Research Activity

Novartis and Relation Therapeutics form AI-driven, multi-program atopic disease collaboration

15 hours ago talkbio0Tagged * * atopic diseases * *, * * functional cell, AI-powered, Asthma, atlases, Billion, Drug Discovery, Eczema, Hypersensitivity, IL13 gene, immuno-dermatology, Lab-in-the-Loop, milestones, multi-program collaboration, Novartis

Novartis; Relation Therapeutics; AI-powered drug discovery; Lab-in-the-Loop; atopic diseases; immuno-dermatology; multi-program collaboration; asthma; allergies; eczema; allergic rhinitis; $55 million upfront; $1.7 billion milestones; functional cell atlases

Dyne Therapeutics Reports Positive Results for Duchenne Drug DYNE-251, Plans FDA Approval Submission

19 hours ago talkbio0Tagged Accelerated, Approved, Biological Factors, Breakthrough Therapy Designation, Clinical Trials, DELIVER (veterinary product), Dyne Therapeutics, DYNE-251, License Application, Muscular Dystrophy, Duchenne, United States Food and Drug Administration

Dyne Therapeutics; DYNE-251; Duchenne muscular dystrophy; exon 51 skipping; DELIVER trial; FDA Breakthrough Therapy Designation; Biologics License Application; accelerated approval

AstraZeneca’s dual-targeting CAR-T AZD0120 shows similar response rates in Western and Chinese patients

2 days ago talkbio0Tagged AstraZeneca, Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F, AZD0120, BCMAxCD19, CAR-T, China, Clinical Trials, dual-targeting CAR-T, DURGA-1, Frequency of Responses, Multiple Myeloma, Western patients

AstraZeneca; AZD0120; GC012F; dual-targeting CAR-T; BCMAxCD19; multiple myeloma; DURGA-1; China; Western patients; response rate; clinical trial; CAR-T

FDA names Tracy Beth Heg as acting CDER chief

6 days ago talkbio0Tagged CDER, Center for Drug Evaluation, Chief, COVID19 (disease), Drug Regulations, Leadership, research, Tracy Beth Heg, U.S. Food and Drug Administration, United States Food and Drug Administration, Vaccine Safety

Tracy Beth Heg; acting CDER chief; FDA leadership; Center for Drug Evaluation and Research; COVID-19 vaccine safety; drug regulation; U.S. Food and Drug Administration

Former FDA Chiefs Criticize Proposed Vaccine Policy Changes at ACIP Meeting

6 days ago talkbio0Tagged * New England Journal of Medicine*., ACIP, Centers for Disease Control and Prevention (U.S.), Changing, commissioners, COVID19 (disease), Policy, research, Senator Bill Cassidy, United States Food and Drug Administration, vaccine safety regulation, Vaccines, Vinay Prasad ; Center for Biologics Evaluation

former FDA commissioners; CDC; ACIP meeting; vaccine policy changes; COVID-19 vaccines; Vinay Prasad; Center for Biologics Evaluation and Research; vaccine safety regulation; Senator Bill Cassidy; New England Journal of Medicine commentary

Bristol Myers Squibb Delays Cobenfy Alzheimer’s Psychosis Trial Readout Due to Site Irregularities

6 days ago talkbio0Tagged ADEPT-2 trial, Alzheimer 's psychosis, Cobenfy, Deferred, Myers Squibb, Phase 3 Clinical Trials, trial site irregularities

Bristol Myers Squibb; Cobenfy; Alzheimer’s psychosis; ADEPT-2 trial; trial site irregularities; Phase III study; delay; 2026

Nona Biosciences Appoints Dr. Hongjiang Miao as Chief AI Officer to Advance A³ Strategy and AI-Driven Drug Discovery

6 days ago5 days ago talkbio0Tagged Biotechnology, Chief AI Officer, Drug Development, Drug Discovery, Harbour Mice ® technology, Hongjiang Miao, integrated solutions, Nona Biosciences, Shanghai

Nona Biosciences; Hongjiang Miao; Chief AI Officer; AI-Driven Drug Discovery; biotechnology; Shanghai; drug development; Harbour Mice technology; integrated solutions

Capricor Therapeutics Reports Positive Phase 3 HOPE-3 Trial Results for Deramiocel in Duchenne Muscular Dystrophy, Planning FDA Resubmission

6 days ago talkbio0Tagged Capricor Therapeutics, cardiac function preservation, Clinical Trials, deramiocel, HOPE-3 trial, Muscular Dystrophy, Duchenne, Phase 3 clinical trial, regulatory approval pathway, Rejection, United States Food and Drug Administration, upper limb function

Capricor Therapeutics; Deramiocel; Duchenne muscular dystrophy; HOPE-3 trial; Phase 3 clinical trial; FDA rejection; cardiac function preservation; upper limb function; clinical trial results; regulatory approval pathway

Recent Developments on Vinay Prasad’s Leaked FDA Memo, Alzheimer’s Disease Updates, and Next-Gen Obesity Drugs

7 days ago talkbio0Tagged Alzheimer 's disease, Cessation of life, Child, COVID19 (disease), next-generation, Obesity, research, United States Food and Drug Administration, Vaccines, Vinay Prasad FDA memo

Vinay Prasad FDA memo; COVID-19 vaccine deaths children; FDA vaccine approval changes; Alzheimer’s disease research 2025; obesity drugs next generation; COVID-19 vaccine safety controversy; FDA vaccine policy overhaul

Top Drug Regulator Richard Pazdur to Retire from FDA Amid Industry Concerns

7 days ago talkbio0Tagged Center for Drug Evaluation, Drug Regulations, Leadership, Personnel Turnover, research, Retirement, Richard Pazdur, United States Food and Drug Administration

Richard Pazdur; FDA; retirement; Center for Drug Evaluation and Research; drug regulation; Marty Makary; leadership turnover