Clinical Trials – Page 7

Lilly to Seek Global Approval for GLP-1 Pill After Obesity and Diabetes Trial Success

2 months ago talkbio0Tagged Approved, Clinical Trials, Contraceptives, Oral, Diabetes Mellitus, Non-Insulin-Dependent, Eli, Eli Lilly, Glucagon-Like Peptide 1, Obesity, orforglipron, United States Food and Drug Administration, Weight Loss

Eli Lilly; GLP-1 pill; orforglipron; obesity; type 2 diabetes; FDA approval; weight loss; clinical trial

Akeso Scores Two Wins in Phase 3 Trials, Tees Up Regulatory Submissions in China

2 months ago talkbio0Tagged Akeso, Ankylosing spondylitis, Autoimmune Diseases, China, Clinical Trials, Dermatitis, Atopic, Gumokimab, Manfidokimab, regulatory submission

Akeso; Phase 3 trials; gumokimab; manfidokimab; ankylosing spondylitis; atopic dermatitis; regulatory submission; China; autoimmune diseases; clinical trial results

Argenx Prepares FDA Filing to Expand Vyvgart Use in Myasthenia Gravis After Late-Stage Trial Win

2 months ago talkbio0Tagged Approved, Argenx, Clinical Trials, Myasthenia Gravis, Myasthenia Gravis, Generalized, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Self-injection, Syringes, United States Food and Drug Administration, Vyvgart

Argenx; Vyvgart; FDA approval; myasthenia gravis; prefilled syringe; self-injection; chronic inflammatory demyelinating polyneuropathy; generalized myasthenia gravis; clinical trial

Resilience Through Reinvention: How Pharma is Navigating Uncertainty During Turbulent Times

2 months ago talkbio0Tagged adaptation, Apis (invertebrate), Clinical Trials, drug price, Generalized, Investments, manufacturing uncertainty, Market, Pharma, Policy, regulatory environment, Reinvention, resilience, strategic reserves, supply chain

pharma; resilience; reinvention; supply chain; manufacturing uncertainty; regulatory environment; global market adaptation; funding; investment; clinical trials; drug pricing policy; APIs; strategic reserves

Viking Therapeutics Shares Crash After Obesity Pill VK2735 Delivers 12% Weight Loss, But Side Effects and Discontinuations Raise Concerns

2 months ago talkbio0Tagged Adverse event, aspects of adverse effects, Clinical Trials, Contraceptives, Oral, drug efficacy, gastrointestinal, Obesity, Stock Crash, Viking, VK2735, Weight Loss

Viking Therapeutics; VK2735; obesity pill; weight loss; clinical trial; stock crash; side effects; adverse events; gastrointestinal; drug efficacy

High Drop-Out Rate Clouds Viking Therapeutics’ Oral Weight Loss Drug Trial Results

2 months ago talkbio0Tagged Clinical Trials, High Drop-Out Rate, oral obesity drug, treatment discontinuations, Viking, VK2735, weight loss data

Viking Therapeutics; oral obesity drug; VK2735; high drop-out rate; weight loss data; clinical trial; treatment discontinuations

FDA Rejection Derails PTC Therapeutics’ Rare Disease Hopeful

2 months ago talkbio0Tagged Clinical Trials, concerns, Effectiveness, factor IX, Failure (biologic function), Friedreich 's ataxia, Rare Diseases, Rejection, Response process, United States Food and Drug Administration, vatiquinone

PTC Therapeutics; FDA rejection; vatiquinone; Friedreich’s ataxia; rare disease; efficacy concerns; complete response letter; clinical trial failure

Battle Intensifies in the Obesity Drug Market as Novo Nordisk and Eli Lilly Vie for Dominance

2 months ago talkbio0Tagged Benefit, Clinical Trials, competition, Compounders, Direct-to-Consumer, eli lilly, Glucagon-Like Peptide 1, manager, Market, Nordisk, Obesity, Pharmaceutical Services, Wegovy, Zepbound

obesity drugs; GLP-1; Wegovy; Zepbound; Novo Nordisk; Eli Lilly; market competition; direct-to-consumer; pharmacy benefit managers; compounders; clinical trials

Federal Appeals Court Overturns FDA Rejection of Vanda’s Hetlioz for Jet Lag Disorder

2 months ago talkbio0Tagged Clinical Trials, Evidence, Federal Appeals Court, Hetlioz, jet lag disorder, New Drug Application, regulatory law, sNDA, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; Hetlioz; FDA; jet lag disorder; Federal Appeals Court; supplemental New Drug Application (sNDA); regulatory law; clinical trial evidence

Reunion Psychedelic Therapy Advances to Pivotal Trials after Postpartum Depression Success

2 months ago talkbio0Tagged Clinical Trials, Depression, Postpartum, Montgomery-Åsberg Depression Rating Scale, Montgomery-Asberg Depression Rating Scale Questionnaire, Neuroscience discipline, Phase 2 Clinical Trials, Phase 3 Clinical Trials, psychedelic therapy, RE104, RECONNECT, remission rates, Reunion

Reunion Neuroscience; RE104; psychedelic therapy; postpartum depression (PPD); Phase II trial; Phase III trial; RECONNECT trial; clinical trial results; Montgomery-Åsberg Depression Rating Scale (MADRS); remission rates