10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Germany’s Merck KGaA and US drug giant Pfizer have received US approval to market Bavencio (avelumab) for the maintenance treatment of locally-advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. 1 July 2020
Swedish immuno-oncology firm BioInvent and New York pharma major Pfizer have extended their ongoing collaboration, through to the end of the year. 1 July 2020
In a therapy sector that has seen little success so far, Akero Therapeutics late yesterday announced results of a 16-week analysis of secondary and exploratory endpoints in its Phase IIa BALANCED study of efruxifermin (EFX), formerly known as AKR-001, in patients with non-alcoholic steatohepatitis (NASH). 1 July 2020
Ever deal-thirsty Japanese pharma giant Takeda has today entered into a collaboration with USA-based Carmine Therapeutics to discover, develop and commercialize transformative non-viral gene therapies for two rare disease targets using Carmine's REGENT technology, based on red blood cell extracellular vesicles. 30 June 2020
The long-running feud between US biopharma Vertex Pharmaceuticals and budget holders for the National Health Service (NHS) in England seems well and truly over. 30 June 2020
As Gilead Sciences revealed the price of remdesivir, its potential antiviral treatment for COVID-19, the US government announced that it has got its hands on another huge batch of the drug. 30 June 2020
Intercept Pharmaceuticals has received a complete response letter from the Food and Drug Administration regarding its New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of fibrosis due to non-alcoholic steatohepatitis (NASH). 30 June 2020
A second patient in the ASPIRO clinical trial investigating AT132 (the investigational gene therapy product candidate) for X-linked myotubular myopathy (XLMTM) has tragically passed away, Audentes Therapeutics has revealed. 30 June 2020
Roche has been granted US approval for Phesgo (pertuzumab/trastuzumab/hyaluronidase) plus chemo, for the treatment of early and metastatic HER2-positive breast cancer. 30 June 2020
US biotech Heron Therapeutics was one of a number of companies to announce on Monday that it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA). 30 June 2020
On Monday, the US Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. 30 June 2020
Efforts to broaden the use of IL-1 blocker rilonacept have been met with Phase III success, lifting shares in Bermuda-incorporated Californian firm Kiniksa Pharmaceuticals. 30 June 2020
Russian President Vladimir Putin has approved the proposal of the Ministry of Health to establish a special state fund that will focus on the purchases of some of the most expensive drugs for the needs of Russian patents, primarily children for years to come, according to recent statements by the press-service of the Russian Presidential Administration. 30 June 2020
Japan’s Ono Pharmaceutical has received a manufacturing and marketing approval of Ongentys (opicapone) Tablets 25mg, a catechol-O-methyltransferase (COMT) inhibitor (COMTi), in its home country. 29 June 2020
The new drug application for Enspryng (satralizumab) has been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica). 29 June 2020
A private placement has raised $250 million for German precision medicines specialist BioNTech, a company focused on immunotherapies for cancer and infectious diseases. 29 June 2020
The European Commission (EC) on Friday approved Reblozyl (luspatercept), developed by Celgene, which is now part of US pharma major Bristol-Myers Squibb under a $74 billion buy-out that completed in November 2019, and Acceleron Pharma. 27 June 2020
Johnson & Johnson has axed its late-stage LOTUS study of Stelara (ustekinumab) in systemic lupus erythematosus (SLE), due to lack of efficacy. A second, China-based Phase III trial will now not go ahead. 26 June 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