AllSci News
Pierre Fabre’s T-cell therapy tabelecleucel met with second FDA CRL
Pierre Fabre Pharmaceuticals revealed that a Biologic License Application (BLA) for Epstein-Barr virus (EBV) T-cell therapy tabelecleucel has been met with a…
AbbVie enters PD-1/VEGF BsAb field via RemeGen licensing deal
AbbVie (NYSE: ABBV) announced the signing of an exclusive licensing agreement with China-based RemeGen to develop, manufacture, and commercialize RC148, a novel…
Minghui Pharma puts novel B7-H4 ADC into first-in-human study
Minghui Pharmaceutical is preparing to launch a first-in-human clinical trial of MHB009C, an investigational antibody-drug conjugate (ADC) targeting advanced solid tumors. Hosted…
Merck KGaA Launches First-in-Human Trial of Ly6E-Targeted ADC in Advanced Solid Tumors
Merck Healthcare KGaA has initiated NCT07311603, a first-in-human interventional study evaluating M7437, an anti-Ly6E exatecan antibody-drug conjugate (ADC), in patients with advanced…
FDA Rejects Vanda’s sNDA for HETLIOZ in Jet Lag Disorder
Vanda Pharmaceuticals (Nasdaq: VNDA) announced receipt of a decision letter from the US FDA, indicating stating that a supplemental New Drug Application…
Immuneering posts ‘extraordinary’ early data for atebimetinib in first-line pancreatic cancer
Immuneering Corporation (Nasdaq: IMRX) reported updated Phase 2a clinical results for its oral MEK inhibitor atebimetinib (IMM-1-104) combined with modified gemcitabine/nab-paclitaxel (mGnP)…
Navigator Medicines puts OX40L/TNFα BsAbs into trials for inflammatory skin disease
New Jersey-based biotech Navigator Medicines is advancing two bispecific antibodies targeting OX40L and TNFα into clinical development, marking a significant progression in…
Arrowhead RNAi obesity candidates show early promise against obesity
Arrowhead Pharmaceuticals announced interim Phase 1/2a clinical results from its RNA interference (RNAi)-based obesity programmes, reporting encouraging weight loss and body-composition improvements…
Astellas puts novel brain delivery drug into first-in-human trial for chronic stroke recovery
Astellas Pharma is launching a pioneering first-in-human clinical trial of ASP2246, a novel therapeutic agent designed to potentially improve motor function in…
GSK’s bepirovirsen hits Phase III endpoints as potential first functional cure for hepatitis B
GlaxoSmithKline (GSK) announced positive topline results from its two pivotal Phase III B-Well 1 and B-Well 2 trials evaluating bepirovirsen, an investigational…
Alzheimer’s symptoms reversed in preclinical study targeting NAD+
A team of researchers has posted potentially paradigm shifting research in the field of Alzheimer’s disease (AD) therapy, showing for the first…
MetaVia posts strong Phase 1b data for DA-1726 in metabolic disease
MetaVia Inc., a clinical-stage biotech focused on cardiometabolic disorders, announced positive, statistically significant results from its Phase 1b clinical trial of its…
Corcept’s NDA for Cushing syndrome drug relacorilant met with FDA’s CRL
Corcept Therapeutics (NASDAQ: CORT) revealed that its New Drug Application (NDA) filing for relacorilant as a treatment for hypertension secondary to endogenous…
J&J halts Phase 2b for BsAb in atopic dermatitis after interim readout
US multinational Johnson & Johnson (J&J) announced that its Phase 2b DUPLEX-AD proof-of-concept study evaluating investigational therapy JNJ-95475939 (also known as JNJ-5939)…
FDA accepts Inovio BLA for INO-3107 but with accelerated approval questions
Inovio Pharmaceuticals, Inc. announced that the US FDA has accepted for review its Biologics License Application (BLA) for INO-3107, an investigational DNA…
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