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BioWorld - Saturday, April 1, 2023
Home » Topics » Infection » Coronavirus

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Regulatory front for April 20, 2020

April 20, 2020
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The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Investors show confidence in biopharmas developing COVID-19 therapies

April 20, 2020
By Peter Winter
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Although the COVID-19 pandemic has decimated the economy and played havoc with the financial markets, there are promising signs that investors are slowly returning as infection curves begin to flatten thanks to social distancing measures. There is no doubt that they are showing confidence in those leading biopharmaceutical companies who they believe hold the keys to unlocking cures for the deadly infection. In addition, amid the intense activity related to COVID-19 research and development, the FDA did take some time to approve several new medicines, reinforcing the fact that innovation has not been completely throttled by the industry’s focus on the pandemic.
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Novartis leaps into hydroxychloroquine fray with new phase III study

April 20, 2020
By Michael Fitzhugh
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Both ballyhooed and questioned as a potential savior from COVID-19, hydroxychloroquine is about to get a high-profile test by Basel, Switzerland-based Novartis AG. The company has reached an agreement with the FDA to run a phase III trial evaluating the drug for the treatment of hospitalized patients with COVID-19, with enrollment of 400 patients beginning within weeks and results to be reported as soon as possible.
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Future imperfect: CBER head weighs good-enough options in virus war

April 20, 2020
By Randy Osborne
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Looking ahead to COVID-19 strategies, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said vaccine studies might be done not in clinics but in the streets. “By definition, we’re probably not going to be able to vaccinate everyone simultaneously,” he noted.
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U.K. pitches £500M bailout for VC-backed firms

April 20, 2020
By Nuala Moran
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LONDON – The U.K. treasury announced a £500 million (US$622.5 million) COVID-19 bailout plan for research-based startups, which could see the government holding equity stakes in venture capital-backed firms.
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Week in review for April 13-17, 2020: Biopharmas gain new product approvals

April 20, 2020
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A quick look back at top stories.
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Regulatory actions for April 20, 2020

April 20, 2020
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D, Futura, Genentech, Mustang, Precigen.
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Other news to note for April 20, 2020

April 20, 2020
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alligator, Anixa, Bayer, CB, Chromadex, Compugen, Cue, Cyclacel, Epsilogen, Esperion, Helsinn, Inmune, Innocan, Melinta, Merck, Molecular Partners, Noxxon, Otsuka, Recce Pharmaceuticals, Som Biotech, Theravance Biopharma.
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In the clinic for April 20, 2020

April 20, 2020
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alexion, Ascendis, BMS, Idorsia, Incyte, Karyopharm, Novartis, Xeris.
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Intuitive climbs on earnings, but cautious on growth in procedures, hospital sales

April 17, 2020
By Stacy Lawrence
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Robotic-assisted surgical procedures have fallen off steeply as the ongoing global pandemic has unfolded, but the real impact on Intuitive Surgical Inc. will come as its hospital customers may have to limit orders for expensive equipment upgrades as they struggle to manage unprecedented financial burdens. The U.S. accounts for about 70% of its robotic surgery procedures, but by the last few weeks in March, that activity had been curtailed by roughly two-thirds.
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