In a tough indication and a space crowded with developers, Eli Lilly and Co.’s phase III study of the monoclonal antibody mirikizumab for treating moderate to severe ulcerative colitis made a mark by meeting its primary endpoint of clinical remission and all key secondary endpoints compared to placebo. Read More
Less than two months after scrubbing a phase III non-small-cell lung cancer trial of the bifunctional fusion protein immunotherapy bintrafusp alfa, Merck KGaA said a phase II test of the candidate in another indication, biliary tract cancer, has missed a predefined threshold that would have enabled a regulatory filing for it. Both studies are part of a rich alliance between Merck and licensee Glaxosmithkline plc. Read More
Only four years after its foundation, Acepodia Inc. raised $47 million in a series B financing round. The funds will help the oncology company move its first cell therapy candidate to phase II trials, while expanding its research and development activities with other products from its tech platform. Read More
LONDON – Exevir Bio NV added a further €15 million (US$17.9 million) to close its series A round at €42 million, providing the means to take its nanobody therapy for treating COVID-19 infection through to registration. Read More
When Amgen Inc. won approval of the oncolytic virus (OV) therapy Imlygic (talimogene laherparepvec, t-vec) for melanoma in late October 2015, hopes ran high for the space. The mood has since faded in some quarters – but hardly all. Read More
In the “The World for Asia, Asia for the World” panel discussion at the virtual Wuxi Healthcare Forum, investors and executives took note of the region’s digital capabilities for reducing R&D costs and timelines, while also calling for more harmonization on the regulatory front to empower R&D in Asia. Read More
A new multilateral working group could bring deeper scrutiny to biopharma mergers, both past and future. The group, made up of competition experts from Canada, the EU, U.K. and U.S., is taking on the job of identifying fresh approaches to analyze and address the competitive concerns raised by biopharma M&As. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: TGA: VTE common, but not with vaccine; FDA looking at investigational labeling risks; ICER to review myasthenia gravis drugs. Read More
New hires and promotions in the biopharma industry, including: Aptose, Be, Immunicum, Innovative Cellular, Iovance, Iterum, Janux, Mydecine, Reform, Remix. Read More
Biopharmas raising money in public or private financings, including: Anchiano, Biohaven, Chemomab, European Biotech Acquisition, Longeveron, Mannkind, Mantra, Neoimmunetech, Rubius, Stridebio. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Adagene, Amerimmune, Ampio, Annovis, Anokion, Azurrx, Chinook, Edesa, Eli Lilly, Evofem, Fibrogen, Galmed, Histogen, Immutep, J&J, Medicago, Mediprint Ophthalmics, Merck & Co., Merck KGaA, Moderna, Nabriva, Novartis, Oramed, Pliant, Roche, Sanford Burnham Prebys, Solid, University of Hong Kong, Ventyx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arbutus, Arch, Corat, Cytocom, Meissa, Merck & Co., Pep-Therapy, Sagimet, Spectrum, Visus. Read More
