Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cepheid, Conformis, Guide Sensmart, Oxford Immunotec, Surgical Innovation Associates.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accelerate Technologies, Aptorum Group, Billiontoone, Confirm Biosciences, Exagen, Genosity, Infirmary Health, Inflammatix, Karl Storz, Labcorp, LC-SCRUM-Asia, Jellagen, Mayo Clinic, Olink Proteomics, Premier, Proterixbio, Provider Network of America, Pulse Biosciences, Radiant Technologies, Saranas, Securiport, Seek Thermal, Stryker, Swift Biosciences, Wright Medical, Thermo Fisher Scientific, Well Health Technologies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acceleron, Aerie, Ascendis, BMS, Bridgebio, Histogen, Infinity, Medimetriks, Neuren, Organicell, Otsuka, Painreform, Pfizer, Seed Health, Windtree.
KARACHI, Pakistan – Faced with lockdowns and massive disruptions to supply chains, distributors and manufacturers of surgical equipment in countries across South Asia like Pakistan, Indian, Bangladesh and Nepal are struggling to find a way forward but also looking for opportunities to expand their share of the global market while reducing their existing reliance on imports of basic supplies.
PERTH, Australia – Australia’s largest health care venture capital firm, Brandon Capital, announced the launch of Australian biotech company Ena Respiratory Pty Ltd., which has developed a nasal treatment to boost the natural immune system to fight common colds and flu and has proved successful in reducing COVID-19 viral replication.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic, Masimo, Quotient, Zymo Research.
With only days left before Inovio Pharmaceuticals Inc. planned to initiate a phase II/III trial of its COVID-19 DNA vaccine candidate, INO-4800, and its accompanying delivery device, the FDA placed a partial clinical hold on the company’s study. This is the study’s second delay as the company originally planned to begin in July or August. November is now the earliest potential start date. Inovio told BioWorld that the company and its partners are continuing to prepare for the phase II/III trial “following resolution of the FDA’s partial clinical hold.”
Wellington Life Sciences general partner Regina Hodits, during a talk with CBT Advisors CEO Steve Dickman at the recent Biopharm America meeting, said the disaster scenario feared for European investments when COVID-19 struck “turned out very different. We never have a lot of time off in summer, not as much as we would want to, but this year we certainly had no time off,” as portfolio firms found money and Wellington tapped new opportunities.
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