MRNA’s the thing and special purpose acquisition company (SPAC) Environmental Impact Acquisition Corp. is following as it will merge with privately held mRNA-developer Greenlight Biosciences Inc. Read More
Fulcrum Therapeutics Inc. shares (NASDAQ:FULC) closed at $18.77, up $10.44 or 125%, on word of positive interim results from a phase I trial in healthy adult volunteers with oral FTX-6058 for sickle cell disease (SCD). The firm has “already achieved maximal target engagement [MTE] at all three doses,” said Christopher Morabito, the company’s chief medical officer. “I don’t think we’ll exceed that.” Read More
Hutchmed Ltd. has struck a deal for Epizyme Inc.’s anticancer therapy Tazverik (tazemetostat) that could bring the latter up to $310 million. The agreement gives Hutchmed rights to research, develop, manufacture and commercialize Tazverik in greater China, which covers mainland China, Hong Kong, Macau and Taiwan. Read More
Sinovac Biotech Ltd. said booster shots of its Coronavac vaccine against SARS-CoV-2 induce strong immune responses in adult and elderly populations following a considerable loss of antibodies six to eight months after completing the current two-dose regimen. Read More
Researchers have shown that glucocorticoids, a type of steroid hormones, target both neuroplasticity-related genes and genes related to ciliary function in the brain. However, the effects on the different processes are mediated via different receptors, and in response to different stimuli. A study investigated the specific targets of glucocorticoids, giving new insights into the biological mechanisms of stress adaptations, and how they are linked to neural plasticity. Read More
SK Bioscience Ltd. has won approval from the South Korean Ministry of Food and Drug Safety (MFDS) to begin a phase III trial for its COVID-19 vaccine candidate GBP-510, making the recombinant protein antigen vaccine the first domestically developed candidate to make it to late-stage testing. “We aim to begin the phase III trials within August and to have the data ready by early 2022,” a company spokesman told BioWorld. Read More
Rick Bright, who filed a whistleblower complaint last year against the U.S. Department of Health and Human Services (HHS) after he was removed from his position as director of the Biomedical Advanced Research and Development Authority (BARDA), reached an undisclosed settlement with HHS, the U.S. Office of Special Counsel reported Aug. 9. Read More
Rather than appeal an April decision by the U.S. Court of Appeals for the District of Columbia Circuit, the FDA is changing how it regulates imaging agents. That means the agency will transition at least some approved imaging agents from drug status to device status and, going forward, it will regulate products that meet both the device and drug definition as devices – unless Congress specifies otherwise. Read More
New hires and promotions in the biopharma industry, including: Abeona, Antios, Atara, Aurion, Black Diamond, Boundless, Emerald Health, Enterin, Haya, Kaleido, Mindmed, Moonlake, Navrogen, Sparx, Tempest, Trevi. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alnylam, Aravive, Axsome, Bavarian Nordic, Biontech, Daiichi Sankyo, Impel, Opthea, Pfizer, Roche, Synedgen, Tracon, Trillium, UCB. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arvinas, Atyr, Finch, Indapta, Insilico, Liminal, Maxcyte, Nervgen, Otsuka, Sana, Takeda, Therapeutic Solutions, Voyager. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Advaccine, Ascletis, Astrazeneca, Autolus, Bluebird, Biohaven, Calliditas, Dare, Eton, Inovio, Moderna, Relief, Sanofi, Yisheng. Read More
