10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, has launched with the support of a $15 million financing. 11 October 2024
German cancer specialist Immatics has announced the pricing of its $150 million public offering, with Jefferies, BofA Securities, and Leerink acting as joint book runners. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
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
Provention Bio has revealed that the US Food and Drug Administration has granted coveted Breakthrough Therapy designation (BTD) to teplizumab (PRV-031) for the prevention or delay of clinical type 1 diabetes (T1D) in individuals at-risk of developing the disease. 5 August 2019
Immunotherapeutics developer Imcyse today announced the appointment of seasoned biotech expert Thomas Taapken as executive chairman and chairman of the board. 5 August 2019
Sosei Group has entered into a strategic multi-target partnership with fellow Japan-based Takeda Pharmaceutical to discover, develop and commercialize novel molecules, including small molecules and biologics, that modulate G protein-coupled receptor (GPCR) targets. 5 August 2019
One of Roche’s star cancer meds, Tecentriq (atezolizumab) has garnered further Phase III trial success, with the Phase III IMvigor130 study meeting its primary endpoint of progression-free survival (PFS). 5 August 2019
The Phase III Rivipansel (GMI-1070) Evaluating Safety, Efficacy and Time to Discharge (RESET) pivotal study did not meet its primary or key secondary efficacy endpoints. 5 August 2019
Late on Friday, the US Food and Drug Administration announced it has granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. 3 August 2019
A month after announcing that Adrian Rawcliffe is to succeed the retiring James Noble as chief executive in September, Adaptimmune has revealed further management changes. 2 August 2019
The European Commission has granted marketing authorization for Maviret (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to eight weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT)1, 2, 4, 5, and 6 infection. 2 August 2019
French biotech company Transgene today announced that the independent Data Monitoring Committee (IDMC) of the PHOCUS study of Pexa-Vec in liver cancer has completed a planned interim futility analysis. 2 August 2019
In Japan, a new filing for marketing approval for the monoclonal antibody tildrakizumab-asmn has been lodged, for the treatment of moderate-to-severe psoriasis and psoriatic arthritis. 2 August 2019
Ireland-incorporated Horizon Therapeutics yesterday announced the availability of an expanded access program for its investigational medicine teprotumumab. 2 August 2019
UK and USA-based clinical-stage biotech Orchard Therapeutics has received a Regenerative Medicine Advanced Therapy (RMAT) designation for OTL-103, a gene therapy for the treatment of Wiskott-Aldrich Syndrome (WAS). 1 August 2019
USA’s AVEO Oncology's 2006 license agreement with Kyowa Kirin has been amended to allow the latter to buy back the non-oncology rights of tivozanib (trade name Fotivda) in AVEO territories, which includes the USA and European Union. 1 August 2019
The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for investigational agent bempegaldesleukin (NKTR-214), from Nektar Therapeutics, in combination with Bristol-Myers Squibb's Opdivo (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma. 1 August 2019
Hotly-tipped Hong Kong-based biotech Chi-Med has said it expects to file for a new cancer drug this year, the second after its approved therapy Elunate (fruquintinib). 31 July 2019
Johnson & Johnson Rx pharma unit Janssen Biotech has returned worldwide rights to develop and commercialize the CD40 agonistic antibody, ADC-1013 (JNJ-64457107), to Sweden-based biotech firm Alligator Bioscience. 31 July 2019