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.
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
UK-based AviadoBio, a LifeArc Ventures portfolio company, and Astellas Pharma today announced an exclusive option and license agreement for AVB-101. 8 October 2024
China-headquartered clinical-stage biotech MediLink Therapeutics has announced a global clinical trial collaboration and supply agreement with US major Amgen. 8 October 2024
South Korean contract development and manufacturing organization Samsung Biologics says that John Rim will become its president and chief executive, with immediate effect. 17 December 2020
Sio Gene Therapies has reported positive six-month follow-up data from the low-dose cohort of the company’s dose escalation study of AXO-AAV-GM1, its adeno-associated viral vector (AAV)9-based gene therapy for the treatment of GM1 gangliosidosis. 16 December 2020
California-based Neuron23, an early-stage biotech focused on developing precision medicines for genetically defined neurological and immunological diseases, has announced its launch backed by a combined $113.5 million Series A and B financing. 16 December 2020
A week on from its review of the Pfizer and BioNTech coronavirus vaccine, the US Food and Drug Administration’s (FDA) overworked Vaccines and Related Biological Products Advisory Committee will consider the case for approving another jab. 16 December 2020
Eli Lilly yesterday revealed that it has signed an agreement to acquire gene therapy company Prevail Therapeutics, with the news sending the latter’s shares roaring up 86% pre-market. 16 December 2020
Following a positive recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October, the European Commission has now granted conditional marketing authorization for Tecartus (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). 16 December 2020
Shares in Australian biotech Mesoblast dropped by a fifth on Tuesday, after the firm announced the DREAM-HF Phase III trial missed its primary endpoint. 16 December 2020
News of a merger deal for Israel-headquartered pre-clinical biopharma firm Anchiano Therapeutics sent the firm’s shares up as much as 183% early yesterday, and still up 87% at $2.8 by close of trading. 16 December 2020
An amended collaboration agreement will see Gilead Sciences hand back certain rights to Jyseleca (filgotinib), following discouraging feedback from the US regulator. 16 December 2020
China and USA-based Harbour BioMed (HBM) and the Netherlands’ Utrecht University (UU) have licensed their fully human, SARS-CoV-2 neutralizing antibody, 47D11 program, to US pharma major AbbVie for the prevention and treatment of COVID-19 and related coronaviruses. 16 December 2020
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has set a date to discuss BioNTech and Pfizer’s conditional marketing authorization (CMA) application for BNT162b2, a COVID‑19 mRNA vaccine. 15 December 2020
Swiss pharma giant Novartis has announced positive findings from the first interpretable results of the Phase III KESTREL study, assessing the efficacy and safety of Beovu (brolucizumab) 3mg and 6mg in diabetic macular edema (DME). 15 December 2020
Californian investment group Westlake Village BioPartners has launched two new funds totaling $500 million, with the goal of promoting promising firms with innovative technologies. 15 December 2020
Japanese firms Ono Pharmaceutical and Chordia Therapeutics have agreed a licensing deal on CTX-177, the latter company’s MALT1 inhibitor and its related compounds. 15 December 2020
Spanish pharma company Reig Jofre has reached an agreement with Janssen to execute the technology transfer to manufacture its investigational COVID-19 vaccine candidate, Ad26.COV2-S. 15 December 2020
Research from industry analyst GlobalData has found that established players in Japan’s immunology market have a dominant lead in the digital marketing space. 15 December 2020
The US Food and Drug Administration has approved a shorter two-hour infusion time for Ocrevus (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). 15 December 2020
Shares of French metabolic diseases biotech company Poxel closed up 4.1% at 6.62 euros today, after it announced an update on results from the PXL770 Phase IIa STAMP-NAFLD trial in non-alcoholic steatohepatitis (NASH). 14 December 2020
A Phase III study of ruxolitinib in COVID-19 has missed its primary endpoint, with no statistically-significant reduction in severe cases of the disease. 14 December 2020