AllSci News
Cardiff and Nerviano settle onvansertib license dispute ahead of planned Phase III trial
Cardiff Oncology (Nasdaq: CRDF) and Italy-based Nerviano Medical Sciences S.r.l. (NMS) have settled their litigation and amended their 2017 exclusive...
GenSci registers Phase I trial of four-target retinal fusion protein across three indications
Changchun GeneScience Pharmaceutical Co., Ltd. (GenSci) has registered a Phase I clinical trial of GenSci148, a multispecific fusion protein targeting...
Lipocine starts second Phase III for postpartum depression drug after first trial misses endpoint
Salt Lake City-based Lipocine Inc. (Nasdaq: LPCN) has initiated BLOOM, a second Phase III study of LPCN 1154 (oral brexanolone, proposed brand name Brlizio)...
Alveus takes aim at post-semaglutide weight regain with ALV-100
Alveus Therapeutics Inc., a clinical-stage biotech with operations in Boston and Copenhagen, has dosed its first patient in a Phase II study of ALV-100, its...
Revelyx reports positive Phase II data for recombinant liquid botulinum toxin
Nashville-based Revelyx Bio reported positive Phase II results for YY003, a recombinant botulinum toxin type A supplied as a ready-to-use liquid, supporting...
Santa Ana Bio takes KIT/Siglec-6 bispecific SAB01 into first-in-human testing
California-based Santa Ana Bio has dosed the first cohort in a first-in-human trial of SAB01, a bispecific antibody designed to deplete mast cells...
China approves Walvax’s third mRNA COVID-19 vaccine, targeting the Omicron JN.1 strain
China's National Medical Products Administration (NMPA) has approved a COVID-19 mRNA vaccine developed by Yuxi Watson Biotechnology Co., Ltd., a...
Hansoh/GSK’s risvutatug rezetecan delivers 54% OS risk reduction in relapsed SCLC
Hansoh Pharmaceutical's risvutatug rezetecan, a B7-H3-targeted antibody-drug conjugate (ADC) being developed globally by GSK outside Greater China, reduced...
MAVERICK Phase III data support MRI surveillance alone in SCLC
Brain MRI surveillance without prophylactic cranial irradiation (PCI) improved cognitive failure-free survival and substantially reduced serious...
J&J's Rybrevant shows numerical OS gain in PAPILLON, but final analysis misses significance
Final overall survival (OS) data from the PAPILLON study showed a numerical survival advantage for amivantamab (Rybrevant) plus carboplatin-pemetrexed...
Pharming expands Joenja's US indication to children aged 4–11 with APDS
The US FDA has approved a supplemental New Drug Application (sNDA) for Joenja (leniolisib), extending its indication to children aged 4 to 11 years weighing...
US FDA approves Scholar Rock’s Isembyld as first muscle-targeted SMA therapy
The US FDA has approved Isembyld (apitegromab-mstn) for spinal muscular atrophy (SMA) in adults and children aged two years and older who are currently...
Enhertu Phase III win supports first-line expansion in HER2-mutant NSCLC
Trastuzumab deruxtecan (Enhertu) cut the risk of disease progression or death by 37% compared with pembrolizumab plus platinum-pemetrexed chemotherapy as...
Cullinan/Taiho's zipalertinib adds six months of PFS in Phase III EGFR ex20ins trial
Adding zipalertinib to platinum-based chemotherapy extended median progression-free survival (PFS) by six months compared with chemotherapy alone in...
Tagrisso shows 16-point eight-year survival advantage in ADAURA
Eight years after randomization, 74% of patients with resected Stage II–IIIA EGFR-mutated non-small cell lung cancer (NSCLC) treated with adjuvant...
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