Organic Chemical – Talk Bio

AstraZeneca’s Self-Administered Myasthenia Gravis Drug Gefurulimab Clears Phase 3 Trial

10 hours ago talkbio0Tagged Acquisition, Alexion, AstraZeneca, Autoimmune Diseases, C5 inhibitor, Clinical Trials, Gefurulimab, Myasthenia Gravis, PREVAIL trial, self-administered drug

AstraZeneca; gefurulimab; myasthenia gravis; self-administered drug; Phase 3 trial; PREVAIL trial; C5 inhibitor; autoimmune disease; clinical trial; Alexion acquisition

LEO Pharma Scores FDA Approval for Anzupgo as First Treatment for Chronic Hand Eczema

12 hours ago talkbio0Tagged Anzupgo, Approved, Chechen language, chronic hand eczema, delgocitinib, pan-JAK inhibitor, Pharma, topical treatment, United States Food and Drug Administration

LEO Pharma; Anzupgo; delgocitinib; FDA approval; chronic hand eczema; pan-JAK inhibitor; moderate-to-severe CHE; topical treatment

RFK Jr. Approves ACIP Recommendation to Remove Thimerosal from U.S. Flu Vaccines

12 hours ago talkbio0Tagged ACIP, RFK Jr., thimerosal, Vaccine Safety

RFK Jr.; Thimerosal; ACIP; Vaccine Safety

Apnimed Advances FDA Filing after Second Pivotal Win for Oral Sleep Apnoea Drug

19 hours ago talkbio0Tagged AD109, Apnimed, aroxybutynin, atomoxetine, Clinical Trials, LunAIRo, oral drug, Sleep Apnea, Obstructive, Submission, SynAIRgy, United States Food and Drug Administration

Apnimed; AD109; obstructive sleep apnea; OSA; oral drug; phase 3 trial; LunAIRo; SynAIRgy; FDA submission; clinical trial; aroxybutynin; atomoxetine

Abivax aces pair of phase 3 ulcerative colitis trials as end of cash runway looms

1 day ago talkbio0Tagged Abivax, ABTECT-1, ABTECT-2, cash runway, clinical remission, induction trials, maintenance trial, Obefazimod, Oral cavity, Ulcerative Colitis

Abivax; Obefazimod; ulcerative colitis; Phase 3 trial; clinical remission; ABTECT-1; ABTECT-2; cash runway; induction trials; oral miR-124 enhancer; maintenance trial

AstraZeneca Highlights Survival Benefit for Tagrisso Combo Amid Competition in Lung Cancer

3 days ago talkbio0Tagged AstraZeneca, Benefit, Combined, EGFR-mutated, FLAURA2 trial, Johnson & Johnson, life-extension, Malignant neoplasm of lung, Non-Small Cell Lung Carcinoma, Overall Survival, Pharmacotherapy, Tagrisso

AstraZeneca; Tagrisso; lung cancer; Johnson & Johnson; EGFR-mutated NSCLC; overall survival; chemotherapy combination; FLAURA2 trial; life-extension benefit

Avalyn Pharma Raises $100M to Advance Inhaled Lung Disease Drugs

3 days ago talkbio0Tagged AP01, AP02, aspects of adverse effects, Avalyn, Clinical Trials, drug safety, Holdings, inhaled lung disease, nintedanib, Pharma, pirfenidone, Pulmonary Fibrosis, Series D, SNCG gene, Suvretta Capital Management

Avalyn Pharma; $100 million Series D; inhaled lung disease medications; pulmonary fibrosis; AP01; AP02; pirfenidone; nintedanib; clinical trials; drug safety; side effects; Suvretta Capital Management; SR One; Novo Holdings

Replimune’s Shares Plunge After FDA Rejects Melanoma Drug Application

3 days ago talkbio0Tagged Antineoplastic Agents, Clinical Trial Design, Complete, Drops - Drug Form, Frequency of Responses, melanoma, Prices, Rejection, Replimune, Response Letter, RETINITIS PIGMENTOSA 1, United States Food and Drug Administration

Replimune; RP1; FDA rejection; melanoma; cancer drug; Complete Response Letter; clinical trial design; objective response rate; share price drop

FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

3 days ago talkbio0Tagged Accelerated, Approved, Columvi, Complete, Diffuse Large B-Cell Lymphoma, gemcitabine, genentech, oxaliplatin, Rejection, Response Letter, Roche (company), second, second-line treatment, STARGLO, Third line treatment, United States Food and Drug Administration

FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy

FDA Advisory Committee Rejects Lundbeck and Otsuka’s PTSD Bid for Rexulti

3 days ago talkbio0Tagged Advisory Committees, brexpiprazole, Clinical Trials, drug efficacy, Lundbeck, Otsuka, Post-Traumatic Stress Disorder, Rexulti, sertraline, United States Food and Drug Administration

Lundbeck; Otsuka; Rexulti; FDA advisory committee; PTSD; brexpiprazole; sertraline; clinical trials; drug efficacy; setback