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