Logo

PharmaShots Weekly Snapshots (October 31 – November 04, 2022)

Share this

PharmaShots Weekly Snapshots (October 31 – November 04, 2022)

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

Related Post: PharmaShots Weekly Snapshots (October 24 - 28, 2022)


Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions