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.
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
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
European and American regulatory submissions for Agios Pharmaceuticals’ mitapivat are imminent, following positive results from the Phase III ACTIVATE trial. 2 December 2020
The first COVID-19 vaccine for the UK, developed by Pfizer and Germany’s BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA). 2 December 2020
Shares of USA-based Moleculin Biotech shot up more than 33% to $1.04 yesterday, after in revealed that the US Food and Drug Administration has approved its request for a Rare Pediatric Disease (RPD) designation for its drug candidate WP1066. 2 December 2020
The US regulator has granted approval for Roche to market Xolair (omalizumab) for the add-on maintenance treatment of nasal polyps in adults. 2 December 2020
The US Food and Drug Administration yesterday approved Blueprint Medicines’ Gavreto (pralsetinib) for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC). 2 December 2020
California’s BridgeBio Pharma has announced that its affiliate QED Therapeutics has had its New Drug Application (NDA) accepted by the US Food and Drug Administration (FDA) for infigratinib, an oral FGFR1-3 selective inhibitor, for cholangiocarcinoma. 1 December 2020
MaaT Pharma has secured an additional 7.35 million euros ($8.7 million) in an extension of its Series B financing, bringing the total raised in this round to 25.35 million euros. 1 December 2020
Biotech firm Zymeworks today announced that its partner, China’s BeiGene, has dosed the first patient in South Korea in a pivotal, single-arm clinical trial of Cmonotherapy in patients with advanced or metastatic HER2-amplified biliary tract cancer (BTC). 1 December 2020
Boosting its position as the leading developer of oral CGRP-receptor blockers, Biohaven Pharmaceutical has entered into a global collaboration and license deal with Japan’s Sosei Group. 1 December 2020
US healthcare giant Johnson & Johnson’s subsidiary Janssen says that the European Commission has granted marketing authorization for Tremfya (guselkumab), alone or in combination with methotrexate (MTX), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. 1 December 2020
Privately-held Scottish biotech ILC Therapeutics has secured an investment from Medical Incubator Japan, a Tokyo-based fund specializing in healthcare. 1 December 2020
Canadian biotech Zymeworks today revealed that the US Food and Drug Administration has granted Breakthrough Therapy designation for zanidatamab (formerly known as ZW25) in patients with previously-treated HER2 gene-amplified biliary tract cancer (BTC). 30 November 2020
Modern today announced that the primary efficacy analysis of the Phase III study of its COVID-19 vaccine candidate mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. 30 November 2020
Sanofi has won a broader European label for Dupixent (dupilumab), adding treatment of children between 6 and 11 with severe atopic dermatitis. 30 November 2020
Thousands of Australians with debilitating back and joint pain will have access to a life changing treatment option through the Pharmaceutical Benefits Scheme (PBS) which would otherwise cost tens of thousands of dollars. 30 November 2020
Vertex Pharmaceuticals on Friday announced that the European Commission has granted approval of the label extension for Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor). 30 November 2020
Takeda Pharmaceutical has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to manufacture and market Cabometyx (cabozantinib) as a treatment for patients with unresectable hepatocellular carcinoma (HCC) that has progressed after prior systemic therapy. 28 November 2020
US drugmaker AbbVie and Eisai on Friday announced approval of an additional indication of Humira (adalimumab), a fully human anti-TNFalpha monoclonal antibody, for the treatment of pyoderma gangrenosum (PG). 28 November 2020
US CNS specialists Biogen and Sage Therapeutics have announced a global collaboration to develop and commercialize potential breakthrough therapies in depression and movement disorders. 27 November 2020
The Russian Direct Investment Fund (RDIF) has bolstered manufacturing capacity for the supply of Sputnik V, Russia’s home-grown coronavirus vaccine. 27 November 2020