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Home » Newsletters » BioWorld

BioWorld

March 16, 2021

View Archived Issues
Abdominal pain illustration

A face in the crowd: Lilly posts positive phase III data in treating severe ulcerative colitis

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

Merck KGaA sees new clinical setback for GSK-partnered bintrafusp alfa

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
Gold dollar sign

Acepodia raises $47 million to move its pipeline forward

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

Exevir adds to series A, stresses need for second-generation COVID-19 antibodies

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
Virus cells

Oncolytic virus’ past in question but promising future lyse ahead

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

Asia’s digital capabilities benefit R&D and patients, but lacking harmonization hinders efficiency

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
MA-strategy.png

New working group to take deep dive on biopharma M&As

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

Sequester fix in the offing?

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

Appointments and advancements for March 16, 2021

New hires and promotions in the biopharma industry, including: Aptose, Be, Immunicum, Innovative Cellular, Iovance, Iterum, Janux, Mydecine, Reform, Remix. Read More

Earnings for March 16, 2021

Quarterly snapshots from biopharma companies with marketed products, including: Catalyst. Read More

Financings for March 16, 2021

Biopharmas raising money in public or private financings, including: Anchiano, Biohaven, Chemomab, European Biotech Acquisition, Longeveron, Mannkind, Mantra, Neoimmunetech, Rubius, Stridebio. Read More

In the clinic for March 16, 2021

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

Other news to note for March 16, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AC Immune, Alchemab, Allero, Ampio, Astrazeneca, Atai, Boehringer, Can-Fite, Cohbar, Cure, Diverse, Elevation Oncology, Enveric, Evaxion, Ewopharma, GBT, Horizon, Immunoprecise, Immutep, Intelgenx, Italfarmaco, Luye, Merck & Co., Neogenomics, Nurix, Otsuka, Pandion, Perception, Purdue, Sanofi, Skye, Viela. Read More

Regulatory actions for March 16, 2021

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

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