10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Kolon Life Science has announced that the clinical hold issued by the US Food and Drug Administration in April 2019 has been lifted effective April 10, 2020, and that the company can continue with its knee osteoarthritis (OA) Phase III clinical trial of Invossa (TG-C). 14 April 2020
Shares of US biotech firm Orgenesis were down more than 6% at $4.22 in early trading yesterday, after it announced an agreement to acquire the assets of Tamir Biotechnology (TamirBio), including ranpirnase, the latter’s broad spectrum anti-viral platform. 14 April 2020
Gilead Sciences has announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an individual compassionate use basis. 13 April 2020
The ADAURA Phase III trial for Tagrisso (osimertinib) in the adjuvant treatment of patients with Stage IB, II and IIIA epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with complete tumor resection will be unblinded early following a recommendation from an Independent Data Monitoring Committee (IDMC) based on its determination of overwhelming efficacy. 12 April 2020
The Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Braftovi (encorafenib) from Array BioPharma, which was acquired last July by Pfizer in an $11.4 billion deal. 10 April 2020
Privately-held US T cell-focused biotech NeoImmuneTech (NIT) has entered into a clinical collaboration agreement with Bristol-Myers Squibb to evaluate the combination of NeoImmuneTech’s NT-I7 (also known as Hyleukin-7), a long-acting interleukin (IL)-7, and the US pharma major’s Opdivo (nivolumab), a PD-1 blocking antibody. 10 April 2020
German immunotherapeutics specialist BioNTech and US pharma giant Pfizer today disclosed details of their collaboration to advance candidates from BioNTech’s mRNA vaccine program, previously announced on March 17, 2020. 9 April 2020
New Jersey, USA-based cell therapy specialist Celularity is expanding an existing collaborative license agreement with Lung Biotechnology, a United Therapeutics company. 9 April 2020
Germany’s Merck KGaA and US pharma giant Pfizer today announced completion of the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for Bavencio (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). 9 April 2020
Shares in Novavax jumped 15% on Wednesday, after the biotech firm announced it has identified a coronavirus vaccine candidate, NVX-CoV2373, and was moving towards a first-in-human trial in mid-May. 9 April 2020
A new project to develop a treatment for COVID-19 has been initiated between CSL Behring, a unit of Australia’s CSL Limited, and antibody specialist SAB Biotherapeutics (SAB). 9 April 2020
London-based cell therapy specialist Quell Therapeutics has kicked off a new collaboration with the Hannover Medical School, aimed at the discovery and validation of multiple Chimeric Antigen Receptor (CAR)-Treg cell therapies. 8 April 2020
Announcing its first partnership, US biotech start-up Arrakis Therapeutics says it has entered a strategic collaboration and license agreement with Swiss pharma giant Roche for the discovery of RNA-targeted small molecule (rSM) drugs against a broad set of targets across all of Roche’s research and development areas. 8 April 2020
The highly-respected, peer-reviewed journal The Lancet has published comprehensive data from the Phase III trials, DISCOVER-1 and -2, evaluating the safety and efficacy of Tremfya (guselkumab) for the treatment of adults with active psoriatic arthritis (PsA). 8 April 2020
Swiss oncology giant Roche has announced an extension to the US review of its risdiplam New Drug Application (NDA) in spinal muscular atrophy (SMA). 8 April 2020
Privately-held, clinical-stage US biotech company Tarveda Therapeutics says that the proposed merger agreement with Organovo Holdings has been terminated following the emergence of unanticipated, late opposition to the proposed transaction by major Organovo stockholders. 8 April 2020
Privately-held US biotech EpiVax yesterday announced its partnership with GAIA Vaccine Foundation (GVF) to crowd-source funds for the COVID-19 project and its pledge to make a free license available to developing countries who qualify, in the context of this partnership. 8 April 2020
Germany’s Biotest and Swiss firm Octapharma have joined an alliance formed by CSL Behring, a unit of Australia’s CSL Limited, and Japan’s Takeda Pharmaceutical to develop a potential plasma-derived therapy for treating COVID-19. 7 April 2020
US RNAi therapeutics company Alnylam Pharmaceuticals has announced the completion of the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO), in development for the treatment of primary hyperoxaluria type 1 (PH1). 7 April 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