The FDA’s Arthritis Advisory Committee panelists groped through cloudy data while complaining about the design of the phase III trial for Chemocentryx Inc.’s avacopan, and after going overtime ended up without consensus. Briefing documents ahead of the meeting darkened what had been a fairly bright picture for the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, but Wall Street held out hope. Wainwright analyst Edward White opined in a May 5 report that the adcom’s outcome “could still be positive,” and a May 4 dispatch from Canaccord Genuity’s Michelle Gilson said the briefing docs “miss[ed] the big picture.” Read More
The Biden administration’s May 5 about-face on the proposed TRIPS waiver of intellectual property (IP) protections for COVID-19-related medical products is not playing well with U.S. industry, EU trading partners and others concerned about the long-term unintended consequences. Read More
The allocation of capital to the build-out of next-generation gene therapies continues apace. Dyno Therapeutics Inc., a leader in applying artificial intelligence to advanced capsid engineering, raised $100 million in a series A round to fund its expansion and that of its Capsidmap platform. Read More
Sporos Bioventures LLC closed a $38.1 million series A financing to develop a pipeline of therapies for treating cancer and immune diseases through four companies with a business structure that its chief financial officer, Michael Wyzga, described as a hub-and-spoke model that leans on diversification. Read More
Amid what Moderna Inc. called "overwhelming" demand from global governments for mRNA vaccines and boosters with efficacy against SARS-CoV-2 variants of concern, the company said both its authorized vaccine, mRNA-1273, and a strain-matched candidate, mRNA-1273.351, increased neutralizing titers against the variants. Read More
PERTH, Australia – Imagion Biosystems Ltd. has entered a collaborative research program with therapeutic antibody development company Patrys Ltd. to combine their technologies to target brain tumor imaging and diagnosis. Read More
The European Commission posted a draft legislative framework for regulation of artificial intelligence, a document that spans all potential uses of such algorithms rather than just medical ones. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Everest, Lyndra, Merck & Co., RDIF. Read More
