9 October 2024 US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company.
Combo therapies featuring an immunotherapy and a tyrosine kinase inhibitor (TKI) are all the rage at this year’s annual congress of the European Society of Medical Oncology (ESMO). 21 September 2020
Chinese biopharma Innovent Biologics and US drugmaker Eli Lilly have jointly announced that biomarker results from the ORIENT-11 study were released in a mini oral presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. 21 September 2020
Health Canada has approved Inrebic (fedratinib), a new once-daily oral medication used to treat adults with an enlarged spleen and associated symptoms caused by intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. 21 September 2020
The Johnson & Johnson unit Janssen has announced interim results from the CHRYSALIS study, evaluating amivantamab in combination with the third-generation EGFR tyrosine kinase inhibitor lazertinib in patients with non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R mutations. 21 September 2020
A late-breaking paper discussed at the annual congress of ESMO 2020 shows positive data for an investigational antibody-drug conjugate (ADC) developed by Seattle Genetics and Genmab. 21 September 2020
Seqirus, a subsidiary of Australia’s CSL Limited, today announced new real-world evidence (RWE) that demonstrated an MF59 adjuvanted, trivalent influenza vaccine (aTIV) was more effective than a standard-dose non-adjuvanted trivalent seasonal vaccine in preventing influenza-related medical office visits and hospitalizations in adults 65 years and older during the 2017/18 US flu season. 21 September 2020
Impressive data for another immuno-oncology / tyrosine kinase inhibitor (TKI) combo add up to yet more competition in the first-line kidney cancer setting. 21 September 2020
Eli Lilly’s Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) significantly decreased the risk of breast cancer recurrence by 25% compared to standard adjuvant ET alone for people with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer. 21 September 2020
Shares of Swiss biotech Relief Therapeutics (SWX: RLF) were up more than 7% at 0.54 Swiss francs by early afternoon, after it announced the completion of the partnership agreement with USA-based NeuroRx for the commercialization of RLF-100 (aviptadil) worldwide. 21 September 2020
Swiss drugmaker Roche has presented detailed results from the Phase III IMpassion031 study of Tecentriq (atezolizumab), at the European Society for Medical Oncology (ESMO) virtual congress. 21 September 2020
New overall survival (OS) Phase III data, showing that Trodelvy (sacituzumab govitecan-hziy) significantly reduced the risk of death for people with triple-negative breast cancer (TNBC) by 52%, with a mean OS of 12.1 months compares to 6.7 months for standard single-agent chemotherapy, were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. 21 September 2020
Results from a pre-specified exploratory analysis of the positive ADAURA Phase III trial showed that UK pharma major AstraZeneca’s blockbuster cancer drug Tagrisso (osimertinib) demonstrated a clinically-meaningful improvement in central nervous system (CNS) disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), after complete tumor resection. 21 September 2020
Netherlands-based Scenic Biotech has entered into a multi-year strategic collaboration with Genentech, a subsidiary of Swiss pharma giant Roche, to discover, develop and commercialize novel therapeutics that target genetic modifiers. 21 September 2020
A new immuno-oncology combination from Bristol Myers Squibb and Exelixis could make a real difference in kidney cancer, the firms outlined on Saturday. 19 September 2020
Co-development partners Astellas Pharma and Seattle Genetics have announced that a Phase III trial of Padcev (enfortumab vedotin-ejfv) met its primary endpoint of overall survival compared to chemotherapy. 18 September 2020
Updated results from the PACIFIC Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) demonstrated a sustained, clinically meaningful overall survival (OS) and progression-free survival (PFS) benefit in patients with unresectable, stage III non-small cell lung cancer (NSCLC) who had not progressed following concurrent chemoradiation therapy (CRT). 18 September 2020
Today Akcea Therapeutics announced that Waylivra (volanesorsen), the first and only for the ultra-rare and life-threatening condition familial chylomicronemia syndrome (FCS), is to become available on the NHS in England. 18 September 2020
Results from the Phase III JAVELIN Bladder 100 study have been published in The New England Journal of Medicine with additional analyses being presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and describe the efficacy of Bavencio (avelumab) as a first-line maintenance treatment across various subgroups of patients with locally advanced or metastatic urothelial carcinoma (UC) and highlight exploratory biomarkers as well as patient-reported outcomes. 18 September 2020
French pharma major Sanofi has announced positive results from the pivotal Phase II trial for the PD-1 inhibitor Libtayo (cemiplimab) in locally advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to hedgehog inhibitor (HHI) therapy. 18 September 2020
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
Gene therapy start-up GEMMA Biotherapeutics (GEMMABio) has announced a significant partnership with Brazil's Fiocruz, a key supplier for the Brazilian Ministry of Health. 10 October 2024
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
Calluna Pharma, a biotech focused on treating inflammatory and fibrotic diseases, has appointed Mark Gaffney as its new chief executive. 9 October 2024
Cambridge, USA-based City Therapeutics has announced its launch with a vision to lead the future of RNA interference (RNAi)-based medicine. 9 October 2024
Zephyrm Bioscience, a Cayman Islands-based biotech, has filed for an initial public offering (IPO) in Hong Kong, seeking to raise additional capital to advance its cell therapy pipeline. 9 October 2024
Privately-held UK biotech Curve Therapeutics has announced the appointment of Rab Prinjha as chief research and development (R&D) officer. 9 October 2024