10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
South Korean company LegoChem Biosciences and Germany’s Glycotope have signed a research collaboration and license agreement to develop an antibody drug conjugate (ADC). 12 July 2022
California, USA-based biotech Epic Bio, which is developing ultracompact therapies to modulate gene expression in vivo, today announced its launch and Series A financing of $55 million. 12 July 2022
A proposed biosimilar to Soliris (eculizumab) has shown clinical equivalence in efficacy and safety in people with paroxysmal nocturnal hemoglobinuria (PNH). 12 July 2022
As part of its efforts to keep up with changing technologies and to eliminate obsolete laws and regulations, the Indian government has unveiled a draft of the New Drugs, Medical Devices, and Cosmetics Bill 2022. 12 July 2022
The European Medicines Agency (EMA) has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorization applications (MAAs) for new medicines as well as post-authorization applications and to explore the practical aspects of the submission and analysis of such data. 12 July 2022
The pandemic revolutionized data collection and patient engagement in clinical trials. Although the life sciences industry has been historically cautious to adopt emerging technology trends, the sudden shutdown of in-person trial sites in adherence to safety protocols left sponsors and researchers with no choice but to adapt with more agile tools for remote data collection. 12 July 2022
New-York, USA-based Inspirna, a clinical stage biopharmaceutical company developing first-in-class small molecule therapeutics, has raised $50 million in a Series D financing round, co-led by new investors Sands Capital and Vivo Capital, with additional participation from new investor Dreavent 6. 12 July 2022
Swiss clinical-stage biotech Vaccentis, which is developing patient-specific medicines, today announced the appointment of Martin Munte, a veteran leader in biotech and pharma. 12 July 2022
US drugmaker Vertex Pharmaceuticals (Nasdaq: VRTX) yesterday announced that the company has entered into a definitive agreement under to acquire ViaCyte, a privately held biotechnology company focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), for $320 million in cash. 12 July 2022
German central nervous system (CNS) specialist Neuraxpharm is to buy two product portfolios within its main therapeutic focus area from French vaccines major Sanofi. 12 July 2022
The US Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DoD), announced that it has secured 3.2 million doses of Novavax’ COVID-19 vaccine (NVX-CoV2373). 12 July 2022
Stockholm-based biotech Swedish Orphan Biovitrum and French drugmaker Sanofi have presented positive results from the XTEND-1 Phase III study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001). 11 July 2022
US mRNA specialist Moderna today announced new clinical data on its bivalent Omicron (BA.1) booster candidate, mRNA-1273.214, lifting the firm’s shares 1.5% to $179.07 by mid-morning. 11 July 2022
US drugmaker La Jolla Pharmaceuticals Company saw its shares rocket 81.7% to $6.16 in early trading, after it was revealed that it has received a takeover approach from Innoviva. 11 July 2022
Shares of Dublin, Ireland-incorporated Perrigo Company were up 2.2% at $42.00 pre-market today, after it announced that its subsidiary HRA Pharma has submitted its application to the US Food and Drug Administration (FDA) for the first-ever over-the-counter (OTC) birth control pill in the USA. 11 July 2022
Swiss pharma giant Roche today announced results from the primary analysis of the Phase III HAVEN 6 study, which show that Hemlibra (emicizumab) continued to demonstrate a favorable safety profile and effective bleed control in people with moderate or mild hemophilia A, without factor VIII inhibitors. 11 July 2022
Research from industry analyst GlobalData suggests that India’s newly-approved COVID-19 vaccine, Gemcovac-19, could struggle to gain market share in the country. 11 July 2022
Phase III results of the explorer7 study, assessing the efficacy and safety of prophylactic treatment with concizumab in people living with hemophilia A or B with inhibitors were presented on Sunday at the International Society of Thrombosis and Hemostasis Annual Congress (ISTH 2022) in London, UK. 11 July 2022
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
Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly. 10 October 2024
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 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
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
Beijing’s InnoCare Pharma has announced encouraging Phase II results for its novel TYK2 inhibitor, ICP-488, aimed at treating moderate-to-severe plaque psoriasis. 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
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 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
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 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