LEO Pharma Reports P-III Trial (DELTA 2) Results of Delgocitinib for Chronic Hand Eczema

Date: Feb 10, 2023 | Tags: LEO Pharma, Delgocitinib, Chronic Hand Eczema, Clinical Trial, P-III, DELTA 2 Trial 

GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Regular Approval for Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer

Date: Feb 10, 2023 | Tags: GSK, Jemperli, dostarlimab-gxly, Mismatch Repair-Deficient, Endometrial Cancer, Regulatory, US, FDA, Regular Approval

Artios Initiates P-II Randomized Trial of ART0380 + Gemcitabine for Platinum Resistant Ovarian Cancer

Date: Feb 10, 2023 | Tags: Artios, ART0380, Gemcitabine, Ovarian Cancer, Clinical Trial, P-II Randomized Trial

Kura Oncology Reports First Patient Dosing of Ziftomenib in P-II (KOMET-001) Registration-Directed Trial for NPM1-Mutant Acute Myeloid Leukemia

Date: Feb 10, 2023 | Tags: Kura Oncology, Ziftomenib, NPM1-Mutant, Acute Myeloid Leukemia, Clinical Trial, P-II, KOMET-001 Trial 

Genentech Reports P-III (BALATON) and (COMINO) Study Results of Vabysmo (faricimab-svoa) for Retinal Vein Occlusion

Date: Feb 10, 2023 | Tags: Genentech, Vabysmo, faricimab-svoa, Retinal Vein Occlusion, Clinical Trial, P-III, BALATON, COMINO Study 

Kite Reports P-I/II Study (ZUMA-3) Results of Tecartus (brexucabtagene autoleucel) for B-Cell Acute Lymphoblastic Leukemia

Date: Feb 10, 2023 | Tags: Kite, Tecartus, brexucabtagene autoleucel, B-Cell Acute Lymphoblastic Leukemia, Clinical Trial, P-I/II, ZUMA-3 Study

Cara Therapeutics Reports P-II Trial (KOMFORT) of Difelikefalin for Pruritus in Notalgia Paresthetica Published in the NEJM

Date: Feb 09, 2023 | Tags: Cara Therapeutics, Difelikefalin, Pruritus, Notalgia Paresthetica, NEJM, Clinical Trial, P-II, KOMFORT Trial

Alvotech and STADA Report EMA Acceptance of MAA for AVT04, a Proposed Biosimilar to Stelara (ustekinumab)

Date: Feb 09, 2023 | Tags: Alvotech, STADA, AVT04, Stelara, ustekinumab, Regulatory, EMA, MAA 

Galapagos Reports P-III Trial (DIVERSITY) Results of Filgotinib for the Treatment of Crohn’s Disease

Date: Feb 09, 2023 | Tags: Galapagos, Filgotinib, Crohn’s Disease, Clinical Trial, P-III, DIVERSITY Trial 

NICE Failed to Recommend Boehringer Ingelheim and Lilly’s Jardiance (empagliflozin) for Heart Failure

Date: Feb 09, 2023 | Tags: NICE, Boehringer Ingelheim, Lilly, Jardiance, empagliflozin, Heart Failure, Pharma, P-III,  EMPEROR-Preserved Trial

LEO Pharma’s Adtralza (tralokinumab) Receives the Health Canada’s Approval for the Treatment of Atopic Dermatitis

Date: Feb 09, 2023 | Tags: LEO Pharma, Adtralza, tralokinumab, Atopic Dermatitis, Regulatory, Health Canada, Approval 

Regeneron’s Eylea (aflibercept) Receives the US FDA’s Approval as First Pharmacologic Treatment for Retinopathy of Prematurity in Preterm Infants

Date: Feb 09, 2023 | Tags: Regeneron, Eylea, aflibercept, Retinopathy, Prematurity, Regulatory, US, FDA, Approval 

UCB’s Fintepla (fenfluramine) Receive EU Approval for Adjunctive Treatment of Seizures Associated with Lennox-Gastaut Syndrome

Date: Feb 08, 2023 | Tags: UCB, Fintepla, fenfluramine, Seizures, Lennox-Gastaut Syndrome, Regulatory, EU, Approval 

Aldeyra Therapeutics Reports the US FDA Acceptance of NDA for Reproxalap to Treat Dry Eye Disease

Date: Feb 08, 2023 | Tags: Aldeyra Therapeutics, Reproxalap, Dry Eye Disease, Regulatory, US, FDA, NDA 

Wellmarker Bio Entered into a Clinical Trial Collaboration with MSD to evaluate WM-A1-3389 + Keytruda (pembrolizumab) for Non-Small Cell Lung Cancer

Date: Feb 08, 2023 | Tags: Wellmarker Bio, MSD, WM-A1-3389, Keytruda, pembrolizumab, Non-Small Cell Lung Cancer, Pharma 

Rocket Pharmaceuticals Receives the US FDA’s RMAT Designation of RP-A501 for the Treatment of Danon Disease

Date: Feb 08, 2023 | Tags: Rocket Pharmaceuticals, RP-A501, Danon Disease, Regulatory, US, FDA, RMAT Designation  

CNS Pharmaceuticals Reports First Patient Enrollment in Pivotal Global Trial of Berubicin for Recurrent Glioblastoma Multiforme in Spain

Date: Feb 08, 2023 | Tags: CNS Pharmaceuticals, Berubicin, Recurrent Glioblastoma Multiforme, Spain, Clinical Trial

Immix Biopharma Reports the Patient Dosing in P-Ib/IIa Trial of IMX-110 + Tislelizumab for the Treatment of Advanced Cancer

Date: Feb 08, 2023 | Tags: Immix Biopharma, IMX-110, Tislelizumab, Cancer, Clinical Trial, P-Ib/IIa Trial  

AstraZeneca’s Forxiga (dapagliflozin) Receives EU Approval for the treatment of Symptomatic Chronic Heart Failure

Date: Feb 07, 2023 | Tags: AstraZeneca, Forxiga, dapagliflozin, Symptomatic Chronic Heart Failure, Regulatory, EU, Approval 

Tonix Reports the First Patient Enrollment in the P-II Study (PREVENTION) of TNX-1900 for the Prevention of Migraine Headaches in Chronic Migraineurs

Date: Feb 07, 2023 | Tags: Tonix, TNX-1900, Migraine, Chronic Migraineurs, Clinical Trial, P-II, PREVENTION Study 

Genentech Reports P-III Study (COMMODORE 2) Results of Crovalimab for Paroxysmal Nocturnal Hemoglobinuria

Date: Feb 07, 2023 | Tags: Genentech, Crovalimab, Paroxysmal Nocturnal Hemoglobinuria, Clinical Trial, P-III. COMMODORE 2 

InnoCare Published P-II Study Results of Orelabrutinib in P-II Study for Cancers in American Journal of Hematology

Date: Feb 07, 2023 | Tags: InnoCare, Orelabrutinib, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Clinical Trial, P-II Study, American Journal of Hematology

Janssen Reports P-II Trial Results of Nipocalimab for the Treatment of Severe Hemolytic Disease

Date: Feb 07, 2023 | Tags: Janssen, Nipocalimab, Severe Hemolytic Disease, Clinical Trial, P-II Trial 

Lantheus Acquires Cerveau Technologies to Expands Imaging Pipeline into Alzheimer’s Disease

Date: Feb 07, 2023 | Tags: Lantheus, Cerveau Technologies, MK-6240, Alzheimer’s Disease, Acquire, M&A

Acutus Reports (AcQForce Flutter Study) Results of AcQBlate Force Sensing Ablation Catheter and System for Right Atrial Typical Flutter

Date: Feb 06, 2023 | Tags: Acutus, AcQBlate Force Sensing Ablation Catheter, Right Atrial Typical Flutter, Clinical Trial,  AcQForce Flutter Study 

Synaffix Entered into a License Agreement with Chong Kun Dang Pharm for ADC Technology

Date: Feb 06, 2023 | Tags: Synaffix, Chong Kun Dang Pharm, ADC Technology, GlycoConnect, HydraSpace, Biotech

Alvotech Entered into Commercialization Agreement with Advanz Pharma for AVT23, a Proposed Biosimilar to Xolair (omalizumab)

Date: Feb 06, 2023 | Tags: Alvotech, Advanz Pharma, BiosanaPharma, AVT23, Xolair, omalizumab, allergic asthma, chronic spontaneous urticaria, nasal polyps, Biosimilar

Takeda’s Takhzyro (lanadelumab-flyo) Receives the US FDA’s sBLA Approval to Prevent Hereditary Angioedema Attacks in Children Aged ≥2 Years

Date: Feb 06, 2023 | Tags: Takeda, Takhzyro, lanadelumab-flyo, Hereditary Angioedema Attacks, Regulatory, US, FDA, sBLA, Approval 

Novartis Published P-III (SUNSHINE) and (SUNRISE) Trials Results of Cosentyx (secukinumab) for Hidradenitis Suppurativa in The Lancet

Date: Feb 06, 2023 | Tags: Novartis, Cosentyx, secukinumab, Hidradenitis Suppurativa, The Lancet, Clinical Trial, P-III, SUNSHINE, SUNRISE Trials

Merck Reports P-III Trial (NRG-GY018) Results of Keytruda (pembrolizumab) as 1L Treatment for Advanced or Recurrent Endometrial Carcinoma

Date: Feb 06, 2023 | Tags: Merck, Keytruda, pembrolizumab, Endometrial Carcinoma, Clinical Trial, P-III, NRG-GY018 Trial