AbbVie Inc.
American pharmaceutical company headquartered in North Chicago, Illinois, producing drugs across a wide range of medical areas; sixth largest biomedical company by revenue with operations across 170+ countries.
相关临床试验
5
5 进行中
药物批准
14
批准总数
监管机构
3
监管机构数
成立时间
2012
进行中（未招募）
4
80.0%
尚未招募
1
20.0%
- Aethlon Medical and North Immunology have signed a definitive all-stock merger agreement to advance NOR-101, a half-life extended IL-13 x IL-18 bispecific antibody for atopic dermatitis. - An oversubscribed $180 million private placement backed by Bain Capital Life Sciences, Janus Henderson and others is expected to fund operations into the second half of 2028. - A Phase 1a study of NOR-101 is expected to begin in the first quarter of 2027, with interim pharmacokinetic and safety data anticipated by mid-2027. - North Immunology investors will own approximately 95.25% of the combined company, which will trade on Nasdaq under the ticker NRTX after an expected first-quarter 2027 close.
- 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.
- Definium Therapeutics' DT120 ODT met its primary and all key secondary endpoints in the Phase 3 Panorama trial of 245 adults with generalized anxiety disorder. - The 100-microgram dose produced a 9.8-point HAM-A reduction versus 4.7 points for placebo at Week 12, a 5.1-point placebo-adjusted difference (p<0.0001, Cohen's d=0.64). - Panorama is the second positive Phase 3 GAD study for DT120 ODT and the third positive late-stage readout overall, following Voyage in GAD and Emerge in MDD. - Definium has scheduled a pre-NDA meeting with the FDA for Q4 2026 and plans to submit its New Drug Application in the first half of 2027.
- The FDA has granted Fast Track designation to KST-6051, an oral pan-KRAS inhibitor, for advanced or metastatic solid tumors harboring KRAS mutations. - Kestrel Therapeutics said the designation rests on its preclinical data package and will enable closer FDA collaboration during the ongoing Phase 1 FALCON trial. - FALCON (NCT07458347) is a first-in-human dose-escalation study evaluating safety, tolerability, pharmacokinetics, and preliminary antitumor activity, with first patient dosed April 28, 2026. - KST-6051 inhibits KRAS in both GTP-bound active and GDP-bound inactive states, with development ultimately targeting pancreatic, colorectal, and lung cancers.
- 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.
- GSK and Hansoh reported that the B7-H3-targeted antibody-drug conjugate risvutatug rezetecan reduced the risk of death by 54% versus topotecan in relapsed small cell lung cancer. - In the phase III ARTEMIS-008 trial, median overall survival reached 18.5 months with Ris-Rez versus 10.3 months with topotecan after a median 12.2 months of follow-up. - Secondary endpoints favored Ris-Rez, with median progression-free survival of 7.2 versus 3.0 months and objective response rates of 58.3% versus 12.6%. - Grade 3 or higher treatment-related adverse events occurred in 60.9% of Ris-Rez patients versus 78.2% with topotecan, with hematologic toxicities predominating.
- AbbVie's oral CGRP receptor antagonist atogepant met the primary endpoint in the Phase III LUNA study of menstrual migraine, cutting perimenstrual migraine days by 1.20 versus 0.40 with placebo. - All eight ranked secondary endpoints, spanning headache burden, acute medication use, functional disability, cognitive function and responder outcomes, improved significantly versus placebo (p<0.0001). - No targeted therapy is currently approved for menstrual migraine, and 68% of surveyed women said they had never been offered a tailored treatment approach. - AbbVie plans worldwide regulatory submissions for a potential label expansion of Qulipta, which is already approved in 60 countries for migraine prevention.
- Arkansas AG Tim Griffin filed a lawsuit against 22 entities, including 13 major drug manufacturers, alleging illegal limits on 340B prescription drug discounts. - The lawsuit accuses companies including Pfizer, Johnson & Johnson, Eli Lilly, and Novo Nordisk of violating Arkansas Act 1103, the 340B Drug Pricing Nondiscrimination Act. - Griffin cited over 300,000 instances of allegedly violative conduct, with the state seeking civil penalties under the Arkansas Deceptive Trade Practices Act. - The legal action follows a 2024 U.S. Supreme Court loss for PhRMA, which had challenged the Arkansas law as unconstitutional on behalf of several manufacturers.
- At ASRS 2026 in Montreal, durable treatment strategies for wet AMD dominated research, with gene therapy, intravitreal implant and optogenetic data presented across four days. - Ocular Therapeutix reported phase 3 SOL-1 results showing a single AXPAXLI injection maintained BCVA in 74.1% of patients at Week 36 versus 55.8% with monthly aflibercept. - Nanoscope Therapeutics presented 3-year REMAIN data showing durable BCVA gains of about 3 ETDRS lines with MCO-010 in retinitis pigmentosa, alongside a rolling BLA submission. - Belite Bio's phase 3 DRAGON trial of oral tinlarebant met its primary endpoint with a 36% reduction in retinal lesion growth versus placebo in Stargardt disease.
- Alembic Pharmaceuticals Limited received final FDA approval for its generic Levothyroxine Sodium Tablets USP across 12 different strengths from 25 mcg to 300 mcg. - The approved product is therapeutically equivalent to AbbVie's Synthroid and is indicated for treating hypothyroidism and as adjunct therapy in thyroid cancer management. - According to IQVIA data, the product represents an estimated US market size of $1.869 billion for the 12 months ending March 2026. - This approval brings Alembic's total ANDA approvals from the FDA to 239, comprising 220 final approvals and 19 tentative approvals.
