The dark matter of long non-coding RNA (lncRNA) is shades brighter, after the signing of two major deals between biotech pioneers and big pharma in the past week. Haya Therapeutics SA announced Sept. 4 that it has sealed a multiyear agreement with Eli Lilly and Co. to apply its lncRNA platform technology to identify targets in obesity and related metabolic disorders. Read More

Athira CEO Mark Litton said the firm is “evaluating all the options” after disclosing top-line results from its phase II/III Lift-AD clinical trial of fosgonimeton (fosgo), a hepatocyte growth factor-positive modulator, in patients with mild to moderate Alzheimer’s disease (AD). Javier San Martin, chief medical officer, said the company will schedule “a conversation at the right time” with the U.S. FDA. Read More

Distinguishing between contract law and patent law, the U.S. Court of Appeals for the Third Circuit ruled against a Merck KGaA subsidiary, saying Ares Trading SA is still on the hook for paying royalties to a research partner through 2027 on sales of its cancer drug Bavencio (avelumab), a PD-L1 inhibitor granted accelerated approval in 2017 as a treatment for metastatic Merkel cell carcinoma. Read More

Biopharma IPOs have faced tough conditions in recent years, but 2024 is showing signs of improvement in terms of value, while stumbling on overall performance. IPO values remain significantly lower than the peak years of 2020-2021 and are still below collective values seen in 2014-2019, however, this year's value marks a recovery compared to the challenging environment of 2023. Read More

Technological breakthroughs are changing the biopharmaceutical landscape and forcing regulators to think on their feet and facilitate (not impede) innovation, experts said at the Global Bio Conference (GBC) 2024. “Regulatory speed and agility are necessary amid emergencies to cater to unmet medical needs,” Choong May Ling, CEO of Singapore’s Health Sciences Authority, told audience members in Seoul, South Korea. Read More

Following a bioresearch monitoring inspection, the U.S. FDA slapped Julio Flamini, a clinical investigator at the Research Center of Atlanta, with a warning letter citing a “significant” protocol violation in which a 15-year-old girl was given 10 times the maximum daily dose of an unnamed study drug for a week. Read More

New hires and promotions in the biopharma industry, including: Context, Egret, Eyepoint, Harness, Lakeshore, Milestone, Nicox, Pulsesight, Secarna, SFA, Stoke, Telomir. Read More

Biopharmas raising money in public or private financings, including: Aptose, Biocardia, Circle, Ensysce, Hanmi, Imugene, Innocan, Jazz, Precision, Qiagen, Revolka. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anthos, Alnylam, Arrowhead, Avadel, Bayer, Bridgebio, Bristol Myers, Cogent, Cytokinetics, Dyne, Elysium, George Medicines, Imugene, IO Biotech, Lexicon, NH Theraguix, Novo Nordisk, Nucana, Praxis Precision Medicines, Prokidney, Recursion, Redhill Biopharma, Regenxbio, Remedy Pharmaceuticals, Sanofi, Valneva, Vaxcyte. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allist, Asahi Kasei, Calliditas, Explorna, Jacobio, Kissei, Metagnenomic, Neurocrine, Nxera, Primrose, Rigel, Shenzhen Targetrx, Semnur, Simcere. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanz, Azurity, Emergent Biosolutions, Hutchmed, Kalvista, Moderna, Novavax, Obsidian, Prilenia, Seabelife SAS, Skyline. Read More