Pfizer and Genmab have announced the U.S. FDA has approved the supplemental Biologics License Application (sBLA) granting full approval for TIVDAK (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. “Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, Executive Vice President at Pfizer. “Today’s full approval by the FDA reinforces the important role of TIVDAK for these patients, as the first antibody-drug conjugate with statistically significant prolonged overall survival data.” The approval is…

The pre-filled syringe (PFS) market is growing rapidly, driven by the rising need for innovative biologics and a desire for self-administration treatment options offering greater convenience. This increased demand for PFS is fuelling innovation in mainstream packaging design to support advancements aiding both useability and patient safety.    However, supporting the PFS packaging needs of the expanding biologics market comes with many challenges. These include carefully selecting the right packaging solutions for each project and potentially committing considerable capital expenditure to upgrade manufacturing lines. As a result, adopting new PFS packaging and harnessing new technologies could be a daunting task, particularly…

Digital health start-up Klineo have announced that it has raised €2 million to improve equity of access to clinical trials. Its AI-based platform connects doctors and patients directly with relevant trials in less than a minute. This solution democratises access to new treatments for patients. This funding will enable Klineo to expand its solution to all types of cancer, in a context where the number of patients and clinical trials are experiencing significant growth. Clinical trials offer a chance to benefit from the latest therapeutic innovations. But today, only a minority of cancer patients (<5%) take part in clinical trials, whereas a majority of patients (>70%) would be willing to participate if they knew about them. Up to…

Novartis have announced that the National Institute for Health and Care Excellence has published its Final Draft Guidance (FDG) recommending the combination therapy of dabrafenib with trametinib, within its marketing authorisation, as an option for treating low-grade glioma (LGG) with a BRAF V600E mutation in children and young people aged 1 year and over who require systemic treatment. The combination was also recommended for the treatment of high-grade glioma (HGG) with a BRAF V600E mutation in children and young people aged 1 year and over after at least 1 radiation or chemotherapy treatment. Gliomas are the most common type of…

Written by: Miroslav Hlaučo, Apheresis Network Manager, SCTbio. In recent years, there have been an increasing number of clinical trials and research projects based on cell technologies that use cells from a patient or healthy donor as the starting material for their production. With the vast potential of these kinds of therapies to treat, or even cure, rare diseases, research, and investment is only set to intensify. However, the logistics, practicalities, and expense involved can be challenging for investors, sponsors, clinical trial management, and investigators to oversee.   Leukapheresis for cell therapies demands precise coordination among the clinical study site investigator/manufacturers regarding…

Ascendis Pharma have announced that the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for YORVIPATH (palopegteriparatide; developed as TransCon PTH) in Great Britain as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, and has also granted YORVIPATH orphan drug status. YORVIPATH is a prodrug of parathyroid hormone (PTH 1-34) administered once daily. “With today’s MHRA approval of YORVIPATH, we are expanding our global geographic reach to meet the needs of adults with chronic hypoparathyroidism in Great Britain,” said Camilla Harder Hartvig, Executive Vice President and Chief Commercial Officer at Ascendis Pharma. MHRA approval…

Regeneron Pharmaceuticals and Mammoth Biosciences have announced a collaboration to research, develop and commercialise in vivo CRISPR-based gene editing therapies for multiple tissues and cell types.  Regeneron is developing adeno-associated viral vectors (AAVs) using antibody-based targeting to enhance delivery of genetic medicine payloads to specific tissues and cell types. Mammoth is developing novel ultracompact nucleases and associated gene editing systems, with a variety of editing functionalities at a significantly smaller size than other CRISPR-based systems, including first generation Cas9 nucleases. By leveraging Regeneron’s expertise in AAV and antibody engineering and Mammoth’s expertise in ultracompact gene editing systems, the teams will endeavor to create disease-modifying medicines…

Aramex has been awarded the Sustainability in Distribution award at the recent Distributing Pharmaceuticals UK award event at the Coventry Building Society Arena. The awards night recognised the very best in innovation and sustainability from those that are directly involved in the design, development or distribution of pharmaceuticals – a sector in which Aramex has a significant footprint. Citing a 42% reduction based on scope 1 & 2 and a 25% reduction on scope 3, dependent on supplier commitment, Aramex has since 2006 implemented a climate change mitigation strategy with the sole aim of minimising its carbon footprint and improving…

Berry Global Group has invested in additional assets and manufacturing capabilities to increase its healthcare production capacity by up to 30% across three of its European sites. Following the opening of its manufacturing facility and healthcare centre of excellence in Bangalore, India, these latest investments underline Berry’s commitment to delivering high-quality packaging and drug delivery devices that enhance the patient experience through improved medicine administration and adherence. “As pharmaceutical innovations progress, so should the packaging and support that delivers each dose. Berry Global is here to provide that expertise in the creation of patient-centred packages and drug delivery device design,” said…

Owlstone Medical have announced it has secured funding from the Bill & Melinda Gates Foundation. The funding is comprised of a $5 million equity investment to advance Owlstone’s Breath Biopsy platform and $1.5 million in grant funding to develop breath-based diagnostics and identify breath biomarkers for tuberculosis (TB) and HIV. Owlstone, with support from the foundation, is interested in developing new cost-effective detection technologies for volatile organic compounds (VOCs) that could serve as markers of diseases that disproportionately affect the developing world. With the new funding, Owlstone seeks to understand whether this approach is suitable for TB and HIV detection and…

Novartis have announced that the U.S. Food and Drug Administration (FDA) approved Lutathera (USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) for the treatment of pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumours (GEP-NETs), including foregut, midgut, and hindgut NETs. This approval makes Lutathera the first therapy specifically reviewed and approved for use in pediatric patients with GEP-NETs. “Lutathera is now the very first therapy approved specifically for children with GEP-NETs, offering new hope to young patients living with this rare cancer,” said Tina Deignan, Therapeutic Area Head, Oncology US. “Radioligand therapies have extraordinary…

In our latest Pharma Explained we look explore what Monkeypox is, how it impacts the body, and the larger-scale issues associated with the disease.

Kühne Holding AG has entered into a definitive agreement to acquire pharma contract development and manufacturing organisation Aenova Group from leading international investment firm BC Partners. As part of the transaction, BC Partners’ advised funds will reinvest alongside Kühne Holding AG and continue to support Aenova as a minority shareholder. Financial terms were not disclosed. The Aenova Group is one of the world’s leading CDMOs (Contract Development and Manufacturing Organisations) in the pharmaceutical and healthcare industry. Headquartered in Starnberg, near Munich, and with approximately 4,000 employees in 14 manufacturing sites worldwide, the company is a one-stop service provider for the…

Benchling announced that Zealand Pharma A/S, a biotechnology company focused on the discovery and development of peptide-based medicines, has selected the Benchling R&D Cloud as its central source of truth for scientific data, collaboration, and insights. Teams across Zealand will use the Benchling R&D Cloud to capture, analyse, and share stability data internally and with their external contract manufacturing organisation (CMO) partners, in compliance with GxP.  “Our research progresses quickly, every action needs to be traceable and verifiable. Scientists and partners can’t be slowed down by siloed systems or a lack of consistent data,” said Ludo Otterbein, Head of IT at Zealand Pharma. “Connecting the lab…

Voydeya (danicopan) has been approved in the European Union (EU) as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia. Voydeya is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care Ultomiris (ravulizumab) or Soliris (eculizumab) to address the needs of the approximately 10-20% of patients with PNH who experience clinically significant extravascular haemolysis (EVH) while treated with a C5 inhibitor. The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the pivotal ALPHA Phase III trial. Results from the 12-week…

Imugene have announced a strategic manufacturing and process development partnership, which includes the sale of Imugene’s North Carolina Current Good Manufacturing Practice (CGMP) manufacturing facility and the transfer of process and analytical development activities to Kincell. Under the terms of an asset purchase agreement between Imugene and Kincell, Kincell will acquire Imugene’s CGMP compliant cell therapy manufacturing facility in North Carolina for a total consideration of up to $6M USD in upfront and milestone-driven payments. Both parties have entered into a manufacturing supply agreement whereby Kincell will manufacture Imugene’s Azer-cel to support ongoing clinical trials. Imugene will also transfer process and…

Neurolentech, have announced a technology access partnership with Kaerus Bioscience. The agreement enables Kaerus Bioscience to access Neurolentech’s NDD Drug Discovery platform and leverage its proprietary cell models and assays for functional screens to drive advances in neurodevelopmental disorders research. Fiona Nielsen, CEO of Neurolentech, said, “We are excited to collaborate with Kaerus Bioscience in advancing their programs in the field of neurodevelopmental disorders. Our platform’s unique capabilities offer unparalleled insights into disease mechanisms, facilitating the development of novel therapies.”  Built for NDD drug discovery, Neurolentech’s Platform comprises a vast collection of human-derived neuronal cell lines from patients with monogenic and complex…