PharmaShots Weekly Snapshots (March 13

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