AstraZeneca has partnered with Quell Therapeutics to develop cell therapies for Type 1 diabetes and inflammatory bowel disorder in a potential deal worth over $2 billion. The collaboration will involve the development of autologous multi-modular Treg cell therapies, which are designed to suppress an overactive immune response seen in organ transplantation, inflammatory and autoimmune disease. As..
Protagonist Therapeutics plans to conduct a two-year extension study, PTG-300-21, to evaluate the long-term effects of rusfertide in patients with polycythemia vera (PV). The decision was based on positive results from the REVIVE study of rusfertide in PV, which showed sustained and durable hematocrit control under 45% in patients who remained largely phlebotomy-free. Nearly 70% of subjects rece..
Japanese pharmaceutical company Astellas Pharma has submitted a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare for zolbetuximab, an investigational Claudin 18.2-targeted monoclonal antibody being evaluated as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tu..
Kymera Therapeutics, a clinical-stage biopharmaceutical company, has released updated clinical data from the phase 1 trials of STAT3 Degrader KT-333 and IRAKIMiD Degrader KT-413. The new data shows that both programs continue to demonstrate substantial target knockdown in ongoing clinical trials with no dose limiting toxicities observed. Kymera is developing these drugs to target protein degrada..
NRx Pharmaceuticals has announced the completion of its registered direct offering for 9,670,002 shares of common stock at $0.65 per share, resulting in gross proceeds of approximately $6.28 million before deducting placement agent fees and other expenses. The company intends to use net proceeds from the offering for working capital and general corporate purposes, as well as potentially using it..
Daré Bioscience has announced the publication of Phase 1/2 clinical study results for its investigational formulation, DARE-VVA1. The tamoxifen-based product is designed to treat vulvovaginal atrophy (VVA) in women without hormones and was found to be safe and well-tolerated in postmenopausal participants with moderate to severe VVA. Daré is developing DARE-VVA1 as a hormone-free option for pati..
Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, has received FDA approval for its generic version of Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL, which is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. The drug should be administered by continuous infusion not to exceed 24..
Medical technology company Inspire Medical Systems has received approval from the US Food and Drug Administration for an expanded indication that increases the upper limit of the Apnea Hypopnea Index (AHI) to 100 events per hour from 65, and raises the Body Mass Index warning in labeling to 40 from 32. The update will provide a safe and effective treatment option for patients with moderate to se..
ACROBioSystems and Diagnostic Biochips have partnered to accelerate neuroscience drug discovery, according to a recent announcement. ACROBioSystems has launched in vivo electrophysiology solutions for neuroscience research under its Aneuro brand that will work without a headstage, reducing the physical burden on animal heads without compromising signal channels. The probes are designed to help r..
