Upstream Bio has closed a $200m Series B funding round to enable the advancement of its investigational antibody UPB-101 for mid-stage studies in asthma and chronic rhinosinusitis with nasal polyps. The start-up will also undergo "translational, manufacturing and device development activities" to aid the launch of its Phase III development program. In addition, Thursday’s Series B raise will all..
Pharmaceutical companies Eli Lilly and Takeda are facing a class-action lawsuit over their diabetes drug Actos, which has been certified by a California Federal Judge. The case claims that the drug was marketed without disclosing its risk of bladder cancer, with plaintiffs alleging that both companies misled the FDA about Actos' mechanism to conceal aspects of the drug's safety profile. A Nation..
The FDA is likely to grant full approval for Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease ahead of an advisory committee vote on the drug. The agency has asked the committee to confirm whether Study 301 results verify lecanemab's clinical benefit, but both the briefing documents and decision will be based on these results. The data from the trial consistently s..
The American Society of Clinical Oncology (ASCO) conference showcased exciting new data for oncology treatments, with several drugs showing significant success rates. AstraZeneca's Tagrisso was found to outperform a placebo in trials for EGFR-mutated non-small cell lung cancer, Novartis' Kisqali impressed researchers with its ability to treat early breast cancer, and Merck's Keytruda was more ef..
Japanese pharmaceutical company Astellas Pharma has partnered with Kate Therapeutics to develop a gene therapy for X-linked myotubular myopathy (XLMTM), a rare and life-threatening neuromuscular disease leading to severe muscle weakness. The partnership aims to reduce the likelihood of severe side effects by using significantly lower doses of viral vectors responsible for delivering genes into p..
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..