Princeton, N.J.-based Soligenix Inc.’s quick response testing SGX-301 (synthetic hypericin) – with results shown after just six weeks of treatment – puts the company in strong position against cutaneous T-cell lymphoma (CTCL) as it readies for a “robust” discussion with the FDA. Read More
Dragonfly Therapeutics Inc., of Cambridge, Mass., has expanded a strategic collaboration with Merck & Co. Inc. on the development of natural killer (NK) cell engager immunotherapies for oncology to add infectious disease and immune disorders. For $47.5 million up front, it's granting Merck the option to license exclusive rights to candidates developed using its TriNKET cell technology platform. Read More
LONDON – As the epicenter of the COVID-19 epidemic shifted to Europe and the number of deaths in Italy exceeded the toll in China, the EU stepped up efforts to mount a coordinated response, with a big boost for collaborative R&D funding and a call for clinical research to be pooled in multicenter, multi-arm randomized controlled trials. Read More
The first attempt at using existing drugs to treat patients infected with SARS-CoV-2 has yielded disappointing results. In 200 hospitalized patients with severe COVID-19, a 14-day regimen of twice-daily treatment with Kaletra/Aluvia (lopinavir/ritonavir, Abbvie Inc.) did not hasten recovery when added to the standard of care. Read More
DUBLIN – The Genentech arm of Basel, Switzerland-based Roche Holding AG plans to move its interleukin-6 (IL-6) inhibitor, Actemra (tocilizumab), into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection. Read More
President Donald Trump has issued an executive order enabling the Defense Production Act, which gives the U.S. Department of Health and Human Services broader leeway to conscript industrial production to deal with the COVID-19 outbreak. Read More
LONDON – The extent to which existing DNA databases fail to reflect human genetic diversity is laid bare in the most geographically comprehensive sequencing initiative to date. The study applied the latest sequencing techniques to 929 genomes from 54 diverse populations around the world. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Bellus, Biondvax, Bioxcel, Cellphire, Genentech, GT Biopharma, ISA, Nantkwest, Novartis, Oramed, Pfizer, Phathom, Soligenix, TFF. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aqualung, Arecor, Cyclica, Entos, Forma, Generex, Hoth, Lilly, Mateon, Nascent, Neurotheryx, Rocket, Roivant, Stabilitech. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Astrazeneca, Applied DNA, Cansino, Cytodyn, Dicerna, Gilead, Hansoh, Janssen, Merck, Novartis, Oramed, Takis and Virpax
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