Pfizer and BioNTech Reports P-II/III Trial Results of Omicron BA.4/BA.5-Adapted Bivalent Booster for COVID-19

Published: Nov 04, 2022 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted Bivalent Booster, P-II/III Trial

AstraZeneca and Sanofi’s Beyfortus (nirsevimab) Receives the EC’s Approval for the Prevention of RSV Lower Respiratory Tract Disease in Infants

Published: Nov 04, 2022 | Tags: AstraZeneca, Sanofi, Beyfortus, nirsevimab, RSV Lower Respiratory Tract Disease, Regulatory, EC, Approval

Pfizer and BioNTech Initiate P-I Study of mRNA-Based Combination Vaccine for the Treatment of COVID-19 and Influenza

Published: Nov 04, 2022 | Tags: Pfizer, BioNTech, mRNA-Based Combination Vaccine, COVID-19, Influenza, P-I Study

Ascentage Pharma to Present P-II Study Results of Lisaftoclax (APG-2575) for Chronic Lymphocytic Leukemia at ASH 2022

Published: Nov 04, 2022 | Tags: Ascentage Pharma, Lisaftoclax, APG-2575, acalabrutinib, lisaftoclax, rituximab, Chronic Lymphocytic Leukemia, ASH, 2022, Clinical Trial

Pfizer’s Elranatamab Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma

Published: Nov 04, 2022 | Tags: Pfizer, Elranatamab, Multiple Myeloma, Regulatory, US, FDA, Breakthrough Therapy Designation

Exelixis Entered into New License Agreement with Catalent for Three Antibody-Drug Conjugate Programs

Published: Nov 04, 2022 | Tags: Exelixis, Catalent, Antibody-Drug Conjugate Programs, SMARTag bioconjugation platform, License Agreement, Biotech

REGENXBIO Presents Interim P-II (ALTITUDE) Trial Results of RGX-314 for Diabetic Retinopathy Using Suprachoroidal Delivery at 55th Annual Retina Society Meeting

Published: Nov 03, 2022 | Tags: REGENXBIO, RGX-314, Diabetic Retinopathy, Suprachoroidal Delivery. 55th Annual Retina Society Meeting, Clinical Trial, P-II ALTITUDE Trial 

Hansa Partner Sarepta Therapeutics Plans to Initiate a Clinical Study of Imlifidase for Duchenne Muscular Dystrophy

Published: Nov 03, 2022 | Tags: Hansa, Sarepta, Imlifidase, SRP-9001, Duchenne Muscular Dystrophy, Clinical Trial

Rigel Reports P-III (FOCUS) Trial Results of Fostamatinib for COVID-19 in High Risk Hospitalized Patients

Published: Nov 03, 2022 | Tags: Rigel, Fostamatinib, COVID-19, Clinical Trial, P-III, FOCUS Trial

Gilead Receives the US FDA’s Approval for Vemlidy (tenofovir alafenamide) sNDA to Treat Chronic Hepatitis B Virus Infection

Published: Nov 03, 2022| Tags: Gilead, Vemlidy, tenofovir alafenamide, Chronic Hepatitis B Virus Infection, Regulatory, sNDA, US, FDA, Approval

IGM Biosciences Entered into a Clinical Collaboration Agreement with ADC to Evaluate Imvotamab (IGM-2323) + Zynlonta (loncastuximab tesirine-lpyl) for B Cell Non-Hodgkin’s Lymphoma

Published: Nov 03, 2022 | Tags: IGM Biosciences, ADC, Imvotamab, IGM-2323, Zynlonta, B Cell Non-Hodgkin’s Lymphoma, P-I Study, Pharma

Arcturus Collaborated with CSL to Develop and Commercialize Self-amplifying mRNA Vaccines

Published: Nov 03, 2022 | Tags: Arcturus, CSL, Self-amplifying mRNA Vaccines, LUNAR delivery platform technologies, COVID-19, influenza, Biotech

BeiGene’s Brukinsa (zanubrutinib) Receives EC’s Approval for the Treatment of Adults with Marginal Zone Lymphoma

Published: Nov 02, 2022 | Tags: BeiGene, Brukinsa, zanubrutinib, Marginal Zone Lymphoma, Regulatory, EC, Approval

Rhythm Receives the US FDA’s Breakthrough Therapy Designation for Setmelanotide to Treat Hypothalamic Obesity

Published: Nov 02, 2022 | Tags: Rhythm, Setmelanotide, Hypothalamic Obesity, Regulatory, US, FDA, Breakthrough Therapy Designation

Henlius' Hansizhuang (serplulimab) Receives NMPA’s Approval for the Treatment of Squamous Non-Small Cell Lung Cancer

Published: Nov 02, 2022 | Tags: Henlius, Hansizhuang, serplulimab, Non-Small Cell Lung Cancer, Regulatory, NMPA, Approval

Exelixis Entered into an Exclusive Clinical Development Collaboration and Option Agreement with Sairopa to Develop ADU-1805 for Cancer

Published: Nov 02, 2022 | Tags: Exelixis, Sairopa, ADU-1805, Cancer, Clinical Development, Option Agreement, Pharma

Exelixis Entered into an Exclusive Collaboration Agreement with Cybrexa to Acquire CBX-12 for Solid Tumors

Published: Nov 02, 2022 | Tags: Exelixis, Cybrexa, CBX-12, alphalex exatecan, Solid Tumors, Pharma

Johnson & Johnson to Acquire Abiomed for ~$16.6B

Published: Nov 02, 2022 | Tags: Johnson & Johnson, Abiomed, ~$16.6B, Heart Failure, Acquire, M&A

Pfizer Reports P-III (MATISSE) Trial Results of RSVpreF for the Treatment of Respiratory Syncytial Virus

Published: Nov 01, 2022 | Tags: Pfizer, RSVpreF, Respiratory Syncytial Virus, Clinical Trial, P-III MATISSE Trial

Memo Therapeutics AG Entered into a Research and Development Collaboration Agreement with Ono to Discover Antibodies Against Immuno-Oncology Targets

Published: Nov 01, 2022 | Tags: Memo Therapeutics AG, Ono, Antibodies, Immuno-Oncology Targets, infectious diseases, Pharma

Dyne Therapeutics’ DYNE-251 Receives the US FDA’s Fast Track Designation for the Treatment of Duchenne Muscular Dystrophy

Published: Nov 01, 2022 | Tags: Dyne Therapeutics, DYNE-251, Duchenne Muscular Dystrophy, Regulatory, US, FDA, Fast Track Designation

Eucure Biopharma Subsidiary of Biocytogen Collaborated with ISU ABXIS to Develop Tri-Specific Antibodies Using YH003 Antibody Sequence

Published: Nov 01, 2022 | Tags: Bioscytogen, ISU ABXIS, Tri-specific Antibodies, YH003, pancreatic ductal adenocarcinoma and melanoma, Biotech

Antengene Receives the US FDA’s IND Clearance of ATG-017 to Initiate P-I (ERASER) Trial for Advanced Solid Tumors

Published: Nov 01, 2022 | Tags: Antengene, ATG-017, Advanced Solid Tumors, Regulatory, P-I, ERASER Trial, US FDA, IND

Ascendis Pharma Reports the US FDA’s Acceptance of NDA for Priority Review of TransCon PTH to Treat Hypoparathyroidism in Adult Patients

Published: Nov 01, 2022 | Tags: Ascendis Pharma, TransCon PTH, Hypoparathyroidism, regulatory, US, FDA, NDA, Priority Review 

BMS Reports P-III (COMMANDS) Study Results of Reblozyl (luspatercept-aamt) for Myelodysplastic Syndromes

Published: Oct 31, 2022 | Tags: Bristol Myers Squibb, Reblozyl, luspatercept-aamt, Myelodysplastic Syndromes, Clinical Trial, P-III COMMANDS Study

Innovent Reports First Patient Dosing of IBI343 in P-I Study for the Treatment of Advanced Solid Tumors

Published: Oct 31, 2022 | Tags: Innovent, IBI343, Advanced Solid Tumors, Clinical Trials, P-I Study

Outlook Therapeutics Reports the US FDA Acceptance of BLA for ONS-5010 to Treat Wet AMD

Published: Oct 31, 2022 | Tags: Outlook Therapeutics, ONS-5010, Wet AMD, Regulatory, US, FDA, BLA

CytoDyn Reports the Withdrawal of BLA for Leronlimab to Treat HIV

Published: Oct 31, 2022 | Tags: CytoDyn, Leronlimab, HIV, Clinical Trials, Withdrawal, BLA, HIV-MDR

AbbVie Reports EMA's Validation of MAA for Epcoritamab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Large B-Cell Lymphoma

Published: Oct 31, 2022 | Tags: AbbVie, Epcoritamab, Diffuse Large B-Cell Lymphoma, Large B-Cell Lymphoma, Regulatory, EMA, MAA

Roche’s Actemra IV (tocilizumab) Receives Health Canada Authorization for Additional Indication to Treat COVID-19

Published: Oct 31, 2022 | Tags: Roche, Actemra IV, tocilizumab, COVID-19, Regulatory, Health Canada

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