Samsung Bioepis Reports P-I Study Results of SB17, a Proposed Biosimilar to Stelara
Date: Mar 17, 2023 | Tags: Samsung Bioepis, SB17, Biosimilar, Stelara, ustekinumab, Clinical Study, P-I Study
CANbridge Reports P-I/II Study Results of CAN008 for Glioblastoma Multiforme
Date: Mar 17, 2023 | Tags: CANbridge, CAN008, asunercept, temozolomide Glioblastoma Multiforme, Clinical Trial, P-I/II Study
Oculis Reports the Completion of Patient Enrolment in P-III Trial (OPTIMIZE) of OCS-01 for the Treatment of Inflammation and Pain
Date: Mar 17, 2023 | Tags: Oculis, OCS-01, Inflammation, Pain, cataract surgery, Clinical Trial, P-III, OPTIMIZE Trial
Novartis’ Tafinlar + Mekinist Receives the US FDA’s Approval for BRAF V600E Low-Grade Glioma in Pediatric Patients
Date: Mar 17, 2023 | Tags: Novartis, Tafinlar, dabrafenib, Mekinist, trametinib, BRAF V600E, Low-Grade Glioma, Regulatory, US, FDA, Approval
Everest Medicines’ Xerava (eravacycline) Receives NMPA’s Approval for Complicated Intra-Abdominal Infections in Adult Patients
Date: Mar 17, 2023 | Tags: Everest Medicines, Xerava, eravacycline, Complicated Intra-Abdominal Infections, Regulatory, NMPA, Approval
Ono Entered into a Drug Discovery Collaboration Agreement with PeptiDream to Discover and Develop Macrocyclic Constrained Peptide Therapies
Date: Mar 17, 2023 | Tags: Ono, PeptiDream, Macrocyclic Constrained Peptide Therapies, PDPS platform technology, Biotech
BD Receives the US FDA’s Clearance for Infectious Vaginitis Test for Use in High Throughput Platform
Date: Mar 16, 2023 | Tags: BD, BD Vaginal Panel, BD COR System, Infectious Vaginitis, Regulatory, MedTech, US, FDA, polymerase chain reaction technology
LumiThera Reports P-III Trial (LIGHTSITE III) Results of Valeda Light Delivery System for Dry Age-Related Macular Degeneration
Date: Mar 16, 2023 | Tags: LumiThera, Valeda Light Delivery System, Dry Age-Related Macular Degeneration, Clinical Trial, P-III, LIGHTSITE III Trial
Prelude Therapeutics Entered into a Clinical Trial Collaboration with BeiGene to Evaluate PRT2527 + Zanubrutinib for Hematologic Cancers
Date: Mar 16, 2023 | Tags: Prelude Therapeutics, BeiGene, PRT2527, Zanubrutinib, Hematologic Cancers, Pharma, P-I dose-escalation study
Medtronic’s Affera Mapping and Ablation System Receives CE Mark for the Treatment of Atrial Arrhythmias
Date: Mar 16, 2023 | Tags: Medtronic, Affera Mapping, Ablation System, Atrial Arrhythmias, Regulatory, MedTech, CE Mark, SPHERE Per-AF Trial
Dermavant Reports P-III Trial (ADORING 2) Results of Vtama (tapinarof) for Atopic Dermatitis
Date: Mar 16, 2023 | Tags: Dermavant, Vtama, tapinarof Cream, Atopic Dermatitis, Clinical Trial, P-III, ADORING 2 Trial
Aitia Entered into a Drug Discovery Collaboration with UCB to Discover New Therapies for Huntington’s Disease
Date: Mar 16, 2023 | Tags: Aitia, UCB, New Therapies, Huntington’s Disease, Gemini Digital Twins, Pharma
InDex Pharmaceuticals Reports Positive PK Results from Cobitolimod in Patients with Ulcerative Colitis
Date: Mar 15, 2023 | Tags: InDex Pharmaceuticals, Cobitolimod, Ulcerative Colitis, Clinical Trial
Puma Biotechnology Publishes P-II Trial (TBCRC041) Results of Alisertib for Endocrine-Resistant Advanced Breast Cancer in JAMA Oncology
Date: Mar 15, 2023 | Tags: Puma Biotechnology, Alisertib, fulvestrant, Endocrine-Resistant Advanced Breast Cancer, Clinical Trial, P-II, TBCRC041 trial, JAMA Oncology
Pfizer and BioNTech Receive the US FDA’s EUA for Omicron BA.4/BA.5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years
Date: Mar 15, 2023 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted Bivalent Booster, COVID-19, Regulatory, US, FDA, EUA
Servier Reports P-III Trial (INDIGO) Results of Vorasidenib for IDH-Mutant Low-Grade Glioma
Date: Mar 15, 2023 | Tags: Servier, Vorasidenib, IDH-Mutant Low-Grade Glioma, Clinical Trial, P-III, INDIGO Trial
Mirum’s Livmarli (maralixibat) Receives the Label Expansion Approval from the US FDA for Alagille Syndrome in Infants Aged ≥3 Months
Date: Mar 15, 2023 | Tags: Mirum, Livmarli, maralixibat, Alagille Syndrome, Label Expansion Approval, Regulatory, US, FDA
Simcere Zaiming Entered into a Clinical Collaboration Agreement with MSD to Evaluate SIM0235 + Keytruda for Advanced Solid Tumors and Cutaneous T-cell Lymphoma
Date: Mar 15, 2023 | Tags: Simcere Zaiming, MSD, SIM0235, Keytruda, Advanced Solid Tumors, Cutaneous T-cell Lymphoma, Pharma
GSK Reports the NMPA Acceptance of NDA for Nucala (mepolizumab) to Treat Severe Eosinophilic Asthma
Date: Mar 14, 2023 | Tags: GSK, Nucala, mepolizumab, Eosinophilic Asthma, Regulatory, NMPA, NDA
Medivir AB Reports the First Patient Dosing of Fostrox + Lenvima in P-IIa Trial for the Treatment of Hepatocellular Carcinoma
Date: Mar 14, 2023 | Tags: Medivir AB, Fostrox, Lenvima, Hepatocellular Carcinoma, Clinical Trial, P-IIa Trial
Bio-Thera Solutions Reports First Patient Dosing of BAT8007 in P-I Clinical Study for the Treatment of Advanced Solid Tumors
Date: Mar 14, 2023 | Tags: Bio-Thera Solutions, BAT8007, Advanced Solid Tumors, Clinical Study, P-I Clinical Study
ALX Oncology and Quantum Leap Report the First Patient Dosing of Evorpacept in the P-I Trial (I-SPY-P1-TRIAL) for Breast Cancer
Date: Mar 14, 2023 | Tags: ALX Oncology, Quantum Leap, Evorpacept, Breast Cancer, Clinical Trial, P-I, I-SPY-P1-TRIAL
Pfizer to Acquire Seagen for ~$43B
Date: Mar 14, 2023 | Tags: Pfizer, Seagen, Adcetris, Padcev, Tivdak, ADC technology, Solid tumors, hematologic malignancies, lung cancer, breast cancer, ~$43B, Acquire, M&A
Astellas Reports P-III Study (SKYLIGHT 1) Results of Fezolinetant for Vasomotor Symptoms Due to Menopause
Date: Mar 14, 2023 | Tags: Astellas, Fezolinetant, Vasomotor Symptoms, Menopause, Clinical Trial, P-III, SKYLIGHT 1 Study
Sanofi to Acquire Provention Bio for ~$2.9B
Date: Mar 13, 2023 | Tags: Sanofi, Provention Bio, Tzield, type 1 diabetes, ~$2.9B, M&A, P-III, PROTECT Trial, ~$2.9B, M&A
Acadia’s Daybue (trofinetide) Receives the US FDA’s Approval for Rett Syndrome in Adult and Pediatric Patients Aged ≥2Years
Date: Mar 13, 2023 | Tags: Acadia Pharmaceuticals, Daybue, trofinetide, Rett Syndrome, Regulatory, US, FDA, Approval
Calliditas’ Nefecon Meets its Primary Endpoint in P-III Trial (NefIgArd) for the Treatment of IgA Nephropathy
Date: Mar 13, 2023 | Tags: Calliditas, Nefecon, IgA Nephropathy, Clinical Trial, P-III, NefIgArd Trial
Guardant Health Reports the Submission of Premarket Approval Application to the US FDA for Shield Blood Test to Detect Colorectal Cancer
Date: Mar 13, 2023 | Tags: Guardant Health, Shield Blood Test, Colorectal Cancer, Premarket Approval, Regulatory, US, FDA
AnnJi Entered into an Exclusive License Agreement with Avenue Therapeutics to Develop and Commercialize AJ201 for Kennedy’s Disease
Date: Mar 13, 2023 | Tags: AnnJi, Avenue Therapeutics, AJ201, spinal and bulbar muscular atrophy, Kennedy’s Disease, Huntington’s Disease and Spinocerebellar Ataxia, Pharma
Pfizer’s Zavzpret (zavegepant) Receives the US FDA’s Approval for the Treatment of Migraine
Date: Mar 13, 2023 | Tags: Pfizer, Zavzpret, zavegepant, Migraine, Regulatory, US, FDA, Approval
Related Post: PharmaShots Weekly Snapshots (March 06 – 10, 2023)
