After hitting the safety and efficacy endpoints in a pivotal study of wet age-related macular degeneration, 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) now is on hold, the company said, because the agency said CMC problems were getting in the way, along with “open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.” In a morning investor call, CEO Russ Trenary repeatedly emphasized the study’s “highly statistically significant” data and said the company would address the FDA concerns as soon as possible. The company’s stock (NASDAQ:OTLK) had been pummelled by midday, with shares down 83% at 24 cents each.

Times hard but future brighter, VC panel agrees 

Optimism from those in venture capital (VC) despite a gloomy current market proved the keynote of a virtual salon hosted by Demy-Colton and titled “VC Trends in Healthcare Investing: Current Pulse Check.” Julia Moore, co-founder and managing partner at Breakout Ventures, was among the panelists. “I don’t think we should do our job if we’re not optimists,” she said, adding that the industry’s path has lately become clearer. “Everyone has more of a grounding of what the next couple of years [will] look like, hopefully,” she said. “I know the pipeline is there.”

Developers making steady progress with IgAN candidates

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 drugmakers, plenty of which are busy in the space. Just two days before the research appeared, one of the IgAN players, Vera Therapeutics Inc., said the phase IIb Origin trial with atacicept for IgAN met its primary and key secondary endpoints. Others with prospects include Alpine Immune Sciences Inc., Chinook Therapeutics Inc., Otsuka Pharmaceutical Co. Ltd., and Remegen Ltd.

Clash over US drug prices continues as IRA negotiations kick in

In response to the Biden administration announcing on Aug. 29 the first 10 medications up for price negotiations 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. U.S. President Joe Biden, however, laid out his argument at a public address following the announcement, saying the move will save the federal government more than $160 billion over the next 10 years. 

Kakao to build private ‘AI data bridge’ connecting hospital, government, industry

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. As Oh Yu-kyoung, Korea’s minister of Food and Drug Safety, and other officials called for innovative regulation to match the equally innovative advances in biotech at the Global Bio Conference 2023 in Seoul, South Korea, on Aug. 30, Kakao Healthcare CEO Hwang Hee showcased a video demonstration of its generative AI-based software that seemed to parallel OpenAI’s ChatGPT, but only for those in the biotech sector.

Also in the news

Aeon, Agex, Aiviva, Akeso, Alkermes, Alvotech, Apogee, Biovaxys, Bioventure, Bloomsbury Genetic Therapies, Bristol Myers Squibb, Cadrenal, Cantex, CCM, Clene, CN, Daré, Eagle, Embark, Epigenic, Erasca, Faron, Fluoguide, Galapagos, Hutchmed, Immucell, Janssen, Kamada, Laurent, Lianbio, Lib, Lyra, Lytix, Merck, Mercury, Mitsubishi Tanabe, Neurocrine, Novo Nordisk, Nymox, Paragon, Recce, Roche, RS, Serina, Spiral, Tango, Teva, Tscan, Valneva, Vertex, Xortx