Amgen Inc.
American multinational biopharmaceutical company headquartered in Thousand Oaks, California; ranks 18th among biomedical companies by revenue, focused on oncology, cardiovascular, bone health, and autoimmune therapeutic areas.
相关临床试验
1193
198 进行中
药物批准
14
批准总数
监管机构
1
监管机构数
成立时间
1980
尚未招募
14
1.2%
No Longer Available
6
0.5%
终止
106
8.9%
招募中
64
5.4%
暂停
1
0.1%
Approved For Marketing
4
0.3%
撤回
21
1.8%
Available
2
0.2%
进行中（未招募）
184
15.4%
Unknown
4
0.3%
已完成
787
66.0%
- Sling Therapeutics raised a $123 million Series C led by Forbion to fund a late-stage trial of its oral thyroid eye disease drug linsitinib. - The global Phase 3 'Orbit' study will enroll about 130 adults with moderate-to-severe active TED, dosed at 150 mg or placebo twice daily for 24 weeks. - An earlier late-stage trial showed a statistically significant 52% response rate at 24 weeks with no drug-related hearing loss or tinnitus reported. - If approved, linsitinib would be the first oral therapy for TED, offering an alternative to injected IGF-1R antibodies Tepezza and Lumvoa.
- Sling Therapeutics has dosed the first patients in the global Phase III ORBIT trial of oral linsitinib in moderate to severe active thyroid eye disease. - ORBIT will randomize approximately 130 adults 1:1 to linsitinib 150 mg or placebo twice daily for 24 weeks, with proptosis response at week 24 as the primary endpoint. - The Phase IIb/III LIDS trial reported positive topline results in January 2025, meeting its primary endpoint with a 52% proptosis responder rate at week 24 (p = 0.01). - Linsitinib is the only oral IGF-1R inhibitor in Phase III TED development, positioned on oral administration and a differentiated safety profile versus infused biologics.
- Bristol Myers Squibb and Ono Pharmaceutical filed suit in Delaware federal court seeking to block Amgen's proposed US biosimilar of the cancer immunotherapy Opdivo. - The complaint alleges Amgen's biosimilar would infringe seven US patents covering Opdivo and asks the court to bar sales while those patents remain in force. - Opdivo generated more than $5.9 billion in US revenue last year, and Bristol Myers expects patent exclusivity over the drug to run until 2028. - Amgen declined to comment on the litigation but said it has applied for FDA approval and remains confident it will be in the first wave of Opdivo biosimilars.
- The FDA approved an update to the IMDELLTRA prescribing information cutting required monitoring for the first two infusions from 22-24 hours to 6-8 hours. - Patients must still receive a follow-up assessment, including vital signs, the day after each of the first two doses on Cycle 1 Days 2 and 9. - Amgen said the change may reduce treatment complexity for community oncology practices, where an estimated 80% to 85% of US cancer patients receive care. - Monitoring recommendations beyond the first two doses remain unchanged, and Amgen recently reported positive topline overall survival data from the Phase 3 DeLLphi-305 study.
- Oncology still accounts for 38.6% of newly identified drug candidates, but the number of cancer drugs in development fell 4.6% for a second consecutive year. - The anti-obesity category grew 30.7% to 588 drugs, and obesity entered the top 10 indications for the first time with 576 candidates. - Rare disease drugs slipped 1.3% to 7,618 candidates yet rose to 33.2% of the overall pipeline, with Novartis leading at 116 candidates. - Lilly's retatrutide delivered 28.3% average weight loss at 80 weeks, while Novo Nordisk's CagriSema missed noninferiority to tirzepatide.
- Novartis's pelacarsen and Novo Nordisk's ziltivekimab both failed to separate from placebo in late-stage cardiovascular outcome trials despite strong genetic support for their targets. - Cardiologist Ethan Weiss said the field can no longer claim that genetics is undefeated in predicting which drugs will work in outcome studies. - Novartis shares fell 14% in a single session and Amgen dropped 9.8% as investors repriced roughly 35,000 patients still enrolled in Lp(a) outcome trials. - Weiss attributed the Lp(a) failure largely to background therapy, arguing the risk signal diminishes in patients already on statins and other powerful medicines.
- The FDA has approved Replimune's oncolytic immunotherapy Tudriqev for unresectable advanced melanoma that has progressed after PD-1 immunotherapy. - Tudriqev, formerly known as RP1, is engineered to selectively target and destroy cancer cells and is the second oncolytic virus approved. - Both approved oncolytic viruses are engineered live attenuated HSV-1 vectors encoding GM-CSF and a fusogenic GALV-GP-R glycoprotein.
- Amgen's phase III DeLLphi-305 trial met its primary overall survival endpoint for tarlatamab plus durvalumab versus durvalumab alone as first-line maintenance in extensive-stage small-cell lung cancer. - The 563-patient randomized study enrolled patients whose disease had not progressed after induction with durvalumab, platinum chemotherapy and etoposide, with PFS and ORR also significantly improved. - No numerical survival data, hazard ratios or safety tables were disclosed, and the full dataset is slated for presentation at an upcoming medical meeting and regulatory submission. - Tarlatamab, a DLL3-directed bispecific T-cell engager already approved in second-line ES-SCLC, could move earlier into the maintenance setting if the benefit is confirmed.
- The Phase III DeLLphi-305 trial met its primary endpoint, showing tarlatamab plus durvalumab significantly improved overall survival versus durvalumab alone in extensive-stage SCLC. - The combination also improved progression-free survival and objective response rate as first-line maintenance in patients whose disease had not progressed after induction therapy. - Amgen and AstraZeneca reported the survival benefit at a planned interim analysis, with full data to be presented at an upcoming medical meeting. - Oncologists called the results potentially practice-changing for a disease where roughly 40% of patients never reach second-line treatment.
- 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.
