10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Results from the head-to-head VARSITY study, the first prospective clinical study to directly compare the efficacy and safety of two commonly used biologic therapies in patients with ulcerative colitis, were released today at the 14th Congress of the European Crohn’s and Colitis Organization (ECCO) in Copenhagen, Denmark. 9 March 2019
Switzerland’s Roche has won European approval for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) plus chemo, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC). 8 March 2019
Danish diabetes giant Novo Nordisk has presented data from the real-world ReFLeCT study at the Diabetes UK Professional (DUK) 2019 conference in Liverpool, UK. 8 March 2019
Today, US biopharma major AbbVie announced that the US Food and Drug Administration has granted a Breakthrough Therapy designation (BTD) to venetoclax (marketed as Venclexta) for use in combination with obinutuzumab as a fixed duration, first-line chemotherapy-free combination for patients with chronic lymphocytic leukemia (CLL) who have not been previously treated. 7 March 2019
In the face of two significant investor objections to Bristol-Myers Squibb’s (NYSE: BMY) proposed takeover of biotech firm Celgene (Nasdaq: CELG), the US pharma major filed an investor presentation with the Securities and Exchange Commission (SEC), and the board of directors sent an open letter to the company’s shareholders defending the deal, ahead of the April 12 investors’ vote. 7 March 2019
Following mixed results in a clinical study, Alnylam Pharmaceuticals lost ground in pre-market trading on Wednesday, ticking down nearly 3% in early morning trading. 6 March 2019
USA-based biotech firm Ambrx is set to get an upfront payment of $10 million under a global research and development collaboration with China’s BeiGene, the news of which pushed the latter’s share down 3.6% to $144.19 today. 6 March 2019
Dutch biopharma Kiadis Pharma today announced senior management appointments to further strengthen the company as it transitions into commercial stage. 6 March 2019
French life sciences investment group Seventure Partners is already halfway to reaching its goal of raising 200 million euros ($227 million) for its microbiome-focused Health for Life Capital II fund. 6 March 2019
The US Food and Drug Administration has accepted the New Drug Application (NDA) for fedratinib and granted a Priority Review to the filing. 6 March 2019
Senators in the US Congress have written to the US Food and Drug Administration seeking changes to official guidance, with the aim of expediting the release of new biosimilar insulin products. 5 March 2019
Iksuda Therapeutics today announced it has signed a licensing agreement with fellow UK-based Femtogenix (FGX), a next-generation ADC payload company. 5 March 2019
Six Sanofi employees in the Philippines are to face criminal prosecution over a number of deaths related to the dengue fever vaccine Dengvaxia (dengue tetravalent vaccine). 4 March 2019
The growing interest in gene therapies was further confirmed by US Biotech major Biogen, which has reached an agreement to acquire a UK-based clinical-stage gene therapy company developing treatments for rare inherited retinal diseases, at a price of $25.50 per share in cash. 4 March 2019
Germany’s Merck KGaA and New York’s Pfizer have joined an existing clinical collaboration between BioXcel Therapeutics and Nektar Therapeutics. 4 March 2019
The world-first launch has taken place of the humanized anti-sclerostin monoclonal antibody Evenity (romosozumab ) in Japan for the treatment of osteoporosis in patients with a high risk of fracture, according to Amgen Astellas BioPharma. 4 March 2019
New Ilumya (tildrakizumab-asmn) clinical insights were presented over the weekend at the 2019 American Academy of Dermatology (AAD) Annual Meeting, including long-term data showing sustained skin clearance in some patients living with moderate-to-severe plaque psoriasis after three years of ongoing treatment with Ilumya. 4 March 2019
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