Gilead Receives EMA’s CHMP Positive Opinion of Trodelvy (sacituzumab govitecan) for Pre-Treated HR+/HER2- Metastatic Breast Cancer

Date: June 23, 2023 | Tags: Gilead, Trodelvy, sacituzumab govitecan, HR+/HER2- Metastatic Breast Cancer, Regulatory, EMA, CHMP, Positive Opinion

Sarepta Therapeutics’ Elevidys Receives the US FDA’s Accelerated Approval for the Treatment of Duchenne Muscular Dystrophy

Date: June 23, 2023 | Tags: Sarepta Therapeutics, Elevidys, Duchenne Muscular Dystrophy, Regulatory, US, FDA, Accelerated Approval 

Cosmo Entered into a License Agreement with Hyundai Pharm for Winlevi in Korea

Date: June 23, 2023 | Tags: Cosmo, Hyundai Pharm, Winlevi, Korea, Acne, Pharma, US

Gilead Presented P-III Trial (MYR301) Results of Hepcludex (bulevirtide) for Chronic Hepatitis Delta Virus at EASL 2023

Date: June 23, 2023 | Tags: Gilead, Hepcludex, bulevirtide, Chronic Hepatitis Delta Virus, Clinical Trial, P-III, MYR301 Trial, EASL, 2023

Talaris Signed a Definitive Merger Agreement with Tourmaline Bio to Advance TOUR006 for Thyroid Eye Disease and Atherosclerotic Cardiovascular Disease

Date: June 23, 2023 | Tags: Talaris Therapeutics, Tourmaline Bio, TOUR006, Thyroid Eye Disease, Atherosclerotic Cardiovascular Disease, M&A

ASLAN Pharmaceuticals Entered into a License Agreement with Zenyaku Kogyo for the Development and Commercialization of Eblasakimab in Japan

Date: June 23, 2023 | Tags: ASLAN Pharmaceuticals, Zenyaku Kogyo, Eblasakimab, atopic dermatitis, Japan, Pharma

Bayer to Initiates P-III Study (FINE-ONE) of Finerenone for the Treatment of Chronic Kidney Disease and Type 1 Diabetes

Date: June 22, 2023 | Tags: Bayer, Finerenone, Chronic Kidney Disease, Type 1 Diabetes, Clinical Trial, P-III, FINE-ONE Study 

VVT Medical Receives the US FDA’s 510(k) Clearance for ScleroSafe System to Treat Varicosities in Superficial Veins

Date: June 22, 2023 | Tags: VVT Medical, ScleroSafe System, Varicosities, Superficial Veins, MedTech, Regulatory, US, FDA, 510(k) Clearance 

Theranica Reports Clinical Study Results of Nerivio Migraine Bioband for the Treatment of Migraine in Pregnant Women

Date: June 22, 2023 | Tags: Theranica, Nerivio Migraine Bioband, Migraine, Pregnant Women, remote electrical neuromodulation, DigiHealth, Clinical Trial

UNION Therapeutics Reports P-II Study (OSIRIS) Results of Orismilast for the Treatment of Hidradenitis Suppurativa

Date: June 22, 2023 | Tags:  UNION Therapeutics, Orismilast, Hidradenitis Suppurativa, Clinical Study, P-II, OSIRIS Study 

Pieris Pharmaceuticals Partner AstraZeneca Discontinue P-IIa Clinical Trial of Elarekibep (PRS-060/AZD1402) for the Treatment of Asthma

Date: June 22, 2023 | Tags: Pieris Pharmaceuticals, AstraZeneca, Asthma, Elarekibep, PRS-060, AZD1402, Clinical Trial, P-IIa Trial 

GSK Reports P-III Trial (AReSVi-006) Results of Arexvy for Preventing Lower Respiratory Tract Disease Caused by Respiratory Syncytial Virus

Date: June 22, 2023 | Tags:  GSK, Arexvy, Lower Respiratory Tract Disease, Respiratory Syncytial Virus, Clinical Trial, P-III, AReSVi-006 Trial      

bluebird bio Reports the US FDA Acceptance of BLA for lovotibeglogene autotemcel to Treat Sickle Cell Disease in Patients Aged ≥12 Years

Date: June 21, 2023 | Tags: bluebird bio, lovotibeglogene autotemcel, Sickle Cell Disease, Regulatory, US, FDA, BLA 

The US FDA Approves Boehringer Ingelheim’s Jardiance and Synjardy for the Treatment of Type 2 Diabetes

Date: June 21, 2023 | Tags: Boehringer Ingelheim, Jardiance, Synjardy, Type 2 Diabetes, Regulatory, US, FDA, Approval

Calliditas Therapeutics Reports sNDA Submission to the US FDA for Tarpeyo to Treat Primary IgA Nephropathy

Date: June 21, 2023 | Tags:  Calliditas Therapeutics, Tarpeyo, budesonide, Primary IgA Nephropathy, Regulatory, sNDA, US, FDA 

Takeda Presents P-III Trial (ADVANCE-CIDP 1) Results of Hyqvia for Chronic Inflammatory Demyelinating Polyneuropathy at PNS 2023, Published in the JPNS

Date: June 21, 2023 | Tags:  Takeda, Hyqvia, Chronic Inflammatory Demyelinating Polyneuropathy, Clinical Trial, P-III, ADVANCE-CIDP 1 Trial, PNS, 2023

Seagen Highlighted German Hodgkin Study Group Presents P-III Trial (HD21) Results of Adcetris (brentuximab vedotin) for Advanced Classical Hodgkin Lymphoma

Date: June 21, 2023 | Tags: Seagen, German Hodgkin Study Group, Adcetris, brentuximab vedotin, Advanced Classical Hodgkin Lymphoma, Clinical Trial, P-III, HD21 Trial

argenx's Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Receives the US FDA’s Approval for Generalized Myasthenia Gravis

Date: June 21, 2023 | Tags: argenx, Vyvgart Hytrulo, efgartigimod alfa, hyaluronidase-qvfc, Generalized Myasthenia Gravis, Regulatory, US, FDA, Approval  

Eli Lilly to Acquire DICE Therapeutics for ~$2.4B

Date: June 20, 2023 | Tags: Lilly, DICE Therapeutics, immunology, M&A, ~$2.4B, Acquire 

argenx to Initiates Second Cohort of P-II Study (ARDA) Results of Empasiprubart for Multifocal Motor Neuropathy

Date: June 20, 2023 | Tags: argenx, Empasiprubart, ARGX-117, Multifocal Motor Neuropathy, Clinical Trial, P-II, ARDA Study

Santhera Entered into an Exclusive License and Collaboration Agreement with Catalyst Pharmaceuticals for Vamorolone

Date: June 20, 2023 | Tags: Santhera, Catalyst Pharmaceuticals, Vamorolone, Duchenne muscular dystrophy, Pharma, US, Canada, Mexico, North America

Eli Lilly Reports (CHALLENGE-MIG) Trial Results of Emgality (galcanezumab-gnlm) for the Prevention of Episodic Migraine

Date: June 20, 2023 | Tags: Eli Lilly, Emgality, galcanezumab-gnlm, Episodic Migraine, Clinical Trial, CHALLENGE-MIG Trial

Cosmo Pharmaceuticals Partner Sun Pharma Receives the Health Canada’s Approval of Winlevi (clascoterone cream) for Topical Treatment of Acne

Date: June 20, 2023 | Tags: Cosmo Pharmaceuticals, Sun Pharma, Winlevi, clascoterone cream, Acne, Regulatory, Health Canada, Approval 

Horizon Presents New P-IV Trial Results of Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease at ENDO 2023

Date: June 20, 2023 | Tags: Horizon, Tepezza, teprotumumab-trbw, Thyroid Eye Disease, Clinical Trial, P-IV Trial, ENDO, 2023 

Coherus BioSciences to Acquire Surface Oncology for ~$65M

Date: June 19, 2023 | Tags: Coherus BioSciences, Surface Oncology, SRF388, SFR114,solid tumors, lung and liver cancer, M&A, ~$65M, Acquire

Zoetis’ Apoquel Chewable Receives the US FDA’s Approval for Control of Pruritus Associated with Allergic Dermatitis and Control of Atopic Dermatitis in Dogs

Date: June 19, 2023 | Tags: Zoetis, Apoquel Chewable, Pruritus, Allergic Dermatitis, Atopic Dermatitis, Dogs, Animal Health, Regulatory, US, FDA, Approval 

IDEXX Launches First Veterinary Diagnostic IDEXX Cystatin B Test to Detect Kidney Injury in Cats and Dogs

Date: June 19, 2023 | Tags:  IDEXX, IDEXX Cystatin B Test, Kidney Injury, Animal Health, Cats, Dogs, Veterinary Diagnostic 

BMS Presented P-II Trial (TRANSCEND FL) and P-I Trial (TRANSCEND NHL 001) Results of Breyanzi for Follicular Lymphoma and Mantle Cell Lymphoma at ICML 2023

Date: June 19, 2023 | Tags: BMS, Breyanzi, Follicular Lymphoma, Mantle Cell Lymphoma, Clinical Trial, P-II, TRANSCEND FL, P-I, TRANSCEND NHL 001, ICML, 2023

Bio-Thera Solutions Expands its Collaboration with Biomm for BAT2206 (biosimilar, ustekinumab)

Date: June 19, 2023 | Tags:  Bio-Thera Solutions, Biomm, BAT2206, biosimilar, ustekinumab, active psoriatic arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis

Ascendis Pharma Presented One-Year P-III Trial (PaTHway) Results of TransCon PTH for Hypoparathyroidism at ENDO 2023

Date: June 19, 2023 | Tags: Ascendis Pharma, TransCon PTH, Hypoparathyroidism, Clinical Trial, P-III, PaTHway Trial, ENDO, 2023

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