PharmaShots Weekly Snapshots (February 27

Aldeyra Therapeutics Reports the US FDA Acceptance of NDA for Priority Review of ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma

Date: Mar 03, 2023 | Tags: Aldeyra Therapeutics, ADX-2191, Primary Vitreoretinal Lymphoma, Regulatory, US, FDA, NDA, Priority Review

Flamingo Therapeutics Signed a Definitive Merger Agreement with Dynacure to Advance RNA-Targeted Oncology Therapies

Date: Mar 03, 2023 | Tags: Flamingo Therapeutics, Dynacure, RNA-Targeted Oncology Therapies, FTX-001, Head & Neck cancer, Pharma

Neuro20 Technologies Receives the US FDA Clearance of Neuro20 PRO System for Treatment of Neuromuscular Injury and Disease

Date: Mar 03, 2023 | Tags: Neuro20 Technologies, Neuro20 PRO System, electro-muscle stimulation suit, Neuromuscular Injury and Disease, Medtech, Regulatory

Santhera Reports the MAA Submission to the MHRA for Vamorolone to Treat Duchenne Muscular Dystrophy

Date: Mar 03, 2023 | Tags: Santhera, Vamorolone, Duchenne Muscular Dystrophy, MAA, MHRA, regulatory

Avenue Therapeutics Entered into an Exclusive License Agreement with AnnJi to Develop and Commercialize AJ201 for Spinal and Bulbar Muscular Atrophy

Date: Mar 03, 2023 | Tags: Avenue Therapeutics, AnnJi, AJ201, Spinal, Bulbar Muscular Atrophy, Huntington’s Disease & Spinocerebellar Ataxia, Pharma

Checkpoint Reports the US FDA Acceptance of BLA for Cosibelimab to Treat Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

Date: Mar 03, 2023 | Tags: Checkpoint, Cosibelimab, Cutaneous Squamous Cell Carcinoma, Regulatory, US, FDA, BLA

Confo Therapeutics Entered into a Global License Agreement with Eli Lilly for CFTX-1554

Date: Mar 02, 2023 | Tags: Confo Therapeutics, Eli Lilly, CFTX-1554, neuropathic pain, Pharma

Biogen Launches Byooviz (biosimilar, ranibizumab) for the Treatment of Retinal Disorders in Canada

Date: Mar 02, 2023 | Tags: Biogen, Byooviz, biosimilar, ranibizumab, Retinal Disorders, Canada, Pharma

Sanofi and Sobi Report P-III Study (XTEND-Kids) Results of Altuviiio for the Treatment of Hemophilia A in Children Aged <12 Years

Date: Mar 02, 2023 | Tags: Sanofi, Altuviiio, Hemophilia A, Clinical Trial, P-III, XTEND-Kids Study

GenFleet Receives EMA Approval to Study GFH925 + Erbitux (cetuximab) as 1L Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer

Date: Mar 02, 2023 | Tags: GenFleet, GFH925, Erbitux, cetuximab, KRAS G12C-Mutant Non-Small Cell Lung Cancer, Regulatpry, EMA, Approval

ImmunoGen Signs a Multi-Target License and Option Agreement with Vertex to Develop Novel Targeted Conditioning Agents

Date: Mar 02, 2023 | Tags: ImmunoGen, Vertex, Targeted Conditioning Agents, ADC technology, Biotech

aTyr Pharma, Efzofitimod, Systemic Sclerosis-Associated Interstitial Lung Disease, Clinical Trial, P-II Study

Date: Mar 02, 2023 | Tags: aTyr Pharma, Efzofitimod, Systemic Sclerosis-Associated Interstitial Lung Disease, Clinical Trial, P-II Study

Merck Reports P-III Trial (KEYNOTE-671) of Keytruda for Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer

Date: Mar 01, 2023 | Tags: Merck, Keytruda, Stage II, IIIA or IIIB Non-Small Cell Lung Cancer, Clinical Trial, P-III, KEYNOTE-671 Trial

Bayer Submits Application to MHLW for Marketing Authorization of Aflibercept in Japan

Date: Mar 01, 2023 | Tags: Bayer, Aflibercept, neovascular (wet) age-related macular degeneration, diabetic macular edema, Regulatory, MHLW, Japan

BMS Reports the US FDA Acceptance of sBLA and EMA’s Validation of MAA for Opdivo (nivolumab) to Treat Stage IIB or IIC Melanoma

Date: Mar 01, 2023 | Tags: BMS, Opdivo, nivolumab, Stage IIB, IIC Melanoma, Regulatory, US, FDA, sBLA, EMA, MAA

Reata Pharmaceuticals’ Skyclarys (omaveloxolone) Receives the US FDA’s Approval for the Treatment of Friedreich’s Ataxia

Date: Mar 01, 2023 | Tags: Reata Pharmaceuticals, Skyclarys, omaveloxolone, Friedreich’s Ataxia, Regulatory, US, FDA, Approval

Regeneron and Sanofi Receive the US FDA’s Approval for Kevzara (sarilumab) to Treat Polymyalgia Rheumatica

Date: Mar 01, 2023 | Tags: Regeneron, Sanofi, Kevzara, sarilumab, Polymyalgia Rheumatica, Regulatory, US, FDA, Approval

Amarin Entered into an Exclusive License and Distribution Agreement with CSL Seqirus to Commercialize Vazkepa (icosapent ethyl) In Australia and New Zealand

Date: Mar 01, 2023 | Tags: Amarin, CSL Seqirus, Vazkepa, icosapent ethyl, cardiovascular disease, Australia, New Zealand, Pharma

JW Therapeutics Initiates Clinical Study of JWATM214 for the Treatment of Advanced Hepatocellular Carcinoma

Date: Feb 28, 2023 | Tags: JW Therapeutics, JWATM214, Hepatocellular Carcinoma, ARTEMIS platform, T cell anti-exhaustion technology, Clinical Trial

Innovent Reports the First Patient Dosing of IBI333 in P-I Clinical Study for Neovascular Age-Related Macular Degeneration

Date: Feb 28, 2023 | Tags: Innovent, IBI333, Neovascular Age-Related Macular Degeneration, Clinical Trial, P-I Clinical Study

Scilex Relaunch Elyxyb (celecoxib oral solution) in the US for Migraine Treatment

Date: Feb 28, 2023 | Tags: Scilex, Elyxyb, celecoxib oral solution, celecoxib, Migraine, non-opioid pain, Pharma

Mitsubishi Tanabe Pharma America Reports 48-Week P-III Trial (MT-1186-A01) Results of Radicava ORS (edaravone) for Amyotrophic Lateral Sclerosis

Date: Feb 28, 2023 | Tags: Mitsubishi Tanabe Pharma, Radicava ORS, edaravone, Amyotrophic Lateral Sclerosis, Clinical Trial, P-III, MT-1186-A01 Trial

Biocytogen’s Subsidiary Eucure Biopharma Signs an Exclusive License Agreement with Chipscreen’s Holding Subsidiary Chipscreen NewWay for YH008

Date: Feb 28, 2023 | Tags: Biocytogen, Eucure Biopharma, Chipscreen, Chipscreen NewWay, YH008, Pharma

SpringWorks Therapeutics Reports the US FDA Acceptance of NDA and Granted Priority Review of Nirogacestat for Desmoid Tumors

Date: Feb 28, 2023 | Tags: SpringWorks Therapeutics, Nirogacestat, Desmoid Tumors, Regulatory, US, FDA, NDA, Priority Review

HUTCHMED Reports the Completion of Patient Enrollment of Amdizalisib in P-II Registration Trial for Follicular Lymphoma in China

Date: Feb 27, 2023 | Tags: HUTCHMED, Amdizalisib, tazemetostat, Follicular Lymphoma, Clinical Trial, P-II Trial

AbbVie Receives EMA’s CHMP Positive Opinion of Rinvoq (upadacitinib) for Crohn's Disease

Date: Feb 27, 2023 | Tags: AbbVie, Rinvoq, upadacitinib, Crohn's Disease, Regulatory, EMA, CHMP

Medtronic Reports One Year (ADAPT) Study Results of MiniMed 780G Advanced Hybrid Closed Loop System for Type 1 Diabetes

Date: Feb 27, 2023 | Tags: Medtronic, MiniMed 780G Advanced Hybrid Closed Loop System, Type 1 Diabetes, Clinical Trial, MedTech, ADAPT Study

Blueprint Medicines Presents P-II Trial (PIONEER) of Ayvakit (avapritinib) for Indolent Systemic Mastocytosis at AAAAI 2023

Date: Feb 27, 2023 | Tags: Blueprint Medicines, Ayvakit, avapritinib, Indolent Systemic Mastocytosis, Clinical Trial, P-II, PIONEER Trial, AAAAI 2023

Regeneron Receives EMA’s CHMP Positive Opinion of Libtayo (cemiplimab) for Advanced PD-L1 Positive Non-Small Cell Lung Cancer

Date: Feb 27, 2023 | Tags: Regeneron, Libtayo, cemiplimab, Non-Small Cell Lung Cancer, Regulatory, EMA CHMP

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) Receives NMPA’s Approval for HER2-Positive Metastatic Breast Cancer

Date: Feb 27, 2023 | Tags: AstraZeneca, Daiichi Sankyo, Enhertu, trastuzumab deruxtecan, Breast Cancer, Regulatory, NMPA, Approval