Pfizer Inc.
American multinational pharmaceutical and biotechnology corporation, develops medications and vaccines across immunology, oncology, cardiology, endocrinology, and neurology.
相关临床试验
5236
1758 进行中
药物批准
91
批准总数
监管机构
2
监管机构数
成立时间
1849
尚未招募
62
1.2%
No Longer Available
14
0.3%
终止
454
8.7%
招募中
280
5.3%
暂停
1
0.0%
Approved For Marketing
4
0.1%
Available
4
0.1%
撤回
126
2.4%
进行中（未招募）
1696
32.4%
Unknown
4
0.1%
已完成
2590
49.5%
- 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.
- The CHMP has adopted a positive opinion recommending enfortumab vedotin plus pembrolizumab as neoadjuvant and adjuvant treatment for adults with resectable muscle-invasive bladder cancer in the EU. - The opinion rests on Phase 3 EV-304 data showing a 47% reduction in risk of recurrence, progression or death and a 35% reduction in risk of death versus gemcitabine-cisplatin. - If the European Commission approves, the MIBC indication would extend from cisplatin-ineligible patients to all adults with resectable disease regardless of cisplatin eligibility.
- Genentech reported that Lunsumio plus lenalidomide significantly improved progression-free survival versus rituximab plus lenalidomide in relapsed or refractory follicular lymphoma. - The Phase III CELESTIMO trial met its primary endpoint at interim analysis, showing a statistically significant and clinically meaningful reduction in disease progression risk. - CELESTIMO is a confirmatory study intended to convert Lunsumio's accelerated third-line approval to full approval and secure a second-line or later indication. - Overall survival data were immature, no new safety signals emerged, and full results including the hazard ratio are awaited at an upcoming medical meeting.
- The European Medicines Agency has validated the Marketing Authorization Application for PF-07307405, Pfizer and Valneva's experimental Lyme disease vaccine candidate, triggering formal regulatory review. - The filing rests on the Phase 3 VALOR trial of 9,437 participants aged five and older across high-incidence regions in the US, Canada and Europe. - Topline data released in March 2026 showed efficacy above 70%, but the primary endpoint analysis reported 73.2% efficacy with a 95% confidence interval lower bound of 15.8%, missing the predefined 20% threshold. - A second prespecified analysis showed 74.8% efficacy and did meet the statistical criterion, while the vaccine was generally tolerated with no safety issues detected.
- GSK has secured full global rights to Chimagen Biosciences' unnamed trispecific T-cell engager for multiple myeloma in a deal worth up to $750 million. - The preclinical asset is designed to bind T cells while targeting two tumor-associated antigens, aiming for deeper responses and better tolerability than existing engagers. - GSK plans to begin Phase 1 testing in 2027, adding to a myeloma portfolio anchored by the BCMA-directed antibody-drug conjugate Blenrep. - The deal is GSK's second with Chimagen, following the 2024 licensing of the CD19/CD20-targeted T-cell engager CMG1A46 for B-cell malignancies and autoimmune disease.
- Shennon Biotechnologies raised $12 million in new financing, bringing total capital raised to $25 million since its founding in 2021. - The company appointed industry veteran Cyril Konto, M.D., as CEO, with founder Li Sun, Ph.D., moving to President and Chief Technology Officer. - ShennonBio disclosed three T-cell engager programs: SBT-121 for small cell lung cancer, SBT-201 for ovarian cancer and SBT-425 for hepatocellular carcinoma. - The financing supports advancement of the company's integrated discovery platform and its first T-cell engager candidates toward an IND filing and Phase 1 development.
- The FDA issued a partial clinical hold on Biohaven's opakalim (BHV-7000) after nonclinical rodent studies flagged a metabolite with uncertain relevance to human safety. - New patient enrollment is paused across the focal epilepsy program, though dosing continues for more than 600 already-randomized patients, including the fully enrolled RISE-3 study. - Biohaven expects RISE-3 topline data in the second half of 2026, with the hold not affecting that timeline, while enrollment resumption timing remains uncertain. - The hold arrives days after Biohaven licensed global rights to opakalim to SK Biopharmaceuticals for $350 million upfront in a deal worth up to $795 million.
- EMD Serono, the US and Canada healthcare business of Merck KGaA, has acquired two AI-designed fertility programs from Boston-based PostEra for a mid-double-digit millions sum. - The programs comprise oral small molecule agonists of follicle-stimulating hormone receptor for IVF ovarian stimulation and luteinizing hormone/choriogonadotropin receptor for male infertility and ovulation trigger. - PostEra used its Proton AI platform to overcome historical hurdles in drugging these biologic-validated targets, including selectivity and metabolic stability, with both candidates still in preclinical development. - A combination of the two agonists could shift IVF protocols from injections to an all-oral regimen, while PostEra retains its polyendocrine metabolic ovarian syndrome program and plans trials next year.
- Intranasal RIG-101 was well tolerated at all tested doses in healthy volunteers and asthma patients, including up to seven days of daily dosing. - Biomarker analyses in asthma patients confirmed induction of type I and type III interferons and interferon-stimulated genes, matching the intended mechanism. - A two-part, randomized, placebo-controlled Phase I/II trial targeting 82 participants at two UK sites is now recruiting, with Part B testing rhinovirus RV-A16 challenge. - Leyden Labs also disclosed it acquired RIGImmune in spring 2026, adding stem-loop RNA therapeutics and the NEED delivery platform to its mucosal protection pipeline.
- An Army doctor testified in federal court that she is examining 2,544 unverified deaths among service members reported to HHS's Vaccine Adverse Event Reporting System (VAERS). - Theresa Long, senior medical military adviser to Health Secretary Robert F. Kennedy Jr., said she knows of 28 people who died from the COVID-19 vaccine but was not permitted to share more details. - Long's Aug. 14 deposition, obtained by Politico, came in a lawsuit over the CIA's dismissal of Terry Adirim, who alleges she was fired for her advocacy of COVID-19 vaccination. - The testimony highlights ongoing scrutiny of COVID-19 vaccine safety, though a 2022 study found 38 deaths could have been related to the vaccine after more than 8 billion doses were administered.
