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Biotechnology
In a Securities and Exchange Commission (SEC) filing last Friday, US oncology focused biotech Syros Pharmaceuticals disclosed it has received notice from Incyte Corp that it was opting out of a blood cancer treatment collaboration. 14 August 2023
Biotechnology
The US Food and Drug Administration (FDA) has granted approval for Talvey (talquetamab-tgvs) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. 11 August 2023
Biotechnology
Ryvu Therapeutics has finalized two important agreements with Fortrea, with the news edging the Polish biotech’s shares up 1.7% to 60.00 zloty by mid-afternoon. 4 August 2023
Biotechnology
US biotech major Amgen has announced financial results for the second quarter of 2023. 4 August 2023
Biotechnology
Agios Pharmaceuticals has signed exclusive worldwide license agreement with fellow USA-based Alnylam Pharmaceuticals to acquire the rights to develop and commercialize Alnylam’s novel pre-clinical siRNA targeting TMPRSS6, as a potential disease-modifying treatment for patients with polycythemia vera (PV). 4 August 2023
Biotechnology
The UK's National Institute for Health and Care Excellence (NICE) has issued a draft Appraisal Consultation Document recommending against CSL Behring’s Hemgenix (etranacogene dezaparvovec) for severe and moderately severe hemophilia B (congenital factor IX deficiency) patients without a history of Factor IX (FIX) inhibitors. 2 August 2023
Biotechnology
The US Food and Drug Administration has dealt a blow to the market value of New Jersey, USA-based oncology company Citius Pharmaceuticals. 31 July 2023
Biotechnology
Shares in US genetic medicines company Homology Medicines leapt more than 35% to $1.34 last Friday, after it revealed it has completed a review of its business, and the board of directors has approved a plan to evaluate strategic alternatives to maximize shareholder value. 31 July 2023
Pharmaceutical
Shares of US pharma major AbbVie were up 3.6% at $147.02 in early trading, after the company announced financial results for the second quarter ended June 30, 2023. 27 July 2023
Pharmaceutical
Swiss pharmaceutical giant Roche this morning revealed that sales for the first half of 2023 had dropped 2% to 29.78 billion Swiss francs ($33.01 billion), or -8% in franc terms. 27 July 2023
Biotechnology
The US Food and Drug Administration (FDA) has granted approval of Balfaxar (prothrombin complex concentrate, human-lans) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. 26 July 2023
Biotechnology
Late Friday, US biotech major Gilead Sciences announced that the Phase III ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been discontinued due to futility based on a planned analysis. 22 July 2023
Biotechnology
Switzerland-headquartered ADC Therapeutics has announced that it plans to discontinue the Phase II LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). 22 July 2023
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended 10 novel medicines, as well as some biosimilars and indication extensions, for approval at its July 2023 meeting. 21 July 2023
Biotechnology
Vanflyta (quizartinib) has won US approval alongside standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for newly-diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive. 21 July 2023
Pharmaceutical
The Sosei Group Corporation has acquired Swiss biotech Idorsia’s pharma business in Japan and Asia Pacific, excluding China. 20 July 2023
Biotechnology
Genetic medicines company Scribe Therapeutics has announced an expanded collaboration with French pharma major Sanofi. 18 July 2023
Biotechnology
Shares of Swedish Orphan Biovitrum, also known as Sobi, edged up 3% to 212.00 kronor today, after it posted financial results for the second quarter of 2023. 18 July 2023
Biotechnology
Deal-making news last week included China-headquartered BeiGene and Swiss pharma giant Novartis terminating their agreement on the development of ociperlimab as a treatment for lung cancer. On a more positive front, US tech-bio firm Recursion saw its shares rocket 115% on the news that NVIDIA had invested $50 million in the company, which will be used to accelerate development of Recursion’s AI foundation models for biology and chemistry. On the regulatory front, Chinese biopharma Innovent Biologics and IASO Biotherapies gained approval for their multiple myeloma drug Fucaso from the China NMDA. Also of note, US biotech Theseus Pharmaceuticals saw its shares slashed by two-thirds following its decision to stop development of lead candidate THE-630 in gastrointestinal stromal tumors. 16 July 2023
Biotechnology
ADC Therapeutics has announced a pause in patient enrollment in the Phase II LOTIS-9 trial of Zynlonta (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously-untreated diffuse large B-cell lymphoma. 12 July 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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