Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Agios, Astrazeneca, Bristol Myers Squibb, Dr. Reddy's, Edesa, Exelixis, Genentech, Gilead, Intellia, Matinas, Mereo, Neurelis, Octapharma, Oncopeptides, Prestige, Recce, Roche, Versantis.
Nec Corp.’s bioinformatics subsidiary Nec Oncoimmunity AS said it is working with Oslo University Hospital to develop an artificial intelligence (AI) platform that will allow the team to design a T-cell diagnostic to complement the current serological tests for infectious diseases, including COVID-19.
In July a major initiative of the International Federation of Pharmaceutical Manufacturers and Associations, designed to combat the rising tide of antimicrobial resistance and accelerate the pace at which new antibiotics are discovered and brought to market, was announced. The $1 billion AMR Action Fund, supported by 23 pharma companies, was created “because there was a clear realization that we have no time to spare to address the lack of innovation in this area,” said Martin Bott, interim general manager of the fund, who described the progress being made with the fund in a fireside chat at this week’s virtual BIO Investor Forum.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Genalyte.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Altrix Medical, Chembio Diagnostics, Eurofins Biomnis, Jud Care, Luxfer, Myriad Genetics, Neurox, Nexgel, Stratus, Transforming Systems, Ursa Health, Vitalhub.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA posts guidance agenda for FY 2021; Third-party 510(k) review report posted; NIOSH testing flunks more imported filter masks; OIG says Cedars-Sinai billed for non-compliant bariatric surgeries.
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Anges, Aslan, Beyond Air, Er-kim, ICER, Macrogenics, Omeros, Takeda.
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