24 September 2024 Japan’s Daiichi Sankyo and Anglo-Swedish pharma major AstraZeneca were trading lower on Tuesday after announcing topline results from the TROPION-Breast01 study.
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
Rare disease firm bluebird bio has announced a company-wide restructuring aimed at cutting costs by 20% and achieving quarterly cash flow break-even by the second half of 2025. 25 September 2024
Wave Life Sciences has announced positive interim data from the ongoing Phase II FORWARD-53 study of WVE-N531, which is an exon skipping oligonucleotide being investigated in boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping. 25 September 2024
USA-based Generate:Biomedicines (Generate) today announced a multi-target collaboration with Swiss pharm giant Novartis to discover and develop protein therapeutics across multiple disease areas. 24 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
BioAtla has granted an exclusive global license to Context Therapeutics for BA3362, a T cell-engaging antibody targeting solid tumors. 24 September 2024
Japan’s Daiichi Sankyo and Anglo-Swedish pharma major AstraZeneca were trading lower on Tuesday after announcing topline results from the TROPION-Breast01 study. 24 September 2024
Belgian drugmaker UCB and US biotech Biogen have announced positive top-line results from the Phase III PHOENYCS GO study evaluating dapirolizumab pegol, 24 September 2024
Takeda has announced the Japanese approval of Fruzaqla (fruquintinib) capsules 1mg/5mg, a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy. 24 September 2024
Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma. 24 September 2024
Aptadir Therapeutics, a biotech company focused on RNA inhibitor-based therapies for cancer and genetic conditions, has launched with $1.6 million in pre-seed funding. 24 September 2024
Australian biotech company Telix Pharmaceuticals is to acquire USA-based RLS Radiopharmacies, expanding its manufacturing and distribution footprint in North America. 24 September 2024
The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
South Korean firm SK bioscience has announced that SKYCovione, the Asian country’s first COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, has been authorized by the Korean Ministry of Food and Drug Safety. 13 July 2022
Belgian biotech Agomab Therapeutics has extended its series B financing round with an additional close of $40.5 million, bringing the total to $114 million. 13 July 2022
An expert review of data from 79 real-world studies showed that AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [recombinant]) and the available mRNA COVID-19 vaccines provide equally effective protection against hospitalization and death from COVID-19 following two doses. 13 July 2022
US biopharma company Greenwich LifeSciences , which is focused on the development of GLSI-100, announced that the Food and Drug Administration (FDA) has removed the clinical hold permitting the Flamingo-01 Phase III clinical trial to proceed. 13 July 2022
Positive results from the A-SURE study were presented at the 30th International Society on Thrombosis and Hemostasis (ISTH) Congress in London, demonstrating improved prophylactic effectiveness in Elocta (efmoroctocog alfa) treated patients compared to a matched treatment group on SHL FVIII treatments, according to Swedish Orphan Biovitrum, also known as Sobi. 13 July 2022
Shares of Finnish drugmaker Orion Corporation jumped 7.6% to 47.60 euros by mid-morning, as it announced an important collaboration with US pharma giant Merck & Co. 13 July 2022
Agios Pharmaceuticals, a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today announced that effective August 8, 2022, Jackie Fouse will transition to the role of chairwomen of the board of directors and Brian Goff will assume the role of chief executive officer. 13 July 2022
A firm developing a novel vaccine technology, which could offer safer and more effective protection against infectious diseases, has appointed a new chief executive officer. 13 July 2022
The cell regeneration medicines market is currently valued at $30.3 billion and is anticipated to reach the valuation of $34.3 billion by the end of 2032 by growing at a CAGR of 14.4%, according to the latest report published by Future Market Insights. 13 July 2022
Centauri Therapeutics, a UK-based immunotherapy company focused on the treatment of infectious diseases, has announced three senior appointments at once. 12 July 2022
Early research conducted at the University of Birmingham, UK, shows that the novel ATM blocker AZD1390 can promote regeneration of damaged nerve cells, potentially restoring sensory and motor function after a spinal injury. 12 July 2022
Israeli generics giant Teva Pharmaceutical Industries today announced that its US subsidiary has reached an agreement with the City and County of San Francisco and the People of the State of California that settles opioid-related claims asserted on behalf of the County and City of San Francisco. 12 July 2022
South Korean company LegoChem Biosciences and Germany’s Glycotope have signed a research collaboration and license agreement to develop an antibody drug conjugate (ADC). 12 July 2022
California, USA-based biotech Epic Bio, which is developing ultracompact therapies to modulate gene expression in vivo, today announced its launch and Series A financing of $55 million. 12 July 2022
A proposed biosimilar to Soliris (eculizumab) has shown clinical equivalence in efficacy and safety in people with paroxysmal nocturnal hemoglobinuria (PNH). 12 July 2022
As part of its efforts to keep up with changing technologies and to eliminate obsolete laws and regulations, the Indian government has unveiled a draft of the New Drugs, Medical Devices, and Cosmetics Bill 2022. 12 July 2022
The European Medicines Agency (EMA) has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorization applications (MAAs) for new medicines as well as post-authorization applications and to explore the practical aspects of the submission and analysis of such data. 12 July 2022
The pandemic revolutionized data collection and patient engagement in clinical trials. Although the life sciences industry has been historically cautious to adopt emerging technology trends, the sudden shutdown of in-person trial sites in adherence to safety protocols left sponsors and researchers with no choice but to adapt with more agile tools for remote data collection. 12 July 2022
New-York, USA-based Inspirna, a clinical stage biopharmaceutical company developing first-in-class small molecule therapeutics, has raised $50 million in a Series D financing round, co-led by new investors Sands Capital and Vivo Capital, with additional participation from new investor Dreavent 6. 12 July 2022
Swiss clinical-stage biotech Vaccentis, which is developing patient-specific medicines, today announced the appointment of Martin Munte, a veteran leader in biotech and pharma. 12 July 2022
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Company Spotlight
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of first-in-class biological therapeutics for the treatment of rare disorders.