A phase III failure for Roche Holding AG unit Genentech Inc.'s anti-TIGIT immunotherapy tiragolumab dragged down the share value of several other class entrants. Read More
The music still goes on for biotech investment – it’s just not as loud and vibrant as it was during the heady days of 2020 and 2021, according to experts at this year’s LSX World Congress in London. After the rush to invest in biotech during the last two years, it has become an uphill battle to raise money – but the message from several panel experts at the event is that there is still hope. Read More
Newly appointed President and CEO Jackie Shea looks to have her work cut out for her, as Inovio Pharmaceuticals Inc. decided to ditch its phase II/III COVID-19 vaccination trial in favor of pursuing a booster strategy with INO-4800. That update, disclosed during Inovio’s first-quarter earnings late May 10 alongside a likely delay in filing for approval of HPV immunotherapy candidate VGX-3100, sent the stock (NASDAQ:INO) falling 27% May 11. Over the past year, shares have fallen more than 70%. Read More
More than 10% of Americans suffer from chronic pain, and how to prevent acute pain from turning chronic has been a critical question in pain research. But according to a study published in the May 11, 2022, issue of Science Translational Medicine, that approach has it backwards. In several animal models of pain, the resolution of acute pain was an active process. Chronic pain happened when those active processes failed to occur. Read More
Nuvig Therapeutics Inc. emerged from stealth mode with a $47 million series A round to back efforts to develop drugs that induce immune homeostasis as a way of treating autoimmune diseases without disturbing the system’s normal function. Read More
The legislation that would renew a number of FDA user fee programs, the Food and Drug Amendments Act (FDA Act) of 2022, has passed the first legislative hurdle in a subcommittee of the U.S. House of Representatives, but there are several issues with the bill. According to members of the subcommittee, the issues include an absence of provisions for medical device servicing, and the absence of legislation for FDA regulation of lab-developed tests (LDTs), issues that are unlikely to be resolved before the legislation is passed out of the House. Read More
With its focus on transformative high-risk, high-reward research to drive biomedical breakthroughs, the new Advanced Research Projects Agency for Health (ARPA-H) may be a good concept, but it shouldn’t come at the expense of increased investment in basic research at the NIH, according to the bipartisan leadership of U.S. House appropriators. Read More
Microbiome-modulating therapies are increasingly being explored to treat a variety of diseases. However, the market is still in its infancy and a lack of solid regulations remains challenging for companies to overcome, speakers at the BioKorea 2022 said May 11. Read More
Beijing Zhifei Lvzhu Biopharmaceutical Co. Ltd. has picked up rights to a whooping cough vaccine candidate from Intravacc B.V. on undisclosed terms. Zhifei Lvzhu gained exclusive rights to develop and commercialize the vaccine in China, as well as nonexclusive rights in Africa, South America, and selected Asian countries. In turn, Intravacc is eligible to receive milestone and up-front payments plus royalties on net sales of the vaccine, should it reach market. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alvotech, Anges, Beckley, Bioasis, Corbus, Dare, Eiger, Entrada, Incannex, Inmune, Lophora, Mycrodose, Neuramedy, Rallybio, Rational. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Eisai, Gilead, Kadmon, Moleculin, Neogene, Novo Nordisk, Turning Point, Zai Lab. Read More
