Generic GLP-1 gets FDA approval
Teva Pharmaceuticals has received FDA approval for its generic version of Saxenda (liraglutide injection), making it the first generic GLP-1 receptor agonist cleared in the US for weight management. The product is indicated for adults with obesity or overweight who also have a weight-related medical condition, and for adolescents aged 12 years and older weighing more than 60 kg with obesity. As with the branded medicine, treatment is intended to be combined with diet and physical activity.
The approval adds to Teva’s portfolio of complex generics and marks its fifth first-to-market generic in 2025. Branded Saxenda recorded approximately $165 million in annual US sales as of June 2025.
A plan to produce CAR-T cells in days
Fresenius has launched the EASYGEN (Easy Workflow Integration for Gene Therapy) consortium – an €8 million, EU-funded public-private initiative aimed at decentralizing CAR-T cell therapy manufacturing. The goal is to develop a modular, fully automated hospital-based platform capable of producing personalized CAR-T treatments in just a few days.
The project is supported through the Innovative Health Initiative under Horizon Europe and builds on technology developed by Fresenius Kabi’s Cell and Gene Therapy team. Fresenius will lead the project alongside partners across Europe, including Fraunhofer IZI in Leipzig, the University of Glasgow, and Bar-Ilan University.
Positive phase III results for AstraZeneca hypertension drug
AstraZeneca has reported positive results from the phase III BaxHTN trial of baxdrostat, an investigational selective aldosterone synthase inhibitor, in patients with hard-to-control hypertension. The study met its primary endpoint of reducing systolic blood pressure.
Baxdrostat is designed to target aldosterone synthase without affecting cortisol synthesis, aiming to address elevated aldosterone levels that contribute to treatment-resistant hypertension. According to AstraZeneca, hypertension affects more than one billion people worldwide, and an estimated 10–20 percent of patients have resistant or hard-to-control disease. Full results will be presented at an upcoming scientific meeting and shared with regulatory authorities to support potential approval pathways.
EC approval for Zemcelpro
ExCellThera has received conditional marketing authorization from the European Commission for Zemcelpro for treating hematological malignancies in adults. Zemcelpro is a cryopreserved, one-time transplant product composed of UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34– cells derived from the same cord blood unit. The therapy was developed for blood cancer patients that do not have access to suitable donor cells.
“The curative potential of allogeneic stem cell transplantation is still limited by the access to a suitable donor. The access to stem cell donation according to the stringent disease course is one of the major limiting factors for success,” said Fabio Ciceri, Professor of Hematology at Vita-Salute San Raffaele University in Italy. “UM171 Cell Therapy offers an option timely available for patients in need.”
Research grant awarded to leukemia researchers in Oxford
The Kaiya Foundation has awarded a major research grants to support leukemia research at the University of Oxford. Awarded to Dr Emily Neil and Professor Anindita Roy from the Childhood Leukaemia Research Group, the funding will underpin investigations into the cellular origins of a high‑risk leukemia subtype known as TCF3‑HLF acute lymphoblastic leukemia. The researchers aim to pinpoint molecular triggers and the biological mechanisms behind malignant transformation in blood cells in order to pave the way for personalized, targeted therapies for children and young people affected by aggressive forms of the disease. The timing of the announcement coincides with Childhood Cancer Awareness Month and what would have been Kaiya Patel’s 13th birthday; the Foundation was established in her memory following her passing at age five from TCF3‑HLF acute lymphoblastic leukemia.
Stem cells for erectile dysfunction
A meta-analysis has reviewed the use of stem cell therapy for erectile dysfunction, bringing together 11 clinical trials, with six included in pooled analysis. In total, 75 men received stem cell injections directly into penile tissue, with outcomes measured by erectile function questionnaires, hardness scores, and blood flow parameters.
At six months, the results showed clear improvements: patients reported higher scores on the International Index of Erectile Function (IIEF-5 and IIEF-EF), firmer erections on the erectile hardness score, and better penile blood flow as measured by peak systolic velocity. Some gains, such as end-diastolic velocity, appeared at three months but were not sustained. Reported side effects were mild, usually limited to local irritation.
However, results varied between trials, sample sizes were small, and most studies tracked patients for no longer than a year. The authors emphasized that larger, longer-term randomized studies are essential.
Celebrating 10 years of EMA and WHO collaboration
The European Medicines Agency and the World Health Organization have marked the tenth anniversary of their formal collaboration agreement to expand global access to medicines. Over the past decade, the two organizations have worked together to streamline regulatory processes, particularly in regions where resources for medicine evaluation are limited. A cornerstone of this partnership is the exchange of scientific assessments and regulatory expertise, which allows WHO to draw on EMA evaluations when considering medicines for prequalification and emergency use.
The collaboration has supported more timely access to essential medicines, including treatments for infectious diseases, vaccines, and therapies for conditions with significant unmet medical need. It has also contributed to strengthening regulatory capacity in low- and middle-income countries by providing shared frameworks, training, and guidance.
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