Functional Concept

Expert Insights to Navigate Your CGT Challenges: Recent Updates and Strategic Guidance for 2025

2 days ago talkbio0Tagged calcium glucarate, Capital, Challenge, Changing, Cognitive function: planning, gains, Investments, Long-term, minimization, Private Equity, rates, Taxes

capital gains tax; CGT challenges; 2025 tax rates; long-term capital gains; tax planning; tax minimization strategies; Net Investment Income Tax; private equity tax changes

Novartis to Acquire RNA Drugmaker Avidity Biosciences in $12 Billion Deal

3 days ago talkbio0Tagged 2026, Acquisition, AOC, Avidity Biosciences, Closed, Muscular Dystrophy, Duchenne, Muscular Dystrophy, Facioscapulohumeral, MYOTONIC DYSTROPHY 1, Neuromuscular Diseases, Novartis, Platform, RNA therapeutics, SpinCo ', xRNA

Novartis; Avidity Biosciences; acquisition; RNA therapeutics; neuromuscular diseases; Duchenne muscular dystrophy; myotonic dystrophy type 1; facioscapulohumeral muscular dystrophy; AOC platform; SpinCo; biotech; xRNA strategy; 2026 closing

GSK, Spero Reveal Full Phase 3 Data for Oral Antibiotic Tebipenem HBr; Regulatory Filing Set for End of 2025

1 week ago talkbio0Tagged Complicated, cUTIs, HBr, IDWeek, non-inferiority, oral carbapenem, Phase 3 PIVOT-PO trial, Regulatory Filing, SmithKline Beecham, Spero Therapeutics, Submission, United States Food and Drug Administration, Urinary tract infection

GSK; Spero Therapeutics; tebipenem HBr; oral carbapenem; Phase 3 PIVOT-PO trial; complicated urinary tract infections (cUTIs); non-inferiority; IDWeek 2025; regulatory filing; FDA submission

Neuphoria Scraps Social Anxiety Drug After Trial Failure; Minerva Doubles Down on Schizophrenia Therapy

1 week ago talkbio0Tagged AFFIRM-1 phase 3 trial, BNC210, Clinical trial failure, Discontinuation (procedure), Merck, Neuphoria, Neuroscience discipline, Partnership, Phobia, Social, Post-Traumatic Stress Disorder, Programs - Publication Format, Schizophrenia

Neuphoria Therapeutics; BNC210; social anxiety disorder; AFFIRM-1 phase 3 trial; clinical trial failure; program discontinuation; PTSD; Merck partnership; Minerva Neurosciences; schizophrenia therapy

Replimune Resubmits Melanoma Drug for FDA Approval After Initial Rejection

1 week ago talkbio0Tagged Approved, melanoma, Replimune, resubmission, RETINITIS PIGMENTOSA 1, United States Food and Drug Administration

Replimune; RP1; Melanoma Treatment; FDA Approval; Resubmission

FDA Announces First Recipients of Makary’s National Priority Voucher Program, Expanding Scope for Accelerated Drug Reviews

2 weeks ago talkbio0Tagged Accelerated, CNPV, domestic drug manufacturing, Drug Approval, Martin Makary, National Priority Voucher, pilot program, Priority Review, public health crisis, recipients, United States Food and Drug Administration

FDA; National Priority Voucher; CNPV; Martin Makary; priority review; accelerated drug approval; 2025 pilot program; voucher recipients; public health crisis; domestic drug manufacturing

Spotlight On: Cabaletta Bio’s Small but Mighty Breakthrough for CAR-T in Autoimmune Arena

2 weeks ago talkbio0Tagged Autoimmune Diseases, B-Lymphocytes, Cabaletta Bio, CAR-T therapy, Clinical Trials, Depletion, Lupus Erythematosus, Systemic, Myositis, Pemphigus Vulgaris, Preconditioning, rese-cel, Systemic Scleroderma, United States Food and Drug Administration

Cabaletta Bio; CAR-T therapy; rese-cel; autoimmune diseases; B cell depletion; myositis; systemic lupus erythematosus; systemic sclerosis; pemphigus vulgaris; preconditioning; clinical trial; FDA

FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

2 weeks ago talkbio0Tagged Accelerated, Alfa, amendment, Approved, Biologics License Application, Clinical pharmacology discipline, Deferred, Denali, Mucopolysaccharidosis II, review extension, tividenofusp, United States Food and Drug Administration

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval

Eli Lilly to Invest Over $1 Billion to Expand Manufacturing Footprint in India

3 weeks ago talkbio0Tagged Alzheimer 's, Autoimmune, contract manufacturing, Diabetes, eli lilly, expansion, Hyderabad, India, Malignant Neoplasms, Manufacturing, Obesity

Eli Lilly; India; manufacturing expansion; contract manufacturing; Hyderabad; pharmaceuticals; obesity; diabetes; Alzheimer’s; cancer; autoimmune

Boehringer Ingelheim Breaks Decade-Long Drought with FDA Approval of Jascayd for Idiopathic Pulmonary Fibrosis

3 weeks ago talkbio0Tagged Approved, Boehringer Ingelheim, Chronic lung disease, Idiopathic Pulmonary Fibrosis, Jascayd, lung scarring, nerandomilast, Pulmonary Fibrosis, United States Food and Drug Administration

Boehringer Ingelheim; Jascayd; nerandomilast; FDA approval; idiopathic pulmonary fibrosis; IPF; lung scarring; first new treatment; chronic lung disease