Capricor Claims FDA Misinterpreted Efficacy Data Leading to Rejection of DMD Therapy
Capricor Therapeutics; FDA rejection; deramiocel; Duchenne muscular dystrophy (DMD); efficacy data misinterpretation; clinical trial endpoints; HOPE-2 trial; non-parametric test; statistical significance; cell therapy
Novartis Acquires Tourmaline Bio for $1.4B to Bolster Cardiovascular Pipeline with Promising Phase 2 Drug
Novartis; Tourmaline Bio; acquisition; $1.4 billion; pacibekitug; cardiovascular disease; anti-inflammatory; IL-6 antibody; ASCVD; phase 2 trial; C-reactive protein; chronic kidney disease
Trump Administration May Exempt Some Pharma Products from Future Tariffs in Trade Policy Shift
pharmaceutical tariffs; tariff exemptions; Trump administration; Section 232 investigation; trade policy; reciprocal tariffs; generic pharmaceuticals; active pharmaceutical ingredients; commerce secretary authority
LB Pharmaceuticals Raises $285M in Upsized IPO to Fund Late-Stage Schizophrenia Drug Development
LB Pharmaceuticals; IPO; schizophrenia; LB-102; amisulpride; Phase 3 clinical trial; bipolar depression; biotech fundraising; CNS drugs; FDA approval
Validated Devices for Easy Self-Collection and Stabilization of Vaginal Microbiome Samples: Recent News and Advances
vaginal microbiome; self-collection devices; sample stabilization; diagnostics; metagenomic sequencing; clinical reproducibility
LB Pharmaceuticals Files for $228M IPO to Fund Phase III Schizophrenia Drug
LB Pharmaceuticals; IPO; Phase III trial; schizophrenia; LB-102; biotech; CNS therapeutics; bipolar depression; Alzheimer’s psychosis; amisulpride; FDA; Nasdaq
Eli Lilly Touts ‘Striking’ Progression-Free Survival Results for Jaypirca in New Front-Line CLL Study
Jaypirca; Eli Lilly; CLL; chronic lymphocytic leukemia; BRUIN CLL-313; progression-free survival; BTK inhibitor; first-line treatment; clinical trial; label expansion
Epigenic Therapeutics and NRG Therapeutics Each Secure ~$60M in Series B Rounds for Epigenetic and Neuroscience Advances
Epigenic Therapeutics; NRG Therapeutics; Series B funding; epigenetic therapy; hepatitis B; hypercholesterolemia; Parkinson’s disease; ALS; biotechnology investment; gene silencing
Takeda and Alkermes Detail Strong Clinical Results for Orexin Drugs in Narcolepsy – Head-to-Head Race Accelerates
Takeda; Alkermes; orexin agonists; narcolepsy; oveporexton; alixorexton; clinical trials; Phase 3; excessive daytime sleepiness; cataplexy; maintenance of wakefulness test (MWT)
BioNTech and BMS Announce First Global Data for PD-L1xVEGF Bispecific in Small Cell Lung Cancer, Set Phase 3 Dose
BioNTech; Bristol Myers Squibb; BMS; PD-L1xVEGF bispecific; BNT327; pumitamig; small cell lung cancer; SCLC; phase 2 trial; phase 3 dose; overall response rate; VEGF-A; PD-L1; chemotherapy