Regeneron Pharmaceuticals, Inc. (REGN) announced that the FDA has approved blockbuster drug Dupixent (dupilumab) for the indication of chronic rhinosinusitis with nasal polyps (CRSwNP) for a broader population.The regulatory body approved the drug as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled CRSwNP.The latest approval expands the initial FDA approval (granted in June 2019) in CRSwNP for patients aged 18 years and older.Regeneron’s shares have ra ...

Company planning for every eligible baby in the US to have access to BEYFORTUSNew BEYFORTUS filling line approved by the U.S. Food and Drug Administration (FDA) to expand manufacturing capacity and help meet demand2 out of 3 babies get respiratory syncytial virus (RSV) disease1BRIDGEWATER, N.J., Sept. 16, 2024 /PRNewswire/ -- Sanofi is shipping BEYFORTUS (nirsevimab-alip) 50mg and 100mg Injection doses in the US to private healthcare providers and to the Centers for Disease Control and Prevention for its Va ...

文章核心观点 - 桑菲与RadioMedix和Orano Med签署了一项独家许可协议,共同开发用于治疗罕见癌症的下一代放射性配体药物AlphaMedixTM [1][2][3] - AlphaMedixTM是一种靶向肽复合物,标记有铅-212(212Pb)放射性核素,可产生高能量的α粒子,有望成为一种革命性的放射性配体治疗 [2][3][4] - AlphaMedixTM已获得美国FDA的突破性疗法认定,用于治疗未经胜肽受体放射性核素治疗的胃肠胰神经内分泌瘤患者 [3] - 桑菲负责AlphaMedixTM的全球商业化,Orano Med负责生产制造,RadioMedix和Orano Med将获得上亿欧元的里程碑付款和销售提成 [6] - 桑菲致力于成为全球免疫科学领域的领导者,正在聚焦难治性癌症如多发性骨髓瘤、急性髓系白血病等的创新治疗 [7] 行业概况 - 神经内分泌瘤(NET)是一类罕见的异质性肿瘤,主要发生在胃肠道和胰腺,5年生存率在转移期仅为60% [8] - 尽管NET的全球患病率逐年上升,但仍被认定为罕见癌症,全球约35/10万人患病 [8] 公司介绍 - RadioMedix是一家总部位于美国的临床阶段生物技术公司,专注于开发用于诊断、监测和治疗癌症的创新性靶向放射性药物 [9] - Orano Med是法国的临床阶段生物技术公司,隶属于Orano集团,专注于开发基于铅-212(212Pb)的靶向α粒子治疗(TAT)技术 [10][11] - 桑菲是一家创新型全球医疗保健公司,致力于通过科学创新改善人们的生活 [12]

Sanofi (SNY) and Regeneron (REGN) announced encouraging data from the confirmatory phase III LIBERTY-CUPID C study evaluating their blockbuster drug Dupixent (dupilumab) in chronicspontaneous urticaria (CSU) indication.Results Confirm Significant Improvement in Itch & HivesThe LIBERTY-CUPID C study enrolled CSU patients aged six years and older who remained symptomatic despite standard-of-care (SOC) antihistamines and were not previously treated with Novartis (NVS) /Roche’s (RHHBY) Xolair (omalizumab).The s ...

EXTON, PA, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Since its 2017 debut as the first advanced systemic treatment for atopic dermatitis (AD), Sanofi/Regeneron’s Dupixent has dominated the US market. However, the introduction of LEO Pharma’s Adbry, Pfizer’s Cibinqo, and AbbVie’s Rinvoq has started to disrupt the treatment landscape. While Dupixent still holds the highest market share by a significant margin, its dominance is gradually diminishing with the rising adoption of these newer treatments and is expected t ...

Investors found something to like about the company's recent round of clinical trials for a key pipeline medication.Although the latest news from the laboratory was mixed for pharmaceutical company Sanofi (SNY 2.26%) on Tuesday, investors gave the company the benefit of the doubt. They bid the share price up by more than 2% on the day, making it a mirror image of the 2%-plus decline of the S&P 500 index. 1 out of 3 trials was a successSanofi published readouts of three phase 3 trials of its tolebrutinib mul ...

Sanofi (SNY) announced that a phase III study evaluating its investigational oral BTK inhibitor, tolebrutinib, demonstrated clinically meaningful benefit in disability accumulation in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS).The HERCULES phase III study met the primary endpoint by showing an improvement over placebo in delaying time to onset of confirmed disability progression.There are no approved therapies to treat nrSPMS at present. Multiple sclerosis (MS) is a chroni ...

  Tolebrutinib meets primary endpoint in HERCULES phase 3 study, the first and only to show reduction in disability accumulation in non-relapsing secondary progressive multiple sclerosis In the HERCULES study, tolebrutinib met the primary endpoint in delaying time to onset of confirmed disability progression in people with nrSPMS, a population for which there are currently no approved therapies and significant unmet medical needThe GEMINI 1 and 2 studies evaluating tolebrutinib in people with relapsing MS ...

SAN DIEGO, Aug. 14, 2024 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced the pricing of an underwritten offering of 2,750,498 shares of its common stock at a price of $36.50 per share, representing a premium of approximately 10% to Anaptys’ closing price on Aug. 13, 2024. The gross proceeds from this offering are expected to be approximately $100 million, before deducting underwriting discou ...

Sarclisa induction treatment demonstrated significantly improved progression-free survival in patients with newly diagnosed multiple myeloma eligible for transplant Sarclisa (isatuximab) in combination with standard-of-care lenalidomide, bortezomib, and dexamethasone (RVd) during 18-week induction treatment followed by transplant resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared to RVd induction therapy, regardless of maintenance therapy assi ...