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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
Biotechnology
Swedish Orphan Biovitrum, also known as Sobi, today released financial results for the fourth-quarter and full-year 2022. 8 February 2023
Biotechnology
Boston, USA-based Garuda Therapeutics, a company creating off-the-shelf, durable blood stem cell-based cellular therapies, is $62 million richer. 7 February 2023
Biotechnology
Roche’s (ROG: SIX) ambition to muscle in on the paroxysmal nocturnal hemoglobinuria (PNH) sector has received another boost, as the Swiss pharma giant today announced positive results from the global Phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with PNH who have not been previously treated with complement inhibitors. 7 February 2023
Pharmaceutical
French drugmaker Sanofi looked set to close Friday’s trading 2% down after presenting its latest financial results and outlook for 2023. 3 February 2023
Pharmaceutical
Having twice previously declined to approve two other products in the class, the US Food and Drug Administration has now granted marketing authorization for UK pharma major GSK’s Jesduvroq (daprodustat) tablets as the first oral treatment for anemia (decreased number of red blood cells) caused by chronic kidney disease in adults on dialysis. 3 February 2023
Pharmaceutical
French privately-held pharma company Servier has announced its financial results for the 2021/22 financial year, highlighting the major steps of its ongoing transformation. 3 February 2023
Pharmaceutical
Roche’s shares dipped 1.4% to 322.60 francs this morning, when the Swiss pharma giant announced that, in full-year 2022, it achieved sales growth of 2% (+1% in Swiss francs) to 63.3 billion francs ($.66.8 billion), but warned that 2023 profits would see a downturn. 2 February 2023
Pharmaceutical
Swiss pharma giant Novartis presented its financial results for the fourth quarter and 2022 as a whole on Wednesday morning. 1 February 2023
Biotechnology
A rosy future is predicted for Sino-American biotech BeiGene oral Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib), which recently gained US Food and Drug Administration (FDA) approval for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). 31 January 2023
Biotechnology
The market for acute lymphocytic leukemia (ALL), the most commonly diagnosed form of leukemia, is expected to see strong growth at a compound annual growth rate (CAGR) of 5% over the next decade across the world’s eight major markets (8MM). 30 January 2023
Biotechnology
Preliminary results from the ongoing global Phase III STAND study in sickle cell disease are not what Novartis had hoped. 30 January 2023
Biotechnology
Positive results from the Phase III CARTITUDE-4 study show the novel BCMA-directed T-cell therapy Carvykti (ciltacabtagene autoleucel) performed well in the treatment of multiple myeloma. 30 January 2023
Biotechnology
Patients with myelofibrosis had clinically significant improvement in disease-related symptoms, including anemia and spleen enlargement, when treated with the targeted therapy momelotinib, according to results from the international Phase III MOMENTUM trial led by researchers at University of Texas MD Anderson Cancer Center. 30 January 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has granted accelerated approval to Jaypirca (pirtobrutinib) for relapsed or refractory mantle cell lymphoma (MCL) - a rare blood disorder - after at least two lines of systemic therapy, including a BTK inhibitor. 28 January 2023
Biotechnology
The US Food and Drug Administration (FDA) has approved the expanded indication for Enjaymo (sutimlimab-jome), the first and only treatment of hemolysis in adults with cold agglutinin disease (CAD), to include patients with or without a history of transfusions. 27 January 2023
Biotechnology
In the second setback in the space of a little over a month, Magenta Therapeutics saw its shares crash 23.3% to $0.38 pre-market today, after the US biotech revealed that the latest participant dosed at the Cohort 3 level (0.08mg/kg) in the ongoing MGTA-117 Phase I/II dose-escalation clinical trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) experienced a Grade 5 serious adverse event (SAE) (respiratory failure and cardiac arrest resulting in death) deemed to be possibly related to MGTA-117. 26 January 2023
Biotechnology
The European Medicines Agency is to review a regulatory submission from Swiss gene editing specialist CRISPR Therapeutics and partner Vertex Pharmaceutical. 25 January 2023
Biotechnology
Boston, USA-based biotech Blueprint Medicines Corporation has announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental new drug application (sNDA) for Ayvakit (avapritinib) to treat indolent systemic mastocytosis (SM). 24 January 2023
Biosimilars
Indian drugmaker Dr Reddy’s Laboratories has completed the trial program for its proposed rituximab biosimilar candidate, and will move ahead with global regulatory interactions. 23 January 2023
Biotechnology
Hematology specialist Disc Medicine has in-licensed certain antibodies from Mabwell Therapeutics, a division of Shanghai-based Mabwell Bioscience. 20 January 2023
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