After hitting the safety and efficacy endpoints in a pivotal study of wet age-related macular degeneration (AMD), Outlook Therapeutics Inc.’s CEO said he had not expected to receive a complete response letter (CRL) from the U.S. FDA. The BLA for ONS-5010 (bevacizumab-vikg) now is on hold, the company said, because the agency said chemistry, manufacturing, and controls management problems were getting in the way, along with “open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.” Read More
“Sometimes the market gets ahead of the science,” said Dennis Purcell, founder of Aisling Capital, pointing to the way backers of genomics firms “went nuts” in the early 2000s. “I think we’re in a position today where the science is ahead of where the market is.” The remarks by venture capital (VC) expert Purcell came during a virtual salon hosted Aug. 30 by Demy-Colton and titled “VC Trends in Healthcare Investing: Current Pulse Check.” Panelists acknowledged the currently unfavorable financing environment but sounded upbeat about the industry’s path forward. Read More
The paper published June 19 in Nature Genetics that described a genome-wide analysis to narrow down the implicated pathogenic signaling pathways and “prioritize drug targets for IgA nephropathy [IgAN]” no doubt proved of great interest to developers, plenty of which are busy in the space. Read More
In response to the Biden administration announcing on Aug. 29 the first 10 medications up for price negotiations with the Centers for Medicare & Medicaid Services as part of the Inflation Reduction Act of 2022, U.S. Senate and House Republicans are firing back, calling the imposed “price-controls set by Washington bureaucrats” part of a scheme that “will lead to higher prices for new drugs coming to market, stifle the development of new cures and destroy jobs,” ultimately driving up costs for seniors. Read More
Data-driven health care platform company Kakao Healthcare Corp. may be embarking on its most ambitious project yet: launching an effective “AI-platform bridge” over patient waters to connect medical institutions, government and the industry for novel drug discovery and research. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agex, Alkermes, Biovaxys, Cadrenal, Embark, Novo Nordisk, RS, Serina, Teva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Bloomsbury Genetic Therapies, BMS, Eagle, Faron, Genentech, Halozyme, Hutchmed, Janssen, Laurent, Merck, Tscan, Valneva, Xortx. Read More
