Cholesgen Entered into a Drug Discovery Collaboration and Licensing Option Agreement with AstraZeneca to Deliver Innovative Therapies for hypercholesterolemia

Date: June 16, 2023 | Tags: Cholesgen, AstraZeneca, hypercholesterolemia, Joint Research Committee, Pharma

Takeda and HUTCHMED Reports P-III Study (FRESCO2) Results of Fruquintinib in the P-III Study (FRESCO-2) for Metastatic Colorectal Cancer

Date: June 16, 2023 | Tags: Takeda, HUTCHMED, Fruquintinib, Metastatic Colorectal Cancer, Clinical Trial, P-III, FRESCO-2 Study 

Mersana Therapeutics Reports US FDA’s Partial Clinical Hold on New Patient Enrollment of UpRi for Platinum-Sensitive Ovarian Cancer

Date: June 16, 2023 | Tags: Mersana Therapeutics, UpRi, Platinum-Sensitive Ovarian Cancer, Clinical Trial, US, FDA, Clinical Hold

BMS Receives the US FDA’s Approval of Camzyos (mavacamten) sNDA for Label Update to Treat Symptomatic Obstructive HCM

Date: June 16, 2023 | Tags: BMS, Camzyos, mavacamten, Symptomatic Obstructive HCM, sNDA, Regulatory, US, FDA, Approval

AbbVie Reports P-III Study (COMMAND) Results of Skyrizi (risankizumab) for the Treatment of Ulcerative Colitis

Date: June 16, 2023 | Tags: AbbVie, Skyrizi, Risankizumab, Ulcerative Colitis, Clinical Trial, P-III, COMMAND Study 

Genentech’s Columvi (glofitamab-gxbm) Receives the US FDA’s Approval for Relapsed or Refractory Diffuse Large B-cell Lymphoma

Date: June 16, 2023 | Tags: Genentech, Columvi, glofitamab-gxbm, Diffuse Large B-cell Lymphoma, Regulatory, US, FDA, Approval 

Iovance Biotherapeutics Reports the First Patient Randomizing of Lifileucel in P-III Trial (TILVANCE-301) for Frontline Advanced Melanoma

Date: June 15, 2023 | Tags: Iovance Biotherapeutics, Lifileucel, Melanoma, Clinical Trial, P-III, TILVANCE-301 Trial 

Verve Entered into an Exclusive Research Collaboration with Eli Lilly to Advance In Vivo Gene Editing Program Targeting Lp(a) for Atherosclerotic Cardiovascular Disease

Date: June 15, 2023 | Tags: Verve, Eli Lilly, In Vivo, Gene Editing Program, Atherosclerotic Cardiovascular Disease, Biotech

Confo Therapeutics Entered into a Research Collaboration with AbCellera for GPCR-Targeting Antibody Discovery

Date: June 15, 2023 | Tags: Confo Therapeutics, AbCellera, GPCR-Targeting Antibody Discovery, Biotech 

Astellas Signed a Research Collaboration and Exclusive Option Agreement with Cullgen to Advance Innovative Targeted Protein Degraders

Date: June 15, 2023 | Tags: Astellas, Cullgen, Innovative Targeted Protein Degraders, breast cancer, solid tumors, Biotech

Amneal Receives NDA Approval from the US FDA for Pemrydi RTU

Date: June 15, 2023 | Tags: Amneal, Pemrydi RTU, non-squamous non-small cell lung cancer, malignant pleural mesothelioma, Regulatory, NDA, US, FDA 

Mirum Published Results of Livmarli (maralixibat) for the Treatment of Alagille Syndrome in Hepatology

Date: June 15, 2023 | Tags: Mirum, Livmarli, maralixibat, Alagille Syndrome, Hepatology, Clinical Studies

Surmodics Receives the US FDA’s 510(k) Clearance for Pounce LP Thrombectomy System

Date: June 14, 2023 | Tags: Surmodics, Pounce LP Thrombectomy System, Regulatory, MedTech, US, FDA, 510(k) Clearance 

Inventiva Reports Investigator-Initiated P-II Trial Results of Lanifibranor for Type 2 Diabetes and Nonalcoholic Fatty Liver Disease

Date: June 14, 2023 | Tags: Inventiva, Lanifibranor, Type 2 Diabetes, Nonalcoholic Fatty Liver Disease, Clinical Trial, P-II Trial 

Chugai Reports the NDA Submission of Crovalimab to the MHLW for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Japan

Date: June 14, 2023 | Tags: Chugai, Crovalimab, Paroxysmal Nocturnal Hemoglobinuria, Regulatory, NDA, Japan

LEXEO Therapeutics Reports the Completion of First Cohort and Dosing in Second Cohort in P-I/II Trial (SUNRISE-FA) of LX2006 for Friedreich’s Ataxia Cardiomyopathy

Date: June 14, 2023 | Tags: LEXEO Therapeutics, LX2006, Friedreich’s Ataxia Cardiomyopathy, Clinical Trial, P-I/II, SUNRISE-

Smith+Nephew’s Aetos Shoulder System Receives 510(k) clearance for Anatomic and Reverse Shoulder Replacement

Date: June 14, 2023 | Tags: Smith+Nephew, Aetos Shoulder System, Anatomic, Reverse Shoulder Replacement, Regulatory, MedTech, 510(k) clearance 

Ipsen’s Bylvay (odevixibat) Receives the US FDA’s Approval for the Treatment of Cholestatic Pruritus Due to Alagille Syndrome

Date: June 14, 2023 | Tags: Ipsen, Bylvay, odevixibat, Cholestatic Pruritus, Alagille Syndrome, Regulatory, US, FDA, Approval 

Ironwood Pharmaceuticals’ Linzess (linaclotide) Receives the US FDA’s Approval for the Treatment of Functional Constipation in Pediatric Patients Aged 6-17 Years

Date: June 13, 2023 | Tags: Ironwood Pharmaceuticals, Linzess, linaclotide, Regulatory, US, FDA, Approval, Pediatric Patients 

AstraZeneca’s Soliris (eculizumab) Receives the NMPA’s Approval for the Treatment of Adults with Refractory Generalised Myasthenia Gravis

Date: June 13, 2023 | Tags:  AstraZeneca, Soliris, eculizumab, Refractory Generalised Myasthenia Gravis, Regulatory, = NMPA, Approval 

Seagen Reports Results from Part C of P-II Trial (SGN35-027) for Adcetris (brentuximab vedotin) to Treat Early-Stage Classical Hodgkin Lymphoma

Date: June 13, 2023 | Tags: Seagen, Adcetris, brentuximab vedotin, Classical Hodgkin Lymphoma, Clinical Trial, P-II, SGN35-027 Trial

Neuronetics Receives the US FDA’s 510(k) Clearance of MT Cap Technology to Treat Obsessive-Compulsive Disorder

Date: June 13, 2023 | Tags: Neuronetics, MT Cap Technology, Obsessive-Compulsive Disorder, Regulatory, MedTech, US, FDA, 510(k) Clearance 

Innovent Presents P-I Clinical Trial Results of IBI322 for the Treatment of Classic Hodgkin Lymphoma at EHA 2023

Date: June 13, 2023 | Tags: Innovent, IBI322, Classic Hodgkin Lymphoma, Clinical Trial, P-I Trial, EHA, 2023 

Mustang Bio Presents Updated P-I/II Trial Results of MB-106 for the Treatment of Waldenstrom Macroglobulinemia at EHA 2023

Date: June 13, 2023 | Tags: Mustang Bio, MB-106, Waldenstrom Macroglobulinemia, Clinical Trial, P-I/II Trial, EHA, 2023

Idorsia Reports the Commercial Availability of Quviviq (daridorexant) in Switzerland for Chronic Insomnia Disorder

Date: June 12, 2023 | Tags: Idorsia, Quviviq, daridorexant, Chronic Insomnia Disorder, Regulatory, Switzerland

AstraZeneca Reports the US FDA Acceptance of NDA and Granted Priority Review of Capivasertib + Faslodex (fulvestrant) for Advanced HR-Positive Breast Cancer

Date: June 12, 2023 | Tags: AstraZeneca, Astex Therapeutics, Capivasertib, Faslodex, fulvestrant, HR-Positive Breast Cancer, Regulatory, US, FDA, NDA, Priority Review  

Servier Presents Updated P-I Study Results of Tibsovo (ivosidenib) for IDH1-Mutated Relapsed/Refractory Myelodysplastic Syndromes at EHA 2023

Date: June 12, 2023 | Tags: Servier, Tibsovo, ivosidenib, IDH1-Mutated, Myelodysplastic Syndromes, Clinical Trial, P-I Study, EHA, 2023 

Novartis Entered into an Agreement to Acquire Chinook Therapeutics for ~$3.5B

Date: June 12, 2023 | Tags: Novartis, Chinook Therapeutics, Atrasentan, Zigakibart, BION-1301, IgA nephropathy, M&A, ~$3.5B

AbbVie Reports P-III (CLL14) and (MURANO) Studies Results of Venclyxto/ Venclexta (venetoclax) for Chronic Lymphocytic Leukemia

Date: June 12, 2023 | Tags: AbbVie, Venclyxto, Venclexta, venetoclax, Chronic Lymphocytic Leukemia, Clinical Trial, P-III, CLL14, MURANO Studies 

Roche Presents P-III Studies (COMMODORE 1 & 2) Results of Crovalimab for the Treatment of Paroxysmal Nocturnal Haemoglobinuria at EHA 2023

Date: June 12, 2023 | Tags: Roche, Crovalimab, Paroxysmal Nocturnal Haemoglobinuria, Clinical Trial, P-III, COMMODORE 1, COMMODORE  2, EHA, 2023

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