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22.10.25 - 13:36
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Portal Therapeutics receives FDA orphan, fast track designations for PORT-77 (PBR)
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In preclinical and Phase I studies in healthy participants, PORT-77 demonstrated a substantial reduction of plasma protoporphyrin IX (PPIX) through rapid ABCG2 inhibition. This outcome has the potential
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21.10.25 - 13:48
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Citius Oncology finalises McKesson deal for Lymphir distribution (PBR)
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Under this agreement, McKesson will act as an authorised distributor for the immunotherapy that has received approval from the US Food and Drug Administration (FDA) to treat adults
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17.10.25 - 14:01
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Tempus partners with Whitehawk on oncology research (PBR)
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This partnership will utilise Tempus' de-identified multimodal database to guide the design of clinical trials. Under the multi-year agreement, Whitehawk will utilise Tempus' real-world dataset to focus on
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16.10.25 - 14:01
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FDA accepts Chiesi triple combination inhaler application for asthma (PBR)
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The inhaler administers three active ingredients through a single device, known as single inhaler triple therapy (SITT), which has already received approval in nearly 50 countries. It combines
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15.10.25 - 12:48
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iQure, University of Padova collaborate to investigate iQ-007 mechanism (PBR)
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The collaboration aims to clarify the underlying mechanism of action of iQ-007. The results will assist in stratifying and identifying patients who may benefit from this astrocyte-targeted therapy,
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14.10.25 - 14:00
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US FDA grants BeOne′s sonrotoclax breakthrough designation for MCL (PBR)
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The FDA has also approved BeOne's application to participate in Project Orbis, an initiative that offers a framework for concurrent submission and oncology products review among collaborating health
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13.10.25 - 13:00
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Adcendo receives FDA fast track status for ADCE-D01 to treat STS (PBR)
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ADCE-D01 is an antibody-drug conjugate (ADC) designed to target the urokinase plasminogen activator receptor-associated protein (uPARAP). Preclinical data indicate that ADCE-D01 exhibits anti-tumour activity in mesenchymal tumour models,
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10.10.25 - 13:48
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Bio-Thera, Intas extend partnership for golimumab biosimilar (PBR)
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BAT2506 is a proposed biosimilar of golimumab, developed by Bio-Thera. Golimumab is a human IgG1 monoclonal antibody that specifically targets tumour necrosis factor alpha (TNF-α), a key pro-inflammatory
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09.10.25 - 13:36
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Nilo Therapeutics raises $101m to develop neural circuit therapies (PBR)
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The funding will facilitate the establishment of Nilo's laboratories in New York City, the growth of the team, and the advancement of preclinical programmes. Furthermore, the company has appointed
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08.10.25 - 14:00
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AeroRx secures $21m for nebulised COPD treatment development (PBR)
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The funds will be used to advance the late-stage clinical development of the company's leading candidate, inhaled AERO-007. This nebulised LABA/LAMA combination is being developed as a potential
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07.10.25 - 13:12
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FDA accepts priority review for Orca Bio′s hematological malignancy therapy (PBR)
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Orca-T is being assessed to treat hematological malignancies, including myelodysplastic syndromes (MDS), acute myeloid leukaemia (AML), and acute lymphoblastic leukaemia (ALL). The FDA has granted priority review, with
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06.10.25 - 14:24
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FDA fast-tracks Alto Neuroscience′s ALTO-101 for CIAS treatment (PBR)
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Currently, there are no approved treatments for CIAS, a key feature of the condition that significantly affects daily functioning and the quality of life for individuals living with
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01.10.25 - 13:36
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FDA approves Novartis′ Rhapsido for CSU treatment (PBR)
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The oral treatment was approved for use on those who continue to experience symptoms despite receiving H1 antihistamine therapy. Rhapsido is administered in pill form twice daily and
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30.09.25 - 13:36
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BioLineRx partners with Hemispherian to advance brain cancer therapy (PBR)
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The companies will collaborate on the development of GLIX1 as a potential treatment for both newly diagnosed and recurrent GBM. This molecule functions by enhancing TET2 activity within
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29.09.25 - 13:00
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AbbVie files NDA with FDA for tavapadon to treat Parkinson’s disease (PBR)
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The submission draws on findings from the TEMPO clinical development programme, which assessed the tolerability, efficacy, and safety of tavapadon in various populations with Parkinson's disease. This programme
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26.09.25 - 13:36
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Lilly secures EC approval for Kisunla to treat Alzheimer’s disease (PBR)
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The approval applies to individuals with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers. Kisunla, administered as a monthly infusion, is already available in several
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25.09.25 - 14:48
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Sandoz launches generic iron sucrose injection in US market (PBR)
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The launch follows approval from the US Food and Drug Administration (FDA). Iron sucrose is a key treatment for iron deficiency anaemia, affecting around five million people in
The post Sandoz launches generic iron sucrose injection in US market appeared first on Pharmaceutical Business review....
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24.09.25 - 13:36
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Leqembi approved in Australia to treat early Alzheimer’s (PBR)
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The drug is indicated for adults with mild cognitive impairment or mild dementia, who are non-carriers or heterozygotes of apolipoprotein E ε4 (ApoE ε4) with confirmed amyloid pathology.
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