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WEBAt the Clinical Trial Supply West Coast 2024 conference, serial biotech entrepreneur Umar Hayat said science should be allowed to advance without political interference. Catherine Longworth. Analyst Comment.
Gilead’s lenacapavir: HIV prospects strongest in long-acting …
WEBAug 25, 2021 · Gilead’s lenacapavir will find its strongest niche as a long-acting HIV combination treatment, experts said. Manasi Vaidya August 25, 2021. Gilead announced a collaboration with Merck in March to study lenacapavir with islatravir, a nucleoside reverse transcriptase translocation inhibitor (NRTTI), which is also a new drug class in HIV.
Mounjaro (tirzepatide) for the Treatment of Type 2 Diabetes, USA
WEBJun 19, 2024 · Mounjaro ™ (tirzepatide) is a dual-targeted, injectable, sustained-release therapy indicated for the treatment of type 2 diabetes (T2D) in adults as an adjunct to diet and exercise.. Developed by Eli Lilly, a pharmaceutical company based in the US, Mounjaro is the first and only once-weekly glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor ...
Phase 0 clinical trials: what you need to know
WEBJul 21, 2022 · Clinical Trials Arena breaks down the two most common types of Phase 0 trials, including window of opportunity trials in neuro-oncology. William Newton July 21, 2022. When the FDA introduced Phase 0 trials in 2006, the goal was to learn more about new drugs without exposing subjects to their full, potentially toxic, effects.
EMA enforces transparency with new clinical trial rules
WEBOct 10, 2023 · The European Medicines Agency (EMA) has revised its transparency rules on publishing information about clinical trials submitted through the Clinical Trials Information System (CTIS). EMA aims to expedite access to trial information to stakeholders including patients and healthcare professionals (HCPs). The revised rules will apply after their ...
Lokelma sodium zirconium cyclosilicate treatment for hyperkalaemia
WEBJul 6, 2018 · Lokelma is an oral suspension of sodium zirconium cyclosilicate that is indicated for the treatment of hyperkalaemia. Formerly known as ZS-9, the drug was discovered and developed by global biopharmaceutical company AstraZeneca. A marketing authorisation application (MAA) for the drug was submitted to the European Medicines Agency (EMA) in ...
Five AI-enhanced clinical trial start-ups to watch in 2021
WEBJul 29, 2021 · Unlearn.AI is a San Francisco startup founded in 2017 by former Pfizer principal scientist Charles Fisher. The firm claims to be the first to create ‘digital twins’ to populate intelligent control arms in clinical studies. In the context of clinical research, Unlearn explains, a digital twin is a “longitudinal, computationally generated ...
Biosimilars: top 10 pharma companies leading the way
WEBJan 20, 2022 · Yesterday (19 January), using the same Thematic Research ecosystem, Clinical Trials Arena revealed the top pharma companies best equipped with artificial intelligence. According to our analysis, Novartis, Pfizer, Catalent, Amgen, Biogen, Patheon, Shanghai Henlius Biotech, Viatris, Celltrion, and Samsung Bioepis are …
Frontera commences subject dosing in trial of gene therapy
WEBFeb 17, 2023 · Frontera Therapeutics has announced the dosing of the first subject in a clinical trial of its recombinant adeno-associated virus gene therapy drug, FT-002, to treat X-linked retinitis pigmentosa (XLRP). FT-002, which is intended for the treatment of patients with XLRP caused by a mutation in the RPGR gene, is the company’s third gene therapy ...
Moderna initiates Phase III trial of cytomegalovirus vaccine …
WEBOct 27, 2021 · Moderna has dosed the first subject in the pivotal Phase III CMVictory clinical trial of its cytomegalovirus (CMV) vaccine candidate, mRNA-1647. mRNA-1647 merges six messenger ribonucleic acids (mRNAs) in a single vaccine that encode for two proteins found on the CMV surface. Five mRNAs encode the subunits that form the membrane-bound pentamer ...