The Federal Trade Commission (FTC) is delaying the closure of Amgen's acquisition of Horizon Therapeutics, as both companies now aim to complete the merger by mid-December 2023. The FTC alleges that Amgen could use its drug portfolio to reinforce monopolistic positions for Horizon’s Tepezza and Krystexxa treatments where there are few competitors in these spaces. A federal court placed a tempora..
Promosome, a New York-based company, has filed lawsuits against Moderna and Pfizer for allegedly violating patent protections related to mRNA technology. According to Promosome's filings submitted to the Southern District Court of California, both companies used Promosome’s patented method in producing their COVID-19 vaccines. The lawsuit claims that in 2009 company-affiliated scientists discove..
FibroGen, a biotech company, experienced a setback as its leading candidate, Pamrevlumab, failed to meet the primary endpoint in a Phase III trial for non-ambulatory patients with Duchenne muscular dystrophy (DMD) on background corticosteroids. The LELANTOS-1 trial tested the candidate against a placebo and found that it missed the primary study endpoint of Performance of the Upper Limb 2.0 at t..
The FDA is poised to grant full approval for Biogen and Eisai's Leqembi drug, which has been developed as a treatment for Alzheimer's disease. The decision is based on data from the pivotal trial Study 301, which showed consistently favorable results for primary and secondary endpoints. In July 2023, the FDA may grant full approval following a vote by an advisory committee that has been asked to..
NanOlogy LLC presents clinical research involving its large surface area microparticle investigational drugs at the DDW 2023 poster presentation and ASCO Annual Meeting. The DDW poster presentation discusses intracystic injection of LSAM-PTX for chemoablation of Intraductal Papillary Mucinous Neoplasms, which reduces cyst volume and surface area, morphological changes, and loss of pathogenic mut..
BioInvent announces additional efficacy data from Phase 1/2 trial with BI-1206 in solid tumors, including one patient with long-lasting stable disease and another experiencing a partial response. The study is testing the novel anti-FcyRIIB antibody in combination with pembrolizumab for patients who have previously progressed on PD-1/PD-L1 immune checkpoint inhibitors. The results suggest that BI..
Lixte Biotechnology has enrolled the first patient in a Phase 1b/2 trial of LB-100 and doxorubicin for advanced soft tissue sarcomas. The aim of the study is to find the appropriate dose of LB-100 with a standard dose of doxorubicin, followed by a randomized Phase 2 trial exploring synergy between the two drugs. Lixte hopes that this combination will improve efficacy exhibited by doxorubicin alo..
Inari Medical, a medical device company, has launched two new purpose-built products designed to address venous stent thrombosis and venous thromboembolism. The RevCore thrombectomy catheter is the first mechanical device made to handle in-stent thrombosis using a unique diameter-controlled coring element that safely engages with the clot within stents. Meanwhile, the Triever16 Curve catheter is..
Vistagen Therapeutics has announced positive results from a Phase 2A study of its PH80 nasal spray for the acute treatment of hot flashes in women diagnosed with menopausal hot flashes. In the randomized, double-blind, placebo-controlled exploratory study, 36 subjects self-administered PH80 intranasally up to four times daily for four consecutive weeks. The spray reduced the daily number of hot ..
