PharmaShots Weekly Snapshots (January 02 - 06, 2023)

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PharmaShots Weekly Snapshots (January 02 - 06, 2023)

Novocure Reports Results from P-III Pivotal Study of Tumor Treating Fields in Non-Small Cell Lung Cancer

Date: Jan 6, 2023 | Tags: Novocure, Tumor Treating Fields, Ici, Docetaxel, Non-Small Cell Lung Cancer, Clinical Trial, Stage 4, The US FDA, EU

Transgene’s CTA for TG6050 Receives French National Agency’s Approval to Initiate P-I Trial for Non-Small Cell Lung Cancer

Date: Jan 6, 2023 | Tags: Transgene, Tg6050, Non-Small Cell Lung Cancer, Regulatory, French National Agency, Ansm, P-I, Delivir

Link, by Smart Tracking Technologies Enters in Distribution Agreement with MWI/Amerisource Bergen for New LinkVet

Date: Jan 6, 2023 | Tags: Link, By Smart Tracking Technologies, Mwi Animal Health, Amerisource Bergen, New Linkvet, Animal Health, Medtech, Distribution Agreement, Concierge Services Team

Genentech’s Glofitamab Receives BLA & Priority Review from the US FDA to Treat r/r Large B-Cell Lymphoma

Date: Jan 6, 2023 | Tags: Genentech, Glofitamab, Relapsed Or Refractory Large B-Cell Lymphoma, Regulatory, Bla, Us Fda, Starglo, P-I/Ii, P-Iii

Synaffix Entered into a License Agreement with Amgen to Develop Antibody-Drug Conjugates to Treat Cancer

Date: Jan 6, 2023 | Tags: Synaffix, Amgen, Antibody-Drug Conjugates, Pharma, Glycoconnect Hydraspace, Toxsyn

Pristine Surgical’s Summit Receives the US FDA’s Approval as a Single-Use Surgical Arthroscope

Date: Jan 6, 2023 | Tags: Pristine Surgical, Summit, Medtech, Regulatory, Arthroscopic Procedure, Us Fda, Pristine Connect

Azafaros Receives IND Clearance and FTD from the US FDA for AZ-3102 to Treat Lysosomal Storage Disorders with Neurological Involvement

Date: Jan 5, 2023 | Tags: Azafaros, Az-3102, Lysosomal Storage Disordersm, Neurological Involvement, Regulatory, Us Fda, Rainbow

Innovent’s IBI351 Receives BTD by the NMPA for the Treatment of Advanced Non-small Cell Lung Cancer

Date: Jan 5, 2023 | Tags: Innovent, Ibi351, Non-Small Cell Lung Cancer, Regulatory, Nmpa, Cde

Checkpoint Submits BLA to the US FDA for Cosibelimab to Treat Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

Date: Jan 5, 2023 | Tags: Checkpointtherapeutics, Cosibelimab, Metastatic Or Locally Advanced Cutaneous Squamous Cell Carcinoma, Regulatory, Us Fda T Cell, Monoclonal Antibody

WuXi Signed a License Agreement with GSK to Develop Multiple Novel Bi- & Multi-specific T Cell Engagers to Treat Cancer

Date: Jan 5, 2023 | Tags: Wuxi Biologics, Gsk, T Cell Engagers, Cd3 Platform, Wuxibody Platform, Cancer, Pharma, Antibodies, Monoclonal Antibodies

Belharra and Genentech Enter into a Research Collaboration to Discover and Develop Small Molecules for Multiple Therapeutic Areas

Date: Jan 5, 2023 | Tags: Belharra, Genentech, Small Molecule, Oncology, Immuno-Oncology Autoimmune, Neurodegenerative Diseases, Pharma, Us, Preclinical, Clinical

Biogen and Alcyone Enter into a License Agreement for ThecaFlex DRx System to Treat Patients with Neurological Conditions

Date: Jan 5, 2023 | Tags: Biogen, Alcyone, Thecaflex Drx System, Neurological Conditions, Medtech, Spinraza

Sedana Medical Receives Fast Track Designation from the US FDA to Isoflurane Administered via Sedaconda ACD-S Device for Sedation

Date: Jan 4, 2023 | Tags: Sedana Medical, Sedaconda Acd-S Device, Sedaconda (Isoflurane), Sedation, Medtech Fast Track Designation, The Us Fda, Inspire-Icu 1 & 2

Daxor Publishes Results of its BVA-100 Blood Volume Diagnostic for Heart Failure

Date: Jan 4, 2023 | Tags: Daxor, Bva-100, Blood Volume Diagnostic, Heart Failure, Clinical Trial, Journal Of Cardiovascular Translational Research

RegeneRx’s New Scientific Publication Reports Results of RGN-259 in P-III Study for the Treatment of Neurotrophic Keratopathy

Date: Jan 4, 2023 | Tags: Regenerx, Rgn-259, Neurotrophic Keratopathy, Clinical Trial, Regenerx Biopharmaceuticals, Hlb Therapeutics

Visby Medical’s Respiratory Health Test Receives Emergency Use Authorization from the US FDA

Date: Jan 4, 2023 | Tags: Visby Medical, The Visby Medical Respiratory Health Test, Medtech, Emergency Use Authorization Pcr Test, Sars-Cov-2 Influenza A, And Influenza B, The Us Fda

Thermo Fisher Reports Completion of Acquisition of The Binding Site at ~$2.8B

Date: Jan 4, 2023 | Tags: Thermo Fisher, The Binding Site, M&A, $2.8b, Diagnostics

Gilead Collaborates with EVOQ Therapeutics to Advance Immunotherapies in Rheumatoid Arthritis and Lupus

Date: Jan 4, 2023 | Tags: Gilead, Evoq Therapeutics, Nanodisc Technology, Rheumatoid Arthritis And Lupus Autoimmune Diseases, Pharma, Collaboration, Licensing, Preclinical

Janssen Reports MAA Submission to EMA for Approval of Talquetamab to Treat Multiple Myeloma

Date: Jan 3, 2023 | Tags: Janssen, Talquetamab, Multiple Myeloma, Regulatory, Maa, Ema, Regulatory

HUTCHMED Completes Patient Enrolment of P-III (ESLIM-01) for Primary Immune Thrombocytopenia Patients in China

Date: Jan 3, 2023 | Tags: Hutchmed, Eslim-01, Primary Immune Thrombocytopenia, Clinical Trial, P-Iii Eslim-01 Study

CStone Reports P-III Study (GEMSTONE-304) Results of Sugelimab as 1L Treatment of Esophageal Squamous Cell Carcinoma

Date: Jan 3, 2023 | Tags: Cstone, Sugelimab, Esophageal Squamous Cell Carcinoma, Clinical Trial, P-Iii Gemstone-304 Study

ABM Respiratory Care Receives the US FDA’s Clearance of Biwaze Clear System

Date: Jan 3, 2023 | Tags: Abm Respiratory Care, Biwaze Clear System, Respiratory Conditions, Regulatory, Medtech, Us, Fda, Clearance

Alligator Bioscience Reports P-II Study (OPTIMIZE-1) Interim Results of Mitazalimab as 1L Treatment of Pancreatic Cancer

Date: Jan 3, 2023 | Tags: Alligator Bioscience, Mitazalimab, Pancreatic Cancer, Clinical Trial, P-Ii Optimize-1

Alteogen Signed an Exclusive License Agreement with Sandoz to Develop and Commercialize Biosimilar Products

Date: Jan 3, 2023 | Tags: Alteogen, Sandoz, Biosimilar Products, Alt-B4, Hybrozyme Technology, Pharma

Hansa Biopharma Receives Positive Reimbursement Decision for Idefirix (imlifidase) in the Czech Republic

Date: Jan 2, 2023 | Tags: Hansa Biopharma, Idefirix, Imlifidase, Czech Republic, P-Ii, Igg, Streptococcus Pyogenes, Regulatory

Legend Biotech Reports NMPA’s Acceptance of NDA for Ciltacabtagene Autoleucel (Cilta-Cel) in Multiple Myeloma

Date: Jan 2, 2023 | Tags: Legend Biotech, Ciltacabtagene Autoleucel, Carvykti, Multiple Myeloma, Regulatory, P-Ii, Cartifan-1, Nct03758417, Us Fda, Eu, Nmpa, China

Everest Medicines and Calliditas Receives Priority Review for Nefecon in IgA Nephropathy for China

Date: Jan 2, 2023 | Tags: Everest Medicines, Calliditas Therapeutics, Nefecon, Budesonide, Immunoglobulin A Nephropathy, Regulatory, Nda, Nmpa, China, Breakthrough Therapy Designation

BeiGene Reports the NMPA’s Acceptance of sBLA for Tislelizumab for 1L Treatment of Hepatocellular Carcinoma

Date: Jan 2, 2023 | Tags: Beigene, Tislelizumab, Hepatocellular Carcinoma, Regulatory, Nmpa, Sbla

OncoC4 Reports First Patient Dosing of ONC-392 + Keytruda (pembrolizumab) in P-II Study (PRESERVE-004) for Platinum-Resistant Ovarian Cancer

Date: Jan 2, 2023 | Tags: OncoC4, ONC-392, Keytruda, pembrolizumab, Platinum-Resistant Ovarian Cancer, Clinical Trial, P-II, PRESERVE-004

Novavax Initiates P-II Trial of COVID-19-Influenza Combination and Stand-Alone Influenza Vaccine Candidates

Date: Jan 2, 2023 | Tags: Novavax, Covid-19 Vaccine, Nvx-Cov2373, Quadrivalent Influenza Vaccine, Clinical Trial, P-Ii Trial

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.

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