10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
AveXis today announced the European Commission (EC) granted conditional approval for Zolgensma (onasemnogene abeparvovec) for the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1; or for patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 gene. 19 May 2020
Mezzion Pharma after-hours on Monday announced that analysis of data from its Phase III FUEL trial showed statistically-significant positive results for an important efficacy endpoint, the myocardial performance index, with the news sending the South Korean biotech firm’s shares up 2.4% to 180,300 won by close of trading today. 19 May 2020
Suzhou, China-based Innovent Biologics has agreed a major collaboration with The University of Texas MD Anderson Cancer Center to co-develop Tyvyt (sintilimab) in rare cancers in the USA. 19 May 2020
New York-based biotech firm Hoth Therapeutics has obtained exclusive worldwide licensing rights to the BioLexa Platform, an antimicrobial therapy focused on treating atopic dermatitis. 18 May 2020
Global contract development and manufacturing organization (CDMO) Vibalogics is to manufacture additional clinical trial material for Johnson & Johnson’s lead COVID-19 vaccine candidate. 18 May 2020
US biotech firm Moderna saw its shares rocket more than 25% to $83.42 in morning trading, having hit $88.50 pre-market, after the company released new data showing that all 45 evaluated volunteers in a study of its coronavirus vaccine candidate had developed antibodies that would help protect them from COVID-19 infection. 18 May 2020
An investment of £138 million ($167 million) from the UK government will help boost vaccines manufacturing capacity, as well as establish a “virtual VMIC” in the country. 18 May 2020
Daiichi Sankyo and partner AstraZeneca today announced that their Enhertu (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy designation (BTD) in the USA for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy. 18 May 2020
The US Food and Drug Administration approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract. 16 May 2020
On Friday, the US Food and Drug Administration granted accelerated approval to Rubraca (rucaparib) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. 16 May 2020
Shares in San Diego-based Sorrento Therapeutics jumped over 200% on Friday, after the firm announced positive data from its COVID-19 antibody program. 15 May 2020
The US Food and Drug Administration has issued a complete response letter (CRL) for the new drug application of avapritinib for the treatment of adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST). 15 May 2020
US biotech Humanigen has announced that the first COVID-19 patient has been dosed in its trial of lenzilumab, the company’s anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody. 15 May 2020
Chugai Pharmaceutical saw its shares close up a modest 1% today as it revealed the signing of a license agreement with US major Eli Lilly that could lead to the creation of an antibody against COVID-19. 15 May 2020
Paris-based Sanofi has been forced to walk back claims that the USA would be entitled to the largest order of its investigational COVID-19 vaccine, should it be successfully developed. 15 May 2020
The European Commission (EC) has extended the current conditional marketing authorization of Adcetris (brentuximab vedotin) to include adults with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with cyclophosphamide, doxorubicin, prednisone (CDP). 14 May 2020
Boehringer Ingelheim has acquired Northern Biologics, a wholly-owned subsidiary of Canada-based Northern LP, the German family-owned pharma major announced today. 14 May 2020
Biotech holding company Roivant Sciences has announced several updates from its BREATHE trial evaluating intravenous gimsilumab’s impact on mortality in COVID-19 patients with lung injury or acute respiratory distress syndrome. 14 May 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