10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Cell and gene specialist Orgenesis has entered into a preliminary, non-binding term sheet with Leidos to develop and potentially obtain US marketing approval of ranpirnase for the systemic treatment of patients with SARS-CoV-2, the virus that causes COVID-19. 22 June 2020
US immuno-oncology (I-O) focussed biotech Agenus saw its shares advance 6% pre-market today, following the announcement of an out-licensing deal, but lost the gains by mid-morning. 22 June 2020
French pharma major Sanofi’s investigational enzyme replacement therapy (ERT), avalglucosidase alfa met the primary endpoint demonstrating non-inferiority in improving respiratory muscle strength, as measured by using percent-predicted forced vital capacity (FVC) in the upright position, compared to alglucosidase alfa (standard of care) in patients with late-onset Pompe disease (LOPD). 22 June 2020
The British biotech industry has released a new report indicating the resilience of the sector under the challenging conditions of the coronavirus pandemic. 22 June 2020
The European medicines regulator is to review a bid from Germany’s Merck KGaA and New York’s Pfizer to extend the marketable use of Bavencio (avelumab). 22 June 2020
British cell therapy specialist Rexgenero has bought all the key assets of Paris-based immunotherapy company aratinga.bio, a preclinical-stage firm developing an off-the-shelf CAR-T cell therapy. 22 June 2020
Ascentage Pharma over the weekend announced a clinical collaboration with Acerta Pharma, the hematology R&D subsidiary of UK pharma major AstraZeneca. 22 June 2020
Miami, USA-based Ridgeback Biotherapeutics has initiated two Phase II clinical trials to test the efficacy of EIDD-2801 as an anti-viral treatment for COVID-19. 22 June 2020
The US Food and Drug Administration will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to review data supporting the Biologics License Application (BLA) for belantamab mafodotin on July 14. 20 June 2020
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Tazverik (tazemetostat) in two follicular lymphoma (FL) indications. 19 June 2020
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) for moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 19 June 2020
Mixed results for Swiss pharma giant Roche show the Phase III IPATential150 study met one of its co-primary endpoints, while missing the other. 19 June 2020
The US Food and Drug Administration has approved Crysvita (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO), a rare disease that is characterized by the development of tumors that cause weakened and softened bones. 19 June 2020
Two subsidiaries of Japan’s Sumitomo Dainippon Pharma, Urovant Sciences and Sunovion Pharmaceuticals, have teamed up to work on the launch of vibregon. 19 June 2020
Seattle, USA-based biotech Alpine Immune Sciences saw its shares rocket 170% pre-market after announcing its biggest deal yet, with AbbVie, for an exclusive worldwide option and license agreement for ALPN-101, a first-in-class dual CD28/ICOS co-stimulation antagonist. 18 June 2020
Chicago-based AbbVie has released positive data from the Phase III MEASURE UP 1 study of Rinvoq (upadacitinib) in moderate to severe atopic dermatitis. 18 June 2020
The marketing authorization application (MAA) for Brukinsa (zanubrutinib) to treat Waldenström’s macroglobulinemia (WM) patients who have received at least one prior therapy or as first-line treatment for those unsuitable for chemo-immunotherapy has been validated for regulatory review by the European Medicines Agency (EMA). 18 June 2020
UK respiratory disease focussed biotech firm Synairgen has announced the expansion of the placebo-controlled home setting clinical trial of SNG001 (inhaled formulation of interferon-beta-1a) in patients with COVID-19. 18 June 2020
Swiss pharma giant Roche has announced positive results from the Phase III IMpassion031 study, evaluating Tecentriq (atezolizumab) plus chemo in triple-negative breast cancer (TNBC). 18 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