower Cold Chain will soon open its new headquarters in Philadelphia.

Tower Cold Chain Expands to American Center of Excellence

GSK announced on June 28, 2023 that it has completed the acquisition of BELLUS Health, a late-stage Candian biopharmaceutical company, through a plan of arrangement in accordance with Section 192 of the Canada Business Corporations Act. This arrangement was approved by the shareholders at BELLUS on June 16, 2023, according to a company press release.

The acquisition of BELLUS includes camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in Phase II development for the first-line treatment of adult patients with refractory chronic cough (RCC). Further, BELLUS has announced the cancellation of its annual shareholder meeting, which was scheduled for June 30, 2023.

“The acquisition of BELLUS is highly synergistic with GSK’s expertise in respiratory medicines and is further supported by GSK’s leading R&D, manufacturing, and commercialization capabilities,” said Luke Miels, chief commercial officer, GSK, in the press release. “We are now focused on progressing camlipixant through Phase III trials to offer a therapeutic option for RCC patients as soon as possible.”

This arrangement was approved by the shareholders at BELLUS on June 16, 2023, according to a company press release.

GSK Acquires BELLUS Health 

FDA announced approval of Pfizer’s NGENLA (somatrogon-ghla), a once-weekly human growth hormone analog, on June 28, 2023. Somatrogon-ghla is approved as a treatment for pediatric patients aged three and older who have growth failure, also known as growth hormone deficiency (GHD), due to inadequate secretion of endogenous growth hormone.

According to a Pfizer press release, FDA based its approval on a multi-center randomized, open-label, active-controlled Phase III study evaluating the safety and efficacy of somatrogon-ghla when administered once-weekly, relative to once-daily somatropin. The study met its primary endpoint of somatrogon-ghla non-inferiority compared to somatropin, as measured by annual height velocity at 12 months. Additionally, it was generally well tolerated and had a safety profile comparable to somatropin.

GHD is a rare disease characterized by inadequate secretion of somatropin, a growth hormone, from the pituitary gland. Without treatment, children will have persistent growth attenuation, a very short height in adulthood, and delayed onset of puberty. According to the release, it’s estimated to affect approximately one in 4000 to 10,000 children.

“For more than 30 years, Pfizer has been committed to supporting children and adults living with growth hormone deficiency, beginning with the delivery of a medicine that has long been a part of the standard of care,” said Angela Hwang, chief commercial officer, president, Global Biopharmaceuticals Business, Pfizer, in the release. “We are excited to bring this next-generation treatment to patients in the United States, continuing our commitment to helping children living with this rare growth disorder reach their full potential.”

FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.

FDA Approves Pfizer Human Growth Hormone Analog

The National Cancer Institute (NCI), part of the National Institutes of Health, announced on June 26, 2023 that it had been awarded $50 million by the Biden-Harris administration to launch the Persistent Poverty Initiative. Intended to alleviate the cumulative effects of persistent poverty on cancer outcomes, the program will build research capacity, foster cancer prevention research, and promote implementation of community-based programs, according to an agency press release.

The awards will create five new centers for cancer control research in persistent poverty areas. Persistent poverty areas are defined as those where, for the past 30 years, 20% or more of the population has lived below the federal poverty line. According to the release, people who live in these areas have a higher incidence of cancer, experience delays in cancer diagnosis and treatment, and are more likely to die from cancer than people not living in poverty.

According to the release, each center will work with targeted low-income communities to implement and measure the effectiveness of structural interventions for cancer control and prevention, follow-up care, and survivorship. This includes research in areas such as reducing obesity, improving nutrition, increasing physical activity, helping people quit smoking, and improving living conditions through supplemental income. Additionally, the centers will help train early-career investigators to work with underserved communities in conducting multilevel intervention research.

“Persistent poverty is a place-based and community phenomenon that reflects a failure of the structures and institutions in society, including health care,” said Shobha Srinivasan, senior advisor for Health Disparities and Health Equity, Division of Cancer Control and Population Sciences, NCI, in the release. “Conducting research to understand the connections between institutions—such as social, economic, and health systems—and persistent poverty is the only way to inform changes to social conditions and determinants of health that will ultimately improve overall health, cancer control, and cancer outcomes.”

The persistent poverty initiative aims to fight the cumulative effects of persistent poverty on cancer outcomes.

NCI Launches Persistent Poverty Initiative

Swedish Orphan Biovitrum (SOBI), a biopharmaceutical company focused on rare diseases, announced the completion merger and acquisition agreement with CTI BioPharma, a biopharmaceutical company focused on blood related cancers and rare diseases, on June 26, 2023. As a result of the deal, valued at approximately $1.7 billion, CIT has become an indirect wholly owned subsidiary of SOBI.

“CTI represents a perfect fit for Sobi’s haematology franchise today, adding a powerful and highly differentiated new product that will make a significant difference for patients”, said Guido Oelkers, president and CEO, Sobi, in a 

. “There is a large unmet medical need within myelofibrosis, in particular for patients suffering from thrombocytopenia who are inadequately treated by existing medicines. The combination of the talented team at CTI, together with Sobi’s broad US and global haematology capabilities, will help get this much needed new therapy to patients faster and more effectively. The acquisition of CTI is the latest in a series of transformative transactions Sobi has conducted to build its leading rare haematology franchise.”

Sobi has officially acquired CTI, a biopharma company focused on blood related cancers and rare diseases, in a merger valued at approximately $1.7 billion.

Sobi and CTI BioPharma Complete $1.7 Billion Acquisition Deal

FDA announced on June 22, 2023 the approval of Elevidys (delandistrogene moxeparvovec-rokl), the first gene therapy for the treatment of children ages four through five years that have Duchenne muscular dystrophy (DMD) and do not have a pre-existing medical reason that would prevent this kind of treatment. DMD is a rare genetic condition that leads to weakness and “wasting away” of the body’s muscles due to a defective gene, which creates an absence of a protein that keeps muscles intact.

Elevidys was approved through FDA’s accelerated approval pathway based on an evaluation of sponsor-submitted data. According to the agency, a randomized clinical trial showed Elevidys increased the expression of the Elvidys micro-dystrophin protein in children ages four to five years with DMD “who do not have significant pre-existing antibody titers against the AAV [adeno-associated virus] rh74 vector or have other contraindications based on the inclusion criteria of the clinical trials.” The approval was granted to Sarepta Therapeutics.

“Today’s approval addresses an urgent unmet medical need and is an important advancement in the treatment of Duchenne muscular dystrophy, a devastating condition with limited treatment options that leads to a progressive deterioration of an individual’s health over time,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research. “The FDA remains committed to facilitating the development of innovative new therapies to reduce the impact of debilitating diseases and to improve outcomes and quality of life for those affected.”

The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.

Gene Therapy for Duchenne Muscular Dystrophy Approved by FDA

Geert Moens, Global Platform Leader Vial Closure Systems, Datwyler Healthcare, speaks with Grant Playter, associate editor, on recent technologies in the film and spray coatings market. 

Filmed shortly after the INTERPHEX conference, Geert discusses the rise of prefilled syringes, the larger state of the paranterals and drug packaging markets, and his company's latest film coating solution, which was launched during the conference.

Geert Moens, Global Platform Leader Vial Closure Systems, Datwyler Healthcare, discusses recent technologies in the film and spray coatings market.

Featured Content

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