Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytodyn, Gracell, I-Mab, Iveric, Novan, Revive.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axon, Denali, Neurocrine, Novan, Oryzon, Regeneron, Restorbio, Sanofi, Umecrine, Urogen, Voyager.
BEIJING – After its masks and test kits were said to be sent back by Western countries due to complaints over poor quality, China this week required only NMPA-approved companies export their products and stepped up regulations to ensure quality.
Warsaw, Ind.-based Orthopediatrics Corp. is scooping up Apifix Ltd., allowing it to gain the Minimally Invasive Deformity Correction (MID-C) system, which is used to treat adolescent idiopathic scoliosis. BTIG’s Ryan Zimmerman noted that the deal has a potential value of $67 million plus potential future revenue milestones. “The initial upfront payment has a ~$37 [million] value, composed of $2 million in cash and ~935k shares of common stock,” he added.
The novel coronavirus pandemic has been managed with widely varying degrees of success around the world. Artificial intelligence (AI), which can help to power all sorts of efforts, has been enlisted thus far in limited ways. But researchers at a virtual conference held on April 1 by the Stanford Institute for Human-Centered Artificial Intelligence explored some of the ongoing and potential applications of AI to systematize efforts to fight COVID-19.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Cellex, Ipsum Diagnostics, Refocus Group.
Given the evolving COVID-19 situation, U.S. House committee chairs are asking the White House Office of Management and Budget (OMB) to direct federal agencies to immediately extend all public comment periods by at least 45 days beyond the end of the declared national emergency, whenever that may be.
In an uncertain time that’s dominated by COVID-19, Flagship Pioneering Inc. and Arch Venture Partners collectively raised a massive $2.56 billion to fund new company creation and growth.
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