PharmaFocus Today – Page 166 – media

MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for a variation in licence for Pfizer-BioNTech’s 30 micrograms dose of Comirnaty XBB.1.5, a Covid-19 vaccine targeting the Omicron variant. The decision follows the vaccine’s fulfilment of the UK regulator’s safety, quality and effectiveness standards. The latest approval for the single-dose vials allows for the vaccine’s thawing and re-labelling by an authorised manufacturer outside of the UK’s National Health Service (NHS), adhering to good manufacturing practice standards. The NHS previously managed the thawing and distribution of the Comirnaty Omicron XBB.1.5 vaccine centrally. The vaccine requires ultra-low temperature storage at -80°C before it is thawed for usage. MHRA noted that the formulation of the Comirnaty vaccine, approved in September 2023, remains unchanged. The new authorisation by the MHRA is applicable only in Great Britain. The UK regulator also approved Novavax’s Nuvaxovid, an adapted vaccine targeting the Omicron XBB 1.5 ...
- Source: https://www.pharmaceutical-technology.com/news/mhra-licence-pfizer-biontech-vaccine/?cf-view
- 99
- February 13, 2024
Alys Pharmaceuticals announces launch with $100m funding

Alys Pharmaceuticals has announced its launch with a research and development (R&D) immuno-dermatology focused pipeline backed by a $100m financing from Medicxi. Co-founded by Medicxi and a team of dermatology and scientific specialists, Alys Pharmaceuticals is led by co-founder and COO Thibaud Portal, with Medicxi’s Francesco De Rubertis serving as board chairman. The company’s pipeline is powered by multiple platform technologies, targeting a range of dermatological ailments. Its goal is to transform the dermatological treatment landscape, focusing on conditions such as atopic dermatitis, vitiligo, alopecia areata and chronic spontaneous urticaria. Alys Pharmaceuticals’ pipeline also includes programmes for less common ailments such as mastocytosis and cutaneous T-cell lymphoma, and therapies to prevent skin side effects from cancer treatments. The company is partnering with establishments including the Institut Gustave Roussy and UMass Chan Medical School to advance its collaborative R&D. Alys Pharmaceuticals integrates the platforms and assets from six Medicxi companies: Aldena ...
- Source: https://www.pharmaceutical-technology.com/news/alys-pharmaceuticals-announces-launch/?cf-view
- 78
- February 13, 2024
Cancer treatment could identify patients most likely to respond to cancer drugs

Tumours with high mtDNA mutations more likely to respond to Opdivo Scientists from the Cancer Research UK Scotland Institute and Memorial Sloan Kettering Cancer Centre have discovered a cancer treatment that can identify patients who are more likely to respond to cancer drugs. Funded by Cancer Research UK and published in Nature Cancer, the study reveals new ways to identify patients who could benefit most from immunotherapy testing for mitochondrial DNA mutations (mtDNA). Researchers rewired the DNA of the mitochondria – energy factories found in living cells – to determine cancer responses to treatments that harness the body’s natural defences to attack cancer cells. Found in up to 50% of all cancers, mtDNA mutations cause mitochondrial dysfunction, which affects adenosine triphosphate levels – the source of energy for use and storage at the cellular level – as well as other cellular processes, leading to neuronal loss. Researchers found that tumours with ...
- Source: https://actionkidneycancer.org/cancer-treatment-could-identify-patients-most-likely-to-respond-to-cancer-drugs/
- 95
- February 13, 2024
Vicore licenses idiopathic pulmonary fibrosis therapy to Nippon in Japan

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 ...
- Source: https://www.pharmaceutical-technology.com/news/vicore-licenses-idiopathic-pulmonary-fibrosis-therapy-to-nippon-in-japan/?cf-view
- 133
- February 12, 2024
AstraZeneca posts 81% rise in FY 2023 profit after tax

AstraZeneca has reported a significant 81% rise in profit after tax, reaching $5.96bn for the fiscal year (FY) 2023 from $3.29bn in the previous year. Despite a $3.73m decline in the sales of Covid-19 medicines, the company’s total revenue for the full year 2023 grew by 6% to $45.81bn, up from $44.35bn in FY 2022. Excluding Covid-19 medicines, AstraZeneca saw a 15% increase in total revenue. The company experienced growth across oncology, where revenues rose by 21%, cardiovascular, renal and metabolism (a rise of 18%), respiratory and immunology (a rise of 10%) and rare disease (a rise of 12%). Reported earnings per share (EPS) stood at $3.84, an 81% increase from the $2.12 reported in the previous year. Core EPS, a key profitability measure, rose 15% to $7.26. The company’s earnings before interest, taxes, depreciation and amortisation also saw a notable increase of 47% ...
- Source: https://www.pharmaceutical-technology.com/news/astrazeneca-fy-2023-profit-after-tax/?cf-view
- 172
- February 12, 2024
Blood biomarkers in TGF-β pathway identify hidden liver cancer risk

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 ...
- Source: https://www.news-medical.net/news/20240209/Blood-biomarkers-in-TGF-ceb2-pathway-identify-hidden-liver-cancer-risk.aspx
- 170
- February 12, 2024
A budget friendly bioprocess control station for microbial applications

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 ...
- Source: https://www.news-medical.net/news/20240210/Discover-the-BIOne-250-A-budget-friendly-bioprocess-control-station-for-microbial-applications.aspx
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- February 12, 2024
Study reveals AI can predict patients’ survival in glioblastoma

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 ...
- Source: https://pharmat.com/news/study-reveals-ai-can-predict-patients-survival-in-glioblastoma/
- 98
- February 12, 2024
Study reveals SARS-CoV-2 can infect dopamine neurons causing senescence

Dopamine neuron senescence is a hallmark of Parkinson’s disease Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center and Columbia University Vagelos College of Physicians and Surgeons have reported that SARS-CoV-2 can infect dopamine neurones in the brain, triggering senescence. Long COVID patients should be monitored for an increased risk of developing Parkinson’s disease (PD)-related symptoms, as dopamine neuron senescence is a hallmark of the condition. The study revealed that dopamine neurons that are infected with SARS-CoV-2, the virus that causes COVID-19, stop working and send out chemical signals that cause inflammation, triggering senescence, when a cell loses the ability to grow and divide. Neurons produce dopamine, a neurotransmitter that acts on areas of the brain and causes feelings of pleasure, motivation, memory, sleep and movement. Damage to these neurons is also associated with PD, a neurodegenerative disorder that progressively damages parts of the brain. After generating multiple cell types from ...
- Source: https://news.weill.cornell.edu/news/2024/01/sars-cov-2-can-infect-dopamine-neurons-causing-senescence
- 167
- February 12, 2024
Regeneron’s linvoseltamab application accepted for review

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 ...
- Source: https://www.echnology.com/news/regeneron-linvoseltamab-application-review/
- 93
- February 11, 2024

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