10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Shares of Innate Pharma shot up as much as 10% in an initial reaction to its announcement that French pharma major Sanofi has made the decision to progress IPH6401/SAR’514 into investigational new drug (IND)-enabling studies, triggering a 3 million-euro ($3.1 million) milestone payment. 21 July 2022
The UK’s R&D tax relief regime will continue to support innovative life sciences and biotech companies to conduct essential clinical trials and some pre-clinical work overseas following the publication of new draft legislation. 21 July 2022
US clinical-stage immuno-oncology company Portage Biotech says it has acquired the outstanding ownership interest (approximately 22%) of its invariant natural killer T cell (iNKT agonist) platform and now fully owns the worldwide rights to its small molecule iNKT agonists, including lead programs PORT-2 and PORT-3. 21 July 2022
New Jersey, USA-based rare disease drug developer PTC Therapeutics today announced that Upstaza (eladocagene exuparvovec) was granted marketing authorization by the European Commission. 20 July 2022
Unofficial American cost-effectiveness watchdog the Institute for Clinical and Economic Review (ICER) has published a Final Evidence Report on betibeglogene autotemcel for the treatment of beta thalassemia. 20 July 2022
Versanis Bio, a privately-held biotech advancing novel therapeutics for cardiometabolic diseases, has announced the appointment of Mark Pruzanski as chairman and chief executive 20 July 2022
In a rare disappointment for leading PARP inhibitor Lynparza (olaparib), researchers are to stop the Phase III LYNK-003 trial after independent monitors judged it likely to fail. 20 July 2022
Japanese drugmaker Ono Pharmaceutical has announced the establishment and start of an investment business of Ono Digital health Investment, GK (ODhI) as a corporate venture capital (CVC) that invests in venture companies in the field of healthcare, other than the ethical pharmaceutical drug-related field. 20 July 2022
The Pharmaceutical Research and Manufacturers of America (PhRMA) is to oppose what it calls “flawed price-setting proposals,” arguing instead for changes to the way Medicare covers and pays for medicines, including biosimilars. 20 July 2022
The US Food and Drug Administration (FDA) has approved Opzelura (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older, the drug’s developer, Incyte, announced late Monday, when the firms share closed up 3.2% at $81.36. 20 July 2022
Cell therapies are among the most researched treatment types for blood cancer and the product pipeline is oversaturated, with over 800 products currently in development for just five major blood cancers. 20 July 2022
Chinese contract research, development and manufacturing organization (CRDMO) WuXi Biologics has announced a 10-year, $1.4 billion investment plan to expand its research, development, and large-scale drug substance and drug product manufacturing capacity and capabilities in Singapore. 19 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