PharmaShots Weekly Snapshots (February 06 - 10, 2023)

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PharmaShots Weekly Snapshots (February 06 - 10, 2023)

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

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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