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Biotechnology
The US Food and Drug Administration yesterday approved Japanese pharma major Takeda’s Adzynma (ADAMTS13, recombinant-krhn; TAK-755), adding to the approval a day earlier of the firm’s bowel cancer drug Fruzaqla (fruquintinib). 10 November 2023
Biotechnology
In another antibody-drug conjugate (ADC) deal for the US pharma major, Bristol Myers Squibb has acquired USA and South Korea-based Orum Therapeutics’ ORM-6151 program. 6 November 2023
Biotechnology
UK-based biotech Roquefort Therapeutics has announced that its mesodermal killer (MK) cell program has reached a significant milestone. 6 November 2023
Biotechnology
Independent French drugmaker Pierre Fabre has expanded a global partnership for Ebvallo (tabelecleucel) with US biotech Atara Biotherapeutics. 3 November 2023
Biotechnology
The US Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Committee concluded that Vertex Pharmaceutical and Swiss gene editing specialist CRISPR Therapeutics’ exagamglogene autotemcel (exa-cel) is generally safe for clinical use. 1 November 2023
Biotechnology
US biotech giant Amgen saw its shares fall by 4.4% to $251.44 on Tuesday, after it announced financial results for the third quarter of 2023. 1 November 2023
Pharmaceutical
US pharma giant Pfizer was trading more than 1% lower during Tuesday morning’s trading in New York, following the release of financial results. 31 October 2023
Biotechnology
In briefing notes released ahead of a key meeting on Tuesday, scientists at the US Food and Drug Administration describe uncertainty in the risks associated with a new gene editing technology. 30 October 2023
Biotechnology
Swedish Orphan Biovitrum (STO: SOBI), also known as Sobi, saw its shares rise 5.5% to 235.80 Swedish kronor in early trading today, as it released financial results for the third quarter of 2023. 30 October 2023
Biotechnology
American critical care specialist Citius Pharma is to list its oncology subsidiary on the Nasdaq exchange, via merger with a special purpose acquisition company (SPAC). 25 October 2023
Biotechnology
Shanghai-based gene therapy company Belief BioMed (BBM) has out-licensed certain rights for the commercialization of its hemophilia candidate, BBM-H901. 23 October 2023
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today authorized a new medicine called, Tepkinly (epcoritamab), as a treatment for diffuse large B-cell lymphoma (a type of blood cancer) in adults. 20 October 2023
Pharmaceutical
Nearly five months have passed since the Annual Meeting of the American Society of Clinical Oncology (ASCO) took place, and cancer-focused drugmakers are ready once again to dump their data to the world’s oncologists, media and more. 19 October 2023
Pharmaceutical
Swiss pharma giant Roche saw its shares fall more than 5% to 254.60 francs this morning, after it posted a cautious forecast for full-year 2023. 19 October 2023
Biotechnology
A first-of-its-kind, made-in-India product catering to advanced cell-and-gene therapies has been developed in the country. 16 October 2023
Pharmaceutical
New York-based SELLAS Life Sciences is on track to complete enrollment for its Phase III REGAL study of galinpepimut-S (GPS). 13 October 2023
Biotechnology
China’s CARsgen Therapeutics has announced the publication of two cases of long-term disease-free survival in the treatment of advanced hepatocellular carcinoma (HCC) with its CAR-GPC3 T-cell therapy. 12 October 2023
Biotechnology
Dutch gene therapy company uniQure saw its shares fall 11.6% to $6.73 yesterday, after it announced a strategic reorganization. 6 October 2023
Biotechnology
Innate Pharma was trading 15% lower by late-activity in Paris Thursday. 5 October 2023
Pharmaceutical
Rare diseases specialist Swedish Orphan Biovitrum, also known as Sobi, today announced that Lydia Abad-Franch has been appointed as senior vice president, head of research, development and medical affairs (RDMA), and chief medical office, a role which she has held on an interim basis since June. 5 October 2023
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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