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Biotechnology
US clinical-stage biotech SpringWorks Therapeutics yesterday announced positive data from the Phase III DeFi trial of nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with progressing desmoid tumors, during the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2022. 11 September 2022
Biotechnology
German biotech company BioNTech, which is aiming to diversify having raking in massive profits from its COVID-19 Comirnaty vaccine collaboration with US pharma giant Pfizer, on Friday released positive clinical results with its novel CAR-T cell therapy candidate, BNT211, at the European Society for Medical Oncology (ESMO) Congress 2022. 10 September 2022
Pharmaceutical
The Phase III PRIMA (ENGOT-OV26/GOG-3012) study showing that Zejula (niraparib) maintained a sustained and clinically meaningful progression-free survival (PFS) benefit as a maintenance therapy in patients with first-line ovarian cancer following a response to platinum-based chemotherapy. 9 September 2022
Pharmaceutical
Long-term follow-up results from the PAOLA-1 and SOLO-1 Phase III trials of Lynparza (Olaparib), with or without bevacizumab, have demonstrated clinically meaningful improvements in overall survival (OS). 9 September 2022
Biotechnology
Spanish dermatology company Almirall has provided some detail on the results from a Phase III atopic dermatitis (AD) trial of lebrikizumab. 8 September 2022
Biotechnology
Chinese biotech Hutchmed today announces summary results of the 691-patient, multi-regional clinical trial (MRCT) of fruquintinib. 8 September 2022
Biosimilars
Competition for one of the best-selling medicines of all time is gaining traction, with new three-year data for Hadlima (adalimumab-bwwd), a biosimilar of adalimumab developed by Samsung Bioepis. 7 September 2022
Biotechnology
Belgium’s largest pharma company UCB has announced new three-year results from the BE BRIGHT open-label extension study of bimekizumab. 7 September 2022
Biotechnology
New findings from the XALOC program support the real-world effectiveness of UK pharma major AstraZeneca’s Fasenra (benralizumab) in the management of patients with severe eosinophilic asthma (SEA), showing reductions in annualized asthma exacerbation rate (AAER), improvements in asthma control and the ability to achieve clinical remission. 6 September 2022
Pharmaceutical
Phase III data from the InPedILD trial, which assessed the pharmacokinetics (dosing) and safety profile of Ofev (nintedanib) in children and adolescents between six and 17 years old with clinically significant fibrosing interstitial lung disease (ILD), German family-owned pharma major Boehringer Ingelheim announced today. 5 September 2022
Biotechnology
Important new data for the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) have been outlined ahead of their presentation at the annual meeting of the European Society of Medical Oncology (ESMO 22). 5 September 2022
Biotechnology
The annual meeting of the European Society of Medical Oncology (ESMO) kicks off in Paris on September 9, and early indications are the event could be full of practice-changing data. In the runup to the event, The Pharma Letter spoke with medical oncologist and ESMO Council member Antonio Passaro for an inside look at some of the leading themes and key presentations at the event. 29 August 2022
Pharmaceutical
Late-breaking data presented today at the European Society of Cardiology Congress 2022 highlight the potential of German pharm major Bayer’s Kerendia (finerenone), compared to placebo, to significantly reduce the incidence of sudden cardiac death across a broad range of patients with early to late-stage chronic kidney disease (CKD) and type 2 diabetes (T2D). 29 August 2022
Biotechnology
US biotech giant Amgen today presented results from the FOURIER-OLE studies – the open-label extension studies of the Repatha FOURIER cardiovascular outcomes trial at the European Society of Cardiology (ESC) Annual Meeting being held in Barcelona, Spain. 29 August 2022
Pharmaceutical
Results from the Phase II AXIOMATIC-SSP dose-ranging study of the investigational oral factor XIa (FXIa) inhibitor, milvexian, were released on Sunday in a Hot Line session at the European Society of Cardiology (ESC) Congress 2022. 29 August 2022
Pharmaceutical
German drug major Bayer has announced the start of a Phase III clinical development program OCEANIC to investigate the efficacy and safety of asundexian, an oral Factor XIa (FXIa) inhibitor, as a potential new treatment in patients with atrial fibrillation and in patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. 29 August 2022
Pharmaceutical
Ireland-headquartered Amarin Corporation today announced that new REDUCE-IT data show that fish oil-based drug Vascepa/Vazkepa (icosapent ethyl) significantly reduced ST-segment elevation myocardial infarction (STEMI), non-ST segment elevated myocardial infarction (NSTEMI), and other MI subtypes in patients with established cardiovascular disease (CVD) or diabetes with risk factors. 26 August 2022
Biotechnology
Shares in liver and cardio-metabolic specialist 89bio were up 5% ahead of the opening bell on Friday, following positive Phase II results from the ENTRIGUE study. 26 August 2022
Biotechnology
Late-breaking post-hoc exploratory results from the POSEIDON Phase III trial suggest a trend for improved overall survival (OS) with a limited course of five cycles of tremelimumab added to AstraZeneca’s Imfinzi (durvalumab) plus platinum chemotherapy, in the first-line treatment of patients with STK11, KEAP1 or KRAS-mutated Stage IV (metastatic) non-small cell lung cancer (mNSCLC). 9 August 2022
Biotechnology
USA-based biotech EQRx on Sunday announced a late-breaking oral presentation of updated data from the Phase III GEMSTONE-301 trial of sugemalimab in non-small cell lung cancer (NSCLC) at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC), taking place August 6 through August 9, 2022. 8 August 2022
Biotechnology
Cellular immunotherapy specialist Fate Therapeutics soared as much as 73%, and closed up 12.45 at $2.27 yesterday, after it released early-stage data on its FT819 in lupus. 19 November 2024
Pharmaceutical
US clinical-stage biopharmaceutical company Boston Pharmaceuticals has announced positive results from a Phase II study evaluating the safety and efficacy of once-monthly efimosfermin alfa (formerly known as BOS-580), a long-acting FGF21 analogue, in participants with stage F2/F3 fibrosis due to metabolic dysfunction-associated steatohepatitis (MASH). 18 November 2024
Pharmaceutical
French drugmaker Ipsen today announced the long-term efficacy and safety of patients treated with Bylvay (odevixibat) from two Phase III open-label extension studies. 18 November 2024
Pharmaceutical
US antiviral giant Gilead Sciences on Friday unveiled two-and-a-half-year interim analysis from the ongoing Phase III ASSURE study of its Livdelzi (seladelpar). 16 November 2024
Pharmaceutical
French drugmaker Ipsen announced late-breaking data for Iqirvo (elafibranor 80mg tablets) from an interim analysis of the ongoing open-label extension of the Phase III ELATIVE study at the American Association for the Study of Liver Disease (AASLD) congress. 16 November 2024
Biotechnology
Belgian drugmaker UCB and US biotech Biogen’s Phase III PHOENYCS GO trial results signal a pivotal development for systemic lupus erythematosus (SLE) treatment, as dapirolizumab pegol met its primary endpoint and demonstrated enhanced disease control and safety at Week 48. 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
Pharmaceutical
Research results featured heavily in the news last week, first with Viking Therapeutics releasing promising early-stage data for its investigational medicine VK2738 at the ObesityWeek meeting. US biotech Beam Therapeutics released early-stage data on its sickle cell disease candidate BEAM-101. Also of note, Arcus Biosciences and Gilead Sciences announced promising Phase III results for their TIGIT inhibitor domvanalimab in combination with zimberelimab. Denmark’s Novo Nordisk released financial results that attracted interest. 10 November 2024
Biotechnology
Shanghai-based BioCity Biopharma has announced promising late-stage results from the Phase II 2-SUCCEED clinical trial of SC0062. 7 November 2024
Biotechnology
Results from the ARC-10 Phase III study of Arcus Biosciences and Gilead Sciences’ domvanalimab and zimberelimab combination therapy indicate a significant reduction in mortality risk for patients with certain advanced lung cancers. 7 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
AstraZeneca has presented early results on three experimental weight-loss drugs at the ObesityWeek conference in San Antonio, showing encouraging signs for its obesity pipeline. 5 November 2024
Pharmaceutical
US neuroscience-focused biopharma Neurocrine Biosciences presented new data from more than 300 patients diagnosed with tardive dyskinesia and treated with Ingrezza (valbenazine) capsules at the 2024 Psych Congress in Boston. 5 November 2024
Pharmaceutical
Viking Therapeutics (Nasdaq: VKTX) reported promising early results for its experimental obesity pill, VK2735, with increased weight loss at higher doses. 4 November 2024
Pharmaceutical
The US subsidiary of Israel’s Teva Pharmaceutical Industries has announced new, positive data on social functioning and quality of life from the Phase III subcutaneous olanzapine extended-release injection study (SOLARIS) trial evaluating TEV-'749 in adult patients diagnosed with schizophrenia. 2 November 2024
Biotechnology
UCB has reported Phase IIa data from the TOGETHER (AH0003) study, investigating the safety, efficacy, and tolerability of bepranemab - an investigational anti-tau antibody targeting the mid-region of the tau protein - in people living with prodromal to mild Alzheimer’s disease. 1 November 2024
Biosimilars
The US unit of South Korea-based biosimilar drug developer Celltrion
has announced a late-breaking post hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of Zymfentra (infliximab-dyyb), during the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 30 October 2024
Biotechnology
US pharma major Eli Lilly has released results from two, multi-year, Phase III studies that showed patients treated with mirikizumab sustained stable, long-term remission across two types of inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn’s disease. 28 October 2024
Biotechnology
California’s Vera Therapeutics has released 96-week follow-up results from its ORIGIN Phase IIb trial of atacicept, targeting IgA nephropathy (IgAN). 28 October 2024
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