Policymakers in the U.S. are grappling with a disastrous pandemic as well as long-standing political tensions, but one aspect of the COVID-19 pandemic that might unify them is the need to ensure that patients in the U.S. are not at the mercy of other nations for needed diagnostics and therapies.
Now that Roche Holding AG has digested its Foundation Medicine and Flatiron acquisitions from a few years ago, it has looked to add more digital capabilities in a couple of recent deals. The earlier big-ticket tie-ups by the Basel, Switzerland-based pharma added genomic and real-world data analytics to deepen the knowledge driving Roche’s R&D efforts, particularly in oncology.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cue Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abound Bio, Advanced Molecular Services, Doctor On Demand, Foundation Medicine, Health Technology Solutions, Innovaqor, Integral Molecular, Lexent Bio, PRA, Quidel, Rennova Health, Tpt Global Tech.
Keeping you up to date on recent developments in neurology, including: Three stages to COVID-19 brain damage identified; ApoE4’s role in Alzheimer’s blood vessels; Lifespan synaptic atlas gives developmental insights.
LONDON – EU health ministers have given the go-ahead for the European Commission to negotiate COVID-19 vaccines contracts on behalf of all 27 member states, approving the use of a €2.3 billion (US$2.6 billion) emergency fund for down payments.
HONG KONG – Singapore-based Tychan Pte. Ltd. is starting a phase I trial for a novel monoclonal antibody (MAb) that specifically targets SARS-CoV-2, the coronavirus that causes COVID-19. The trial is expected to take only around six weeks to complete.
HONG KONG – India has been slowly easing restrictions on the export of its med-tech products, giving hope to domestic manufacturers looking to meet global demand for their output. “We are pleased to share that many of the routine IVD diagnostic kits falling under HSN code 3822 have been removed from export restrictions and a few specific items related to COVID-19 testing retained,” Rajiv Nath, the forum coordinator for the Association of Indian Medical Device Industry (AIMED), told BioWorld recently.
Partners Adaptive Biotechnologies Corp., which is based in Seattle, and Redmond, Wash.-based Microsoft Corp. have started sharing an open database that details the immune response in COVID-19 patients with researchers and public health officials. The project is analyzing thousands of de-identified patient blood samples submitted from institutions around the world and is dubbed ImmuneCODE.
The U.S. FDA granted San Diego-based Illumina Inc. an emergency use authorization (EUA) for the first COVID-19 diagnostic test that uses next-generation sequencing (NGS). In addition to diagnosing infection with SARS-CoV-2, the COVIDSeq test can help researchers track mutations in the coronavirus.
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