Date: Mar 31, 2023 | Tags: PDS Biotech, PDS0101, Keytruda, pembrolizumab, Head, Neck Cancer, Clinical Trial, P-III, VERSATILE-003 Trial
Omega Therapeutics Entered into a Clinical Supply Agreement with Roche to Evaluate OTX-2002 for Hepatocellular Carcinoma
Date: Mar 31, 2023 | Tags: Omega Therapeutics, Roche, OTX-2002, Hepatocellular Carcinoma, Pharma, P-I/II, MYCHELANGELO I Trial
EIP Pharma Entered into a Definitive Merger Agreement with Diffusion Pharmaceuticals to Advance Neflamapimod for Neurodegenerative Diseases
Date: Mar 31, 2023 | Tags: EIP Pharma, Diffusion Pharmaceuticals, CervoMed, Neflamapimod, Neurodegenerative, dementia, Lewy bodies, M&A
GSK Entered into an Exclusive Licence Agreement and SCYNEXIS to Develop and Commercialise Brexafemme (ibrexafungerp) for Fungal Infection
Date: Mar 31, 2023 | Tags: GSK, SCYNEXIS, Brexafemme, ibrexafungerp, Fungal Infection, invasive candidiasis, Pharma
BMS to Present P-III Trial (CheckMate -816) Results of Opdivo (nivolumab) for Resectable Non-Small Cell Lung Cancer at ELCC 2023
Date: Mar 31, 2023 | Tags: BMS, Opdivo, nivolumab, Non-Small Cell Lung Cancer, Clinical Trial, P-III, CheckMate -816 Trial, ELCC, 2023
Nanoscope Therapeutics Reports P-IIb Trial (RESTORE) Results of MCO-010 for the Treatment of Retinitis Pigmentosa
Date: Mar 31, 2023 | Tags: Nanoscope Therapeutics, MCO-010, Retinitis Pigmentosa, Clinical Trial, P-IIb, RESTORE Trial
Takeda Published P-IV Study (EARNEST) Results of Vedolizumab for Chronic Pouchitis in NEJM
Date: Mar 30, 2023 | Tags: Takeda, Vedolizumab, Chronic Pouchitis, Clinical Trial, P-IV, EARNEST Study, NEJM
Confo Therapeutics Entered into a Collaboration Agreement with Daiichi Sankyo to Discover Novel Therapies for Central Nervous System Disease
Date: Mar 30, 2023 | Tags: Confo Therapeutics, Daiichi Sankyo, Novel Therapies, Central Nervous System Disease, Pharma
Théa Open Innovation Signs a License Agreement with Galimedix to Develop and Commercialize GAL-101 for Ophthalmic Indications
Date: Mar 30, 2023 | Tags: Théa Open Innovation, Galimedix, GAL-101, Ophthalmic Indications, dry age-related macular degeneration, glaucoma, Pharma
Takeda’s Entyvio (vedolizumab) Receives the MHLW Approval for the Maintenance Treatment of Moderate to Severe Ulcerative Colitis
Date: Mar 30, 2023 | Tags: Takeda, Entyvio, vedolizumab, Ulcerative Colitis, Regulatory, MHLW, Approval
Janssen Reports P-I Study (CHRYSALIS) Results of Rybrevant (amivantamab-vmjw) for Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Date: Mar 30, 2023 | Tags: Janssen, Rybrevant, amivantamab-vmjw, Non-Small Cell Lung Cancer, EGFR, Exon 20 Insertion Mutations, Clinical Trial, P-I, CHRYSALIS study
Regeneron’s Libtayo (cemiplimab) Receive EC’s Approval as 1L Treatment of Advanced PD-L1 Positive Non-Small Cell Lung Cancer
Date: Mar 30, 2023 | Tags: Regeneron, Libtayo, cemiplimab, Non-Small Cell Lung Cancer, Regulatory, EC Approval
Affimed Reports First Patient Dosing of AFM28 in the P-I Study for the Treatment of CD123-Positive Acute Myeloid Leukemia
Date: Mar 29, 2023 | Tags: Affimed, AFM28, CD123-Positive, Acute Myeloid Leukemia, Clinical Trial, P-I Study
AstraZeneca’s Tezspire (tezepelumab) Receives NICE Recommendation as an Add-On Treatment for Severe Uncontrolled Asthma
Date: Mar 29, 2023 | Tags: AstraZeneca, Tezspire, Tezepelumab, Asthma, Regulatory, NICE
Covant Entered into an Exclusive Research Collaboration and Worldwide License Agreement with Boehringer Ingelheim to Develop Cancer Immunotherapies
Date: Mar 29, 2023 | Tags: Covant, Boehringer Ingelheim, ADAR1 Inhibitor,Immunotherapies, Cancer, Pharma
BMS’ Sotyktu (deucravacitinib) Receives EC’s Approval for the Treatment of Plaque Psoriasis
Date: Mar 29, 2023 | Tags: BMS, Sotyktu, deucravacitinib, Plaque Psoriasis, EC, Approval, Regulatory, POETYK PSO-1, POETYK PSO-2 trial
Bicycle Therapeutics Signs a Collaboration Agreement with Novartis to Develop and Commercialize Multiple Targeted Bicycle Radio-Conjugates Therapies
Date: Mar 29, 2023 | Tags: Bicycle Therapeutics, Novartis, Bicycle Radio-Conjugates Therapies, BT5528, BT8009, BT7480, BT1718, Cancer, Pharma
Sonoma Biotherapeutics Collaborated with Regeneron to Develop and Commercialize Treg Cell Therapies for Autoimmune Diseases
Date: Mar 29, 2023 | Tags: Sonoma Biotherapeutics, Regeneron, Treg Cell Therapies, SBT-77-7101, Autoimmune Diseases, inflammatory diseases, Biotech
OncoVent, a Subsidiary of Hepalink and Orient EuroPharma Enters into a License and Distribution Agreement to Develop and Commercialize Oregovomab in Taiwan
Date: Mar 28, 2023 | Tags: OncoVent, Hepalink, Orient EuroPharma, Oregovomab, License and Distribution Agreement, Taiwan, $11.2M
Zealand Pharma Reports Results from P-Ia Study of ZP8396 for Patients with Obesity and Diabetes
Date: Mar 28, 2023 | Tags: Zealand Pharma, ZP8396, Clinical Trial, Obesity and Diabetes, amylin analogue
Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) Receives the MHLW’s Approval as the First HER2 Directed Therapy for HER2 Low Metastatic Breast Cancer
Date: Mar 28, 2023 | Tags: Daiichi Sankyo, Enhertu, trastuzumab deruxtecan, HER2 Low Metastatic Breast Cancer, Regulatory, MHLW, Approval
GSK Reports P-III Trial (RUBY/ENGOT-EN6/GOG3031/NSGO) Results of Jemperli (dostarlimab) for Primary Advanced or Recurrent Endometrial Cancer
Date: Mar 28, 2023 | Tags: GSK, Jemperli, dostarlimab, Endometrial Cancer, Clinical Trial, P-III, RUBY/ENGOT-EN6/GOG3031/NSGO Trial
Novartis Reports P-III Trial (NATALEE) Results of Kisqali (ribociclib) for the Treatment of Early Breast Cancer
Date: Mar 28, 2023 | Tags: Novartis, Kisqali, ribociclib, Breast Cancer, Clinical Trial, P-III, NATALEE Trial
Ionis Reports P-III Study (NEURO-TTRansform) Results of Eplontersen for Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
Date: Mar 28, 2023 | Tags: Ionis, Eplontersen, Hereditary Transthyretin-Mediated Amyloid Polyneuropathy, Clinical Trial, P-III, NEURO-TTRansform Study
Pharming’s Joenja (leniolisib) Receives the US FDA’s Approval as First Treatment for Activated Phosphoinositide 3-Kinase Delta Syndrome
Date: Mar 27, 2023 | Tags: Pharming, Joenja, leniolisib, Activated Phosphoinositide 3-Kinase Delta Syndrome, Regulatory, US, FDA, Approval
Merck Reports P-III Trial (NRG‑GY018) Results of Keytruda (pembrolizumab) as 1L Treatment for Advanced or Recurrent Endometrial Carcinoma
Date: Mar 27, 2023 | Tags: Merck, Eytruda, pembrolizumab, Endometrial Carcinoma, Clinical Trial, P-III, NRG‑GY018 Trial
Vertex Entered into a Non-Exclusive License Agreement with CRISPR Therapeutics to Advance Hypoimmune Cell Therapies for Type 1 Diabetes
Date: Mar 27, 2023 | Tags: Vertex, CRISPR Therapeutics, Hypoimmune Cell Therapies, Type 1 Diabetes, Pharma
Incyte Announces Japanese Approval of Pemazyre (pemigatinib) for the Treatment of Patients with Myeloid/Lymphoid Neoplasms (MLNs)
Date: Mar 27, 2023 | Tags: Incyte, Pemazyre, pemigatinib, Myeloid/Lymphoid Neoplasms, Regulatory, MHLW, Approval
Bayer’s Kerendia (finerenone) Receives NICE Recommendation for Chronic Kidney Disease Associated with Type 2 Diabetes
Date: Mar 27, 2023 | Tags: Bayer, NICE, Kerendia, finerenone, Chronic Kidney Disease, Type 2 Diabetes, Regulatory
Roche’s Columvi (glofitamab) Receives Health Canada Authorization for the Treatment of Adult Patients with Diffuse Large B-cell Lymphoma
Date: Mar 27, 2023 | Tags: Roche, Columvi, glofitamab, Diffuse Large B-cell Lymphoma, Regulatory, Health Canada
Related Post: PharmaShots Weekly Snapshots (March 20 – 24, 2023)