Finding – Talk Bio

Alkermes Advances Narcolepsy Therapy with Promising Phase 2 Trial Results for Alixorexton

2 days ago talkbio0Tagged alixorexton, Alkermes, Cataplexy, Daytime Somnolence, Excessive (qualifier value), late-stage testing, Narcolepsy, Narcolepsy type 1, normative wakefulness, Orexin Receptor Agonist, Vibrance-1 study

Alkermes; narcolepsy; alixorexton; Phase 2 trial; orexin 2 receptor agonist; narcolepsy type 1; normative wakefulness; late-stage testing; Vibrance-1 study; cataplexy; excessive daytime sleepiness

FDA Commissioner Makary Proposes Fast-Track Drug Review Vouchers Tied to Lower US Prices, Without Detailing Criteria

2 weeks ago talkbio0Tagged drug price, fast-track approval, Makary, national priority review vouchers, Parity, pilot program, Prices, United States Food and Drug Administration

FDA; Makary; national priority review vouchers; drug pricing; fast-track approval; price parity; pilot program

Rhythm’s Oral MC4R Agonist Bivamelagon Shows Promising Results in Rare Obesity Type

2 weeks ago talkbio0Tagged Agonist, Bivamelagon, Body mass index procedure, Clinical Trials, Hypothalamic obesity, MC4R protein, human, oral weight loss drug, Rhythm

Rhythm Pharmaceuticals; oral weight-loss drug; bivamelagon; MC4R agonist; Phase 2 trial; hypothalamic obesity; BMI reduction; clinical trial results

FDA Investigates Patient Deaths Linked to Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

4 weeks ago talkbio0Tagged ELEVIDYS, Evaluation, gene therapy, Liver, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient deaths, regulatory, Toxicity aspects, Unable to walk (finding), United States Food and Drug Administration

FDA; Sarepta; Elevidys; Duchenne muscular dystrophy; gene therapy; patient deaths; acute liver failure; liver toxicity; regulatory investigation; non-ambulatory patients

Nektar Declares Phase IIb Eczema Win for Rezpeg, but Analysts Remain Skeptical

4 weeks ago talkbio0Tagged analysts, Clinical Trials, Dermatitis, Atopic, Dupixent, EASI, Eczema, Lilly partnership, Nektar Therapeutics, Phase II B Trial, Rezpeg, Rezpegaldesleukin, Score, Skepticism

Nektar Therapeutics; Rezpegaldesleukin; Rezpeg; Phase IIb trial; eczema; atopic dermatitis; clinical trial; EASI score; Dupixent; analyst skepticism; Lilly partnership

FDA Acting CDER Head Jacqueline Corrigan-Curay to Retire Amid Leadership Turnover

4 weeks ago talkbio0Tagged agency departures, CDER, Drug Regulations, Jacqueline Corrigan-Curay, Leadership, Personnel Turnover, Retirement, United States Food and Drug Administration

FDA; Jacqueline Corrigan-Curay; CDER; retirement; leadership turnover; drug regulation; agency departures

Zealand Pharma’s Dual GLP-1/GLP-2 Agonist Dapiglutide Shows Promising 11.6% Weight Loss at 28 Weeks

1 month ago talkbio0Tagged Clinical Trials, Dapiglutide, Glucagon-Like Peptide 1, Glucagon-Like Peptide 2, Obesity, Safety, Weight Loss, Zealand Pharma

Zealand Pharma; dapiglutide; GLP-1; GLP-2; weight loss; obesity; phase 1b trial; clinical trial; dual agonist; safety

Scholar Rock’s SMA drug helps Zepbound patients retain muscle in phase 2 trial

1 month ago talkbio0Tagged apitegromab, GDF8 protein, human, Inhibitor, Lean Mass, muscle preservation, Obesity, Phase 2 trial, Scholar Rock, Spinal Muscular Atrophy, Weight Loss, Zepbound

Scholar Rock; apitegromab; SMA drug; Zepbound; tirzepatide; muscle preservation; obesity; weight loss; phase 2 trial; lean mass; myostatin inhibitor

Ousted ACIP Members Criticize RFK Jr.’s ‘Destabilizing’ Changes to U.S. Vaccine Policy

1 month ago talkbio0Tagged ACIP, CDC, Centers for Disease Control and Prevention (U.S.), Committee, Decision, Employment Termination, Policy, public health medicine (field), Recommendation, RFK Jr., Vaccines

ACIP; RFK Jr.; vaccine policy; CDC; committee dismissal; public health; vaccine recommendations; destabilizing decisions

Federal Judge Rules NIH Grant Terminations Illegal, Orders Restoration of Hundreds of Grants

1 month ago talkbio0Tagged Biomedical Research, DEI, federal judge, Gender, health disparity, LGBTQ+, NIH Mouse, public health medicine (field), Racism, Sense of identity (observable entity), terminations, Trump administration

NIH; grant terminations; federal judge; racial discrimination; DEI; gender identity; Trump administration; biomedical research; public health; LGBTQ+; health disparities