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Biotechnology
Slightly earlier than expected, US pharma giant Pfizer last week announced positive top-line results from the Phase III BENEGENE-2 study evaluating fidanacogene elaparvovec, an investigational gene therapy, for the treatment of adult males with moderately severe to severe hemophilia B. 3 January 2023
Biotechnology
The Indian pharma market is increasing at an annual growth rate of 15%, twice the world market growth rate, and has become one of the most expansive sectors in India. While the pharma industry is expected to grow to $130 billion by 2030, there are deep seated challenges posed at this industry when it comes to rare disease management. 30 December 2022
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva (obinutuzumab [genetical recombination]) intravenous infusion for an additional indication of CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma). 27 December 2022
Biotechnology
The market position of Bristol Myers-Squibb’s Abecma (idecabtagene vicleucel; ide-cel) for the treatment of relapsed or refractory multiple myeloma (RRMM), is facing a serious threat from a relatively novel class of drugs known as bispecific T-cell engagers (BiTEs), as they leverage clinical advantages such as improved duration of response to therapy and quicker administration. 27 December 2022
Biotechnology
US health technology assessor the Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of two gene therapies intended for the treatment of hemophilia A and B. 22 December 2022
Biotechnology
Bayer subsidiary Asklepios BioPharmaceutical (AskBio) has drawn attention to the role of its own adeno-associated virus technology in all US Food and Drug Administration-approved gene therapies of this type. 22 December 2022
Biotechnology
The European Commission (EC) has granted conditional marketing authorization for the use of Zynlonta (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), Swedish Orphan Biovitrum, also known as Sobi, and Switzerland’s ADC Therapeutics announced today. 21 December 2022
Pharmaceutical
Japan’s Daiichi Sankyo today announced it has launched Ezharmia (valemetostat tosilate), a first-in-class dual inhibitor of EZH1 and EZH2, in Japan for the treatment of patients with relapsed or refractory adult T-cell leukemia-lymphoma (ATLL). 20 December 2022
Biotechnology
Clinical-stage US biotech Mustang Biotech, which is focused on cell and gene therapies for hematologic cancers, solid tumors and rare genetic diseases, today provided updates on its CAR-T portfolio and 2023 anticipated milestones. 19 December 2022
Pharmaceutical
UK specialty pharma firm Shield Therapeutics has entered into an exclusive, multi-year agreement with US generics major Viatris to co-commercialize Accrufer (ferric maltol), a novel, oral iron therapy differentiated from other conventional irons by its efficacy, well-tolerated formulation, and broad indication, in the USA. 17 December 2022
Biotechnology
The European Medicines Agency’s human medicines committee (CHMP) recommended four novel medicines for approval at its December 2022 meeting. A final approval decision from the European Commission can be expected within the next two or three months. 16 December 2022
Biotechnology
USA-based Immix Biopharma, which is pioneering tissue-specific therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, saw its shares leap more than 41% to $2.07, after it announced a licensing deal and the formation of a new subsidiary. 16 December 2022
Pharmaceutical
As the 64th annual meeting of the American Society of Hematology (ASH) drew to a close in New Orleans on Tuesday, more clinical updates provided a window into the development prospects for two important programs in this therapy area. 14 December 2022
Biotechnology
German immuno-oncology company Affimed has sought to impress with data on its blood cancer candidates at the ongoing ASH (American Society of Hematology) meeting. 13 December 2022
Biotechnology
US biotech major Regeneron added to its offering at this year’s American Society of Hematology (ASH) meeting with data on linvoseltamab in multiple myeloma. 13 December 2022
Pharmaceutical
Eli Lilly’s (NYSE: LLY) oncology company, Loxo@Lilly, has announced updated clinical data from the global Phase I/II BRUIN trial of pirtobrutinib. 13 December 2022
Biotechnology
USA-based Regeneron Pharmaceuticals has announced positive new and updated data from the Phase I ELM-1 and pivotal Phase II ELM-2 trials of its lymphoma candidate odronextamab. 12 December 2022
Biotechnology
With Imbruvica (ibrutinib) sales of nearly $10 billion recorded by Janssen and AbbVie combined in 2021, the blood cancer drug has already changed the standard of care for patients in certain settings. 12 December 2022
Biotechnology
Autoimmune diseases specialist argenx has previously referred to Vyvgart (efgartigimod alfa-fcab), an antibody fragment that binds to the neonatal Fc receptor (FcRn), as a ‘pipeline in a product’. 12 December 2022
Biotechnology
At the 2022 American Society of Hematology (ASH) annual meeting, new results for Tecvayli (teclistamab) have been presented by US pharma giant Johnson & Johnson. 12 December 2022
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024
Biotechnology
UK drugmaker GSK might be trading lower following Thursday’s nomination of vaccine sceptic Robert F Kennedy Jr as the USA’s next health secretary, but the day brought good news for the group elsewhere in the business. 15 November 2024
Biotechnology
Adaptimmune Therapeutics reported promising data Wednesday from its pivotal Phase II trial of lete-cel in certain solid tumors with few effective treatments. 14 November 2024
Biotechnology
Sanofi has announced that the UK's health technology assessor will conduct a new review of its Sarclisa (isatuximab) combo therapy for relapsed or refractory multiple myeloma. 13 November 2024
Biotechnology
Syndax Pharmaceuticals has announced that its Phase II AUGMENT-101 trial of experimental drug revumenib achieved its primary endpoint. 13 November 2024
Biotechnology
VarmX, a Dutch biotech developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and inherited coagulation disorders, has appointed industry veteran John Glasspool (pictured, above) as chief executive. 12 November 2024
Biotechnology
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
Biotechnology
Geron Corporation, a biopharma company focused on telomerase inhibition therapies, has announced a $375 million financing agreement aimed at supporting the commercial rollout of Rytelo (imetelstat). 11 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) issued final guidance recommending reimbursement of Ayvakyt (avapritinib) from USA-based Blueprint Medicines. 6 November 2024
Biotechnology
French drugmaker Sanofi has revealed the results from the Phase III LUNA 3 trial of rilzabrutinib, an oral bruton tyrosine kinase (BTK) inhibitor, in persistent or chronic immune thrombocytopenia (ITP). 6 November 2024
Biotechnology
Beam Therapeutics will detail new clinical and preclinical data on its sickle cell disease (SCD) therapies at the upcoming American Society of Hematology (ASH) meeting. 6 November 2024
Pharmaceutical
An impressive set of quarterly financial results and an improved outlook for the rest of the year were announced by Bristol Myers Squibb on Thursday. 31 October 2024
Biotechnology
Maryland, USA–based glycobiology specialist GlycoMimetics has entered into an acquisition agreement with Crescent Biopharma, a privately held biotechnology company advancing a pipeline of oncology therapeutics designed to treat solid tumors. 30 October 2024
Pharmaceutical
Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024
Biotechnology
Last week Vertex Pharmaceuticals released positive Phase III results for its suzetrigine for moderate-to-severed pain. Belgium’s UCB revealed that Swiss pharma giant Roche was terminating its collaboration on the Alzheimer’s candidate bepranemab. The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) declined to recommend a second Alzheimer’s treatment, this time Eli Lilly’s Kisunla. Also of note, Lyell Immunopharma announced its planned acquisition of ImmPACT Bio and reprioritization of its own clinical pipeline. 27 October 2024
Biotechnology
California, USA-based Lyell Immunopharma (Nasdaq: LYEL) has entered into a definitive agreement to acquire privately-held US CAR-T company ImmPACT Bio. 26 October 2024
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