10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Swiss cancer giant Roche has outlined the data it intends to present at the upcoming annual meeting of the European Society for Medical Oncology (ESMO). 23 September 2019
In a surprise change of leadership at Akcea Therapeutics, Paula Soteropoulos, chief executive, Sarah Boyce, president, and Jeff Goldberg, chief operating officer, have all resigned with immediate effect. 23 September 2019
China-based biotech CARsgen Therapeutics has been granted PRIority MEdicines (PRIME) eligibility to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of relapsed or refractory multiple myeloma, by the European Medicines Agency 23 September 2019
As well as recommending approval of four novel medicines and three generic medicines at its September 2019 meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced positive opinions for a number of label extensions, as follows: 23 September 2019
Japanese drugmaker JCR Pharmaceuticals has withdrawn its application with the Ministry of Health, Labor and Welfare of Japan (MHLW) for additional marketing approval of Temcell HS Inj, allogeneic bone marrow-derived mesenchymal stem cells, for the indication of epidermolysis bullosa (EB) (development code: JR-031EB). 20 September 2019
On Thursday, US House of Representatives Speaker Nancy Pelosi unveiled drastic proposals that would allow Medicare to negotiate lower prices on as many as 250 drugs and apply those discounts to private health plans. 19 September 2019
The full results of Strongbridge Biopharma’s Phase III SONICS study of the use of Recorlev (levoketoconazole) in endogenous Cushing’s syndrome have been published online in The Lancet Diabetes & Endocrinology. 19 September 2019
Bristol-Myers Squibb has outlined the data it will present at this year’s annual meeting of the European Society for Medical Oncology (ESMO), in Barcelona. 19 September 2019
New research examining the impact of antibiotics suggests that fluoroquinolones could create an elevated risk of developing aortic and mitral regurgitation, serious heart problems. 19 September 2019
A new report from industry analyst GlobalData finds that the market for hidradenitis suppurativa (HS) therapies is expected to grow from $898 million in 2018 to $1.81 billion in 2028, across the major markets. 19 September 2019
Privately-held oncology specialist Rgenix says that Robert Wasserman, has joined the Rgenix management team as its new chief medical officer. 19 September 2019
,veXis today announced that new interim data from the Phase III SPR1NT trial in pre-symptomatic patients as well as interim data from the ongoing Phase III STR1VE clinical program for Zolgensma (onasemnogene abeparvovec-xioi) showed positive outcomes, demonstrating age appropriate major milestone gain with pre symptomatic treatment and prolonged event-free survival* in patients with spinal muscular atrophy (SMA) Type 1. 19 September 2019
The US Food and Drug Administration has approved Erleada (apalutamide), from Johnson & Johnson subsidiary Janssen Biotech, for patients with metastatic castration-sensitive prostate cancer (mCSPC). 18 September 2019
Data presented in a symposium session at the annual meeting of the European Association for the Study of Diabetes (EASD) provide insights into imeglimin, an investigational type 2 diabetes medicine. 18 September 2019
Shares of Alexion Pharmaceuticals dipped 1.3% to $106.44 in after-hours trading on Tuesday, after the US biotech company announced plans for the transition of executive vice president and chief financial officer Paul Clancy later this year. 18 September 2019
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, has launched with the support of a $15 million financing. 11 October 2024
German cancer specialist Immatics has announced the pricing of its $150 million public offering, with Jefferies, BofA Securities, and Leerink acting as joint book runners. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
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