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.
Chicago’s AbbVie has submitted to the US regulator for approval to market Rinvoq (upadacitinib) for people with active ankylosing spondylitis (AS). 25 August 2020
Privately-held Engitix, a biotech developing programs in fibrosis and solid tumors using its proprietary human extracellular matrix (ECM) platform, has entered into a licensing and collaboration agreement with Japanese pharma major Takeda. 25 August 2020
With rates of COVID-19 infection continuing to climb worldwide, and a proven vaccine still at least months away, the value of therapeutic options under development is increasing. 25 August 2020
US oncology specialist Onconova saw its shares decimated after it announced that INSPIRE, the company’s pivotal Phase III study assessing the efficacy and safety of IV rigosertib in higher-risk myelodysplastic syndrome (HR-MDS) patients, did not meet its primary endpoint of improved survival. 25 August 2020
Vaccine research specialist Intravacc has partnered with Therapyx, a company based in Buffalo, New York, on development of the gonorrhea vaccine candidate NGoXIM. 25 August 2020
US biotech Moderna has concluded advanced exploratory talks with the European Commission (EC) to supply 80 million doses of mRNA-1273, its vaccine candidate against COVID-19. 24 August 2020
Bristol Myers Squibb has entered into a definitive agreement to acquire Forbius, a privately held, clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of cancer and fibrotic diseases. 24 August 2020
The Phase III COMBI-i study evaluating the immunotherapy spartalizumab (PDR001), in combination with the targeted therapies Tafinlar (dabrafenib) and Mekinist (trametinib), did not meet its primary endpoint of investigator-assessed progression-free survival. 22 August 2020
US biotech major Gilead Sciences and co-developer Belgium-based Galapagos received a big shock following the Food and Drug Administration’s complete response letter (CRL) for its rheumatoid arthritis (RA) candidate filgotinib earlier this week. 21 August 2020
The European Commission has approved Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor for cystic fibrosis (CF) patients aged 12 and older with one F508del mutation and one minimal function mutation (F/MF), or two F508del mutations (F/F) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 21 August 2020
Japan’s Ono Pharmaceutical has received a supplemental approval for Velexbru (tirabrutinib) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, in Japan for additional indication of Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma, for a partial change in approved items of the manufacturing and marketing approval. 21 August 2020
Shares in German company BioNTech and US pharma giant Pfizer are both set to open Friday’s training with significant gains after the latest update on their COVID-19 vaccine. 21 August 2020
The US Food and Drug Administration has approved Kesimpta (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 21 August 2020
The US Food and Drug Administration has approved the expansion of the Kyprolis (carfilzomib) US prescribing information to include its use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens — once weekly and twice weekly — for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received one to three previous lines of therapy. 21 August 2020
UK pharma major AstraZeneca has secured approval in Japan for Imfinzi (durvalumab) as a treatment for extensive-stage small cell lung cancer (ES-SCLC). 21 August 2020
Tokyo’s Chugai Pharmaceutical has secured a label update for Kadcyla (trastuzumab) from the Japanese Ministry of Health, Labour and Welfare. 21 August 2020
Clinical-stage German biotech CureVac saw its shares rise 16% on Thursday and a further 6% to $70.00 pre-market today after it was revealed that the company had concluded exploratory talks with the European Commission with respect to the purchase of its investigational vaccine against COVID-19. 21 August 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