Swedish biotech Vicore Pharma has entered an exclusive licensing agreement for the Japanese rights for its idiopathic pulmonary fibrosis (IPF) therapy C21 with Nippon Shinyaku. Vicore will receive a $10m upfront payment and will be in line to receive up to $275m in development and commercial milestone-based payments. The company will also be placed to get tiered royalties that extend into “the low 20s” based on annual net sales of C21 in Japan, as per a 9 February press release. As per the agreement, Nippon will hold exclusive rights to develop and commercialise C21 in Japan. The company will be responsible for operational and financial costs for developing C21 in the country. Nippon will also contribute financially to the Japanese trial sites and patients in the global late-stage development of C21. Following the news, Vicore’s stock was up over 18% in trading today. The company’s market ...
A new research paper was published in Genes & Cancer on February 5, 2023, entitled, “Mechanistically based blood proteomic markers in the TGF-β pathway stratify risk of hepatocellular cancer in patients with cirrhosis.” Hepatocellular carcinoma (HCC) is the third leading cause of death from cancer worldwide but is often diagnosed at an advanced incurable stage. Yet, despite the urgent need for blood-based biomarkers for early detection, few studies capture ongoing biology to identify risk-stratifying biomarkers. In this new study, researchers Xiyan Xiang, Krishanu Bhowmick, Kirti Shetty, Kazufumi Ohshiro, Xiaochun Yang, Linda L. Wong, Herbert Yu, Patricia S. Latham, Sanjaya K. Satapathy, Christina Brennan, Richard J. Dima, Nyasha Chambwe, Gulru Sharifova, Fellanza Cacaj, Sahara John, James M. Crawford, Hai Huang, Srinivasan Dasarathy, Adrian R. Krainer, Aiwu R. He, Richard L. Amdur, and Lopa Mishra, from The Feinstein Institutes for Medical Research, Cold Spring Harbor Laboratory, University of Maryland, University ...
Distek, Inc., a leader in laboratory pharmaceutical instruments for over 48 years, proudly presents the BIOne 250 Bioprocess Controller, designed for microbial applications. This latest model is a process optimized design of our well-established BIOne 1250 benchtop bioreactor system, offering an approachable solution to meet the nuanced requirements of advanced microbial bioprocessing. This new addition to the Distek bioprocessing instrument family is designed as a cost-effective solution for microbial bioprocess applications. Building on the success of the award-winning design of the BIOne 1250 controller, the BIOne 250 provides sophisticated functionality to laboratories and research facilities of all sizes. The controller retains the popular user interface of the BIOne 1250 via a remote PC or monitor. This unique capability supports the management of multiple bioreactors from a single central screen. A standout feature of the BIOne 250 is its scalability, accommodating the evolving needs of bioprocess applications, making it suitable for ...
The aggressive brain cancer is responsible for over 3,000 cases in the UK every year Researchers from King’s College London (KCL) have developed an artificial intelligence (AI)-based model that can predict adult brain cancer patients’ rates of survival after receiving radiotherapy treatment. Published in Neuro-Oncology, researchers applied deep learning to predict whether glioblastoma patients would survive eight months. Responsible for around 3,200 cases every year in the UK, glioblastoma is a very aggressive and difficult-to-treat cancer, with just one in four patients surviving over one year after diagnosis. Currently, patients are regularly and routinely tested to see whether chemotherapy is effective or not. However, some patients can suffer from harmful side effects as a result of chemotherapy. Instead, by giving patients an instantaneous and accurate prediction from a single routine MRI scan, the AI will allow doctors to identify patients who would not benefit from chemotherapy and try a different ...
The neurodegenerative condition currently affects over 944,000 people in the UK A new programme led by Queen Mary University of London and funded by the Alzheimer’s Society has received positive trial results that could benefit carers and patients living with dementia. The New Interventions for Independence in Dementia (NIDUS-Family) programme was successful in supporting patients and carers to achieve their goals compared to those who received usual care. Affecting more than 944,000 people in the UK, dementia is a neurodegenerative disease that impairs a person’s ability to remember, think or make decisions on a daily basis. Set up at University College London and now running at Queen Mary’s University London, NIDUS-Family aims to understand how to support carers who look after those with dementia at home. Researchers tested the programme on a small number of participant pairs with over 300 people living with dementia and their unpaid carers. The first ...
Regeneron Pharmaceuticals marketing authorisation application (MAA) for linvoseltamab has received acceptance for review from the European Medicines Agency (EMA) to treat adults with r/r MM. Linvoseltamab is a bispecific antibody designed to target and destroy cancer cells by bridging the B cell maturation antigen on MM cells with CD3 (cluster of differentiation 3, a protein complex)-expressing T cells. The MAA submission is based on findings from the Phase I/II LINKER-MM1 clinical trial of linvoseltamab in r/r MM patients. The open-label, multicentre, dose-escalation and dose-expansion study is designed to evaluate the investigational drug in patients who have undergone multiple prior treatments. All 282 enrolled trial subjects had received a minimum of three lines of therapy or were considered triple refractory. They subsequently received linvoseltamab through an initial step-up dosing regimen, followed by a full dose. The completed Phase I portion of the trial evaluated the tolerability, safety ...
Hemogenyx has received the all-clear from the US Food and Drug Administration (FDA) to begin a Phase I clinical trial of its acute myeloid leukaemia (AML) chimeric antigen receptor (CAR) T-therapy in the US. In June 2023, the US FDA placed a clinical hold on the trial for HEMO-CAR-T, requesting additional information from Hemogenyx after a splicing deficiency during manufacture of the lentivirus used to produce CAR-T cells. Hemogenyx produced a plan, supported by laboratory tests to address FDA’s concerns in August 2023, which was accepted the following month. In January, the London, UK-based biopharma issued a complete response to the agency to lift the hold. Hemogenyx’s stock price has increased by 62% following the announcement of the lifting of the hold today (9 February) since the market close yesterday.CAR-T therapies have been hitting the headlines recently after the FDA launched an investigation into the incidence of potentially associated secondary ...
AbbVie has reported a decrease in net revenues to $54.32bn for the year ended 31 December 2023, marking a 6.4% decline from the previous year’s $58.05bn.The company’s diluted earnings per share (EPS) on a generally accepted accounting principles basis also fell sharply by 59% to $2.72, compared to $6.63 in 2022.Adjusted diluted EPS saw a 19.3% decrease from $13.77 to $11.11. The company’s global immunology portfolio, which faced stiff competition from Humira biosimilars, saw revenues decrease by 9.6% to $26.14bn.Humira’s global net revenues stood at $14.40bn while Skyrizi and Rinvoq contributed $7.76bn and $3.97bn respectively. In the oncology sector, AbbVie’s global net revenues experienced a 10.1% decrease, amounting to $5.92bn.Its neuroscience portfolio showed resilience with an 18.2% increase in global net revenues, reaching $7.72bn. The aesthetics portfolio, however, recorded a slight decrease of 0.8%, with revenues of $5.29bn.AbbVie has provided an adjusted diluted EPS guidance range for 2024 between $11.05 ...
Novo Holdings, the Novo Nordisk Foundation’s holding and investment company, declared plans for a $16.5bn acquisition of Catalent as the company expands its manufacturing capabilities. In the merger, Novo Holdings will receive all outstanding shares of Catalent for $63.50 per share in cash. This price reflects a premium of 39.1% to the closing price of Catalent’s common stock on 28 August 2023. This date was the contract development and manufacturing organisation’s (CDMO) last trading day before announcing Catalent’s new strategic and operational review committee, which assessed the company’s business strategy and operations. The Catalent board unanimously advised Catalent stockholders to complete the merger. In a 5 February press release, Novo expressed plans to complete the deal towards the end of this year, dependent on closing conditions, which include gaining approval from Catalent’s stockholders and securing necessary regulatory approvals. Novo is flush with cash these days as is evident in Novo ...
US-based biotech RegenxBio is seeing a pivotal Phase III study on the horizon as its Phase I/II AFFINITY study of RGX-202 for Duchenne muscular dystrophy (DMD) completes patient enrolment for the second dose level. In a 7 February press release, the company announced that of the three patients treated with dose level 1 of RGX-202 in the AFFINITY trial (NCT05693142), the third patient demonstrated by far the largest increase (83.4%) in microdystrophin expression compared to control at three months. In DMD, a mutation in the dystrophin gene normally responsible for protecting muscle fibres from progressively breaking down contributes to the condition. Microdystrophin is an abbreviated yet functional version of dystrophin, and its expression is often used as a surrogate measure to evaluate therapies. The patient also showed a decrease (93%) in serum creatinine kinase (CK) levels from baseline at ten weeks. The company expects to initiate a pivotal study for ...
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