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Pharmaceutical
Despite positive top-line data, Syndax Pharmaceuticals stock has fallen more than a tenth, following an interim analysis from the AUGMENT-101 trial. 3 October 2023
Biotechnology
US pharma major AbbVie (NYSE: ABBV) saw its shares dip 2.1% to $149.06 on Friday after it announced disappointing data from its Phase III CANOVA study evaluating the safety and efficacy of Venclexta (venetoclax). 2 October 2023
Biotechnology
Moving the compound a step closer to regulatory approval, the US Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) filed by US biotech Regeneron Pharmaceuticals for odronextamab. 29 September 2023
Biotechnology
Gilead Sciences has released a statement confirming it has stopped its ENHANCE-2 study of magrolimab in acute myeloid leukemia (AML). 27 September 2023
Biotechnology
The US Food and Drug Administration has granted a new approval for US pharma giant Pfizer’s hematologic malignancies drug Bosulif (bosutinib). 27 September 2023
Biotechnology
The European Commission (EC) has granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. 25 September 2023
Biotechnology
Having gained US and Taiwan regulatory approval for its hematology drug Altuviiio (efanesoctocog alfa) earlier this year, French pharma major Sanofi has now bagged marketing clearance in Japan. 25 September 2023
Biotechnology
Regulatory news last week included the US Food and Drug Administration a(FDA) approving UK pharma major GSK’s new myelofibrosis drug Ojjaara (momelotinib) with a wider indication than what hade been expected. The US Federal Commission (FTC) issued a policy on the listing of patents in the FDA’S Orange Book. Last Tuesday, Chinese biotech BeiGene revealed that Swiss pharma giant Novartis has pulled out of a second collaboration, this time regarding time regarding Tevimbra (tislelizumab). Also of note on the research front, US CNS specialist Relmada Therapeutics released positive Phase III results for its REL-1017 as a treatment for major depressive disorder (MDD). 24 September 2023
Biotechnology
The European Medicines Agency has granted marketing authorization to Jazz Pharmaceuticals for Enrylaze (JZP458). 22 September 2023
Biotechnology
The National Institute for Health and Care Excellence (NICE) has recommended Darzalex (daratumumab) alongside lenalidomide and dexamethasone (DLd) for untreated multiple myeloma (MM) for routine use in England and Wales. 22 September 2023
Biotechnology
The US Court of Appeals for the Federal Circuit has quashed an appeal from the Takeda unit Baxalta in relation to Roche’s hemophilia treatment Hemlibra (emicizumab). 22 September 2023
Biotechnology
The past year has been one of ups and downs for Blueprint Medicines Corporation, a US precision medicines company developing therapies for people with cancer and blood disorders. 20 September 2023
Pharmaceutical
Swiss pharma firm Acino has acquired M8 Pharmaceuticals, a specialty biopharmaceutical company focused on licensing, marketing, and distributing innovative and established medicines in Mexico and Brazil. 20 September 2023
Pharmaceutical
The European Commission (EC) has approved Otsuka Pharmaceutical and its subsidiary Astex Pharmaceuticals’ Inaqovi (oral decitabine and cedazuridine) as monotherapy for the treatment of adults with newly-diagnosed acute myeloid leukemia (AML) who are ineligible for standard induction chemotherapy. 19 September 2023
Biotechnology
Gilead Sciences subsidiary Kite has released new data supporting the value of its already-approved chimeric antigen receptor (CAR) T-cell therapy Yescarta (axicabtagene ciloleucel). 18 September 2023
Pharmaceutical
Just three months ago, the US Food and Drug Administration (FDA) extended the review period of the new drug application (NDA) for blood cancer drug momelotinib by three months to provide time to review recently submitted data. 18 September 2023
Biotechnology
Ryvu Therapeutics, Poland’s largest biotech firm, says it licensee, the Italian family-owned Menarini Group, will expand development of MEN1703 (SEL24) by initiating a new Phase II study in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in addition to continued translational work in other hematologic indications. 15 September 2023
Pharmaceutical
US pharma major Bristol Myers Squibb has highlighted its major pipeline updates at its R&D Day in New York. 14 September 2023
Biotechnology
Shares of London-listed blood disease specialist Hemogenyx Pharmaceuticals were up more than 9% at 1.80 pence, after it revealed in a stock exchange filing a positive development for its investigational product. 14 September 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted a supplemental biologics license application (sBLA) for Altuviiio [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl]. 13 September 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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