PharmaShots Weekly Snapshots (March 27 – 31, 2023)

PDS Biotech to Initiate P-III Trial (VERSATILE-003) of PDS0101 + Keytruda (pembrolizumab) for Head and Neck Cancer

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

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