相关临床试验
15
9 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
7
46.7%
已完成
6
40.0%
尚未招募
2
13.3%
暂无批准数据
- The EMA's CHMP has recommended marketing authorization for Zeydovio (glepaglutide) in adults with short bowel syndrome, the first major advance in the indication in Europe in over a decade. - The positive opinion rests on the Phase 3 EASE-1 trial, where twice-weekly glepaglutide cut weekly parenteral support volume by 5.13 L/week versus 2.85 L/week with placebo (p=0.0039). - At 24 weeks, 65.7% of twice-weekly glepaglutide patients achieved at least a 20% reduction in parenteral support volume versus 38.9% on placebo, and 14% weaned off support entirely. - The European Commission is expected to decide on the marketing authorization application within approximately 67 days, while the Phase 3 EASE-5 trial continues to support a planned U.S. NDA.
- The EMA's CHMP has recommended extending TECVAYLI (teclistamab) approval to adults with relapsed/refractory multiple myeloma after at least one prior therapy. - The recommendation rests on the Phase 3 MajesTEC-9 study, in which teclistamab monotherapy cut the risk of disease progression or death by 71% versus standard of care. - Teclistamab also reduced the risk of death by 40% and produced a complete response or better in 65.9% of patients versus 16.8% with PVd or Kd. - The opinion follows European Commission approval of teclistamab plus daratumumab in the same second-line setting, based on the MajesTEC-3 study.
- The EMA's CHMP issued a positive opinion recommending once-weekly Sogroya (somapacitan) for children with idiopathic short stature and persistent growth disturbance. - If approved, Sogroya would become the first and only growth hormone treatment authorised for idiopathic short stature in the European Union. - The recommendation rests on the REAL8 trial, in which once-weekly Sogroya was non-inferior to once-daily growth hormone for mean annualised height velocity at Week 52. - The European Commission is expected to decide later in 2026 on a marketing authorisation covering idiopathic short stature, children born small for gestational age, and Noonan Syndrome.
- The EMA's CHMP adopted a positive opinion recommending KEYTRUDA plus Padcev as neoadjuvant and adjuvant treatment for adults with resectable muscle-invasive bladder cancer. - The recommendation is based on the Phase 3 KEYNOTE-B15 trial, which reduced event-free survival events by 47% versus neoadjuvant chemotherapy and surgery. - KEYNOTE-B15 also showed a 35% reduction in risk of death and a pathologic complete response rate of 55.8% versus 32.5% with chemotherapy. - The European Commission will review the opinion, with a final decision on marketing authorization in the EU expected by the fourth quarter of 2026.
- Japan's Ministry of Health, Labour and Welfare granted marketing authorization to eptinezumab for the prevention of migraine attacks in adults, Lundbeck announced on Sept. 16, 2026. - Eptinezumab is the only intravenous CGRP-targeted preventive migraine treatment approved in Japan and is now launched in more than 30 markets worldwide. - The authorization was supported by the Phase III SUNRISE trial in a predominantly Asian chronic migraine population and the SUNSET long-term extension study in Japanese patients. - The approval paves the way for Lundbeck's first launch in Japan as marketing authorization holder, enabling the company to operate independently in the Japanese market.
- CSL Seqirus's MF59-adjuvanted, cell-based, higher-dose quadrivalent influenza vaccine (aQIVc) met its primary objectives in a 7,699-participant Phase 3 study published in The Lancet Infectious Diseases. - The vaccine showed superiority over an adjuvanted egg-based comparator across all four influenza strains and non-inferiority versus a recombinant vaccine for three of four strains in adults 50 and older. - Immune responses persisted throughout the influenza season with a well-tolerated safety profile, and exploratory analyses showed enhanced neuraminidase antibody responses versus both comparators. - The trivalent formulation, marketed as AUJEMFLU, is already approved by the MHRA in the UK and by the European Commission for adults aged 50 and older, with further submissions underway.
- An NBER survey of 916 early-career biomedical scientists found the share likely to remain in the United States fell 21 percentage points, from 93% to 72%, between late 2024 and March 2025. - The decline was steepest among foreign scientists (30.8 percentage points), with European researchers showing the largest drop, followed by those from India and Latin America. - A Nature poll of over 1,600 researchers found three-quarters were considering leaving the U.S., while a STAT survey reported 13% of NIH-supported labs had lost researchers to other countries. - Competitors including Canada (C$1.7 billion), the European Commission (€500 million), France (€100 million), and China (new "K visa") are actively recruiting U.S.-based scientific talent.
- The Council of the EU agreed on its negotiating position for targeted amendments to health legislation aimed at boosting biotechnology innovation across the European Union. - Certain genetically modified microorganisms meeting predefined safety standards would become eligible for an expedited regulatory procedure under the proposed reforms. - The Council introduced a 10-year limit on initial marketing consent for GMMs, with indefinite validity upon renewal, as an added safeguard. - Updated organ processing rules distinguish autologous from donor transplantation and recognize scientific advances extending the time between procurement and transplant.
- The new U.S. National Security Science and Technology Strategy (NSSTS) explicitly frames scientific and technological leadership as a national security objective, placing biotechnology alongside AI and quantum computing as potentially transformative technologies. - The COVID-19 pandemic acted as an accelerator, exposing the fragility of global supply chains for medicines and turning biomedical research capacity into an issue of national resilience and strategic autonomy. - The convergence of AI and biology is transforming biology from a descriptive science into a predictive, design-oriented one, enabling in silico design of biological sequences and rapid conversion into physical material. - Europe and Italy are responding with initiatives such as the proposed European Biotech Act and the Critical Medicines Act, while seeking to balance competitiveness, strategic autonomy, and research security.
- The European Commission's Biotech Act I aims to reverse Europe's declining share of global clinical trials, which fell from 22% in 2013 to 12% in 2023, through streamlined regulation and stronger innovation support. - EU health-biotech venture funding reached only €25 billion over the past decade compared to approximately €219 billion in the US, highlighting a stark capital gap that the Act seeks to address. - Biotech Act II has officially launched with a focus on industrial biotechnology and biomanufacturing, led by DG Grow, while Biotech Act I remains under consultation ahead of formal scrutiny. - Industry leaders are calling for contract manufacturers, vaccine platform technologies, and mid-cap companies to qualify for strategic project designations that unlock priority regulatory support and funding access.
