Loading...Loading...Biogen Inc BIIB and Eisai Co Ltd ESALF ESALY faced a setback as the much-anticipated Oral Explanation slated for March 19 at the Committee for Medicinal Products for Human Use (CHMP) was postponed. This delay, attributed to procedural issues at the European Medicines Agency (EMA), has implications for the review process of lecanemab, a pivotal drug currently under EMA evaluation.Also Read: Biogen Could Engage In $1B-$2B Deals To Fill Revenue Shortfall Gaps, Analyst Says.Lecanemab has been under EMA review since January 2023 for early Alzheimer’s disease with confirmed amyloid pathology.The postponement comes on the heels of a significant ruling by the Court of Justice of the European Union on March 14, 2024, concerning the organization of EMA’s Scientific Advisory Groups (SAGs). This ruling impacts EMA’s policy regarding the management of conflicting interests among experts, particularly SAG members. Consequently, EMA opted to nullify the counsel provided at the SAG-N meeting for lecanemab held on March 11, 2024, signaling the necessity for a fresh round of deliberations. However, the scheduling of the forthcoming SAG-N meeting remains uncertain, pending further updates from EMA.Citing RBC Capital Markets analyst, Reuters noted that an approval is expected in the second half of 2024, versus Eisai’s expectation of a decision in the quarter ending June 30.Read Next: Eli Lilly’s Donanemab For Alzheimer’s Hits FDA Speed Breaker, Biogen Stock Gains On Delayed Decision.Price Action: BIIB shares are down 1.10% at $218.32 on the last check Friday.Photo via ShutterstockLoading...Loading....

正在加载。。。正在加载。。。Biogen Inc BIIB和Eisai Co Ltd ESALF ESALY遭遇挫折，因为原定于3月19日在人类使用药品委员会（CHMP）上进行的备受期待的口头解释被推迟。这一延误归因于欧洲药品管理局（EMA）的程序问题，对lecanemab的审查过程产生了影响，lecanemab是目前正在接受EMA评估的关键药物。另请阅读：分析师表示，Biogen可能参与10亿至20亿美元的交易，以填补收入缺口。自2023年1月以来，Lecanemab一直在接受EMA审查，以治疗早期阿尔茨海默病，并证实淀粉样蛋白病理。此前，欧盟法院于2024年3月14日就欧洲药品管理局科学咨询小组（SAG）的组织作出了重要裁决。这一裁决影响了EMA关于管理专家之间利益冲突的政策，特别是SAG成员。因此，EMA选择取消2024年3月11日举行的SAG-N会议上为lecanemab提供的律师，表明有必要进行新一轮审议。然而，即将举行的SAG-N会议的日程安排仍不确定，等待EMA的进一步更新。路透社援引加拿大皇家银行资本市场分析师的话指出，预计2024年下半年将获得批准，而卫材预计将在截至6月30日的季度做出决定。接下来阅读：礼来公司（Eli Lilly）针对阿尔茨海默氏病的多纳单抗（Donanemab）将成为美国食品和药物管理局（FDA）的减速剂，Biogen股票因延迟决定而上涨。价格走势：周五最后一次检查，BIIB股价下跌1.10%，至218.32美元。通过快门加载照片。。。正在加载。。。。