相关临床试验
13
9 进行中
药物批准
0
批准总数
监管机构
0
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成立时间
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已完成
4
30.8%
尚未招募
9
69.2%
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- 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.
- India's Ministry of Health and Family Welfare has restricted the manufacture, sale, and distribution of fixed-dose combinations containing chlorpheniramine maleate and phenylephrine hydrochloride for children under four years of age. - The restriction, issued under Section 26A of the Drugs and Cosmetics Act, 1940, requires a prominent warning on labels, package inserts, and promotional materials stating the combination must not be used in children below four. - The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board, which found safer alternatives exist and the combination may pose risks such as excessive drowsiness, agitation, and rapid heartbeat. - The Delhi High Court clarified the ban is not retrospective, allowing existing stock manufactured before the notification to continue being sold, reducing potential financial losses for manufacturers.
- Waters Corporation unveils BioResolve Peptide and GTxResolve Lipid Columns, the first reversed-phase columns specifically QC batch-tested for GLP-1 peptides and lipid nanoparticles. - The new platform delivers up to 3x faster GLP-1 characterization and 2x faster LNP component analysis compared to existing fully porous particle technologies. - Up to 2x increase in resolving power and sensitivity enables better identification and tracking of low-level impurities, improving regulatory readiness. - The columns are designed to resolve structurally similar impurities that differ by as little as one atom, addressing a persistent challenge in biopharmaceutical development.
- 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.
- Alembic Pharmaceuticals Limited received final FDA approval for its generic methotrexate injection in two dosage strengths: 50 mg/2 ml multi-dose vials and 1g/40 ml single-dose vials. - The approved product is therapeutically equivalent to Hospira's reference listed drug and treats multiple cancers including acute lymphoblastic leukemia, osteosarcoma, and breast cancer. - The approval also covers autoimmune conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, and severe psoriasis, strengthening Alembic's presence in the US generics market. - This regulatory clearance supports the company's strategy of expanding complex injectable offerings in high-value therapeutic areas like oncology.
- Alembic Pharmaceuticals secured tentative FDA approval for its 400mg Bosutinib tablets, a kinase inhibitor used to treat Philadelphia chromosome-positive chronic myelogenous leukemia. - The approved product is therapeutically equivalent to Bosulif tablets marketed by PF Prism C.V., with an estimated US market size of $251 million for the twelve months ending September 2025. - This approval adds to Alembic's existing final FDA approvals for 100mg and 500mg Bosutinib tablets, bringing the company's total ANDA approvals to 232. - Bosutinib is indicated for adult patients with chronic phase Ph+ CML, including newly-diagnosed cases and those resistant or intolerant to prior therapies.
- Alembic Pharmaceuticals received final FDA approval for its generic version of Zylet ophthalmic suspension containing loteprednol etabonate and tobramycin for treating inflammatory eye conditions with bacterial infection risk. - The company was granted Competitive Generic Therapy designation, making it eligible for 180 days of market exclusivity upon commercialization of the product. - This approval brings Alembic's total ANDA approvals from the US FDA to 231, comprising 211 final approvals and 20 tentative approvals.
- Alembic Pharmaceuticals Limited received final FDA approval for its generic ticagrelor tablets 60mg, therapeutically equivalent to AstraZeneca's Brilinta. - The medication is indicated to reduce cardiovascular death, myocardial infarction, and stroke risk in patients with acute coronary syndrome or history of MI. - The approved generic has an estimated market size of $236 million for the twelve months ending June 2025 according to IQVIA data. - This approval adds to Alembic's portfolio of 227 total ANDA approvals from the FDA, including a previously approved 90mg strength of ticagrelor.
- Alembic Pharmaceuticals received FDA approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, therapeutically equivalent to the reference drug. - The approved product targets hypoprothrombinemia due to vitamin K deficiency and vitamin K-deficiency bleeding in neonates, entering a $44 million market. - This approval brings Alembic's total ANDA approvals to 225, positioning the company to capitalize on the growing generic sterile injectables market projected to reach $251.03 billion by 2030.
- Alembic Pharmaceuticals has received final FDA approval for its generic Tretinoin Cream USP (0.025%) to treat acne vulgaris in the US market. - The approved generic is therapeutically equivalent to Bausch Health's reference drug Retin-A Cream, targeting a market estimated at $94 million annually. - This approval brings Alembic's total ANDA portfolio to 224 applications, with 202 final approvals and 22 tentative approvals from the FDA.
